News roundup: Now Clover Health faces delisting; BlackCat/ALPHV affiliate with 4TB of data puts it up for sale; $58M for Biolinq’s ‘smallest blood glucose biosensor’

Clover Health takes another pass at Nasdaq delisting. Once again, Clover’s Class A shares (CLOV) have been trading with an average closing price of below $1.00 over a consecutive 30 trading-day period, which violates Nasdaq’s continued listing minimum price criteria for the Nasdaq Global Select Market. This was announced in their most recent 8-K filed with the SEC 2 April. Clover has until 30 September to remedy the situation. An additional 180-day period may be elected if Clover transfers to the Nasdaq Capital Market. FierceHealthcare, Becker’s

The delisting is a rerun of their situation last year at this time. Clover considered a reverse stock split to be approved by shareholders but the share price improved on its own and the action was not necessary. This year, it may be. Clover is currently trading at $0.7365. Last August, it hit a high of $1.55 before sliding to below $1.00. An example of a SPAC through Social Capital Hedosophia Holdings, it hit a high of over $15 on 8 January 2021 before cracking that year based on revelations that Clover did not reveal a Department of Justice investigation starting the prior year, which prompted an SEC investigation [TTA 9 Feb 2021], triggering seven shareholder lawsuits that were not settled until December 2023. Clover Health exited the advanced value-based primary care program, ACO REACH, at the end of the 2023 performance year after two years to focus on their Medicare Advantage and Clover Assistant businesses [TTA 6 Dec 2023]. Financially, Clover closed 2023 with revenue of $2.033 billion (down from 2022’s $3.5 billion), net loss of $213.4 million, and an adjusted EBITDA loss of $44.7 million, with the losses improved over 2022. Clover release 

As predicted, 4TB of Change Healthcare data is up for sale. In a typical ransomwareiste move, the affiliate making nasty comments about BlackCat/ALPHV and claiming it had 4TB of data now has put the specs out on a dark web site called Ransomhub. The post first accuses ALPHV of stealing the $22 million ransom paid by UnitedHealth Group and not sharing it with the affiliate. It then claims it has highly sensitive data from multiple Change customers including active military PII (from Tricare), patient PII, payment and claims data, and much more. If Change/UHG isn’t interested, it will be up for sale to the highest bidder. Readers will recall the claims of ‘notchy’ early in the Change Healthcare attack [TTA 7 Mar] though UHG has not confirmed any payment to ALPHV. The demand for payment for the 4TB of data that ‘notchy’ claimed to possess was hardly unexpected. DataBreaches.net

A non-invasive “smallest ever” transdermal biosensor in development may turn the CGM business upside down. Biolinq’s latest round of $58 million will fund a pivotal clinical trial and FDA submission of its intradermal glucose sensor. The funding was led by Alpha Wave Ventures, with participation from Niterra’s corporate venture capital fund jointly operated with Pegasus Tech Ventures and existing investors RiverVest Venture Partners, AXA IM Alts, Global Health Investment Corporation, and four others, for a total since 2014 of $254 million. Crunchbase Current blood glucose sensors penetrate the skin with tiny needles. The Biolinq biosensor uses electrochemical sensors to measure glucose levels from the intradermal space just beneath the surface of the skin, on top of the capillary layer avoiding scarring. To access the intradermal layer, the sensors must be “200 times smaller than a human hair filament” according to Biolinq CEO Rich Yang. It also can combine blood glucose information with relative levels of activity in one device to eventually measure other analytes. The device as currently designed displays key information directly on the sensor–yellow light for high blood glucose, blue for normal. Release, MedCityNews

News roundup: ONC recommends ‘nutrition labeling’ for healthcare AI apps but Google moves forward; CVS’ health services rebranding as Healthspire (updated); Clover Health repots out of ACO REACH

Straining toward a model for AI app information? The latest grope by Federal regulators towards the “trustworthy use of artificial intelligence”, as the American Telemedicine Association terms it, is a labeling system that has been likened to ‘nutrition labeling’. This near-incomprehensible analogy to food labeling was proposed back in April by the Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC), now headed by Micky Tripathi, Ph.D. This disclosure would consist of how the app was trained, how it performs, how it should be used, and how it shouldn’t, which does not sound onerous at all. The disclosures are designed to forestall issues around performance and bias that have previously appeared, such as Epic’s AI system designed to predict sepsis risk and an algorithm designed to flag patients needing assistance with complex treatment regimens. 

An optional proposed disclosure around how the app was trained and tested would be important to healthcare organizations but potentially problematic to developers. There are quite a few caveats expressed by Silicon Valley investors around hurting startups and even giants like Epic through over-disclosure of proprietary information, enabling reverse engineering and poaching of intellectual property. Everyone likes transparency, trust, safety, and efficacy, but the conundrum is to disclose what is needed for proper and cautious use without providing an entreé to IP. Wall Street Journal, Becker’s, ATA release and AI principles 

Google, predictably, damns the torpedoes, full speed ahead with healthcare AI. And intends to write the rules. They’ve deployed AI tools already with Mayo Clinic and HCA Healthcare–Mayo for medical records and research papers, HCA for clinical notes. EHR Meditech is using Google’s AI for clinical documentation and to summarize patient histories. Bayer is also working with Google. Their products include a licensed algorithm for breast and lung cancer detection, a tool for diagnosing diabetic retinopathy, and a question-answering bot. Google makes no secret that they plan to influence Federal efforts at setting standards by hiring lobbyists, most of whom are out of the Food and Drug Administration (FDA), and playing a large role in industry groups such as the Coalition for Health AI (CHAI).  If you believe that Google, Microsoft, Amazon (playing catchup), or other healthcare service companies like UnitedHealth Group’s Optum will twiddle their thumbs and wait for the Feds to set standards and (good grief) enforce disclosure on AI tools, this Editor has several lovely bridges for sale. POLITICO, Becker’s

CVS Health grouping health services and multi-payer assets under CVS Healthspire. Monday’s announcement at the Forbes Healthcare Summit will roll up new $20 billion acquisitions Oak Street Health and Signify Health along with 1,100 MinuteClinics, the CVS Caremark pharmacy benefit manager (PBM), CVS Specialty, and its new Cordavis operation that works with pharmaceutical companies to bring to market  biosimilars. The rebranding, a clever melding of ‘health’ and ‘inspire’, will start this month into 2024. It’s not revealed whether the current names will be sunsetted for CVS Healthspire, or whether they will keep their established brand names. The parallels are with Evernorth (Cigna), Optum (UnitedHealth Group), and Carelon (Elevance, the former Anthem) in creating a vertically integrated healthcare company. At Investor Day, CVS Pharmacy announced a cost-plus arrangement for retail prescriptions built on the cost of the drug, a set markup, and a fee that reflects the care and value of pharmacy services–clearly in competition with Mark Cuban CostPlus.  Forbes, FierceHealthcare, CVS release, Investor Day release  

Clover Health exits the advanced value-based primary care program, ACO REACH. Clover’s exit at the end of the 2023 performance year after two years disbands their practice arrangements for CMS’ advanced original Medicare shared savings program, formerly Direct Contracting, and provision of beneficiary services after completing their required wrapups and reporting. It is part of their recent moves to become profitable, focusing on their Medicare Advantage business and Clover Assistant management. They outsourced their Medicare Advantage plan administration to UST HealthProof for a savings of $30 million and laid off 10% of staff as part of restructuring. A 2021 SPAC on Nasdaq debuting above $16 that survived investigations by the SEC and DOJ now has shares trading currently under the $1.00 minimum for listing. Clover also finally settled seven shareholder lawsuits over its non-disclosure of the DOJ investigation at the time of the SPAC. Cleaning house is all part of living to fight another day, like other ‘insurtechs’ such as Oscar Health. Clover release, FierceHealthcare  Also: Looking back at insurtechs and their ‘disruption’,  Insurtechs in the widening gyre

Living to fight another day: insurtechs Bright Health, Clover Health, and Oscar Health report improved Q2s, H1s (updated)

Have the upstart payers turned a corner–even if that means exiting the business? ‘Insurtech’ is the term given to the tech-enabled, health tech-friendly US payers which were supposed to deliver health insurance plans more efficiently (buy online!), more conveniently using apps and telehealth, lead in value-based care through strong networks, provider software, internal automation tools, and wrap it up with a ribbon of lower delivery cost to consumers, from those who needed individual exchange plans to Medicare Advantage. This utopian model cracked like the SPACs of Bright Health and Clover Health, and the IPO of Oscar Health, as this Editor noted last month, perhaps to the glee of traditional payers. But when survival is at stake, some surprising things can happen. All three are Not Dead Yet.

Bright Health Group succeeded last month in selling its remaining plans to ‘pure payer’ Molina Healthcare–their California Medicare Advantage plans Brand New Day and Central Health Plan. The deal: purchase 100% of the issued and outstanding capital stock of the two plans in a deal structured to be about $600 million. The Catch-22: stay solvent and absorb plan operational costs and losses (which are many) until Q1 2024 when the Molina deal will close. [TTA 6 July]

Last Friday (4 August), Bright secured a life preserver and line just as the waves started to crash–$60 million through a credit facility with an investment partnership of New Enterprise Associates (NEA). They also entered into a permanent waiver of default on its existing credit facility, which expires in February 2024. This has to refer to their prior $500 million credit facility with JP Morgan which was long overdue and now waived until the Molina close, apparently. Bright also is issuing penny warrants to NEA to purchase up to 1,656,789 shares of the Company’s common stock to the lenders under the new credit facility, approved by the board without the usual shareholder approval. This leaves an open question about who is really controlling the company. Release, Healthcare Finance, FierceHealthcare

There seems to be an even brighter (sic) picture in that their adjusted EBITDA for Q2 and H1 were actually in the black: $6.4 million for Q2 and $670,000 for H1. Even more bullishly, they project a full-year profitable adjusted EBITDA.

  • Reduced Q2 and H1 net losses: Q2 was $125 million versus $284 million in prior year. For H1 2023, the losses were $312 million and $488 million respectively.
  • Their other businesses in consumer care delivery, value-based care with providers in shared risk including ACO REACH (NeueHealth), and enterprise seemingly perform well. Their 2023 totals: consumer care $250-275 million, care solutions $900-925 million, and enterprise $1.15 -$1.2 billion.
  • Lives covered in value-based care are up to 371,000, an increase of 214% over last year’s 118,000–excluding any covered under their now exited commercial plans. ReleaseHealthcare Finance

Looking at Clover Health, it was revealed this week that they survived a delisting off Nasdaq, which happens when the minimum closing share price requirement falls below $1 for at least 10 consecutive days. Now with closings for 10 days over $1, they are in Nasdaq’s good graces for now. They are exploring a reverse stock split or authorized share reduction, to be discussed at the 30 August shareholder meeting.

Clover then followed this up with a cheerful lead in their Q2 results that they had adjusted profitable EBITDA of $10 million versus last year’s $83.9 million loss. This is also remarkable as their revenue fell by over $333 million to $513.6 million due to a drop in non-insurance revenue of $384 million. Insurance plan revenue made up some of it by growing 17% to $314.4 million. In total, Clover recorded a net loss of $28.8 million. But for the year, adjusted EBITDA is projected to remain in the red between $70 and $120 million. Mobihealthnews, FierceHealthcare, release

Clover provides both Medicare Advantage (MA) plans in eight states plus a tool for practices, Clover Assistant, which assists in patient chronic care management through machine learning and aggregated data. They also entered value-based care in 2021 in the Medicare Direct Contracting (now ACO REACH) model which was a major loss generator in 2022 (Healthcare Dive) and has been cut back. Clover also survived an epically cracked SPAC out of the gate in January 2021 with the news that the Department of Justice (DOJ) had been investigating the company on investor relationships and business practices starting in fall 2020. A little over a month ago, the company finally settled seven shareholder lawsuits over its non-disclosure of the DOJ investigation at the time of the SPAC [TTA 28 June]. 

Now to NYC-based Oscar Health reporting its Q2, the first under its new CEO Mark Bertolini [TTA 30 March]. Their adjusted EBITDA went from red to in the black with a Q2 of $35.6 million, an improvement of $111.4 million versus prior year, and the second profitable quarter in a row with H1 adjusted EBITDA of $86.6 million, improving by $198 million from 2022. Revenue for Q2 was $1.5 billion with H1 at $3 billion. Net loss narrowed substantially to $15.4 million, an improvement of $96.7 million versus prior year, with H1 loss at $55.3 million, reduced by 70% from last year’s $187.3 million. The year will still be in the red with projected EBITDA loss of $75 to $175 million. The reasons for this gap–two profitable quarters, but an overall disappointing year–are not clear.

Bertolini touted factors such as improved medical loss ratios and rate increases. Oscar also pulled out of unprofitable Affordable Care Act marketplaces in Arkansas, Colorado, and California, as well as trimming MA plans in New York and Texas. On the earnings call, they announced that they were given state approval to resume MA enrollments in Florida and that they were relaunching +Oscar with help from ChatGPT to build automation tools in its Campaign Builder platform. In other news, their CFO is stepping down on 13 August, but remains on the board. He will be replaced internally by the chief transformation officer. Other staff are reportedly changing. Release, Healthcare Dive, FierceHealthcare

Update: you may also want to read Ari Gottlieb’s comments on these three companies on LinkedIn from the view of an expert financial analyst. Further comments on Bright’s perilous situation and Clover’s ‘legitimately good quarter’ here.

Why the ‘insurtechs’ didn’t revolutionize health insurance–and the damage they may have done

crystal-ballIce water on hopes that many placed in ‘insurtechs’. This is the umbrella term that healthcare dubbed the upstart tech-enabled, health tech-friendly US payers which were supposed to deliver health insurance plans more efficiently (buy online!), more conveniently using apps and telehealth, with strong networks and at a lower delivery cost to consumers, from those who needed individual plans to Medicare Advantage. Around 2019-2020, these insurers gained billions in funding before going public through IPO or SPAC: Bright Health’s $500 million Series E in 2020 was only a chunk of their total $2.4 billion; Oscar Health raised $1.6 billion, Clover Health $1.3 billion. All three have struggled to stay clear of the insolvency precipice, with Friday Health Plans going over [TTA 23 June]. Bright Health Group will be exiting the insurance business after this year with the stock sale of their plans to Molina Healthcare–provided they survive to Q1 2024 [TTA 6 July]. Oscar and Clover have exited states and cut back offerings. In April, in a real retrenching, Oscar hired on Mark Bertolini, late of Aetna, pushing back a founder to an operational role. 

This Editor, in a marketing assessment for a client two years ago, believed as many did that Insurtechs Were The Future. At the very least, their practices would be adopted by the legacy insurers: easy online enrollment, lower premiums, predictive analytics, machine learning, digital documentation, online health education via apps, outsourcing areas such as customer service 24/7 and even marketing. Even those like Cigna through their Ventures arm bet some millions on insurtechs redefining payer-member relationships and payer structure, gaining better margins at profitable lines of business like Medicare Advantage (MA) and special needs plans (SNPs). After all, these plans did have people with decades of experience at insurers in their management, didn’t they, and they’d know what NOT to do. (And that’s the problem with gazing into crystal balls…eyestrain.)

Marissa Plescia’s article in MedCityNews is an excellent review on why the insurtechs’ centre did not hold. Key points made from her dive among the experts:

  • They underpriced and took heavy losses to grow their member base
  • They didn’t understand that some ‘inefficiencies’ in the health insurance market exist for reasons–perhaps not good ones, like state mandates through their departments of banking and insurance, but they exist and cannot be ignored. [Ed.–health education for MA has to be provided or at least available in written form in most if not all states]. Compliance can’t be skirted or ignored. Were they paying attention to the compliance of their plans?
  • They didn’t pay provider claims efficiently or at all [the SSM lawsuit of Bright]–a nifty way to lose networks and be sued by states, very damaging if the network wasn’t all that competitive to begin with.
  • Contracted rates with providers weren’t competitive. Were they managing risk adjusting coding well? 
  • Did they leverage sales channels beyond online such as brokers and their provider network? What about customer service?
  • The plans were not sticky enough to create some loyalty to an infamously non-loyal product

The insurtechs perhaps expected the technology to do too much–and for legacy payers to not catch up to them if they weren’t already moving there. Another problem–they (largely) were.

Disruption–but not the Clayton Christensen definition. Their disruption so far has been financial and legal (insolvency, cracked SPACs, lawsuits, share prices below $1.00, and delistings pending), loss of coverage for members; unpaid providers. With this track record, investors will avoid this category beyond the legacies. States won’t approve new plans from new companies. (This Editor believes that there are some overlooked positives such as inclusion in marketing of specialized and underserved groups, as well as some forced streamlining of processes.) There will be survivors–Alignment Health, kind of a below-the-radar operation and an afterthought in funding at $375 million, is in a few states and is mentioned. It’s also hard to bet against Bertolini leading Oscar–except that this is maybe Act V for him and he’s had his share of bunts and misses (bunt–ActiveHealth Management, misses–Healthagen, CarePass, iTriage) before his contentious departure from CVS. But in this particular widening gyre, while more revelations will be at hand, innovative newcomers in health plans won’t be seen for a long time, if ever. If the saga of airline deregulation (1980-1995) is a model, payer disruption just took a fraction of that time.

Mid-week roundup: Optum buying Amedisys home care for $3.3B; Clover Health settles 7 shareholder lawsuits around SPAC non-disclosures; Walgreens cuts 2023 outlook, stock plummets 11%

UnitedHealth Group expands home health again, aces out Option Care Health in all-cash deal. Amedisys had previously accepted Option Care’s all-stock deal in May valued at $97.38 per share. Optum’s offer is at $101 per share in cash, a dollar higher than its previous offer, creating a valuation for the company at $3.7 billion. Amedisys will add to UHG’s $5.4 billion acquisition of the LHC Group in February, including the hospital-at-home market from its acquisition of Contessa Health for $250 million in 2021. 

Option Care is a public (Nasdaq: OPCH) post-acute and home infusion care company for which Amedisys in-home care delivery would have been an exceptional fit. It was last heard from in August making a run at Signify Health for home health and ACO providers. At that time, the not-well-known company was discovered to have some impressive backing from Goldman Sachs. Walgreens Boots Alliance also backed the company but cut its stake in March and sold the rest for $330 million earlier this month. Option Care will receive a termination fee of $106 million. Healthcare Dive, FierceHealthcare

Insurtech Clover Health settles seven lawsuits around its 2021 SPAC. Clover, with Medicare Advantage plans in eight states, went public in January 2021 at the very peak of ‘blank check’-dom. Almost immediately, after an explosive report by Hindenburg Research that revealed that the Department of Justice (DOJ) had been investigating the company on investor relationships and business practices starting in fall 2020 [TTA 9 Feb 2021], there were multiple lawsuits filed by shareholders (derivative litigation) over not revealing this material fact. Shares took the expected dive from their intro of $15.90 to today’s $0.85. The seven derivative lawsuits were in Delaware, New York, and Tennessee courts and are being settled without payment. According to Clover’s release, “the defendants in the derivative lawsuits will receive customary releases and the Company will implement a suite of corporate governance enhancements. The settlement does not involve any monetary payment, other than payment of an award of fees and expenses to plaintiffs’ counsel, which has not yet been set. The defendants have denied all wrongdoing and have entered into this settlement to avoid the burden, expense, and distraction of ongoing litigation.” In April, Clover settled a securities class action in which the class will receive $22 million, $19.5 million paid by the company’s insurance. Mobihealthnews

Walgreens Boots Alliance missed Wall Street expectations and lowered its outlook for the year. In their Q3, net earnings fell 59% to $118 million, mostly due to lower operating income. Their topline was healthy–$35.4 billion, up 9% year over year–driven by the US health provider segment (VillageMD, Summit Health, and CityMD plus at-home care provider CareCentrix and specialty pharmacy Shields Health Solutions) which was up 22%. However, both retail consumer sales and CityMD underperformed due to the absence of COVID and a mild respiratory illness winter. Together with VillageMD’s clinic expansions, this led to an adjusted operating loss of $172 million for US Healthcare. WBA cut its earnings guidance for the year to $4.00 to $4.05 per share from its previous outlook of $4.45 to $4.65. Walgreens has been selling off businesses or investments that are peripheral to providing healthcare services, such as its investment in Option Care (above). FierceHealthcare, Healthcare Dive

Mid-week roundup: Kaiser Permanente to buy Geisinger, setup separate system; GoodRx co-CEOs step down; strong earnings for Centene, Humana; Clover Health stock woes, settles $22M lawsuit

Today’s big news was that Kaiser Permanente will be acquiring Geisinger Health. Technically, the acquisition is being made by Risant Health, a separate non-profit organization founded by the Kaiser Foundation Hospitals that will acquire other non-profit community health systems. Acquisition costs and a timetable for the transaction were not disclosed and will be subject to the usual state and Federal regulatory review and requirements.

Geisinger will be the founding system of Risant Health, a non-profit that will be headquartered in the Washington, D.C. area. Its current president, Jaewon Ryu, MD, JD, will become CEO when the acquisition closes. Risant’s purpose will be to advance value-based care by acquiring and connecting other multi-payer, multi-provider, community-based health systems in areas such as care model design, pharmacy, consumer digital engagement, health plan product development, and purchasing. 

Kaiser Permanente is a giant integrated care system with 12.6 million members based in California. It operates in eight states (California, Colorado, Georgia, Hawaii, Maryland, Oregon, Virginia, and Washington) and the District of Columbia. Geisinger Health is Pennsylvania-based, has 10 hospital campuses, its own health plan that covers more than 500,000 members, and the Geisinger College of Health Sciences with schools of medicine, nursing, and graduate education. Geisinger was also a pioneer in incorporating telehealth and remote patient monitoring into its healthcare system. The benefit to Geisinger joining Risant is that as the lead system, it will help to shape their operational model. Reportedly, Kaiser will spend $5 billion and acquire five to six health systems over the next five years. The health systems will retain their names and operational areas.

On the face of it, this seems to be a novel solution to both health systems’ challenges. Both have had operating losses and net losses in recent years and difficulty expanding out of their geographic areas. Kaiser has a tightly integrated health plan and service model that is location-dependent. Geisinger has been squeezed in Pennsylvania by UPMC and Penn Medicine along with other community systems. In 2020, it ended its effort to expand into southern New Jersey via a merger with AtlantiCare. However, this current administration and state regulators have not favored health system mergers, which has seemingly been anticipated by Kaiser in forming the Risant Health organization. Healthcare Dive, FierceHealthcare, Kaiser/Geisinger/Risant release

GoodRx names Scott Wagner as interim chief executive officer. Current co-CEOs and founders Doug Hirsch and Trevor Bezdek will be stepping down but staying with the company as chief mission officer and chairman respectively. Wagner was formerly CEO of GoDaddy and is a board member of other digital and advertising businesses. In February, GoodRx was the first ‘victim’ of the newly aggressive Federal Trade Commission policies on Meta Pixel and other ad trackers collecting user health-related data and sharing for revenue with Facebook, Google, Criteo, and other advertising sites. The FTC used the Health Breach Notification Rule, created in 2009, to GoodRx in a Federal court with misuse of consumer health information. Even though GoodRx is not a HIPAA-covered entity and they ended the practice in 2019, they settled with the FTC for $1.5 million. But the likely reason for the CEO change is that the company is still unprofitable. It ended 2022 with a net loss of $32.81 million and laid off 16% of staff last September. Mobihealthnews, FierceHealthcare

It’s earnings report season for payers. The news has been good for some, not for others. 

  • Centene reported year-over-year gains, with Q1 revenue of $38.9 billion versus prior year $37.2 billion. Q1 profitability also gained at $1.1 billion versus prior year $849 million, which missed Wall Street projections. Their outlook was scaled back due to Medicaid redeterminations, 2024 Medicare bids and investments. They also attributed the increased profitability through the strategic sale of Magellan Rx and internal reorganizations. Fierce Healthcare
  • Humana’s Q1 was also profitable and met Wall Street analyst expectations with earnings of $1.24 billion, or $9.87 a share (adjusted to $9.38/share), up from prior year $930 million, or $7.29 a share. This reflects investments in their Medicare Advantage business. Humana is projecting an aggressive target of a 17% membership increase, reversing from last year’s losses.  Fierce Healthcare
  • Clover Health’s Nasdaq notice, settles $22 million in SPAC class action lawsuit. Nasdaq notified Clover on 20 April that since their stock traded below $1.00 for 30 days, they have 180 days to 17 October to regain compliance with the Minimum Bid Price Requirement. This was disclosed in Clover’s SEC 8-K filing last week. There are other ways to maintain a listing (e.g. transferring to Nasdaq Capital Markets) but the anemic share price (closing today at $0.73, a drop of over 90% from the SPAC high) shows no signs of reviving. On Monday, Clover announced a $22 million settlement in a class action lawsuit filed in Tennessee around the company’s January 2021 SPAC. The following month, Hindenburg Research published that Clover did not disclose a Department of Justice (DOJ) investigation in 2020, claiming it was ‘non-material’ [TTA 9 Feb 2021]. The share price fell off the roof and kicked off multiple similar class action suits which are proceeding in New York and Delaware. Release

Insurtechs in the widening gyre: Bright Health sued for claims non-payment, fined $1M by Colorado; Clover Health lays off 10%, outsources operations

When the centre cannot hold, more revelations are at hand.

Bright Health, facing insolvency and a violation of a liquidity covenant by the end of this month, is now facing a lawsuit by health system SSM Health in the US District Court for the Western District of Oklahoma. At issue: payment of $13.1 million for 2,541 unpaid claims incurred for services SSM provided to Bright Health members between 1 January 2020 and 7 February 2023. This three-year plus timespan is not a simple glitch. SSM alleges in the suit that it provided $15.6 million worth of services in total to Bright Health plan members across facilities in three regions. In Oklahoma, SSM Health’s base, Bright exited Oklahoma’s Affordable Care Act exchange in December 2022 while under investigation by regulators. SSM has no contract with Bright to discount services in return for access to Bright’s network so charges the ‘rack rate’. The lawsuit docket is listed here though PACER is restricted access. FierceHealthcare

Bright Health is also under serious challenge at the state level. It was fined $1 million by the Colorado Division of Insurance (DOI) for violations during 2021-22. According to the DOI release, the complaints and violations centered on four areas: 1) failure to pay provider claims according to Colorado law; 2) failure to communicate with their members; 3) inability to accurately process consumer payments and accounts; 4) untimely processing of claims for physical and behavioral health coverage. $500,000 must be paid now, with the remainder held for specific improvement and compliance with metrics. Department of Regulatory Agencies (DORA) release  Bright is also under investigation in Tennessee, Texas, and Florida; it is under regulatory supervision in Florida and Tennessee with Texas considering receivership. Bright Health shares today closed at $0.164 and is on the verge of being delisted from the NYSE. Our recent coverage here.

New Jersey’s Clover Health, while not near the extremis that Bright is in, is cutting and outsourcing its way to profitability. Announced on Monday was a ‘corporate restructuring’ cut of 10% or 66 employees, based on public estimates of 656 (Pitchbook). Simultaneously, Clover’s CEO, Andrew Toy, announced outsourcing of core Medicare Advantage health plan operations to UST HealthProof in a move to increase operational efficiencies and reduce administrative costs. Both the layoffs and the UST implementation are expected to incur a 2023 first-half charge of $7-9 million, shifting to a $30 million savings beginning in 2024. Both moves were predictable as the company posted an $84 million loss in Q4 2022, a slight narrowing over prior year. Clover release, FierceHealthcare    Clover shares on Nasdaq were also below the delisting threshold at $0.80. Also industry analyst Ari Gottlieb on its overdue-ness on LinkedIn.

‘Insurtech’ Bright Health’s IPO second largest to date, but falls slightly short of estimates (updated)

Bright Health Group’s IPO last Friday (23 June) fell a little short of the $1 billion+ raise and valuation projection two weeks ago, but not by much on a bad market day. Their $924 million raise was based on a float of 51.3 million shares at an opening price of $18 per share, with a targeted price range of $20 to $23. (Thursday 1 July’s BHG close: $16.85, a typical pattern.)

The raise compares favorably to Oscar Health’s blockbuster $1.44 billion IPO, Clover Health’s controversial but lucrative SPAC [TTA 9 Feb]. and Alignment Health’s $490 million.  Bright Health also acquired Zipnosis, a telehealth/telemedicine ‘white label’ triage system for large health systems, in April [TTA 6 Apr].

The IPO now creates a company value of $11.23 billion, down from the expected $14 billion. Bright Health is unique in its category in not only offering exchange and Medicare Advantage plans but also NeueHealth, 61 advanced risk-bearing primary care clinics delivering in-person and virtual care to 75,000 unique patients. FierceHealthcare, Reuters, Bright Health Group release. Also see TTA 18 June and 28 May.

A smash Q1 for digital health funding–but the SPAC party may be winding down fast

An Overflowing Tub of Big Funding and Even Bigger Deals. The bubble bath that was Q1 deals and funding is no surprise to our Readers. Your Editor at one point apologized for the often twice-weekly roundups. (Better the Tedium of Deals than COVID and Shutdown, though.)

Rock Health provides a bevy of totals and charts in its usual quarterly summary of US digital health deals.

  • US funding crested $6.7 bn over 147 deals during January through March, more than doubling 2020’s $3.1 bn in Q1 over 107 deals.
  • Trending was on par through February, until it spiked in March with four mega-deals (over $100 million) over two days: Clarify (analytics), Unite Us (SDOH tech), Strive Health (kidney care), and Insitro (drug discovery). These deals also exceeded 2020’s hot Q3 ($4.1 bn) and Q4 ($4.0 bn).
  • Bigger, better. Deals skewed towards the giant economy size. $100 million+ deals represented 66 percent of total Q1 funding
  • Deal sizes in Series B and C were bigger than ever, with a hefty Series B or C not uncommon any more. Series B raises were on average $49 million and C $77 million. One of March’s megadeals was a Series B–Strive Health with a $140 million Series B [TTA 18 Mar].
  • Series A deal size barely kept up with inflation, languishing in the $12 to $15 million range since 2018.
  • Hot sectors were a total turnaround from previous years. Mental health, primary care, and substance use disorders, once the ugly ducklings which would get their founders tossed out of cocktail parties, became Cinderellas Before Midnight at #1, #2, and #3 respectively. Oncology, musculoskeletal (MSK), and gastrointestinal filled out the Top 6 list.
  • M&As were also blistering: 57 acquisitions in Q1, versus Q4 2020’s 45

Given the trends and nine months to go, will it blow the doors off 2020’s total funding of $14 bn? It looks like it…but…We invite your predictions in the Comments below.

Les bon temps may rouler, but that cloud you see on the horizon may have SPAC written on it. A quick review: Special Purpose Acquisition Companies (SPACs) typically are public companies that raise money through their own IPOs for the express purpose of buying other companies. Often called a ‘blank check’, they have no purpose other than buying one or two other companies–in the latter case, merging them like the announced Cloudbreak and UpHealth last November–and converting over to the company’s identity and business. The timeframe is usually two years. Essentially, the active company goes public with a minimum of the messy, long, expensive, and revelatory process of filing directly with the SEC (in the US). This quarter, Rock Health’s stat on SPACs was that they raised $83.1 bn this quarter, exceeding by $0.5 bn all SPAC activity in 2020, mainly late in the year. Their count was two SPACs closing in Q1 and 8 more announced but not yet closed (counting Cloudbreak/UpHealth as one).

As an exit door for investors, it’s worked very well–but is dependent on private equity and public investors having confidence in SPACs. One thinning of the bubble may be the scrutiny of Clover Health’s SPAC by the SEC [TTA 9 Feb] over not revealing that they were under investigation by the Department of Justice (DOJ). Certainly this was a material circumstance that could dissuade investors, among other dodgy business practices later unveiled. Mr. Market tells a tale; Clover went public 8 Jan at $15.90 and closed today at $7.61. Their YahooFinance listing has a long list of law firms filing class-action lawsuits on behalf of shareholders.

Clover may be the leading edge of a SPAC bust. SPACs are losing their luster because there are too many going through, jamming bandwidth at the bank and law firm level. As time ticks by and deals are delayed, the private funders of SPACs are growing squeamish, according to this report in National Review’s Capital Note (yes, National Review has a finance newsletter). “In the past two weeks alone, four blank-check deals have been halted, with SPAC shares declining significantly from their highs early this year. The slowdown follows an influx of short-sellers into the opaque financial vehicles and a sell-off in high-profile SPACs such as Churchill Capital Corp IV.” Reasons why: lower quality of companies available to go public via SPAC–the low hanging ripe fruit has been picked–and the last mile in SPACs, which is PIPE funding (private equity-investment-in-public-equity financing) is getting skittish. The last shoe to drop? The SEC in late March announced an investigation into SPACs, making inquiries into several banks seeking information on their SPAC dealings, which is alluded to near the end of the Rock Health report. CNBC  (Read further down into the NR article for a Harvard Business Review dissection of the boom-bust dynamics of ‘controversial practices’ like reverse mergers as a forecast of what may happen to SPACs. Increased popularity led to increased negativity in reverse mergers.)

And speaking of SPACs...Health tech/digital health eyes are upon what Glen Tullman and the ‘late of Livongo’ team will be doing with their SPAC, Health Assurance Acquisition Corp., which is backed by Hemant Taneja’s General Catalyst, also a former Livongo funder. Brian Dolan, who is now publishing Exits and Outcomes. His opinion is their buy will be Color, formerly Color Genomics: opinion piece is here. Messrs Tullman and Taneja are also leading Transcarent, a company that brings together employers, employees, and providers in a seamless, app-driven integrated care model. Forbes

The cool-off in SPACs may burst a few bubbles in the bath–and that may be all to the good in the long term.

‘Neoinsurer’ Oscar Health goes for $100 million IPO; Clover Health’s big SPAC under SEC microscope

Oscar Health, one of a number of US ‘insurtech’ or ‘neoinsurance’ private health insurance companies that have nipped at the heels of the Big 9, announced late Friday an IPO on the NYSE. The number of shares and their value is not on the SEC S-1 filing but the estimate of the raise is $100 million. Timing is not disclosed but rumored to be by March or early Q2. The offering is underwritten by Goldman Sachs, Morgan Stanley, and Allen and Company.

Oscar was one of the first to offer members apps, telehealth, and fitness trackers–revolutionary back in 2012 but routine now. Expanding beyond its original base of individual health insurance coverage, it now offers Medicare Advantage and small group coverage in 18 states to over 500,000 members. Oscar remains a virtual-first platform with the majority of its members in Florida, Texas, and California. Oscar makes much of member engagement and its partnerships; 47 percent of its overall subscribing membership and 44 percent of its 55-and-up subscribers are monthly active users. Oscar has also partnered with Cleveland Clinic and other larger insurers like Cigna. 

Financing for Oscar to date is over $1.5 bn. It has tidily grown in geographic coverage, members, and revenue–$1.67 billion in 2020 and $1.04 billion in 2019–no simple feat against the Big 9. Oscar’s problem is profitability–operating losses grew proportionately, $402.3 million (+56% from $259.4 million). Operating expenses also grew by 16 percent. TechCrunch gives additional crunch in the financial analysis (article in part, full paid access). Mobihealthnews

Oscar is one of a few health-tech heavy survivors of insurance companies that bloomed like flowers–and wilted–during and post-Obamacare. Clover Health, which thrived in a slice of the Medicare Advantage market, went the SPAC (blank check) route 8 January with Social Capital Hedosophia Holdings. Now with an enterprise value of approximately $3.7 billion, the SPAC indeed put Clover in the clover [TTA 14 Jan].

But perhaps short-lived. Clover’s SPAC is now being scrutinized by the SEC based on last week’s explosive charges by short-seller maven Hindenburg Research (!). Hindenburg’s research report alleges that Clover “lured retail investors into a broken business” by not disclosing a Department of Justice (DOJ) investigation that started (at least) last fall. Clover countered that the investigation is “routine” since Clover is in the Medicare business. Thus, it was not disclosed by Clover to investors as ‘non-material’. DOJ investigations are far more serious than CMS fines for compliance violations, which are not uncommon. Back in 2016, Clover was fined just over $106,000 by CMS on misleading marketing practices.

In short, DOJ investigations are never routine. They usually are the start point for enhanced claims scrutiny and a concatenation of charges, as WellCare, then a scrappy upstart insurer, found out over six agonizing years, 2006-2012, that were serious enough to send much of top management to Club Fed.  The Hindenburg paper (linked above) details other business practices that if true, are dodgy at best and fuel for further investigations.

The SEC notice of investigation was disclosed by Clover last Friday evening, usually a good time to disclose Bad News. This SPAC may have feet of clay.  PYMNTS.com, CNBC

Comings, goings, and more: YouTube goes healthy, COVID vax distribution and EMA hack, IPO/M&A roundup, Japan’s health tech startups highlighted at CES

Short takes on news snippets from just about everywhere. It’s been that kind of a week. (Picture: the famous Raymond Loewy-designed ’49 Studebaker Commander, of which it was joked ‘you can’t tell whether it’s coming or going)

Google-owned YouTube has decided to take a more organized approach to healthcare content with the hiring from CVS Health of Garth Graham, MD, who will serve as its director and global head of healthcare. At CVS, he was chief community health officer and president of the Aetna Foundation. His portfolio will include the development of content from providers including the Cleveland Clinic, the Mayo Clinic, the National Academy of Health, and Harvard’s School of Public Health. It’s seen as a platform for video-formatted health education both US and globally. The importance to Google is evident in the reporting line: Dr. Graham will report to Karen DeSalvo, MD, the chief health officer at Google. One wonders if the next step is the curating (a/k/a demonetizing or removal) of health content not Google-generated. FierceHealthcare, YouTube press release

Some states have done well on COVID-19 distribution. Others haven’t. It apparently doesn’t matter if you’re large or small. In the US, states were given vaccines based on CDC information and consultation with them. The states then designed their own distribution and priorities. Here’s a running tally on Becker’s Hospital Review Meanwhile, back in Hackerville, the European Medicines Agency (EMA) confirmed on 12 January that data relating to regulatory submissions by Moderna, Pfizer, and BioNTech that were on a hacked server was leaked to the internet. Becker’s

In IPO/M&A news:

Centene Corporation is acquiring Magellan Health, a behavioral health, specialty healthcare, and pharmacy management company, for $2.2 billion. Centene continues its transformation into a UnitedHealthcare structured company, with payer programs on one side and health services including population health management, data analytics and other areas of health tech on the other side. Magellan will be operated independently. The deal requires Federal and state review, and is expected to close in second half 2021. Release  Magellan this week announced its lead investment in a $20 million Series B raise by Philadelphia-based NeuroFlow, a clinical behavioral health monitoring system. Philadelphia Business Journal

Amwell announced a public offering of over 11 million shares. The date and pricing for the offering were not mentioned in the release, but at the current share price of $28, this would raise in excess of $308 million. This is on top of their socko IPO last September which raised in excess of $700 million. 

Behavioral therapy continues to be hot, with online behavioral therapy company Talkspace going the SPAC ‘blank check’ route in merging with investor company Hudson Executive Investment. It provides them with $250 million cash. Estimated net revenue is $125 million in 2021, up 69 percent from 2020, creating an enterprise value of $1.4 bn, which is quite a reach. Healthcare Dive, release.

Medicare Advantage payer Clover Health of Jersey City, NJ also went the SPAC route this week with Social Capital Hedosophia Holdings Corp. III, giving it an enterprise value of approximately $3.7 billion. Clover Health styles itself as a health tech company as it analyzes member health and behavioral data to improve medical outcomes and lower costs for patients, many of whom have multiple chronic conditions or are classified as underserved.  Release

Israel’s Itamar Health, which focuses on integrating sleep apnea management into the cardiac patient care pathway, is buying SF-based Spry Health for an undisclosed amount. Founded in 2014, Spry has an FDA-cleared wrist-worn device, the Loop System, that monitors SpO2, respiration rate, and heart rate. Itamar plans to develop a wrist-worn device based on their Peripheral Arterial Tonometry (PAT) immediately, with initial market launch anticipated in 2022. Release

Hinge Health’s Series D raised $300 million and a new valuation of the company at $3 bn. (Remember when $1 bn was a unicorn amount?) Hinge’s specialty is musculoskeletal–a virtual MSK Clinic for back and joint pain care and rehab including access to physical therapists, physicians, health coaches, and wearable sensors to guide exercise therapy. Release

In startup news…Under the radar, Japan has been developing a crop of health tech startups. They were highlighted at this year’s virtual CES by Jetro–the Japan External Trade Organization. Their CES web page has a teaser video and sortable profiles on companies, many of which look very interesting. According to their materials, there are perhaps 10,000 Japan startups but few of them make it out of Japan. This Editor looked forward to their presentation on ‘Turning the Super Aging Society into a Super Smart Society’ yesterday evening, but virtual doesn’t mean that links work or events actually happen, so our reporting will attach some statistics on their super-aging society, as well as a comparison with other countries (PDF).

Where’s the evidence? Healthcare unicorns lack the proof and credibility of peer-reviewed studies.

Another sign that too many healthcare unicorns are decoupled from the rock-solid fundamental reality–that they work. Healthcare unicorns–those startups valued over $1 bn–are unicorns because they have patents, processes, or a line of business that has immense potential to be profitable. The standard in healthcare, unlike other tech, is the peer-reviewed study. Is this process or device effective based upon the study? Does this drug looks like it will work? Is this study validating, encouraging? Peer-reviewed research takes place before a drug or device goes into clinical trials — a precursor. It ensures a certain level of disclosure, validation, and transparency at an early stage.

Instead, these unicorns largely rely on ‘stealth research’–a term coined by Dr. John P.A. Ioannidis, the co-director of the Meta-Research Innovation Center at Stanford University (METRICS). He summed it up in his latest peer-reviewed paper, “Stealth research: lack of peer-reviewed evidence from healthcare unicorns” (co-authored with Ioana A. Cristea and Eli M. Cahan), published in the European Journal of Clinical Investigation 28 Jan: 

In 2014, one of us (JPAI) wrote a viewpoint article coining the term “stealth research” for touted biomedical innovation happening outside the peer-reviewed literature in a confusing mix of “possibly brilliant ideas, aggressive corporate announcements, and mass media hype.”

The term ‘stealth research’ was prompted to the author by the practices of Theranos–ironically, a company that started and was funded in the Stanford nexus. By the time Dr. Ioannidis’ viewpoint paper was published in JAMA in Feb 2015, Theranos had ballooned to a $9 bn valuation. His paper was the first to question Theranos’ science–and Theranos aggressively pushed back against Dr. Ioannidis, including their general counsel attempting to convince the author to recant his own writing. Three years later, we know the outcome.

This latest study concludes that there is a real dearth of peer-reviewed research among healthcare unicorns–and that it’s detrimental. It measured whether these unicorns published peer-reviewed articles and whether they publish highly-cited (in other publications) articles; compared them against companies with lower valuations; and whether founders or board members themselves impacted the scientific literature through their own citations.

The meta-study looked at 18 current and 29 exited healthcare unicorns. Highlights:

  • Two companies–23andMe and Adaptive Biotechnologies published almost half of all unicorn papers–196 combined
  • Three unicorns (Outcome Health, GuaHao and Oscar Health) had no published papers, and two more (Clover Health, Zocdoc) had published just one
  • Seven of the exited unicorns had zero to one papers
  • In fact, ‘there was a negative, non-statistically significant association between company valuation and number of published or highly-cited papers’

As our Readers know, Outcome Health had a little problem around artificially inflated advertising placement wrapped in health ed and placed in doctors’ offices [TTA 29 Jan 18]. Oscar and Clover Health are insurers. Zocdoc…well, we know their business model is to get as many doctors to sign up in their scheduling app and pay as much as possible. But it’s the drug and device companies that are especially worrisome in a stealth research model. The paper points out among other examples StemCentrx, bought for $10.2 bn in 2016 by AbbVie for its Rova T targeted antibody drug for cancer treatment, was halted at Phase III because it was not effective. Acerta Pharma, also focused on cancer treatments, was bought by AstraZeneca for $7.3 bn; two years ago, AstraZeneca had to withdraw the Acerta data and admit that Acerta falsified preclinical data for its drug.

The conclusions are that healthcare unicorns contribute minimally to relevant, high-impact published research, and that greater scrutiny by the scientific community through peer-reviewed research is needed to ensure credibility for the underlying work by these startups. “There is no need for numerous papers. Discrete pivotal, high-impact articles would suffice.”

This Editor returns to #5 on Rock Health’s Bubble Meter: high valuations decoupled from fundamentals. Based on this, the lack of publishing represents risk–to investors and to patients who would benefit from better vetted treatments. To these companies, however, the risk is in having their technology or researched poached–as well as the investment in time and money research represents.

The study authors point out several ways to minimize the risk, including collaborating with academic centers in research, validation without disclosing all technical details, secure patents, and contributing their technology to other research. A higher-risk way is to “withhold significant publications until successful validation from agencies such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA)” but usually investors won’t wait that long. ‘Stealth Research’ paper, TechCrunch review Hat tip to David Albert, MD, of AliveCor via Twitter

CVS’ bid for Aetna–will it happen, and kick off a trend? (updated)

We have scant facts about the reported bid of US drugstore giant CVS to purchase insurance giant Aetna for a tidy sum of $200 per share, or $66 billion plus. This may have been in development for weeks or months, but wisely the sides are keeping mum. According to FOX Business, “an Aetna spokesperson declined to chime in on the reports, saying the company doesn’t “comment on rumors or speculation” and to Drug Store News, a CVS Health spokesperson did the same. Aetna’s current market cap is $53 billion, so it’s a great deal for shareholders if it does happen.

Both parties have sound reasons to consider a merger:

  • CVS, like all retailers, is suffering from the Amazon Effect at its retail stores
  • Retail mergers are done with the Walgreens Boots AllianceRite Aid merger going through considerable difficulties until approved last month
  • The US DOJ and Congress has signaled its disapproval of any major payer merger (see the dragged-out drama of Aetna-Humana)
  • It has reportedly had problems with its pharmacy benefit management (PBM) arm from insurers like Optum (United HealthCare), and only last week announced that it was forming a PBM with another giant, Anthem, called IngenioRx (which to Forbes is a reason why this merger won’t happen–this Editor calls it ‘hedging one’s bets’ or ‘leverage’)
  • Aetna was hard hit by the (un)Affordable Care Act (ACA), and in May announced its complete exit from individual care plans by next year. Losses were $700 million between 2014 and 2016, with over $200 million in 2017 estimated (and this is prior to the Trump Administration’s ending of subsidies).
  • It’s a neat redesign of the payer/provider system. This would create an end-to-end system: insurance coverage from Aetna, CVS’ Minute Clinics delivering care onsite, integrated PBM, retail delivery of care, pharmaceuticals, and medical supplies–plus relationships with many hospital providers (see list here)–this Editor is the first to note this CVS relationship with providers.

We will be in for more regulatory drama, of course–and plenty of competitor reaction. Can we look forward to others such as:

  • Walgreens Boots with Anthem or Cigna (currently at each others’ throats in Delaware court
  • Other specialized, Medicare Advantage/Medicare/Medicaid networks such as Humana or WellCare?
  • Will supermarkets, also big retail pharmacy providers, get into the act? Publix, Wegmans, Shop Rite or Ahold (Stop & Shop, Giant) buying regionals or specialty insurers like the above, a Blue or two, Oscar, Clover, Bright Health….or seeking alliances?
  • And then, there’s Amazon and Whole Foods….no pharmacy in-house at Whole Foods, but talk about a delivery system?

Also Chicago Tribune, MedCityNews.

UPDATED. In seeking an update for the Anthem-Cigna ‘Who Shot John’ court action about breakup fees (there isn’t yet), this Editor came across a must-read analysis in Health Affairs 

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