2021 predictions: telehealth law and if at all possible, stay away from FDA (US)

January 14, 2021 | by

crystal-ballFoley & Lardner rolls out five predictions for telehealth/digital health law and policy in the US:

1. Licensing: More Efforts to Increase Reciprocity and Reduce Barriers. During the current PHE, HHS and states waived many telehealth requirements, including HIPAA and licensing. As the PHE does not look to be ending anytime soon, look for this to continue and eventually be part of Federal policy as soon as the fall. The status quo in Medicare is rural telehealth only–and that restriction is being recognized as absurd. (Related TTA article on the 2021 Physician Fee Schedule [PFS])

2. Modalities: Technology-Neutral State Laws that Prioritize Quality of Care. States are all over the place with telehealth. Currently, changes have been through legislation with others by executive order or regulation. The American Telemedicine Association published a guide to standard practice and terminology language mid-last year (revised in September) to help guide state lawmakers. One can only hope they follow this recommendation from the ATA. 

3. Privacy: Greater Sensitivity to Patient-as-Consumer in Digital Health. Increased privacy regulations will run up against interoperability and data sharing. In this Editor’s view, this will continue to be a battleground, as in data sharing, there’s Gold In Them Thar Hills and Big Tech has its eye on it.

4. Enforcement: OIG/DOJ Will Build on Prior Investigations. This is the area of Medicare overpayment, wrong payment, and fraudulent tele- and TV marketing of medications, genetic testing, and DME. This massive takedown including opioids made headlines last year [TTA 2 Oct] and included $4.5 bn in fake telemedicine claims. It’s kind of a no-brainer that with the expansion of telehealth, this will continue. It’s always been on the Fed’s radar screen.

5. Payment: Continued Expansion of Telehealth Reimbursement. Again, a ‘Captain Obvious’ with the changes in the 2021 PFS plus resistant states like NY and Massachusetts finally on board with parity (ATA on NY and MA). There are some interesting adds that employers will increasingly pay for tele-primary care, behavioral health, and specialty care like fertility, which again is a no-brainer when your workforce is remote and you want to keep them online. Where telehealth needs a permanent boost is in Federal value-based care programs run by CMS, like shared savings and Primary Care First.

So you’re introducing a telehealth platform or device that you’d like to say ‘FDA-cleared’. This may not be the time to deal with FDA.  Bradley Merrill Thompson of Epstein Becker & Green, P.C., well known to be one of the leading lights in telehealth law and advocacy since Ur-Days, makes a very convincing case to avoid the FDA 510(k) process–if you can. 1) FDA is jammed. 2) it’s a long haul, nearly a year as of 2019, probably longer for 2020 and 3) if you are de novo without any predicate device, you have maybe a 50 percent chance of success.  His anecdotal take is that FDA clearance doesn’t lead to a boost in revenue. Mr. Thompson has also studied the fearsome Warning Letters, and the few for 2020 mostly involved exaggerated or unproven claims around COVID-19. None involved unapproved claims for a digital health product. 

In this Editor’s view, customers won’t be hung up on an FDA clearance if you do what you say you’re going to do at the price they want to pay. Investors need to know this. Some markets do require FDA clearance, however. This Editor experienced this working for her first digital health company, Living Independently Group, where GE Healthcare before acquiring insisted that we take the system through an unnecessary Class I (!) approval. In dealing with vital signs monitoring and Federal purchasing, our Class II filing at Viterion was required. His advice is to watch your claims and work on your business model. Much, much more from Mr. Thompson in Mobihealthnews.

COVID-19 and telehealth–promise or peril? And the perils of digital health in conflict countries and India.

January 14, 2021 | by

The Journal of the International Society for Telemedicine and eHealth (JISfTeH) has published its latest issue today (13 Jan). JISfTeH is one of the few journals which shine a bright spot on digital health in developing countries. This month concentrates on conflict countries and COVID in India: 

  • Scaling Up Digital Health In Conflict Countries discusses the lack of any form of digital health and coordination in Afghanistan, Somalia, Sudan, and, with some exception, Nigeria. It compounds the extreme lack of healthcare services–for instance, 23 percent of Afghanis have poor access to healthcare, resulting in a high mortality rate. It can change. Rwanda, once synonymous with war, has one of the best healthcare systems in Africa due to the use of digital health services. India is using digital health in combating the TB explosion of 300,000 cases in one year. The exception in Nigeria is the liftoff of 54Gene, a genomic studies company in the world’s most genetically-diverse continent, which has secured $4.5 million in seed funding.
  • Speaking of India, telehealth has been kickstarted there due to COVID-19. The Indian Government is prioritizing the use of telehealth in the population and both public and private institutions have rolled out initiatives. India’s challenges are how patients pay for it (70% of healthcare expenses out of pocket) and how it reaches the two-thirds of population in rural areas where there is inadequate telecom and broadband for services. The irony, of course, is that India is a huge exporter of software and telecom services to the world. COVID-19 As A Catalyst for Telehealth Growth In India: Some Insights.

The editorial by Richard E. Scott of Canada and Prof. Maurice Mars of South Africa, COVID-19 and eHealth: A Promise or Peril Paradox?, cautions on the floodgates opening for telehealth in COVID’s wake. Spontaneous telehealth, where “healthcare providers themselves saw the value of an eHealth solution and implemented it independently and without traditional steps or approval” is quite separate from evidence- and needs-based telehealth. There is a lot of pressure at the national level, by the WHO, and by vendors to ‘make hay while the sun shines’. “Enthusiasm must be tempered with thoughtful guidance” on multiple and quite variable factors.

The Theranos Story, ch. 69: Elizabeth Holmes ‘faked it till she made it’–like other Silicon Valley startups? (Updated)

January 12, 2021 | by

Lifestyles of the Rich, Famous, and Busted, Silicon Valley Style. As promised by the prosecution in the cases being brought against Elizabeth Holmes, the CEO/founder of Theranos, and separately with COO Ramesh ‘Sunny’ Balwani, they are proceeding with filings that connect Theranos’ continued defrauding of investors with Holmes’ extravagant lifestyle and desire for fame. “The causal connection between Defendant’s fraud and the benefits at issue is strong,” the filing stated, going on to detail how the fraud funded hotels, private jet travel, and “multiple assistants” paid by the company who also assisted with her personal needs.  “In addition to the tangible benefits that she received from her fraud, she also was the beneficiary of a great deal of favorable attention from the media, business leaders, and dignitaries”. Sustaining the illusion was necessary to continue the lifestyle and recognition.

Countering the prosecution filing on Friday was–of course–a defense filing that attributed Silicon Valley’s ‘fake it till you make it’ startup culture as a rationale for Holmes’ and Theranos’ actions. That filing states “founders in this area frequently use exaggeration and dramatic promises to generate needed attention for their companies and attract capital.” The “culture of secrecy” that concealed Theranos’ fraud?  “…if it is admitted Ms. Holmes surely could present evidence that other Silicon Valley start-ups used similar practices, and that persons at Theranos were aware of these practices.” In November, they also filed to block as ‘unfairly prejudicial’ any mention of Holmes’ lifestyle as irrelevant to her guilt or fraud. 

Another fake was pretending that problems didn’t exist and everything was just ducky. The prosecution also introduced emails that confirmed Holmes’ direct awareness of problems with the blood tests in 2014. One example was from her brother Christian, who worked in product management. It requested a meeting to discuss a customer complaint where it was “pretty obvious that we have issues with calcium, potassium and sodium specifically.” According to the filing, “Theranos emails contain many examples of customer complaints routinely being escalated” to Elizabeth Holmes and other senior company personnel. At trial, the evidence will show that defendant shaped Theranos’s response to those complaints, prioritizing the company’s reputation over patient safety.” This Editor would argue that it’s no different with car manufacturers (Ford and the now lower-case GM) than startups to spin a response, but the proper reaction to clinical product faults would be to pull back the offending tests and solve the problem before going any further. But the Edison lab and their technology didn’t work.

Updated with further analysis. In retrospect, it’s obvious that Theranos crossed the ethical line between massive hype (expected) and outright fraud (not), which is why the defense is fighting so hard to keep Silicon Valley Lifestyle and Startup Culture out of the case unless it can be spun their way. A key: Holmes’ emotional state and a psychiatric evaluation have also been introduced by the defense, countered by the prosecution. In this case, the fraud was based on dual ethical nightmares, the first worse than the second: faking of medical results, then defrauding small and large investors by faking company performance. Too many just wanted to believe, like the X Files. But we should not forget another high-profile hype and fraud that happened around the same time, Outcome Health [TTA’s articles here].  Outcome Health’s fraud was strictly financial–ad performance falsification leading to fraud and money laundering. They defrauded Big Pharma advertising and some of the largest global investors like Goldman Sachs. The Federal lawsuits on Outcome have gone very quiet after settlements, plea bargains, and COVID halting court actions.

Thanks in large part to Theranos and Outcome Health, that startup culture is mostly kaput. The lessons are learned–we believe. A modicum of modesty along with a large dose of telehealth/telemedicine/data analytics is The 2020-2021 Thing. A lasting effect? Perhaps. Small-batch blood testing is only now recovering from being radioactive.

Before the start of the company’s collapse in 2016, Theranos had raised a reported $900 million ($700 million in some accounts) and was privately valued at $9 bn. Few of the investors clawed back their money. Fraud doesn’t work. It never works.

The trial in Federal District Court, San Jose, is now scheduled for jury selection 13 July. It was moved just before Christmas from 9 March by Judge Edward J. Davila due to California’s COVID-19 surge (MassDevice). So here we are five years later It promises to be popcorn-worthy, with possible appearances by famous men such as Henry Kissinger, Rupert Murdoch, and former Defense Secretary James Mattis. CNBC, Bloomberg For those interested in the full sturm und drang by chapter, it is here.

Digital Health as Boom Town: 2020’s dizzying funding rounded up by Mercom Capital, StartUp Health

January 9, 2021 | by

BOOM! Mercom Capital Group published their Q4 and 2020 roundup of global digital health investment and, no surprise, the investment picture for just about anything digital health was in sharp contrast to most of the COVID-afflicted world economy.

The topline:

  • Global VC funding (private equity and corporate venture capital) was $14.8 bn across 637 deals. It was a 66 percent increase in funding compared to 2019’s $8.9 bn in 615 deals. The modest increase in deal number and huge increase in funding points to the acquisition of more established companies requiring Big Deals.
  • Total corporate funding, including VC, debt, and public market financing, totaled $21.6 billion

 

In a stunning change, telemedicine was Top Of The Pops, with $4.3 bn in investment, 139 percent over 2019’s $1.8 bn. It was over double the former star categories of data analytics and mHealth apps.

The top five disclosed M&A transactions in 2020 they tracked were:

  • Teladoc’s acquisition of Livongo Health for $18.5 bn
  • Blackstone’s acquisition of a majority stake in Ancestry.com for $4.7 bn (despite the ‘bloom off the rose’ of consumer genetic testing)
  • Philips’ acquisition of BioTelemetry in cardiac monitoring for $2.8 bn
  • Invitae’s acquisition of ArcherDX for $1.4 bn
  • WellSky’s acquisition of Allscripts’s CarePort Health (CarePort) for $1.35 bn

The Executive Summary is available for free download at the link in the release. The full report will set you back $599 – $999, depending on the version.

StartUp Health has slightly different numbers but in total investment tracks almost to Mercom Capital’s estimate at $21.5 bn. For telemedicine, it still triples year-over-year but StartUp’s totals are lower: 2019’s $1.1 bn to 2020’s $3.1 bn. Part of the difference may be remote monitoring, which StartUp considers separately. It doubled from $417 million to $941 million. Their deal counts were also higher: 764 in 2020 compared to 716 in 2019. Another fun fact in their tracking are their city leaders in health innovation funding: Beijing, Tel Aviv, and London, confirming that New York and the San Francisco metro no longer have money, interest, or their former attraction. A fuller list would have been interesting. More is in their Part 1 study. Part 2, to be released next week, will cover their dozen ‘health moonshots’.

New Year’s Deal and Event Roundup: Optum-Change Healthcare, Walgreens-Amerisource Bergen, December’s deal potpourri, CES and JPM

January 7, 2021 | by

Mutated COVID virii may be spreading, the UK locked down tight, but the deals with big numbers just keep on coming….

Change Healthcare not sold for pocket change. $13bn from the coffers of UnitedHealth Group’s Optum took it, though word was that it wasn’t for sale. Change will be part of OptumInsight to reinforce data analytics, technology-enabled services, and revenue cycle management. The deal pays common stock shareholders $25.75 per share in cash plus assumption of Change’s debt. Closing is slated for second half 2021. Neil de Crescenzo, Change’s CEO, will be CEO of OptumInsight which will integrate Change into its structure.

Change houses a dizzying group of diverse businesses including radiology, imaging, revenue cycle and payment management, consumer experience, clinical decision support, workflow integration, communication and payment solutions, network optimization, value-based care enablement….and that is about half of the list. The release emphasized RCM, provider payment, claims transaction analysis, and clinical decision support. It will be interesting what Optum chooses to retain and discard.  Press release, Fierce Healthcare, Forbes. Credit Suisse has also published a lengthy financial analysis (PDF) of the deal which opines that it’s likely to not run afoul of Federal anti-trust interest or significant conflicts of interest (Optum currently serves many payers other than UHC). There may be Federal concern about a concentration of data and transaction information as Change alone serves 19 of 20 major US payers and is a leader in network services and payments.

Walgreens Boots Alliance sells the majority of their Alliance Healthcare pharmaceutical wholesale businesses to AmerisourceBergen, a leading US drug wholesale company, for about $6.5 billion in cash and stock ($6.275 billion in cash and 2 million shares of AmerisourceBergen common stock). Interestingly, Walgreens is the single largest shareholder of Amerisource Bergen at 30 percent of common shares. Both Walgreens and Amerisource Bergen will continue their US distribution agreement until 2029 and Alliance UK with Boots until 2031. One way of interpreting this is fattening their ‘war chest’ for expansion, including their major bet with Village Medical. Perhaps a payer or a health tech company? Press release

December’s potpourri of Big Deals was rounded up by FierceHealthcare:

  • Alphabet’s Verily closed out 2020 with a massive $700 million funding round primarily from Alphabet to fund its commercial work
  • 23andMe got a lifeline of $82.5 million in Series F funding from an offering of $85 million in total equity shares. TTA analyzed why the bloom had faded from the genetic testing rose, so hot only a few years ago, last August and February. Bloomberg
  • New Agey Calm is meditating on $75 million in Series C funding and visualizing a valuation of $2 bn.
  • Pear Therapeutics, developer of prescription apps to treat addiction and insomnia, counted $80 million in Series D sheep. 
  • Provider CityBlock Health raised $160 million to support care for marginalized populations with complex needs and now has an estimated value of $2 bn.
  • On the payer side, Oscar Health raised $140 million in a venture round as we reported before Christmas.
  • And we reported on Everlywell’s digital home testing/telehealth consult Series D of $179 million in early December.

And the Big January Events Roll On, Virtually.  CES 2021 and the JP Morgan Healthcare conference for their clients will be held next week as usual, along with the usual constellation of independent conferences. These are usually a major venue for deals and deal announcements, and even in the virtual space, will likely be no different. One wonders if Haven’s closure [TTA 5 Jan] will be even whispered.

Haven finds no haven in healthcare, will close in February

January 6, 2021 | by

Man Plans, God Laughs. Haven, the joint venture cobbled together by JP Morgan, Berkshire Hathaway, and Amazon to transform corporate healthcare three years ago, will be shuttering next month. The website has but a single page of signoff. All it is missing is a bit of sad synth music like the air crash simulations and analyses so popular on YouTube.

Haven’s founding in January 2018 made for expansive, far-seeing (sic) 50,000-foot quotes by JPM’s Jamie Dimon and B-H’s Warren Buffett about the ‘hungry tapeworm’ of healthcare costs and the need to simplify it for their million-odd employees. Surely it made for great speeches at annual meetings and glossy Annual Report pages. But in its three years of existence, Haven never found a home. It had the ambitious mission of “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” [TTA 31 Jan 2018]. Yet it spent its first six months without a CEO, over a year without a name, and never created a clear direction. 

Atul Gawande, MD, one of the big thinkers on the broken US healthcare system, joined as CEO six months in, but oddly did not give up his teaching, clinical, and writing commitments. It left the sense that for the doctor, Haven was a part-time gig [TTA 21 June 2018]. One can imagine how Dr. Gawande, without a strong business management background, dealt with the egos of the Bezos-Dimon-Buffett trio without a strong backup team to deal with them, get a plan together, and execute.

The signs of failure were increasingly apparent by the Year of the Pandemic. Health systems and insurers–the ones with the data and the leverage–were never bought (though WellCare, a leading Medicare Advantage payer, was up for sale in 2019 and snapped up by Centene) or even engaged in partnerships. Management fled starting in 2019, accelerating in 2020: COO Jack Stoddard for personal reasons in May 2019, then in 2020 financial head Liam Brenner and people head Bryan Jones in April, Dr. Gawande in May, Head of Measurement Dana Safran in July, and CTO Serkan Kutan in September. Becker’s Hospital Review The one partner with retail consumer healthcare experience–Amazon–increasingly and publicly pulled off in its own beneficial directions, acquiring PillPack in mid-2019 as the first move towards a PBM, then in the past few months pushing Amazon Care for large employers and creating Amazon Pharmacy. The other two companies also, according to reports, executed their own projects with their own teams.

The small employee group (under 60) may find spots at one of the three companies. The official announcement states they will ‘collaborate informally’. Not with a bang, but with a whimper. Fierce Healthcare, CNBC, HISTalk.

News roundup, lockdown edition: Oscar Health’s $140M raise, IPO filing; Centene’s Diameter Health investment; Abbott’s telehealth-guided COVID antigen test

December 23, 2020 | by

Before we break for the Christmas and New Year’s festive season, though most of us are partially or fully locked down for travel and get-togethers, binge-watching the telly for comfort, a few items of interest–we’ll keep it short:

An Oscar Health Double Header. Not only did this relatively new payer in the individual, small group, and Medicare Advantage markets gain a $140 million funding round last week, adding to a $225 million raise in June (Fierce Healthcare), but they quietly filed their S-1 registration with the US Securities and Exchange Commission (SEC) to go public on Monday (Healthcare Dive, Oscar release). Since their founding in 2012, the company has raised $1.6 bn in 10 rounds. The fresh funding will go towards 19 new markets and four new states in 2021, adding to their current 18 states and 211 counties. 

Speaking of payers getting into other lines of business, Centene Corporation, which has Medicare plans with different brands in all 50 states, seems to be moving in a different direction with some recent acquisitions and investments. Centene was the lead investor in an $18 million Series B round for Diameter Health, an enterprise data interoperability developer. Optum Ventures, LRVHealth, Connecticut Innovations, and Activate Venture Partners also participated. Fierce Healthcare Centene recently finalized their acquisition of Apixio (AI-assisted clinical data mining of unstructured data) [TTA 14 Nov] and is acquiring Pantherx, a specialty pharmacy focused on orphan medications and rare diseases, to blend into their Envolve Pharmacy Solutions unit. It does appear that Centene is moving into the UnitedHealthcare/Optum model of dividing services and innovations which can be sold to third parties (Optum) from their health plan and pharmacy businesses (UHC), which may be less profitable in the next few years.

An antigen test for COVID-19 with a telehealth spin is Abbott Pharmaceuticals’ BinaxNOW 15-minute antigen test. It is the first at home, telehealth guided test to get an FDA emergency use authorization (EUA). The Ag Card Home Test requires a prescription and used telehealth to guide users through the sample self-collection process, then to help them read and understand their results. MedTech Dive  It was followed up this week by Quidel’s EUA for a dipstick-style collection with a reading in minutes, similar to that of a pregnancy test, but is only cleared for healthcare settings for now. MedTech Dive

Above: Rockefeller Center, 2011. This year’s tree was mangy and the decorations leading to the plaza scarce.

Weekend Must Read: The Future of Remote Care Technology and Older Adults 2020

December 10, 2020 | by | 1 Comment

Laurie Orlov, founder of Aging and Health Technology Watch and well-known industry analyst/advocate in health and aging-related technologies, has released her latest report, The Future of Remote Care Technology and Older Adults 2020 (PDF, free download). Recently, Laurie and I had an opportunity to catch up and review her findings.

This Editor immediately went to the ‘bleed lead’ which was:

COVID-19 HARMED THE WELLBEING OF OLDER ADULTS
Gap in technology access widened into connection chasm

The University of Michigan study from June (cited above and elsewhere in the report) illustrates the change in social isolation for those aged 50 to 80, with numbers that were slightly high to begin with in 2018. Isolation rocketed to 56 percent, putting a Klieg light on mental health that we’ve seen continued in the recent ‘lockdown loneliness’ PLOS One and SECOM studies. The reasons why will be no surprise, as they’re true for nearly all: a screeching halt to in-person experiences, severing in-person connections with family and friends, closing the doors of senior living and nursing homes to visitors (still closed in many states!), breaking healthcare contacts with providers, and losing timely diagnosis of health conditions, new and ongoing.

Most of the report documents the consequences: how telehealth rose, then fell (Epic and Commonwealth Fund last reports), how the experience wasn’t entirely satisfactory and held multiple structural limitations (e.g. tech, vision, hearing, dexterity) for the 50-80 age group (nor providers in obtaining a physical sense of the patient)–a POV you won’t see in mainstream healthcare/tech media nor the funding markets–and how technologies scrambled to fill the gaps (with plenty of examples).

But moving on to the future, which is the aim of this report, there are many gaps which need to be closed that are bigger than Teladongo:

  • synchronous and asynchronous telehealth–the latter primarily remote patient monitoring (RPM)
  • adoption of voice tech
  • broadband and device access, including training and management
  • governmental policy at all levels from Federal to local, including payer reimbursement

The last section of the report (page 18 to end) takes a look at where innovations could take remote care, where expectations are now, and where the opportunities are in connecting older adults. On page 22, there is a checklist for care providers and what they must consider in managing remote care. The summary of the future on page 23 wraps it all nicely.

The Future of Remote Care Technology and Older Adults 2020 (PDF, free download)

 

News roundup: Cera hits £89.5M revenues, Alcove Carephone in new elder housing, Everlywell home test kits raise $179M; FDA clears Lucira’s all-in-one COVID test kit, Apple Watch new ECG feature

December 10, 2020 | by

Farringdon, London-based Cera announced a high point in its revenues of £89.5 million ($120 million) since their 2016 launch. While it is primarily a home care company d/b/a-ing under Cera Care (and seeks to hire an additional 5,000 staff, mostly professional carers), we noted back in March their £52 million ($70 million) raise and the launch of SmartCare, a sensor-based analytics platform that uses machine learning and data analytics in real-time on behaviors to personalize care and detect health risks with a reported 93 percent accuracy. Cera also has a proprietary app to connect families with Cera on visits and progress. Unfortunately the Cera website is singularly uninformative on company news and SmartCare. Mobihealthnews

Alcove is partnering with Cornell Court in Saffron Waldon, Essex, an extra-care community developed and run by L&Q Living, to fit out apartments with their in-residence Carephone tablet. Having the access to the tablet, residents can easily initiate a group video call with family members, as well as attend virtual care and therapy sessions and activities including bingo and exercise classes. There is also access to a ‘virtual concierge’. The combination of onsite services and the Carephone access helps with resident independence. All helpful as the UK remains on a non-virtual lockdown in most places and Christmas looks distinctly un-festive this year, especially for older adults. Local Authority Building & Maintenance (LABM) Online.

COVID-19 has certainly been a boom of a boon for at-home testing companies.

  • Everlywell just raised a hefty Series D of $179 million. They market and process over 30 FDA-cleared kits, including (of course) symptomatic COVID-19 (SARS-CoV-2, lower nasal swab) with a follow up from the lab in 24-48 hours via their app coupled with a telehealth consult. Other kits include thyroid, indoor/outdoor and food allergies, and hepatitis C, at prices ranging from $49 to a comprehensive food sensitivity test at $259. Prediction: Everlywell and similar companies will be 2021’s 23andMe/Ancestry.com.  Fierce Biotech
  • An equally intriguing ‘home run’? FDA cleared the first ‘all-in-one’ home test for COVID-19 under an EUA (Emergency Use Authorization). The Lucira Health molecular test from a nasal swab sample is completed by a battery-powered handheld unit that includes all the reagents needed to process the test. The unit then shows the result with a green light for positive or negative. Average time: 2 minutes. Molecular tests are more sensitive and accurate than the current quick tests of antigens. Go-to-market of the single-use test kit is expected early spring 2021, at a cost of $50. The by-prescription test can also be performed in point of care settings. The company will be filing early next year to have as an option prescription via telehealth. Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale participated in the trials and will be first on distribution. Fierce Biotech, Lucira press release, FDA release

Remember when any burp from Apple was Major News, breathlessly awaited? Now ho-hum. FDA cleared the latest update of the Apple Watch’s ECG monitoring. Now the feature enables heart rate detection up to 150 beats per minute and adds a classification category called A-Fib with high heart rate. The Apple Watch has been used in some studies to monitor for atrial fibrillation. No release date is set for the watch. However, AliveCor is suing Apple on patent infringement of three patents, from the Apple Watch Series 4 and later devices, so stand by. Mobilhealthnews

CMS expands telehealth, RPM in 2021 Physician Fee Schedule, creates post-pandemic temporary category (updated)

December 3, 2020 | by

On 1 December, the Center for Medicare & Medicaid Services (CMS) announced its all-important 2021 Physician Fee Schedule (PFS), which sets out the fees and rules for physicians providing services to Medicare fee-for-service beneficiaries and generally serves as a guideline to commercial payers. If one only reads the release headline, one would assume that the national telehealth payment expansion that was approved when the public health emergency (PHE) was declared in March would be largely retained permanently in the 2021 PFS after the earnestly desired end of the PHE, extended to 20 January 2021,

Interpreting CMS-speak is always a task, and so it is here. Your Editor will do her best to unpack it. 

Paragraph 5 is the sobering note for the telehealth ‘bulls’. Telehealth expansion, on a permanent basis, applies to Rural Health, Federally Qualified Health Centers (FQHC), and certain Medicare program models (e.g. two-sided Medicare Shared Savings Program ACOs, ESRD, Episode Payment models, and Medicare Advantage), and with a limited number of new codes. From the release:

“This final rule delivers on the President’s recent Executive Order on Improving Rural Health and Telehealth Access by adding more than 60 services to the Medicare telehealth list that will continue to be covered beyond the end of the PHE….These additions allow beneficiaries in rural areas who are in a medical facility (like a nursing home) to continue to have access to telehealth services such as certain types of emergency department visits, therapy services, and critical care services.”

The release then goes on to explain the kicker: “Medicare does not have the statutory authority to pay for telehealth to beneficiaries outside of rural areas or, with certain exceptions, allow beneficiaries to receive telehealth in their home.” (Editor’s emphases) 

What seems like a pullback in the PFS is a reversion to status quo ante in geographic and model restrictions, which can’t be changed except by Congress. What CMS can do is expand, and create, new Categories for covered codes.

  • CMS expanded Category 1 which is the basic list of telehealth covered codes (CPTs and HCPCS). If you are in a rural area or a covered model, the expansion is real but limited: the number of new codes in Category 1 is nine codes of the 60 stated in the release. 60 is also far less than the 144 service codes added since the start of the PHE.
  • The remaining telehealth codes of the 60 quoted are in a new, temporary Category 3, which will extend through the calendar year the PHE ends–which is, as of today, 31 December 2021. (If the PHE goes into 2022, unless the rule is changed, 31 December 2022.)
    • Category 3 includes over 50 telehealth service codes for the PHE that are not in Category 1–thus the count of 60 the CMS press release trumpeted. 
    • What is not spelled out in CMS’ press release or public Fact Sheet is if statutory geographic (rural) and model restrictions will apply to this category after the PHE ends. Given the above, this Editor’s interpretation is that statutory restrictions will apply unless there’s a Federal change.
  • The Fact Sheet also clarifies certain frequency limitations, who can deliver telehealth services in a practice, telephone-only interactions with a new HCPCS code, and direct practitioner supervision.  Fact Sheet–Final Policy, Payment, and Quality Provisions Changes

For remote patient monitoring (remote physiologic monitoring) services which were modified during the PHE, there are important clarifications and two finalizations of modifications to RPM services made during the PHE, also in the Fact Sheet. 

The exception to the above is apparently the Medicare Diabetes Prevention Program (MDPP). Virtual delivery of certain services, such as educational classes which shifted from in-person to virtual and weight measurement, will not continue past the end of the PHE. CMS MDPP release. Also mHealth Intelligence.

What this all really means. CMS has Kicked The Telehealth Can Down The Road for 2021. They have retained many of the changes that the pandemic forced, but the geographic and model restrictions remain. But practices have made serious procedural modifications to incorporate remote and telephonic visits. Many patients in the Medicare age group are still self-isolating to a significant degree, and depending on the path of COVID-19 (and the flu) have good reason to limit in-office visits. This year’s use of telehealth in this group, according to CMS, was astounding: between mid-March and mid-October 2020, over 24.5 million out of 63 million beneficiaries received at least one of those 144 Medicare telemedicine services. What remains unclear is if Category 3, after the PHS, could continue to apply nationally through Congressional action, as there are several bills before this soon-to-close Congress.

Certainly this, plus post-COVID usage, will influence the 2022 PFS and perhaps stimulate Congress to allow CMS to permit payment for telehealth services nationally.

Editor’s note: References in addition to above are Center for Connected Health Policy’s Telehealth and Medicare page, the proposed CY 21 PFS Fact Sheet (PDF), and COVID-19 Telehealth Coverage Policies. Hat tip to former colleague Madeline Short, COO of Wilems Resource Group.

Update 3 December: The American Telemedicine Association published its comments on 2 December, agreeing with CMS Administrator Seema Verma’s comments on making telehealth permanent outside of geography, itemizing the present bills languishing in Congress, and also lamenting the short shrift that the final rule gave to remote patient monitoring. Also, Healthcare IT News includes additional comments from ATA chief Ann Mond Johnson. Some states like Texas and Wisconsin are pushing for updated parity rules applying to state-regulated plans, which would include commercial plans and Medicaid. Hat tip to reader Paul Costello for the heads-up.

The Theranos Story, ch. 68: the texts told the tech failure–and please omit Holmes’ ‘luxurious lifestyle’ and profane meeting language from trial

November 26, 2020 | by

The trials of Elizabeth Holmes and ‘Sunny’ Balwani churn on towards a March 2021 court date. Two major revelations have entered the record from last Friday 20 November’s flurry of filings on both sides. 

  • The prosecution introduced panicky Holmes/Balwani texts, iMessages, and Skype messages indicating that Theranos was having major trouble with validating its lab technology from 2014 on. One text from Balwani described a lab as a ‘disaster zone’. “The spreadsheets are replete with admissions by defendant and Balwani that demonstrate their knowledge that their statements to investors were false and misleading and that Theranos’s testing was beset with problems.”  CMS in 2015 concluded that their California lab posed an “immediate jeopardy to health and safety.” The messages were from previous civil cases and collected by securities regulators, with many still under seal from those cases.
  • The defense for Holmes moved to prohibit prosecutors as ‘unfairly prejudicial’ evidence of Holmes’ wealth, spending, and lifestyle,  citing Federal rules of evidence and that this information is not relevant to Holmes’ guilt or innocence on the fraud charges. In 2015, Holmes was worth an estimated (by Forbes) $4.5 bn despite what is claimed as a moderate salary and not selling equity. The government has detailed her company-paid perks such as a luxury SUV, a rented luxury house, and luxury-level travel, in addition to a ‘substantial salary’. 
  • The defense is also seeking to omit any references to Theranos employees making claims about the technology, including Theranos sales representatives falsely claiming that the FDA approved the company’s lab machines. The grounds to omit are that Holmes could not be responsible for their false statements.
  • The defense also seeks to omit transcripts of a company meeting that used profane language to refer to reporting in the Wall Street Journal investigating the company and a competitor at that time, on the grounds that such language is par for the course in High-Tech-Land. Mercury News (may be paywalled)

Fox Business 23 November, 24 November. BNNBloomberg.

In a separate case, a former Theranos lab scientist, Diana Dupuy, has claimed that she was wrongfully terminated from her job with medical testing company DiaSorin nine days after receiving a subpoena to testify at the Theranos trial. DiaSorin is claiming the reason is unrelated to Theranos. The suit has been filed in US District Court in San Francisco. Anecdotally, many former Theranos employees have reported that Theranos has been a glaring black mark in their resumes that make them close to unhireable. Mercury News

Weekend reading: HISTalk’s interview with Spirion’s CEO on healthcare data security

November 20, 2020 | by

A short but must-read if you care about data security and your customers/patients/residents. Where this HISTalk interview with Kevin Coppins, CEO of Spirion, excels is leading the reader through areas that are usually filled with fog and IT jargon. The view is from his company and a healthcare organization sitting in a conference room and scoping the problem without ‘paralysis by analysis’ or a turnkey ‘solution’ that may not be one. What’s different here is the clear, and few, logic steps, particularly the first three listed, that Mr. Coppins takes to get the ball rolling rather than befogging the discussion with too many factors or the punitive consequences of regulatory non-compliance.

“The concept of data and sensitive data is at the core of both security and privacy.”

  1. How much data do you have? (Nobody really knows, admit it)
  2. Of that data, what would you consider ‘sensitive’, and how do you define ‘sensitive’? Not only by regulation/compliance directives, but what your patients, clients and the board would consider ‘sensitive’.
  3. How much of that data is actually critical? 
  4. What’s the impact? How personal is it to your organization, not just in a compliance way but in your community, etc.
  5. How do I reduce the risk of loss?
  6. If I lost the data due to hacking or ransomware, what’s the backup? How fast can this happen?

This Editor notes that these points (quantity, definition, risk of loss and recovery, and community impact) can be applied to other situation analyses.

The litany of ransomware attacks that have ramped up during the pandemic waves has pushed data security issues to the ‘gotta tackle’ list. According to Emsisoft, a security company, there were 41 attacks on healthcare organizations in first half 2020. This didn’t stop during the summer, with a rash of them at end of October and a hit list of 400 hospitals, according to Becker’s.) Hacking attacks persist but aren’t getting the headlines.

And his conclusion is pertinent: “When it comes to security and privacy and all the drama and all the noise that you hear about it and read about it, just boil it down to this — am I doing everything I can today to protect what matters most to the constituents I serve?”

Early detection of Parkinson’s via AI (and a surprising medium); Ed Marx on the digital transformation (or not) of health systems and COVID treatment at home

November 20, 2020 | by

Somewhat off our normal beat….but of interest.

Ardigen and The BioCollective are collaborating on early detection research for Parkinson’s Disease, based on a microbiome-based biomarker. Ardigen has developed an Artificial Intelligence (AI) Microbiome Translational Platform. The BioCollective has a bank of metagenomic and patient metadata generated from an unexpected source: Parkinson’s patients’ stool samples. Release

The BioCollective is headed by Martha Carlin, who came from well outside of healthcare and pulled together a research group to address her husband’s diagnosis. A visit to this website is worth an examination on how these samples are collected for microbiome extraction. An interesting twist is the marketing of a probiotic mix developed using their BioFlux metabolic model for ‘gut health’.

Ed Marx, the former CIO of the Cleveland Clinic, has written a new book, ‘Healthcare Digital Transformation: How Consumerism, Technology, and the Pandemic are Accelerating the Future’. It’s billed as a wake-up call for healthcare systems and hospitals under challenge by Big Retail, Big Pharma, and Big Tech. This Editor met Mr. Marx when he premiered his entertaining memoir, ‘Extraordinary Tales from a Rather Ordinary Guy’, a few years ago. On treatment for COVID patients, except for the very sickest, he advocates it being done from home. From the release: “When the pandemic hit, a lot of progressive organizations would send most of their Covid patients home with monitoring equipment hooked up to phones unless they needed a ventilator. It’s a lot cheaper than staying in the hospital.”

Shock news: a very muted HIMSS 2021 set for 9-13 August, Las Vegas

November 13, 2020 | by

Yes, Virginia, there will be a HIMSS21, of sorts, we think. The news of a HIMSS21 in Las Vegas next August (when it will be 110° in the shade) is like the forecast of rain for this parched-of-business convention city and the parched-of-contact health tech community. The basics, mostly from the FAQ:

  • Registration will open in January (date TBD). If you paid your registration for the canceled 2020 conference, your registration will automatically be carried over to the 2021 conference, with details to come. If you cannot attend, no refunds.
  • Programming, exhibits, and events will be held at the Venetian-Sands Expo Center, Caesars Forum Conference Center, and Wynn 
  • The program and topics are sketched in (see the website dropdowns).
  • Proposals for the education track are closed, but open till mid-January for the optional events.  

Exhibitor registrations and paid badges will be carried over (unless you don’t plan on exhibiting, then again, no refunds). For whatever reason, the exhibit floor will be worthy of a Woman’s Christian Temperance Union (WCTU) convention in Des Moines, based on the published rules:

  • NO SOLICITING OUTSIDE THE CONFINES OF YOUR BOOTH (replicating their capitals, including hotels–what fun is this?)
  • All demos and promo activities must be performed five feet set into your booth space. It’ll get cozy for the small, poor exhibitors in a 10 x 10! In fact, straying outside your booth for anything is apparently prohibited.
  • No megaphones, loudspeakers, or what is quaintly called ‘sideshow’ tactics, for instance, clowns, whistles, or high school marching bands in the aisle. Noise must be less than 75db. If there are speakers, they must face into the booth–and better be small.
  • Tchotchkes must have logos on them, so no running out for brand-name candy needed to fuel a looong floor day
  • You have to stay in your booth during exhibit AND non-exhibit hours. (I guess this means no food, event attendance, bathroom breaks–or scoping out/chatting up the competition, a key activity at any trade show.) And don’t wear lights or signage of any type on your clothes.
  • Speaking of clothes, they’re NOT optional–tops and bottoms required. At all times. Even though it’s HIMSS. And Las Vegas.
  • No cameras or video equipment on the floor. (I guess this means you can’t shoot reference pictures, booths you like, or cute videos to share on your blog, Twitter feed, and LinkedIn. Sounds like a closed shop for HIMSS Media.)
  • Exhibitors must use the official booker (onPeak), or you can lose your badges and booth. No economizing! Rough on the small, poor companies.
  • “Event Participants are expected to behave responsibly and to treat each other – and treat the community – with respect, kindness, and compassion.” If you don’t, you lose Exhibitor Points. (No comment!)

This Editor wonders that with all these restrictions and the mid-summer timing, how many exhibitors will simply walk away from HIMSS21 and its high expense? Or wait till March 2022 in Orlando? After all, 2020 booth expense was in last year’s budget and written off. Is going to HIMSS worth it to you?  Hat tip to HISTalk.

Perspectives: How Advanced Communications Technology Has Created A ‘New Normal’ In Healthcare

October 30, 2020 | by

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion area. Today, we have a contribution from Dave O’Shaughnessy, Avaya’s Healthcare Leader for EMEA and APAC, with a brief discussion of how AI and advanced communications technology can help healthcare in the long term. (It’s hard to say ‘a post-COVID world as France and Germany are experiencing second round lockdowns, and UK may not be far behind.) Interested contributors should contact Editor Donna. (We like pictures and graphs too)

Across industries, we see working patterns being transformed to create the ‘new normal’ as a result of COVID-19 and our reactions to the pandemic. The healthcare sector has been no different. The pandemic and its restrictions have brought a great number of new challenges to healthcare systems. And as has been the case across so many other sectors, communications technology has stepped in to plug the gaps caused by the pandemic.

The good news is that, not only have communications solutions successfully plugged the gaps, but they’ve also provided a blueprint for the future of healthcare. As we’ve found in other industries, we’ve actually seen the intelligent adoption of this technology lead to better experiences for patients, and better outcomes for providers, than were present before.

The most important (and immediate) area where this is most obvious is in contact tracing – tracking the physical, interpersonal interactions of those who have tested positive for COVID-19. This helps identify people who may need to be quarantined more quickly, therefore reducing the spread of the virus.

Helping government and healthcare organizations across the world with their contact tracing efforts, what we’ve found is that the most effective contact tracing efforts make use of artificial intelligence and automation. After all, the effort involves mountains of meticulous information gathering and analysis—all required to meet standards set by global health and government agencies. Acting upon that data manually just isn’t feasible, given the immediate needs at hand.

Therefore, the best systems employ AI virtual agents for initial patient contact, as well as for the simple data collection interactions – only falling back to live agents when the interaction becomes more complex. AI is also employed to deliver cloud-based, proactive notifications to automatically reach out to individuals or groups with optional response tracking, text interaction, and auto-forms to capture critical information.

Patients benefit from a smoother experience while providing the tracing information required, while healthcare providers and governments are able to collect more information with the resources they have.

Even without these focused AI technologies, however, our customers are putting their advanced contact centers to good use in combating the pandemic. In Saudi Arabia, for instance, one medical facility adopted a multi-experience approach, making it easy for patients to get the COVID-19-related information they need through a wide range of communications channels. This provided demonstrated results for improved knowledge on coronavirus safety measures in the community.

Going forward, we see tremendous use cases for extending this technology to make it easier for patients to directly engage with their doctors through asynchronous messaging. Such capabilities are of particular interest to mental health providers, who have found themselves unable to conduct in-person therapy sessions in the face of increased demand.

All of these solutions were implemented because of specific, pandemic-related challenges. But once the pandemic subsides, they’ll continue providing value, making it easier for patients to consume healthcare services, while delivering increased efficiency for providers.

Hat tip to Mary Burtt of AxiCom UK

Telemedicine office visits versus in-person recede to 6%, concentrating in behavioral health. Will the gains hold?

October 29, 2020 | by

Has the telehealth wave receded to a ‘new normal’ tide? An updated Commonwealth Fund/Phreesia/Harvard University study, including data through 4 October, confirms that we are far past the point of telemedicine dominance of the office visit. Office visits to providers have largely returned to the 1-7 March baseline and even slightly above for ages 6 and above. But telemedicine visits, from their high in this study of 13.9 percent on 18 April during the peak of the COVID-19 pandemic, have continuously dropped and have leveled off to 6.3 percent. (Telemedicine here includes both video and telephonic visits; the sample is 50,000 providers that are Phreesia clients.)

To put this in proper perspective, the pre-pandemic baseline of telemedicine in practice use was an infinitesimal .1 percent.

Larger organizations use more telemedicine than smaller ones. Primary care practices with 6 or more physicians in the group account for 9.4 percent of telemedicine visits, while practices of 1 to 5 physicians account for 4.3 percent.

Even so, by September, only 9 percent of practices were heavy users (20 percent +) of telehealth, compared to 35 percent in April. Minimal use (5 percent or less) moved up to 39 percent. One-third never used telemedicine at all–did they shut down completely?

For those seeking to segment the overall telehealth market, the chart detailing telemedicine in visits to medical specialists is of interest. It confirms the anecdotal information this Editor has heard that telehealth remains highly popular and used in behavioral health (psychiatry)–41 percent of visits. By comparison, the next most popular are rheumatology and endocrinology at 14 percent of visits. The pandemic apparently has forever changed the mental health visit and acceptance of non-face-to-face delivery, with interesting (isolating?) consequences for both patients and doctors.

crystal-ballCan telehealth hold this gain, and develop from this base? What will it look like for the average practice? Pay the lady with the crystal ball! CMS will eventually roll back the waivers on usage of non-HIPAA platforms such as Facetime (appropriately so for security and privacy reasons). Reimbursement by Medicare and commercial plans will be a major hot button. A recent survey of health system executives presented at the HLTH virtual conference indicated yawning uncertainty at the top level:

  • 30 percent of respondents said they were unsure what their plans are if telehealth reimbursements return to pre-COVID levels
  • 13 percent said they’d return to face-to-face visits
  • 20 percent said they’d continue doing virtual visits regardless
  • 17 percent said they’d analyze the financial viability of continued use

(Nokia-UPMC Center for Connected Medicine and Klas Research, Healthcare Dive)

More on this: The hazy post-pandemic future of telehealth and From back-to-work to telehealth to retail rebranding: HLTH 2020 takeaways   

Previously: As practices reopen, telemedicine visits continue to plunge from 69% to 21%: Epic (September), COVID effect on US practices: in-person visits down 37%, telehealth peaks at 14% (Commonwealth Fund through July)