SNF emergency telehealth provider Call9 shuts down most operations, after $34M raise (updated)

June 26, 2019 | by

Is it a symptom of a bubble’s downside? In an interview with CNBC, Dr. Timothy Peck, the CEO of Call9, profiled in TTA only a month ago, confirmed that his company will be shutting down operations. Call9 provided embedded emergency first responders in skilled nursing facilities (SNFs) on call to staff nurses. The first responders not only could provide immediate care to patients with over a dozen diagnostic tools, but also would connect via video to emergency doctors on call. 

Headquartered in Brooklyn, the shuttering of the four-year-old company has laid off over 100 employees as it winds down operations. They claimed 142,000 telemedicine visits and 11,000 patients who were treated via its services. In the past few months, Call9 had inked deals with Lyft for patient transportation and was expanding to Albany NY. They also operated a community paramedicine division utilizing their emergency doctor network.  

This Editor can now reveal that through a reliable industry source, I was informed of Call9’s difficulties earlier this month. Not wanting to ‘run with a rumor’, I contacted Dr. Peck. He confirmed to me information that later appeared in the CNBC article: that the company was refining its model in the face of a change in previous funders and working with some new partners to stay in a model with embedded clinical care specialists in nursing homes. While they would scale back, they still had current contracts. However, the changes in their model would mean that the company would be in a ‘bit of a stealth mode’. After we discussed the business situations that most early-stage health tech companies have faced with funding, we agreed to touch base in a few weeks when things developed.

CNBC, with a different source, had essentially the same information from Dr. Peck on the winding down of the company but in this case also confirmed layoffs, including a ‘pivot’ of the company into a different model around technology in nursing homes. They also confirmed that a part of the company, Call9 Medical, will remain in operations.

Update: Skilled Nursing News had additional detail on Call9’s partnerships which included SNF providers Centers Health Care, CareRite, and the Archdiocese of New York’s long-term care arm, ArchCare. Their first client was Central Island Healthcare, where Dr. Peck lived for three months testing the model. The article goes on with Central Island’s executive director explaining that he is now seeking a telemedicine provider, as they adjusted their services to Call9’s capabilities.

Payer providers included Anthem, Blue Cross Blue Shield, and Healthfirst, plus some Medicare Advantage plans, splitting the savings from avoiding unnecessary ER admissions. Another appeal made by the company for its services was to keep in place higher acuity–sicker–patients in SNFs who would otherwise have to go into the hospital.

As our Readers know, these pages have covered the comings and goings of many health tech and app companies. Some succeed on their own, are acquired/combined with others and go on in different form, or are bought out at their peak, leaving their founders and some employees cheerful indeed. On the other hand, and far more common: the demise of some is understandable, others regrettable, and nearly none of them are cause for celebration in our field–Theranos and Outcome Health being exceptions. This Editor has been a marketing head of two of them (now deceased except for their technology, out there somewhere), and has discussed marketing, funding, and business models with more startups and early-stage companies than she can count.

If anything, investors have less patience than they did back in the Grizzled Pioneer period of the early 2000s, when a $5 million round put together from a few personally (more…)

The Theranos Story, ch. 59: there’s life left in the corporate corpse–patents! And no trial date in sight.

April 25, 2019 | by

You can get blood out of this. Really! The US Patent and Trademark Office (USPTO) awarded five–count ’em, five!–patents to Theranos in March and April. All of them were filed between 2015 and 2016, when the whispers of fraud were getting louder, as were the legal threats.

The five patents are:

1. Systems, devices, and methods for bodily fluid sample collection, transport, and handling
2. Systems, devices, and methods for bodily fluid sample transport
3. Systems and methods for sample preparation using sonication
4. Systems and methods for sample preparation using sonication (cell disruption)
5. Rapid measurement of formed blood component sedimentation rate from small sample volumes

The CB Insights Research article has the details on what they cover, including patent application illustrations. It’s not stated, but looking back to TTA’s many articles, in this Editor’s judgment, the heir to these patents cannot be Elizabeth Holmes or her many investors now feeling the lint in their pockets, but the company holding the last note, the $65 million (not $100 million) loan from Fortress Investment Group LLC, part of Japan’s SoftBank Group [TTA 28 Dec 17]–collateralized by the portfolio of over 70 patents. Hat tip to HISTalk 19 April

If you hunger for a deep dive into the design of Theranos’ blood analyzers that never really worked, and can appreciate that the miniLab was what “one expert in laboratory medicine called “theater … not science”, this Design World article is for you: Schadenfreude for Theranos — and satisfaction in how engineering doesn’t lie

Meanwhile, back in the US District Court in San Jose, California, we learn that the trial of Ms. Holmes (now engaged to William “Billy” Evans, a 27-year-old heir to the Evans Hotel Group, which has three West Coast resort properties and who is also a techie) and former Theranos president Ramesh ‘Sunny’ Balwani has been delayed indefinitely. Originally reported to be summer entertainment with a start date of 8 July, the judge set the next status conference for the case for 1 July, but refused to set a trial date, which means that the trial may not begin till next year. According to the San Jose Mercury News, the defense is seeking materials from the FDA and CMS, which are, according to defense lawyer, lawyer Kevin Downey, are “in many instances exculpatory.”

Ms. Holmes’ lawyers are also seeking information on the communications between John Carreyrou of the Wall Street Journal, the FDA, and CMS. In a motion filed last week, they accused Mr. Carreyrou under the guise of investigative journalism of “exerting influence on the regulatory process in a way that appears to have warped the agencies’ focus on the company and possibly biased the agencies’ findings against it.” Stat

The bubbly Ms. Holmes and Not-So-Sunny Balwani are facing Federal charges of two counts of conspiracy to commit wire fraud and nine counts of wire fraud. They each face a maximum of 20 years in prison and up to $2.7 million in fines.

The wind may be even stronger at the back of telehealth this year–but not without a bit of chill

February 13, 2019 | by

Late last year, this Editor noted that ‘the wind may finally be at the back of telehealth distribution and payment’. The expansion of telehealth access for privately issued Medicare Advantage (MA) plans, state-run Medicaid and CHIP (Children’s Health Insurance Plan) plan members, and this year’s Medicare Physician Fee Schedule, along with a limited expansion of telemedicine in the Value-Based Insurance Design (VBID) model for MA announced earlier this year by CMS, is a leading indicator that government is encouraging private insurers to pay doctors for these services, who in term will pay vendors for providing them.

The Veterans Health Administration (VA) has historically been the largest user in the US of telehealth services (home telehealth, clinical video telehealth, store-and-forward). They are also a closed and relatively inflexible system (disclosure–this Editor worked for Viterion, a former RPM supplier to the VA). In 2017, under then Secretary David Shulkin (who left under a cloud, and not an IT one), there were hopes raised through the Anywhere to Anywhere VA Health Care Initiative. So the news released at the start of HIMSS’ annual meeting that veterans will be able to access their health data through Apple’s Health Records app on the iPhone, perhaps as early as this summer, was certainly an encouraging development. According to mHealth Intelligence, the key in enabling this integration and with other apps in the future is the Veterans Health Application Programming Interface (API), unveiled last year.

Anywhere to Anywhere is also making headway in veteran telemedicine usage. Of their 2.3 million telehealth episodes in their FY 2018, over 1 million were video telehealth visits with veterans, up 19 percent from 2017. 105,000 of those video visits were through VA Video Connect to veterans’ personal devices. The remainder were real-time interactive video conferences at a VA clinic. The other half were assessment of data between VA facilities or data sent from home (the underused Home Telehealth).  Health Data Management

Virginia also moved to make remote patient monitoring part of covered telehealth services for commercial health plans and the state Medicaid program. The combined bills HB 1970 and SB 1221 will be sent for signature to Governor Ralph Northam, to whom the adjective ‘beleaguered’ certainly applies. National Law Review

But service providers face compliance hurdles when dealing with governmental entities, and they’re complex. There are Federal fraud, waste, and abuse statutes such as on referrals (Anti-Kickback, Stark Law on self-referral), state Corporate Practice of Medicine Doctrine statutes, and medical licensure requirements for telehealth practices. Telehealth: The Beginner’s Guide to Legal Pitfalls is a short essay on what can face a medical practice in telehealth.

Medicare Advantage model covering telehealth for certain in-person visits starting in 2020

January 22, 2019 | by

Another small step for remote monitoring and visits. Late last week, the Center for Medicare & Medicaid Services (CMS) announced a limited expansion of telehealth (remote patient visits) coverage as part of the Value-Based Insurance Design (VBID) model. In 2020, plans can apply to use telehealth as part of their coverage. According to the CMS release, Medicare Advantage (MA) is testing a new series of service delivery approaches, including “increasing access to telehealth services by allowing plans to use access to telehealth services instead of in-person visits, as long as an in-person option remains, to meet a range of network requirements, including certain requirements that could not previously be fulfilled through telehealth.” Other MA additions under the VBID mode include expanded rewards and incentives for beneficiaries for health improvement, and reduced cost sharing and additional benefits to enrollees, including those around chronic conditions or socio-economic status, such as aid around social determinants of health. 

The VBID model is administered under CMS’ Center for Medicare and Medicaid Innovation (Innovation Center, also CMMI), which tests innovative payment and service delivery models to lower costs and improve the quality of care. It began in 2017. The CMS VBID page lists 14 participating plans concentrated in a few states; however, it was open to 25 states this year. The 2020 model expands to 50 states under the Bipartisan Budget Act of 2018 plus will accept other MA plan types such as Special Needs Plans and Regional PPOs. Applications will start later this year. CMS press release, mHealth Intelligence 

The wind may finally be at the back of telehealth distribution and payment (US)

November 15, 2018 | by

Medicare Advantage may lead, but Medicaid and regular Medicare are not far behind. The Centers for Medicare & Medicaid Services (CMS) has announced in two proposed rules changes expansion of telehealth access for both privately issued Medicare Advantage (MA) plans (26 Oct) and state-run Medicaid and CHIP (Children’s Health Insurance Plan) (14 Nov) plan members. This may mean greater acceptance by providers because they will be paid for these services.

For MA, the proposal would, starting in 2020 as part of government funded basic benefits, eliminate geographic restrictions (rural telehealth) and allow members in urban areas to access telehealth services. It would also broaden present location restrictions, allowing MA members to receive telehealth from home versus traveling to a health care facility. The most intriguing wording is here: “Plans would also have greater flexibility to offer clinically-appropriate telehealth benefits that are not otherwise available to Medicare beneficiaries.” which very well could mean remote patient monitoring in conjunction with visits. MA plans have always had more latitude to offer telehealth benefits to members, which are about 1/3 of Medicare-eligibles (over 65). Over 11 percent growth is forecast and it is highly competitive though dominated by United Healthcare and Aetna–over 600 new plans are entering the market next year. Enrollments close on 7 Dec for 2019. CMS.gov release, mHealth Intelligence, Healthcare Finance News.

For Medicaid and CHIP, which states use to extend insurance to low-income individuals and families via private plans, states would be able to, under an approved rule, to more flexibly determine what criteria determine telehealth access. Currently, states use proximity factors–distance from provider and time. The proposed criteria under 10. Network Adequacy (pages 15-16) recommends that time and distance be deleted and instead “adding a more flexible requirement that states set a quantitative minimum access standard (later listed) for specified health care providers and LTSS (long term services and supports) providers”. The reasons why are the limited supply of providers and the functional limitations of the LTSS population. Also notable was language in section 8 discussing access to provider directories via smartphone, as 64 percent of the population with incomes less than $30,000 own a smartphone and use it to access health information.  CMS proposed rule, POLITICO Morning eHealth

This adds to the momentum of the Medicare Physician Fee Schedule published on 1 Nov that added even more:

  • Virtual brief patient checkins and evaluation of patient-recorded photos and video to payments
  • CMS is also finalizing separate payments for three new codes covering chronic care remote physiologic monitoring that unbundle 99091 (CPT codes 99453, 99454, and 99457) and interprofessional internet consultation (CPT codes 99451, 99452, 99446, 99447, 99448, and 99449).
  • Two new codes covering telehealth for prolonged preventive services
  • Finalizing the addition of renal dialysis facilities and the homes of ESRD beneficiaries receiving home dialysis as originating sites
  • After 1 July, the home will be permitted as a permissible originating site for telehealth services furnished for purposes of treatment of a substance use disorder or a co-occurring mental health disorder. CMS.gov fact sheet 

The importance of this is that more digital health covered by Medicare and government payments in public/private programs such as Medicaid and MA lead private insurers to pay doctors for these services, who will then be willing to pay vendors for providing them. For the telehealth and telemedicine companies that have weathered the storms and lean times of the past decade, there may be light at the end of the tunnel that is not an oncoming train.

Soapbox: Big Genomics and DNA testing–why we need a Genomic Data Bill of Rights

August 29, 2018 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]This week, consumer genomics testing company 23andMe announced that outside app developers would no longer have access to raw genomic data, as they have had since 2012. They will continue to have access to data through reports generated by the company. 23andMe cited privacy concerns–wisely, in this Editor’s opinion, to safeguard this burgeoning area of digital health. Seeking Alpha

TimiHealth is an affected firm that seeks to move customer data, with consent, to an allegedly more secure blockchain platform, TimiDNA, citing 23andMe’s monetization of their data and CMS’ Blue Button initiative, a recent meeting in which 23andMe participated as a developer. Blasting away, TimiHealth stated that “It flies in the face of the mission of CMS, and the MyHealthEData initiative and the goal of putting patients first.” Release

However, the consumer marketing of DNA testers such as 23andMe, Ancestry.com, and smaller competitor Helix, has already led to multiple privacy questions on how the data of millions are being used and sold. 

This Editor would feel safe in assuming that most customers do not know nor particularly care that GlaxoSmithKline (GSK) as of July owns 50 percent of 23andMe via a $300 million investment. Both have announced a four-year partnership to use the 23andMe genetic database for drug research. For instance, the LRRK2 gene has been linked to some forms of Parkinson’s disease. GSK needs about 100 for a trial sample of one, but 23andMe has already provided 250 Parkinson’s patients who have agreed to be re-contacted for GlaxoSmithKline’s clinical trials. Scientific American

While most data is de-identified, you can agree to be contacted for further use in clinical trials, which is fine–but most users do not know how to opt out. It’s a surprisingly tricky process, as outlined in this useful Business Insider article, and you may not be able to withdraw all your data or have your saliva sample destroyed.

Data can be hacked and reprocessed. Three years ago, TTA explored reports on exactly how de-identified genomic data could be made identifiable through the ‘nefarious use’ of genomic data sets available through research networks [TTA 31 Oct 15].

Despite the trite, simplistic, and condescending commercials by Ancestry.com on how someone found they had ethnic or national roots they never dreamed of, or were related to royalty, both giving meaning to their presumably mundane life, genetic info has value beyond the feel-good. It’s long past time for a plain language Genomic Data Bill of Rights.

  • Individuals should know how their personal genomic data is being used and how it is being protected
  • They should be able to opt out of use, identified and de-identified, easily–and not have to jump through hoops
  • Reporting/interpretation should also have integrity, consideration, and respect that it may upset a person or that it may not be interpreted correctly, which is a fundamental problem 
  • A more radical view is that the same individuals should be compensated when their data is used

This Editor will settle for the first two bullets, for now. 

The 50,000 foot pick as CEO of the JP Morgan Chase-Berkshire Hathaway-Amazon health joint venture

June 21, 2018 | by | 2 Comments

US healthcare is abuzz at the choice that JP Morgan Chase-Berkshire Hathaway-Amazon made to head their healthcare JV: Dr. Atul Gawande, currently practicing general and endocrine surgery at Brigham and Women’s Hospital and teaching as a professor at the Harvard T.H. Chan School of Public Health and Harvard Medical School. Dr. Gawande is presently an executive director of Ariadne Labs, a healthcare innovation center, a writer of four best sellers on healthcare and noted as an outspoken theorist on how the ‘broken’ healthcare system in the US can be fixed. (This Editor’s definition of ‘broken’ is slightly different, encompassing countries like Venezuela, Cuba, Zimbabwe, post-WWII Germany, and the Ceausescu-era Romania where the basics are simply not there for the average person.)

Dr. Gawande will transition to chairman of Ariadne and retain his surgical and teaching positions.

Praise for Dr. Gawande comes from many quarters. Andy Slavitt, the former head of CMS during the previous administration, said “There are few better people in health care” and praised his ‘moral leadership’ when approached by Messrs. Dimon, Bezos, and Buffett. Jeff Bezos: “We said at the outset that the degree of difficulty is high and success is going to require an expert’s knowledge, a beginner’s mind, and a long-term orientation. Atul embodies all three, and we’re starting strong as we move forward in this challenging and worthwhile endeavor.”

What is missing from this sterling public health advocate and practitioner’s resumé is obvious: real business management experience. Among his three soon-to-be-bosses, there is plenty of pontificating from 50,000 feet–for but one example, see this Editor’s POV on Jamie Dimon’s annual shareholder letter [TTA 10 Apr]. Here is what they stated as the purpose of the JV back in January: “partnering on ways to address healthcare for their U.S. employees, with the aim of improving employee satisfaction and reducing costs” and setting up an independent company “free from profit-making incentives and constraints. The initial focus of the new company will be on technology solutions that will provide U.S. employees and their families with simplified, high-quality and transparent healthcare at a reasonable cost.” And more in that vein. (Whew!) It was eye-rolling, even shortly after the announcement back in February.

But actually getting this done is not a TEDTalk. First, there is the hard in-the-trenches work to bring both the management and the 1 million employees of three very different companies onto the same page. Second, it is running the gauntlet of regulations on the national level (that CMS and HHS) plus in 50 states, if this combine chooses to operate as an insurer or PBM. Third, if they don’t, there is getting the cooperation of insurers (payers) who aren’t in business to lose money. There is not only regulation, but also what they are willing and can afford to do. This Editor noted back in January that large companies, including these three, “generally self-insure for healthcare. They use insurers as ASO–administrative services only–in order to lower costs. Which leads to…why didn’t these companies work directly with their insurers to redo health benefits? Why the cudgel and not the scalpel?”

This Editor would expect that a group of skilled senior, operationally focused executives will be hired to work under Dr. Gawande in Boston, where this unnamed-yet venture will be headquartered. There may be some more high-profile senior executives with unconventional backgrounds. From this (lower than 50,000 feet) perspective, Dr. Gawande will be the attention-getting CEO, spokesman, and pace-setter; others will be doing the heavy lifting behind the scrim. 

Beyond the usual glowing coverage on CNBC and TechCrunch, those in the business of healthcare are already expressing more sanguine opinions on the enterprise and how Dr. Gawande will be leading it with multiple medical, teaching, and writing commitments. Modern Healthcare has a fairly balanced article.

Scary Monsters, Take 3: one week later, JPMorgan Chase takes heat, Amazon speculation, industry skepticism

February 7, 2018 | by

It’s the Week After the Amazon/Berkshire Hathaway/JPMorgan Chase announcement of their partnership in a non-profit joint venture to lower healthcare costs for their 1.1 million employees, and there’s a bit of a hangover. Other than a few articles, there’s been relative quiet on this front. This could be attributed to the financial markets’ roller coaster over the past few days, at least in part due to this as healthcare stocks were hardest hit. In the US, healthcare is estimated to be 18 percent of the economy based on Centers for Medicare and Medicaid Services (CMS) actuarial statistics for 2015…and growing. 

Jamie Dimon, CEO of JPMC, had some ‘splainin’ to do with some of the bank’s healthcare clients, according to a report in the Wall Street Journal (paywalled) summarized on MarketWatch. He assured them that the JV would be to serve only the employees of the three companies. JPMC bankers handling the healthcare sector also needed some reassuring as they are “paid handsomely to help clients with mergers and other deals and worry the move could cost them business.”

Speculation on Amazon’s doings in healthcare remains feverish. A more sober look is provided by the Harvard Business Review which extrapolates how healthcare fits into Amazon’s established strength in delivery systems. Amazon could deliver routine healthcare via retail locations (Whole Foods, Amazon Go), same day prescription delivery, passive data capture developed for Amazon Go sold as a service to healthcare providers (on the model of Web Services), and data analytics.

Headlines may have trumpeted that the three-way partnership would ‘disrupt healthcare’, but our Readers in the business have heard this song before. While agreeing with their intent, this Editor differed almost immediately with the initial media cheering [TTA 31 Jan]. The Twitterverse Healthcare FlashMob in short order took it down and apart. STAT racks up some select tweets: in the ACO model, savings come when providers avoid low-value care; the contradiction of profitable companies avoiding profit; that the removal of healthy employees from existing plans will increase inequity and the actuarial burden upon the less insurable; the huge regulatory hurdle; and the dim view of investment advisory firm Piper Jaffray that it will not be a ‘meaningful disruptor’. 

In this Editor’s view, there will be considerable internal politicking, more unease from JPMC customers, and a long time before we find out what these three will be doing.

Rounding up the roundups in health tech and digital health for 2017; looking forward to 2018’s Nitty-Gritty

December 29, 2017 | by | 2 Comments

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/Lasso.jpg” thumb_width=”100″ /]Our Editors will be lassoing our thoughts for what happened in 2017 and looking forward to 2018 in several articles. So let’s get started! Happy Trails!

2017’s digital health M&A is well-covered by Jonah Comstock’s Mobihealthnews overview. In this aggregation, the M&A trends to be seen are 1) merging of services that are rather alike (e.g. two diabetes app/education or telehealth/telemedicine providers) to buy market share, 2) services that complement each other by being similar but with strengths in different markets or broaden capabilities (Teladoc and Best Doctors, GlobalMed and TreatMD), 3) fill a gap in a portfolio (Philips‘ various acquisitions), or 4) payers trying yet again to cement themselves into digital health, which has had a checkered record indeed. This consolidation is to be expected in a fluid and relatively early stage environment.

In this roundup, we miss the telecom moves of prior years, most of which have misfired. WebMD, once an acquirer, once on the ropes, is being acquired into a fully corporate info provider structure with its pending acquisition by KKR’s Internet Brands, an information SaaS/web hoster in multiple verticals. This points to the commodification of healthcare information. 

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/12/canary-in-the-coal-mine.jpgw595.jpeg” thumb_width=”150″ /]Love that canary! We have a paradigm breaker in the pending CVS-Aetna merger into the very structure of how healthcare can be made more convenient, delivered, billed, and paid for–if it is approved and not challenged, which is a very real possibility. Over the next two years, if this works, look for supermarkets to get into the healthcare business. Payers, drug stores, and retailers have few places to go. The worldwide wild card: Walgreens Boots. Start with our article here and move to our previous articles linked at the end.

US telehealth and telemedicine’s march towards reimbursement and parity payment continues. See our article on the CCHP roundup and policy paper (for the most stalwart of wonks only). Another major change in the US is payment for more services under Medicare, issued in early November by the Centers for Medicare and Medicaid Services (CMS) in its Final Rule for the 2018 Medicare Physician Fee Schedule. This also increases payment to nearly $60 per month for remote patient monitoring, which will help struggling RPM providers. Not quite a stride, but less of a stumble for the Grizzled Survivors. MedCityNews

In the UK, our friends at The King’s Fund have rounded up their most popular content of 2017 here. Newer models of telehealth and telemedicine such as Babylon Health and PushDoctor continue to struggle to find a place in the national structure. (Babylon’s challenge to the CQC was dropped before Christmas at their cost of £11,000 in High Court costs.) Judging from our Tender Alerts, compared to the US, telecare integration into housing is far ahead for those most in need especially in support at home. Yet there are glaring disparities due to funding–witness the national scandal of NHS Kernow withdrawing telehealth from local residents earlier this year [TTA coverage here]. This Editor is pleased to report that as of 5 December, NHS Kernow’s Governing Body has approved plans to retain and reconfigure Telehealth services, working in partnership with the provider Cornwall Partnership NHS Foundation Trust (CFT). Their notice is here.

More UK roundups are available on Digital Health News: 2017 review, most read stories, and cybersecurity predictions for 2018. David Doherty’s compiled a group of the major international health tech events for 2018 over at 3G Doctor. Which reminds this Editor to tell him to list #MedMo18 November 29-30 in NYC and that he might want to consider updating the name to 5G Doctor to mark the transition over to 5G wireless service advancing in 2018.

Data breaches continue to be a worry. The Protenus/DataBreaches.net roundup for November continues the breach a day trend. The largest breach they detected was of over 16,000 patient records at the Hackensack Sleep and Pulmonary Center in New Jersey. The monthly total was almost 84,000 records, a low compared to the prior few months, but there may be some reporting shifting into December. Protenus blog, MedCityNews

And perhaps there’s a future for wearables, in the watch form. The Apple Watch’s disconnecting from the phone (and the slowness of older models) has led to companies like AliveCor’s KardiaBand EKG (ECG) providing add-ons to the watch. Apple is trying to develop its own non-invasive blood glucose monitor, with Alphabet’s (Google) Verily Study Watch in test having sensors that can collect data on heart rate, gait and skin temperature. More here from CNBC on Big Tech and healthcare, Apple’s wearables.

Telehealth saves lives, as an Australian nurse at an isolated Coral Bay clinic found out. He hooked himself up to the ECG machine and dialed into the Emergency Telehealth Service (ETS). With assistance from volunteers, he was able to medicate himself with clotbusters until the Royal Flying Doctor Service transferred him to a Perth hospital. Now if he had a KardiaBand….WAToday.com.au  Hat tip to Mike Clark

This Editor’s parting words for 2017 will be right down to the Real Nitty-Gritty, so read on!: (more…)

The Theranos Story, ch. 39: good news, bad news, and the ugly lawsuit news

April 20, 2017 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]It’s that darn well again! Theranos‘ News of the Week ran the gamut from cheap, to expensive, to potentially business terminating.

Cheap was the settlement of the Center for Medicare and Medicaid Services (CMS) civil penalty against the company for a pinprick of $30,000. What remains: that Theranos cannot own or operate any labs for the next two years. As the company has downsized and done the Silicon Valley pivot to developing labs and testing platforms, the settlement is the barn door closing after the horse has exited and crossed the state line. Theranos press release,

Expensive was the settlement of the Arizona legal action brought by the state Attorney General, Mark Brnovich. $4.65 million settled matters, providing full refunds for 175,940 Arizona consumers who ordered between 2013 and 2016 approximately 1.5 million blood tests and 7.8 million results. Also on the tab are $200,000 in civil penalties, $25,000 in attorneys’ fees, and a claims administrator to dole out the refunds. While it was estimated that only 10.5 percent of tests were inaccurate, the consumer fraud charges were easier for Theranos to settle without admitting wrongdoing. A solid win for the AG as well. Background on this in Ch. 33. Ars Technica, Bloomberg, Theranos press release

Potentially disastrous is the go-ahead given to one of the many lawsuits against Theranos, also charging Elizabeth Holmes and former CEO Ramesh ‘Sunny’ Balwani. The US District Court for the Northern District of California ruled in the case brought by two shareholders, Robert Colman and Hilary Taubman-Dye, represented by Hagens Berman (Ch. 27), that most of the claims of investor fraud would proceed. Theranos’ sole success was having the charge of misrepresentation of securities under the California Corporations Code dismissed on the technicality of purchase from a third party seller. The more damning claims of direct misrepresentation by Ms Holmes and Mr Balwani, mentioning news articles and their advertising campaign, were upheld. Interestingly, the plaintiffs must now show cause why the third party sellers (Lucas Venture Group, Celadon Technology Fund, SharePost), should not be included as defendants. The stage is now set for a class-action lawsuit with potentially thousands of other investors. Theranos page on Hagens Berman website, District Court ruling document.

The final countdown is at the bank. In March, Theranos reported $150 million in cash (ch. 38), down from $200 million in January. Subtract $30,000 to CMS, $4.65 million to Arizona, legal fees, pending lawsuits, and running expenses–with no investors and revenue in–and a burn of about $50 million a quarter, it will be Taps for Theranos before end of year.

Humana-Omada Health diabetes prevention program could cut $3 bn in Medicare expense: study

February 8, 2017 | by

A study performed by insurer Humana using the Omada Health program for diabetes prevention effectively lowered weight, improved cholesterol, blood glucose and mood. 500 volunteer subjects from Humana’s Medicare Advantage program, enrolled during 2015, lost an average of 13 to 14 pounds over a year (7.5 to 8 percent). They also saw improvements in cholesterol levels, blood glucose levels and subjective measures of moods and self-care. Individuals were chosen from administrative medical claims based on metabolic syndrome diagnosis or a combination of three of four of the following diagnoses: prediabetes, hypertension, dyslipidemia, and obesity. Based on the researchers’ calculations, this type of prevention program among this group if widely implemented among overweight adults could reduce Medicare costs by $3 bn over 10 years, not only for diabetes but also heart disease and high blood pressure.

Omada Health’s program included an online small group support, personalized health coaching, digital tracking tools, and a weekly behavior change curriculum. These one-hour lessons focused on a single topic were delivered via laptop, tablet, or smartphone, and included interactive games or exercises, written reflections, and goal-setting activities. The content was approved by the CDC Diabetes Prevention Recognition Program. Data was gathered via wireless scale, pedometer for physical activity, online food intake logging and standard lab results. “In conclusion, this study demonstrated that older adults who agreed to participate in this program were able to engage meaningfully and gain important health and wellness benefits during a relatively short time frame.”

While the cost reduction estimate is exactly that, other studies directionally confirm health improvement and savings: the National Diabetes Prevention Program (NDPP) which is the model for the Omada program, the BMJ/Noom Health study, and the Fruit Street/VSee telehealth program being used by St. Jude Children’s Research Hospital, University of South Florida and University of Michigan. mHealth Intelligence, study (full text in Journal of Aging and Health/Sage Journals)

Health execs’ wish list for 2017: security, analytics, pop health…and telehealth (US)

January 6, 2017 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/01/2017-upgrade-HITN-survey.jpg” thumb_width=”200″ /]Healthcare IT News published the results of their October survey of 95 healthcare executives as to their forward plans (resolutions?) for 2017. It’s unsurprisingly centered on upgrades to the following areas:

  • Data security (52 percent)–definitely making up for lost time and spending due to the obvious threats from hacking and data breaches. In November alone, nearly two incidents a day (57) and over 458,000 records were reported by healthcare entities to HHS. (Protenus Breach Barometer)
  • Data analytics (51 percent)–figuring out what to do with all that patient data generated by….
  • Patient engagement and population health (44 percent each)–demanded by quality standards in CMS’ MACRA Quality Payment Program (QPP), including the Merit-Based Incentive Payment System (MIPS) and the Advanced Alternative Payment Models (APMs)
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/01/2017-introduce-investigate-HITN-survey.jpg” thumb_width=”200″ /]The surprises come here–the technologies they expect to introduce or investigate. Analytics and workflow correspond to the last two points above, but what is compelling is an apparent tipping point for technology which links the patient to care monitoring and access: telehealth (44 percent), smart medical devices (41 percent) and remote patient monitoring (34 percent). These overlap (as in telehealth and RPM require smart medical devices), yet these are strong numbers if they accurately reflect these execs’ actual (or eventual) spending. (Does it point to more clinically validated use of trackers like Fitbit? The Magic 8 Ball does not tell here….)

The presence of 2016-17’s ‘It Girl’, precision medicine (21 percent), which applies both data analytics and genomics to improve patient outcomes, isn’t surprising with the emphasis on quality care.

One can quibble that the sample size is small N, and the report doesn’t confirm the selection details like title, location, and type of organization, but the direction has to be cheering on many fronts. HITN’s overview, survey results (16 slides)

The Theranos Story, ch. 28: when the SecDef nominee is on the Board of Directors

December 3, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/12/jim_mattis.jpg” thumb_width=”150″ /]Does ‘Mad Dog’ ‘Warrior Monk’ James Mattis, General, USMC (ret.) have a blind spot when it comes to Theranos? President-Elect Donald J. Trump has selected him as the next Administration’s nominee for Secretary of Defense. A remarkable leader and, yes, scholar (check his background in various sources), but he has some ‘splaining to do, in this Editor’s opinion.

This Editor leads with this question because those who have been following the Continuing Saga (which, like the Nordics, seems never-ending) know that Theranos stuffed its Board of Directors (BOD), prior to last October, with a selection of Washington Luminaries, often of a great age: Henry Kissinger, George Shultz, Sen. Sam Nunn, Sen. Bill Frist (the only one with an MD), William Perry and Gary Roughead, a retired U.S. Navy admiral. It also reads like a roster of Hoover Institution Fellows except for Sen. Frist, who sticks to the East Coast. Another interesting point: Hoover is based at Stanford University, an institution from which Elizabeth Holmes dropped out to Follow Her Vision. Obviously, there was an accompanying Vision of Washington Pull.

Also joining the BOD as of July 2013, well before The Troubles, and shortly after his retirement, was Gen. Jim Mattis (also a Hoover Fellow, photo above). When the Washington Luminaries were shuffled off to a ‘board of counselors’ after the Wall Street Journal exposé hit in October, Gen. Mattis remained on the governing BOD. Unlike his fellow Fellows, he had actually been involved with a potential deployment of the lab testing equipment. As we previously noted, as commandant of US Central Command (CENTCOM is Middle East, North Africa and Central Asia), he advocated tests of the Theranos labs under in-theatre medicine conditions in 2012-13. Leaked emails cited by the Washington Post (in Gizmodo) and also in the Wall Street Journal indicate the opposition from the US Army Medical Research and Materiel Command at health-intensive Fort Detrick MD, which oversees medical research, based on the undeniable fact that the equipment and the tests weren’t FDA-cleared, which remained true two years later…and which Gen. Mattis tried to get around, being a good Marine. Nonetheless, the procurement of Theranos equipment was halted. DOD permitted him to join the BOD after retirement as long as he was not involved in any representations to DOD or the services. (Wikipedia bio)

Yesterday, Theranos also announced that it is dissolving (draining?) the ‘board of counselors’. They led with a BOD shuffle, with Daniel J. Warmenhoven, retired chairman of NetApp, replacing director Riley P. Bechtel, who is withdrawing for health reasons. (Warmenhoven also serves on the Bechtel board, so they are keeping an eye on the estimated $100 million they invested). Gizmodo and Inc. While effective January 1, the Theranos website has already scrubbed the counselors and updated the BOD.

However, Gen. Mattis remains a director, until such time as he actually becomes Secretary of Defense, which is not a lock for Senate approval by a long shot. First, he requires a Congressionally approved waiver demanded by the National Security Act of 1947, as he has been retired only four years (as of 2017) not the required seven. Second, his involvement with Theranos has already been questioned in the media. After all, it is a Federal Poster Child of Silicon Valley Bad Behavior: censured by CMS, under investigation by SEC and DOJ. It is a handy, easily understandable club with which to beat him bloody (sic). WSJ’s wrapup.

In this Editor’s opinion, the good General should have left in October, but certainly by April when CMS laid the sanctions down, banning Ms Holmes and Mr Balwani from running labs for two years in July. What is going on in the ‘Warrior Monk’s’ mind in sticking around? Is there anything to save? 

If the WSJ articles are paywalled, search on ‘Gen. James Mattis Has Ties to Theranos’ and ‘Recent Retirement, Theranos Ties Pose Possible Obstacles for Mattis Confirmation’.  Oh yes…see here for the 27 previous TTA chapters in this Continuing, Consistently Amazing Saga.

The Theranos Story, ch. 24: looking for the nadir in Walgreens’ lawsuit

November 17, 2016 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]When will we find the nadir of Theranos’ business practices? Between the excruciating details of the Walgreens lawsuit and the treatment of an employee who knew the truth in 2014 (part 2), the bottom, like Jacob’s Well in Texas at left, may be unfindable.

The first is what is revealed in the public version (filed 15 Nov) of the civil complaint filed with the US District Court, District of Delaware (PDF). While heavily redacted in parts of text and in the exhibits, it is damning if all true–and there is little available information that does not fit Walgreens‘ narrative, though this Editor was left wondering why red flags about Theranos didn’t flap ‘n’ fly at Walgreens much earlier, especially with a reported $140 million investment at stake.

The relationship began in January 2010. A March presentation by Theranos included some astonishing claims: the Theranos finger-stick blood draw lab analysis had been comprehensively validated by ten of the leading fifteen pharmaceutical companies over seven years; that bio-pharma companies, “prominent research institutions, and US and foreign government health and military organizations” had already used the technology; that Theranos was capable of launching it in retail stores by end of 2010. They also represented that they were positioned with FDA to introduce the technology outside of clinical studies. Johns Hopkins, contracted by Walgreens to validate their methodology, could only work with data provided by Theranos.

Did anyone at Walgreens think to check with said pharmas, researchers, government health and military organizations? There was time. The master agreement was not signed until 2012 and pilot stores opened in 2013.  (Pages 5-10, section 24 through 50). Interestingly, pages 11-12 which may deal with the labs, as well as many other parts, are heavily redacted.

In short, there is a gap of at least two years when Walgreens could have double-checked Theranos’ claims and methods, especially in the crucial period before pilot locations were opened. (To be fair, Theranos successfully maintained a veil of secrecy and a wall of PR smoke.) But the repercussions were huge.  It seems that Walgreens only woke up from the dream when the Wall Street Journal published its investigation another two years later in October 2015. In the immediate aftermath of the article, Walgreens learned that Theranos had abandoned the finger-stick draws…and that the head of the Newark CA lab was a full-time dermatologist onsite once a week (page 15).

After that point, the Theranos fan dance with Walgreens accelerates.

  • Theranos concealed the January and March 2016 CMS notices and subsequent reports on its labs to Walgreens until again the WSJ publicly revealed it (pages 17-18, 25). They also attempted to conceal the CMS rejection of the Plan of Correction for its labs (page 24).
  • Theranos accused Walgreens of breaching the agreement and confidentiality to the WSJ , and also cited delay in building out Wellness Centers–in February 2016 (pages 20-21)
  • Walgreens received nothing but evasions from Theranos including no notification of ‘tens of thousands’ voided results, including critical PT/INR coagulation results, until after the WSJ broke that bit of news on 18 May (page 26).

By 12 June 2016, the wheels were fully off (and the world was minding, indeed) and Walgreens called the breach of warranty. But even then, this was not until a final push–lawsuits were filed against both Theranos and Walgreens starting in late May.

One wonders how many reputations are on a stake (to mix two metaphors) at Walgreens Boots. Details in Ars Technica (which obtained the PDF and broke the story) and of course Neil Versel’s acerbic POV in MedCityNews. Hat tip to reader David Albert MD of AliveCor.

See here for the 23 previous TTA chapters in this Continuing Saga.

The Theranos Story, ch. 22: the human cost of lab error (updated)

October 26, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/upside-down-duck.jpg” thumb_width=”150″ /]Save this one for the coffee or lunch break. What is the cost of a lab error on the human psyche? It can be mildly upsetting to you and your doctor, warning of a developing condition and some changes have to be made–or make for a very bad day/week/months. It can be falsely reassuring or simply confusing.

We know that in April, Theranos flunked a CMS review, and in May voided all test results from its proprietary Edison devices from 2014 and 2015, as well as some other tests it ran on conventional machines. The results were not only off, but way off, according to the WSJ. “Notes from the CMS inspection show that 834 out of 2,890 quality-control checks run on the Edison in October 2014, or 29%, exceeded the company’s threshold of two standard deviations from its average result. Standard deviation is a statistical measurement of variation. In addition, 80% of the 834 quality-control checks that raised a red flag under Theranos’s internal standards were more than three standard deviations from its average result, the inspection notes show.”

They also failed to notify patients for weeks or months, and often not until forced to. At least 10 lawsuits have been filed in Arizona and California. Some of the human stories of Theranos’ improbable lab results, which included tens of thousands of patients, with the cost of retesting, repeated doctor visits and agonizing suspense :

  • After five widely different Theranos blood coagulation tests in six weeks, a retired marketer living in Arizona and his doctor so distrusted the results that the latter recommended that he stop taking warfarin and switch to a milder medication. This patient found out only last Friday that Theranos had corrected a September 2015 test showing his blood taking more than six times longer than normal to clot. The other four tests showed the warfarin wasn’t thinning his blood enough. Contradictory results confusing both doctor and patient on treatment.
  • A thyroid cancer survivor got thyroxine results (T4) from three tests conducted in October 2014. The extremely high results could have indicated hyperthyroidism at the least, or a more serious condition. The results–false after retesting failed to confirm.
  • A breast cancer survivor had extremely high levels of estradiol, which could have been produced by a rare adrenal tumor that can secrete estradiol or an elevated risk of breast-cancer recurrence. Again, false results but found only after retesting.

The comments under the article are worth the long scroll. (They are running 98 percent in favor of Holmes for Prison 2017. Also there are a few shots at Walgreens’ role in legitimatizing Theranos by putting their centers in store; this embarrassing part of the story isn’t over, in this Editor’s opinion.) What is evident–fraud perpetrated on patients and doctors–and anyone who invested. David Boies, their legal supremo and board member, is gonna have a full docket between this and the various legal actions taken by the Alphabet Agencies.

Agony, Alarm and Anger for People Hurt by Theranos’s Botched Blood Tests. If the WSJ is paywalled, search under the headline text.

See here for the agony of TTA’s 21 previous Theranos chapters. We hope that John Carreyrou and the WSJ investigative team, which we’d assume includes Mr Weaver, this article’s author, are awarded the Pulitzer Prize.

Population health is everywhere (US)

October 20, 2016 | by

Last week, CMS published the ominously dubbed Final Rule on MACRA (the Medicare Access and CHIP Reauthorization Act of 2015) which utterly changes how physicians are compensated by Medicare and the various monetary incentives they have in quality and patient-centered care. This Editor is not going to get into interpretation of 2,300+ pages, but her belief is that this will not be effective in 2017 as designed, as literally it is over-complex and not understood by those who implement patient care. The dizzying models include Merit-Based Incentive Payment System (MIPS) and for the daring, the Advanced Alternative Payment Model (APM). All great business for the 100 or so ‘value-based consultants’ ready to help those expensively organized ACOs which thought they’d be rich from Meaningful Use. Oh, and what about the patient and their well-being in the meantime?? Healthcare Dive, Healthcare IT News and here  Don’t hunt for CMS’ fact sheet–it’s here. Don’t look for much about telemedicine and remote monitoring, which apparently was included in the law but not in the Final Rule for MIPS but is a part of the Advanced APM. Congress may act to expand Medicare’s payment policy on telehealth, but don’t hold your breath for it happening this year. POLITICO Morning eHealth 19 Oct

But population health and the data analytics that’s needed to get a handle on both large-scale patient health trends to allocate care where it is needed, and the financial metrics that organizations need, is hot. Verily Life Sciences (Alphabet-Google’s ever versatile healthcare tech arm) is allying itself with 3M Health Information Systems. (This Editor bets that you never thought that the Post-It Notes company was in health information!) According to the article, 3M’s part has to do with its business in coding, classification and risk-stratification methodologies. Verily will bring to the party data analytics, algorithms and software development. Healthcare IT News

This Editor also noted IHS Markit’s analysis of MACRA mixed with a bit from ATA’s Fall Forum. One insight: And now CMS plans to tie 90 percent of traditional Medicare fee-for-service payments to value-based payments in 2018. A lagninappe: “MACRA will help telemedicine to simply become another modality within healthcare delivery.” The wrapup is quite illuminating.

As identified during a recent consumer survey conducted by IHS Markit on digital health trends in the US, patients are interested now more than ever in sharing their healthcare data, and provider communication is at a low: (more…)