TTA’s Blooming Spring: Walgreens tidies opioids for $350M, health AI more show than go, Blue Shield CA’s Googly breach, Veradigm’s CEO to depart, BCI meets telehealth for stroke, fundings, more!

25 April 2025

Back at the desk….hope your holiday was great!

Cherry blossoms are blooming (finally) and so is the news. The roundups include Walgreens’ continuing Aisle 9 cleanup of their Federal opioid prescribing allegations, a huge and mysterious breach of Google Analytics sending member info to Google Ads, and Veradigm’s interim CEO will be taking the summer off. Our big reads include two surveys: the first on the state of healthcare AI (more show than go) and the second on RPM utilization–and effectiveness. Two raises, a BCI/telehealth merge, and international initiatives.

Product & funding very short takes: South Australia 1st with Sunrise EMR; S. Korea pain research, new emergency services app; BCI + telehealth for stroke patients; VirtuSense monitoring launches at Emory; Series B raises for Nourish, Healthee

Short takes: Veradigm’s interim CEO departing, Blue Shield CA breached 4.8M members’ PHI to Google, advice on expanded M&A premarket notification rules (You can’t blame that CEO for ankling! And Blue Shield has 2nd largest breach–involving Google Analytics.)

News roundup: Walgreens’ $350M opioid settlement, only 30% of healthcare AI pilots reach production, Medicare RPM usage up 10-fold despite benefit limitations (Walgreens cleans up again, and two surveys on AI and RPM for weekend perusal)

Two weeks ago, we were still going through a chilly Spring. Our big pre-Easter/Passover read for the weekend was Halle Tecco’s quantifying of the Cracked SPAC phenomenon and what’s happened with OpenAI. Transcarent closes its Accolade buy and changes its tune to ‘one place’, Walgreens doing a bit better. In touting, Keir Starmer’s bet on NHS data research and Elon Musk on human trials for Neuralink Blindsight. Hinge Health may postpone its long-awaited IPO and FTC pauses its long-awaited toss of the book at PBMs. Plus a new Perspectives on rural healthcare and telehealth.

The weekend read: why SPACs came, went, and failed in digital health–the Halle Tecco analysis/memorial service; why OpenAI is going to be a bad, bad business (Grab the cuppa and lunch for a good read and podcast. Updated–Also Tecco’s blog post on why she quit being an angel investor.) 

Extra, extra!: ATA Action forms Virtual Foodcare Coalition, Ophelia and Spring Health partner on opioid treatment, ISfTeH renews NSA status with WHO (More action from ATA Action and a partnership to watch in telementalhealth)

Midweek roundup: Transcarent closes Accolade; Walgreens beats Street; New Mountain Capital’s Office Ally buy-in; Neuralink Blindsight human trial coming up; PM Keir Starmer touts NHS data research; FTC’s PBM litigation break (Transcarent’s pivot?)

Rock Health’s digital health Q1: more money, fewer deals, more additions and partnerships in ‘leapfrogging’ (Still in a minor key this year)

News roundup: Hinge Health may postpone IPO, Rite Aid may enter 2nd bankruptcy, Veterans Affairs committees want new EHR costs & timeline, fired Texas health plan head hired private eyes to spy on members, providers, lawmakers (The last one is shocking)

Perspectives: Bridging the Gap in Rural Healthcare Through Telehealth (From Yosi Health)

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Short takes: Veradigm’s interim CEO departing, Blue Shield CA breached 4.8M members’ PHI to Google, advice on expanded M&A premarket notification rules

Veradigm’s interim CEO departing, CFO continuing. Tom Langan, who has been in place as Veradigm’s CEO for the last 11 months, will be departing after a little more than 13 months, according to Veradigm’s SEC Form 8-K securities filing dated 22 April. The former president and chief commercial officer (CCO), who replaced an earlier interim CEO, Dr. Dr. Shih-Yin (“Yin”) Ho, on 7 June 2024, has signed a separation agreement effective 31 July. According to the filing, the Veradigm board will be resuming a search for a permanent CEO. Mr. Langan declined the opportunity to participate as a candidate.

Lee Westerfield, who has been interim CFO since 7 December 2023 through three six-month agreements, has signed an extension until 31 December. 

Both Mr. Langan and Mr. Westerfield have been through considerable tumult at Veradigm: first (for Mr. Langan), the inability to file audited financial reports for 2022-24; the failed effort to sell, merge, or find a strategic partner [TTA 31 Jan]; finally, a major investor, Kent Lake, stepping in and controlling the board with the chairman stepping down as well as two other directors [TTA 22 Feb]. While the 2022 financial report was released last month along with 2025 guidance, the catchup won’t be done until sometime in 2026 [TTA 19 Mar].

One could not blame either of them, but especially CEO Langan, for tiring of the entire situation. He has been there in various positions since 2018 when it was Allscripts. His tenure will certainly be worth his while. Based on the filing, after termination he will receive $1.4 million over 12 months, which is a year of salary plus his target bonus; a lump sum cash payment for $406,000 for his pro-rated annual bonus, based on target performance; a year of health and dental coverage at active employee rates; and reimbursement of $10,000 in attorney’s fees incurred in negotiation of the separation agreement. His unvested portions of the stock options, restricted stock units or other equity awards will vest through those dated 31 July 2027. CFO Westerfield, on board as an interim for a considerably shorter time but in a mission-critical position, has a less golden package–a simple pay continuance through the end of the year plus five months if he is terminated not for cause or departs for good reason. Healthcare Dive

Blue Shield of California breached personal health information (PHI) via Google, in the second largest breach of 2025 to date. The unusual breach was not from the usual bad actor, but from Blue Shield’s use, unbelievably, of Google Analytics. According to their submission to the Department of Health and Human Services’ Office for Civil Rights’ (HHS-OCR) breach portal, their Google Analytics on how customers used their websites was configured in such a way that sent selected member PHI data over to Google Ads. Google Ads could then send these users and members targeted advertising. This went on for three years, ending only in January 2024. 

The data included:

  • Insurance plan name, type and group number
  • Patient names, city, ZIP code, gender and family size
  • Blue Shield of California identifiers for members’ online accounts, medical claim service date and service provider and patient financial responsibility.

It may have also included data around “Find a Doctor” search criteria and results, such as location, plan name and type, provider name and type. Other sensitive information, such as SSI#, credit cards, and driver license numbers, were not included. Because of its duration, it could potentially affect up to 4.8 million BSC members. BSC’s notice

The questions are–who programmed it this way? Was it Google? And if Google, who is responsible there? Is it configured that way at other health plans? And if not Google, who did it at BSC?

The analyses in both FierceHealthcare and Healthcare Dive point accusing fingers at Google, which has also been kicked very hard by the Department of Justice in their antitrust win on Google’s online advertising products or “ad tech stack” that dominates the industry–and may force the divestiture of Google Chrome as the result of another decision on web search. The Verge

M&A-ing? Premarket Notifications now in place makes it tougher. Our series of articles in 2023-24 explained the steeper requirements to our Readers for transactions that fall under the nearly 50-year-old Hart-Scott-Rodino (HSR) Act requirements. The threshold of value for 2025 is set at $126.4 million. Our 15 October 2024 overview summarizes the changes and links to other documentation on the many changes, particularly around the buyer’s investors and a five-year lookback at the under-the-HSR-wire serial acquisitions (rollups) made by both companies. The information required now is much more extensive and demanding. FTC will also have an online portal for comments on every acquisition. HIMSS has a six-minute plus interview with Michael Ramey, a managing principal of Strategic & Transaction Solutions at PYA (better known to many of us as Pershing), that touches on the highlights.

News roundup #2: why Walgreens is considering selling to a PE, December fundings, 2024’s surprises, M&A ’25 predictions, Transcarent buying Accolade for $621M

Why would Walgreens sell out to a private equity investor, reportedly Sycamore Partners? This news leaked early in December to the Wall Street Journal that this PE would either buy Walgreens Boots Alliance (WBA) in whole, in parts, or with partners [TTA 10 Dec 2024]. This MedCityNews article gathers the speculation from multiple financial executives, and the answer is a resounding Maybe.

  • Primary care was a losing bet–and their retail pharmacies are challenged by new models like Amazon Pharmacy and Cost Plus.
  • It will take about $9.2 to $10 billion, which is a lot for Sycamore to pony up. But it’s a bargain from what PE giant KKR offered in 2019– $70 billion.
  • Sycamore may have competition for buying WBA.
  • The 12,000 store network is now seen not as an asset, but a liability, not only for pharmacy but also for retail goods.
  • Sycamore may be more interested in the retail and e-commerce sides of Walgreens versus healthcare. For instance, WBA company Boots in the UK has leveraged its beauty business to nearly the prominence of health in their stores.
  • A private company may have more power to swiftly make the changes that Walgreens needs, versus a company having to report quarterly to shareholders. 

There was the usual rush to announce fundings by December’s end, a refreshing change from 2023’s end. MedCityNews helpfully rounded up five of the last-minute closings:

  • Already noted: Oura’s $200 million plus funding for a Series D from Dexcom ($75 million) and Fidelity Management. Our earlier reporting noted total financing at $223 million and the valuation at $5 billion.
  • Cleerly’s $106 million Series C led by Insight Partners. Cleerly developed AI-assisted detailed phenotyping of coronary artery disease.
  • Remodel Health gained $100 million in a funding led by Oak HC/FT and Hercules Capital. Remodel works with employers and employees to build and access Individual Coverage Health Reimbursement Arrangement (ICHRA) plans.
  • Cala Health raised $50 million from Vertex Growth Fund and Nexus NeuroTech Ventures. Cala is a bioelectronic medicine company which developed FDA-cleared, noninvasive devices for hand tremors.
  • Soda Health’s $50 million Series B, led by General Catalyst, is in the hot sector of ‘food as medicine’. Soda provides a ‘smart benefits’ card to use at approved retailers for food, health products, and pharmacy benefits.

2024 had its share of surprises in this two-part Mobihealthnews roundup. No surprise for our Readers in that GLP-1 drugs for weight loss went to radioactive-level hot (but this Editor predicts a collapse in 2025). The failure of retail clinics such as Walmart Health and VillageMD surprised many in the industry–as well as Optum shuttering its telehealth business. Developing: menopause and autoimmune health (and their relationship)–and food as medicine. On the insurance side, the troubles of the Medicare Advantage health plan model multiplied, not moderated. And AI? On top of everything, but you maybe shouldn’t develop your own LLM. Part One, Part Two

Predictions for 2025 mergers and acquisitions center on consolidations. There’s little foo-foo or froth in this Mobihealthnews article– instead, lots of New Reality. Many pandemic-born startups will die quiet deaths in sales, shotgun marriages, and shutdowns. Much caution in any M&A. The emphasis is on interoperability, which is widely defined as acquirer-acquiree and a clearly presented integrated value proposition to customers. Their industry leader panel cannot agree whether M&A will accelerate as a result of changes at FTC (Lina Khan’s departure and a new chair) or slow down. And at least one leader believes that Medicare Advantage will stabilize and recover.

But one buyer plays it high and wide in ’25–the deep-pocketed Transcarent, agreeing to buy Accolade for $621 million in 2025’s First Big Deal. Accolade is also in enterprise care navigation, as well as providing virtual primary care, specialist consultations, and patient advocates. It went public on Nasdaq in 2020. Transcarent’s offer is $7.03 per share in cash, an approximately 110% premium over the company’s closing stock price yesterday 7 January. The funding is coming from General Catalyst (!) and Glen Tullman’s 62 Ventures. Accolade will go private at the closing, expected to be Q2 following shareholder and regulatory approvals, and be integrated into Transcarent. The combined Transcarent will have 1,400 employer and payer clients. Release, Healthcare Dive

FTC drops the hammer on premerger notification requirements–what will be M&A and investment effects?

Premerger Notification just got a lot tougher. As the Federal Trade Commission (FTC) and the Department of Justice (DOJ) Antitrust Division promised us back in June 2023, FTC has now finalized their changes on the Premerger Notification rules. Changes were pared back after public review and comments, notably by the American Hospital Association (AHA) but thousands of others. The Final Rule will take effect 90 days after publishing in the Federal Register. 

Premerger Notification applies to mergers and acquisitions that fall under the 48-year-old Hart-Scott-Rodino Act (HSR). Companies larger than the threshold (previously $111.4 million) must submit information based on standard forms in advance of filing the merger or acquisition. Both agencies then have 30 days to determine whether or not the M&A is legal or not especially around antitrust and restricting competition. Either agency can request additional information from the companies, extending the process through a Second Request. The purpose is to deny M&A in advance that may violate primarily antitrust law–an approach that has had mixed results in the past decade or so.

This is the first time in just under 50 years that there have been other than minor changes to the Premerger Notification Form. The new rules considerably tighten requirements–and increase paperwork. The Final Rule changes from the FTC press release were clearly highlights and not a full list:

  • Additional transaction documents from the supervisor of each merging party’s deal team as well as a small set of high-level business plans related to competition. 
  • A description of the business lines of each filer to reveal existing areas of competition between the merging firms (including for products or services that are in development) and supply relationships
  • Disclosure of investors in the buyer, including those with management rights. According to Healthcare Dive’s analysis, this will also include minority stakeholders and investors. FTC has recently focused on the rise of private equity investments across all M&A, which have increased to over 40% of transactions (2022), but less in healthcare varying by sector (e.g. 8% hospital, up to 11% of nursing homes).

The Healthcare Dive analysis, unlike the FTC release, confirmed that both acquirer and acquiree have to detail their prior acquisitions within a five-year window. FTC is going after “roll-ups,” the small, under-the-HSR-wire serial acquisitions that private equity groups and some companies utilize. Previously, only the acquirer had to disclose this information. Roll-ups have become popular in healthcare and health tech as startup companies with similar or complementary technologies attempt to grow and in some cases survive market evolutions.

The FTC’s Premerger Notification Office (PNO) will provide future compliance guidance in advance of the final rule’s effective date on the PNO’s website. The FTC estimates that the additional information required will increase the time required to complete the form to 105 hours from the current 37 hour average. In June, the proposed rule changes were estimated to require 144 hours.

The AHA’s objections centered around the extensive Federal disclosures hospitals already make in the course of business and transactions and the additional time taken administratively away from care.

Another online wrinkle to M&A: FTC’s new online portal for M&A commenters. FTC will collect comments on any and all proposed transactions submitted for premarket notification review. This will enable a long list of parties–consumers, workers, suppliers, rivals, business partners, advocacy organizations, professional and trade associations, local, state, and federal elected officials, academics, and others–itemized in the release to say their piece to the FTC about how the proposed M&A will affect competition. FTC can then point to the ‘public uproar’.

What will be the effect on M&A?

  • Possible end of year rush to complete any deals before the Final Rule takes effect
  • Rollups or complementary transactions will take place at earlier stages, under the HSR limits, but companies will limit them until they determine what is permissible and not if down the road they are acquired.
  • Longer term, it may overall further depress healthcare M&A from small to large, and investor exits–already barely recovering.
  • It may also affect large-scale funding for growth beyond Series A and B. Beyond that point, investors get larger, get on the FTC radar, and ultimately look to Other People’s Money to exit–if not an IPO, then to be acquired. 

One wonders what creative solutions VCs, PEs, and Mr. Market will concoct.

Signs of life: another view on healthcare investments and exits as of mid-year

Silicon Valley Bank and their reports live! Now under the aegis of First Citizens Bank, SVB’s 14th Healthcare Investments & Exits Mid-Year Report for 2024 covers four healthcare areas: biopharma, health tech, DX (diagnosis)/tools, and device. Concentrating on health tech, highlighting their findings which are very different than the other three sectors and mostly in line with H1 findings from Rock Health that this Editor analyzed as possibly a ‘dead cat bounce’:

  • Series A raises are easier than in other sectors, and growing. It is the second-strongest start for Series A health tech investment since 2021. While average valuation sizes are remaining static around $10 million, and deals to date are just under $8 billion.
  • For later-stage companies, their high valuations during the palmy days of 2020-early 2022 created a ‘valuation trap’. The report uses ‘nadir’ to describe it–“now investors (who) are now opening up their coffers for new investments.” (The picture might be less optimistic if one pulled out Transcarent, which is controlled by two investors, General Catalyst and 7wireVentures.) Flat and down rounds are the norm.
  • They term the above ‘price discovery’, defined as the opportunities to extend due diligence, “build conviction” and build the “right syndicate” of investors.(Above all page 14)
  • Investment is accelerating at a rate above the other sectors (page 18). 
  • Exits have cratered at $0.2 billion with only four M&A deals reported. “Companies are preparing themselves to be good public market performers by tuning their cash efficiency and ensuring good unit economics”. Their view is that this may accelerate in H2 2024. (page 21).

SVB is offering the report online as a free preview download. Contact them for the full report.

What the DOJ and FTC Merger Guidelines mean for healthcare M&A–review of the Epstein Becker Green podcast

Are you in the (mostly) lucky group of companies seeking to buy or be bought? This podcast is a ‘must hear’ as likely you’ll be affected. Healthcare law firm Epstein Becker Green’s roundtable podcast in the ‘Diagnosing Health Care’ series is their half-hour condensed view on the new Federal Merger Guidelines that the Department of Justice (DOJ) and the Federal Trade Commission (FTC) finalized last 18 December. Their view on how it will affect healthcare organizations is not too different from your Editor’s lengthy review of the DOJ/FTC document published on 20 December. The DOJ/FTC end-of-year drop perhaps (ahem) was timed to bury the bad news, drowning it in a punch bowl of good cheer or in holiday busy-ness.

This Editor (note: not a lawyer nor do I play one on TV or YouTube) took the view that it was that it was a whole scuttle of coal for healthcare holiday stockings (right) and that it would discourage much of 2024’s healthcare M&A until companies figured what mergers would likely past muster, among other predictions. The EBG folks mostly agree. They also point out that the final Guidelines’ language is “more aggressive” than the draft that many healthcare organizations took issue with–what the article referred to as “substantially more restrictive language and interpretation”. There are some wins from the draft, but much of the language, especially on vertical mergers, simply moved into one or another of the 11 Guidelines. 

The EBG team on the podcast (available for play on the web page and download) are Trish Wagner, John Steren, and Jeremy Morris, moderated by Dan Fahey. Below are some key points made by the team on the podcast. Your Editor recommends that you pull up our 20 December article as a reference to the specific Guideline references they make.

  • Background: Horizontal merger Guidelines were last updated in 2010. Vertical merger Guidelines were issued in 2020 but later rescinded. These new Guidelines apply to both horizontal and vertical mergers and acquisitions. US antitrust is based on three acts passed by Congress: The Sherman Antitrust Act (1890), the Clayton Act (1914), and the Federal Trade Commission Act of 1914, now in US Code Title 15. The Guidelines since then are based on them as well as case law.  (From the wrapup) Courts tend to be very deferential to the Guidelines.
  • The wording of Guideline #8, When a Merger is Part of a Series of Multiple Acquisitions, the Agencies May Examine the Whole Series, is both interesting and aggressive in that it will be considered and opens up a pattern of acquisitions. This can be by private equity (PE) or other owners.
  • Guidelines #1, Mergers Raise a Presumption of Illegality When They Significantly Increase Concentration in a Highly Concentrated Market, and 2, Mergers Can Violate the Law When They Eliminate Substantial Competition Between Firms, impact hospital mergers. Prior merger guidelines focused on highly concentrated markets using a point system (HHI, the Herfindahl-Hirschman Index, is a common measure of market concentration). This measure sets a lower bar.
    • To trigger #1, a market share above 30% and an HHI over 100 can trigger it even in unconcentrated markets.
    • On #2, elimination of direct competition is maybe in and of itself harmful
  • Guideline #6, Mergers Can Violate the Law When They Entrench or Extend a Dominant Position: for horizontal mergers, ‘entrench’ is in practice the operative term, whereas ‘extend’ applies mainly to vertical mergers. Companies will have to demonstrate that the beneficial competitive effects outweigh the anticompetitive, especially when involving consumers. And they will have to demonstrate why the merger is necessary. 
  • Wrapping up:
    • Ms. Wagner: the Guidelines don’t have the force of law, but they do have impact because they are about the process on how mergers are evaluated. Courts have been very deferential to the Guidelines.
    • Mr. Morris: hospital leaders will have to contemplate this “huge change in a moment” which he questioned. He emphasized that organizations involve their antitrust counsel now even earlier than previously.
    • Mr. Steren: “healthcare has a bullseye on its back”. It is immediately more restrictive. It fits right in with what current enforcers do in trying to bring “persuasive authority” to bring new, novel, cases into court. He seconded Mr. Morris’ last remark.

This Editor, as the Canary in the Coal Mine, will assume that UnitedHealth Group and others have already anticipated that they will have difficulty now making new acquisitions, obtaining approvals for ones that haven’t been finalized, or making quick sales of units they no longer want (Walgreens). Hospitals will find that divestiture and regional mergers will be discouraged. Acquirers who’ve been concentrating on filling out their platforms with vertical acquisitions may find that these Guidelines are also written to trip them up–and once tripped, each Guideline knocks on another. (For other predicted consequences, see the 20 December article.)

Digital health’s Q1 according to Rock Health: the New Reality is a flat spin back to 2019

Though it’s busier, and no banks collapsed, the New Reality takes us back once again to 2019, before the champagne days of 2021 and first half 2022. Rock Health’s Q1 2024 summary of US digital health deals hasn’t a bit of froth to it and is headlined “Great (reset) expectations”. But the highlights show a bit of revival after 2023, where there was, in the immortal words of Frank Zappa, “no way to delay that trouble comin’ every day”.

  • In Q1 2024, there was $2.7 billion in funding across 133 deals, with an average deal size of $20.6 million. This was a great improvement over Q4 2023’s limp $1.9 billion across 122 deals, the lowest funding quarter since Q3 2019. [TTA 8 Feb]
  • 2024’s Q1 was the lowest first quarter by sector funding since 2019, since 2022 and 2023’s Q1’s were the best of their respective years.
  • Number of deals are up but the deal size remains small at $20.6 million–no blockbusters. Q1’s 133 deals beat out each of the past six quarters, but just edged out Q1 2023’s 132. 
  • Unlabeled rounds grew from 2023: 48% to year 2023’s 44% of the total. Labeled rounds, predicted to make a comeback in 2024, haven’t come back quite yet.
  • Deal structures are getting very, very creative. DecisionRx gave Carlyle Group the option to convert a $100 million debt facility to 25% of outstanding shares, which is trading a lot of equity in the company for not a lot of money. Transcarent has a $125 million Series D that tags a sweetener of 2.5x to funders should the company M&A or IPO. This Editor noted the structure of Dario Health’s February acquisition of Twill as “a dizzying chronicle of funding legerdemain that this Editor hasn’t seen since her airline days”

It wasn’t a surprise that AI was ‘the thing this year’ in attracting funding–almost as much as financial success being redefined as bottom-line profitability, conservative (what we used to call sandbagged) forecasts, and an emphasis on outcome data.

  • Companies that claimed AI in their products or services accounted for 45 deals with $1.1 billion of Q1’s funding, or 40%, versus 2023’s 33% of funding. 

Rock Health’s analysis made much of outcomes data and that showing efficacy is now more important--and at earlier stages. It serves to differentiate players in the market (something we marketers have known about forever). For funders it can illuminate the value for their investment. And funders will scrutinize x 3.

  • Companies, unable to satisfy public shareholders so easily pleased in the SPAC and IPO palmy days of 2021-23, are leaving, not entering, public markets. Veradigm had to delist this year because of Nasdaq financial reporting problems from bad software despite being financially healthy–and acquiring ScienceIO. Rock Health does not include the recent pending delistings of Clover Health and Amwell. Both NextGen Healthcare and SOC Telemed went private last year. Others were acquired: Science 37, BenefitFocus, Castlight, Signify Health, and Tabula Rasa. Four went out of business: Babylon Health (Ch. 7 US, administration in UK), Pear Therapeutics (Ch. 11, IP sold), UPHealth (Ch. 11), and Better Therapeutics (closure).
  • Rock Health sees this as an important ‘recalibration’ for valuations, particularly for startups. “Startup valuations stem from expected investor returns at exit, and funders often use comps from publicly-traded players’ market capitalizations to triangulate company potential.”

Rock Health concludes that the expectations around exits have shifted drastically. The predicted return of M&A hasn’t yet. Their latest projection is that companies “may embark on dual-track processes, pursuing IPO and M&A exit pathways concurrently to keep options open”. For now, for digital health, it’s the end of growth-minded forecasting and the start of reporting their financials conservatively, with plenty of outcomes attached–as if they were being publicly traded and had quarterly earnings calls with analysts and journalists on their tail.

Editor’s note: Notably missing from their summary was the usual charts of raises by series stage (A, B, etc.) and digital health sector (mental health, cardiac, etc.).

2023 was buying time, 2024 is face the music time: Rock Health

Rock Health’s year-end wrapup, which usually makes a splash, didn’t this year. It was released this year in conjunction with the JP Morgan Healthcare Conference in the week after New Year’s, which almost guaranteed it would fly below the radar.

Another analogy: if you were doing aerobatics, 2023 for digital health was maintaining a flat spin from altitude if you could (left/above), 2024 would be getting out of the flat spin and into level flight before you and the ground had a meeting, so to speak.

Rock Health’s summary of 2023 was minus their typical frothiness:

  • It was back to 2019 across the board, as if 2020-21 never happened.
    • Full year 2023 raised $10.7 billion across 492 US deals. It was the lowest amount of capital invested since 2019, which finished with $8.1 billion across 413 deals. By comparison, 2022’s total was $15.3 billion across 577 deals.
    • Q4 2023 was the lowest funding quarter since Q3 2019, with an anemic raise of $1.9 billion across 122 deals.
  • M&A was left for dead, unexpectedly so from their earlier projections. (Note to Rock Health–it could be the negative attitude toward deals emanating from Washington)
  • A and B stage companies had trouble raising money in the usual lettered way. 81% of currently active venture-backed startups that raised a round in 2021 didn’t raise a labeled one in 2023. Some resorted to ‘extensions’ that further diluted existing ownership or unlabeled rounds that left more questions about when the next raise was going to be. Unlabeled rounds hit an all-time record of 44% of total raises, double that of 2022. (This Editor notes that there were no analyses of C and D rounds, because there were so few.)
  • “Silent rounds” of financing happened but were hard to gauge–and because they were inside, didn’t measure the attractiveness or competitiveness of the company in the real market. It was pure, simple survival of the company and the investment.
  • Startup shutdowns, in their view, were no higher than usual–less than 5% of venture-backed US digital health companies (i.e., have raised >$2M).

In this Editor’s view, the percentage does not capture the prominence of the startup shutdowns: Babylon Health, Quil Health, Pear Therapeutics, OliveAI, Smile Direct, Cureatr, SimpleHealth, The Pill Club, Hurdle. It also doesn’t count Amazon shutting down Halo, Cano Health’s parting out before this week’s bankruptcy, as well as Bright Health’s (now NeueHealth) divestitures and shutdowns through 2023 leading to their becoming a very different company in 2024. 

For 2024, Rock Health is seeing:

  • The return of labeled raises (A, B, C etc.) In their view, many companies will not be able to manage this without moving into ‘hot’ areas like obesity care (cue the Ozempic), value-based care enablement, or AI. Those that can’t will either have ‘down’ rounds or close (see this week’s closing of Astarte Medical in the NICU segment because they wouldn’t integrate AI).
  • M&A will increase, with acquirers buying low among the now cash-strapped companies. This Editor would add that both DOJ and FTC will have their say about this, having published new Merger Guidelines in December.
  • Publicly traded companies will ‘recalibrate’, which is a polite way of saying a lot of companies will face delisting. As of 31 December 31, 2023, at least 17% of public digital health companies trading on the NASDAQ or NYSE were noncompliant with listing standards. This Editor notes that 23andMe is the latest cracked SPAC in jeopardy. Some will rally, the strongest may IPO. BrightSpring Health IPO’d on 26 January, Waystar’s is pending. 

Their sobering conclusion. Too many companies were created in the last few years of the boom. “2024 will be a year of recalibration and consolidation. Some startups will rally, finding that high capital efficiency and exceptional offerings pay off to secure them their next major fundraise. Others will need to make the tough call to wind down operations or accept lower-than-hoped-for M&A offers, particularly in saturated segments.”

At last, Rock Health and TTA have met on similar ground. This Editor’s take back in December. From ‘Signs of the next phase in 2024’:

“…the board is being cleared of the also-rans and never-should-have-beens. They are like dead plants and brush that need to be cleaned out so that new growth can happen. We are cycling through some of them already as we move to a New Reality and winding this up.”

Additional TTA views on 2024: The New Reality permeating JPM, and Peering through the cloudy crystal ball into 2024

Peering through the cloudy crystal ball into 2024 healthcare investment and company health

crystal-ballWill 2024 be the mirror image of 2023? This time last year, signs pointed to slow, steady growth after the bubble bath of 2020-early 2022 was followed by failures of tech-leveraged banks (SVB and Signature in March 2023) leading to a mid-year bust [TTA 11 Aug 23]. Some big deals kicked off the year (CVS’ Carbon Health investment, Oak Street mega-buy TTA 16 Feb 23). Then as the year went on, they were followed by sheer turmoil–huge losses and business divestitures (Cano Health, Bright Health, insurtechs like Clover and Oscar), bankruptcies and shutdowns (Babylon, Pear, Quil, OliveAI, Smile Direct, Cureatr, Rite Aid), IP lawsuits (Apple-Masimo, Apple-AliveCor, FruitStreet-Sharecare), C-levels walking the plank (Walgreens, Noom), and big layoffs nearly every week. Cigna and Humana called off merging again, perhaps because Cigna didn’t like what it saw. M&A fell to its lowest level in years and IPOs fell to zero.

To cap the year, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued new Merger Guidelines that made the M&A mountain even steeper, and will follow up this year with Pre-Merger Notification guidelines that will make that part even more costly. Both signal hard times for M&A. Add to that the overt hostility the chair of the FTC has to any kind of M&A and the weaponization of the tools government has at hand…..Even early-stage, independent companies which allegedly these agencies are trying to foster don’t catch a break. A change in the tax law hitting hardest in 2023 forces annual expenses in research and experimentation (R&E) to be amortized over five years versus one year which severely affects their financials. (Section 174 explained here)

The crystal ball promises to be more like a Magic 8 Ball this year. Other than a flurry of smaller-scale investments, a rumor of a $5 billion EHR company sale (Netsmart), and predictable layoffs in health systems, the start of the year in healthcare has been fairly (ominously?) quiet.

HealthcareFinance talked to two partners in law firm Akerman’s healthcare practice group to get their take, weaving in some findings from a PWC report: 

  • Buyer interest in acquiring practices and surgery centers
  • Partnerships on rise, for example Amazon’s One Medical with health systems 
  • Smaller hospitals in mid-America will merge as there is “safety in numbers’
  • More investment in life sciences and drug development, especially diabetes/weight loss drugs in the GLP-1 category
  • Anything around AI attracts interest

The two big factors: interest rates (the Federal Reserve has signaled no further increases, and maybe cuts in 2024) and (of course) a presidential election as well as all of the House, much of the Senate, and state gubernatorial offices.

Bubbling under this are reports of two big pending IPOs:

  • Home health, pharmacy, and eldercare services provider BrightSpring Health filed with the SEC on 3 January for a near-billion dollar IPO (publicly released on 17th). This is estimated to raise $960 million, valuing the company at about $3 billion. Common stock will debut between $15 and $18 on Nasdaq under the symbol BTSG. They are also selling 8 million tangible equity units at $50. Proceeds will go from the offerings to repay outstanding debt under various credit facilities and pay penalties associated with terminating its monitoring agreement with Kohlberg Kravis Roberts & Co. L.P. (KKR, the current owner) and Walgreens Boots Alliance. BrightSpring serves 400,000 daily patients and dispensed 34 million prescriptions in 2022. IPO timing is still to be announced. This is the second time the company has filed, abandoning its first attempt in late 2021 as the market softened in 2022. KKR is signalling an exit…will it happen this time? Release, FierceHealthcare
  • Waystar’s IPO is still pending after being announced late last year [TTA 26 Oct 23]. The RCM and payments software company delayed it to 2024 due to an uncertain market at year’s end. Reportedly the roadshows were postponed to December but there has been no confirmation that they took place. Will it happen?

Fasten your seatbelts…it may be a bumpy ride.

DOJ and FTC finalize Merger Guidelines, deliver coal for holiday stockings and the New Year (updated)

DOJ and FTC deliver a scuttle of coal for healthcare holiday stockings. The Department of Justice (DOJ) and the Federal Trade Commission (FTC) finalized the Merger Guidelines that were drafted back in July [TTA 20 July]. They update prior guidelines first issued in 1968 that have been revised six times since then. They are not legally binding but demonstrate how each agency will examine any merger or acquisition going forward–and are advance notice on how they can and will stop either. US antitrust law is based on three acts passed by Congress: The Sherman Antitrust Act (1890), the Clayton Act (1914), and the Federal Trade Commission Act of 1914, now in US Code Title 15.

After 30,000 public comments in the 60-day period, the published Guidelines are now down to 11, but in context based on this Editor’s read (caveat, not a lawyer nor play one on TV) are not materially different than the July draft of 13, perhaps considered unlucky. The language in each Guideline restates the draft language in substantially more restrictive language and interpretation. The agencies’ stated purpose is that when two companies propose a merger that “raises concerns” on one or more of these Guidelines, the agencies “closely examine” whether the effect of the merger may be to substantially lessen competition or to tend to create a monopoly (sometimes referred to as a “prima facie case”). Two “C” words are repeated throughout–concentration and consolidation. 

The guidelines are verbatim from the 51-page DOJ/FTC document (PDF link) issued 18 December and are grouped on how the agencies use these guidelines. They are effective immediately.

Distinct frameworks the agencies use to identify that a merger raises prima facie concerns (1-6)

Guideline 1: Mergers Raise a Presumption of Illegality When They Significantly Increase Concentration in a Highly Concentrated Market.
Guideline 2: Mergers Can Violate the Law When They Eliminate Substantial Competition Between Firms.
Guideline 3: Mergers Can Violate the Law When They Increase the Risk of Coordination
Guideline 4: Mergers Can Violate the Law When They Eliminate a Potential Entrant in a Concentrated Market
Guideline 5: Mergers Can Violate the Law When They Create a Firm That May Limit Access to Products or Services That Its Rivals Use to Compete
Guideline 6: Mergers Can Violate the Law When They Entrench or Extend a Dominant Position

How to apply those frameworks in several specific settings (7-11)

Guideline 7: When an Industry Undergoes a Trend Toward Consolidation, the Agencies Consider Whether It Increases the Risk a Merger May Substantially Lessen Competition or Tend to Create a Monopoly
Guideline 8: When a Merger is Part of a Series of Multiple Acquisitions, the Agencies May Examine the Whole Series
Guideline 9: When a Merger Involves a Multi-Sided Platform, the Agencies Examine Competition Between Platforms, on a Platform, or to Displace a Platform
Guideline 10: When a Merger Involves Competing Buyers, the Agencies Examine Whether It May Substantially Lessen Competition for Workers, Creators, Suppliers, or Other Providers
Guideline 11: When an Acquisition Involves Partial Ownership or Minority Interests, the Agencies Examine Its Impact on Competition

The Guidelines are summarized in the Overview. Section 2 explains them more completely with how the agencies apply the Guidelines. Section 3 identifies rebuttal evidence that companies could typically present, and Section 4 presents a non-exhaustive discussion of analytical, economic, and evidentiary tools the Agencies use for evaluation. 

More coal, Ebenezer Scrooge. As this Editor described the draft guidelines in July, it it is hard to see that any merger or acquisition of like companies or even complimentary organizations building out capabilities or platforms could pass. Each one of these Guidelines is a tripwire and once tripped, can trip others. Each one of these can be used by FTC and DOJ to present to a Federal district court, where decisions are now more influential than the body of US Supreme Court decisions. Healthcare Dive notes the Illumina decision in the Fifth Circuit appeals court, liberally cited in the Guidelines document. This is forcing Illumina’s divestiture of cancer test developer Grail, earlier purchased for $7.1 billion. 

So now the coal’s been delivered…what will 2024 and out look like?

  • This will freeze M&A for months as companies try to figure this out. It’s not hard to guess that the imminent publication of the Guidelines nudged the termination of the Cigna-Humana deal. Hospital and health system mergers will continue to find nothing but discouragement.
  • Watch for an acceleration of existing company failures in 2024 and disruption in the current funding structure. Smaller healthcare companies, fattened on the investment binge of 2020-21, but now betting on a buyout from a near competitor, are either going to stick it out on their own or run out of runway. VC and PE companies investing not strategically, but for the purpose of a 18-24 month exit or quick payday, will largely be out of luck. Public companies may languish unless they move quickly to profitability. This may stimulate a new look at investing–strategic investors that look at the very long term–or not. (JP Morgan in January will be verrrrry interesting.)
  • Companies that have grown organically or benefited from previous acquisitions but need to acquire capabilities for a platform to continue to be competitive will also be affected. These could trip Guideline 9 and if found to be anti-competitive, may trip Guideline 8: “If an individual transaction is part of a firm’s pattern or strategy of multiple acquisitions, the Agencies consider the cumulative effect of the pattern or strategy.”
  • The behemoths like UnitedHealth Group, Walgreens Boots Alliance, and CVS Health will have no rivals for many years. The flip side: they will have trouble making additional acquisitions without forcing divestitures, or find buyers when they wish to divest money-losing units.
  • Partnerships may accelerate–with all their risks of purloined IP and monetary disputes. But smaller companies may use it to band together without antitrust risk.
  • The SPAC (special purpose acquisition company) may make a comeback. They will not have any antitrust conflicts but risk a chancy public market, at least in the US. 
  • The conglomerate–unrelated businesses under a holding or investment company–may rise again, as it did in a tight antitrust environment in the 1960s. Remember Gulf + Western and LTV (Ling Temco Vought)–both gone? Berkshire Hathaway is a prime example of a current conglomerate. Foreign investment groups may also find US healthcare an attractive proposition.
  • Offshore reincorporation. Much as Medtronic moved its corporate headquarters from Minneapolis to Dublin, Ireland, companies may move offshore to friendlier climes like Ireland, Estonia, Hungary or the Visegrad nations, and the Channel Islands, effecting their M&A there and making their US branches operational only. 

But…there’s more. Both DOJ and FTC will be reviewing the 2010 Horizontal Merger Guidelines and the 2020 Vertical Merger Guidelines. Fasten your seatbelts, it’s going to be a bumpy year. 

FTC press release (which makes clear what agency is leading!), Crowell (law firm) short analysis, PrivateFundsCFO

Additional sources added 2 January: National Law Review (article by Foley & Lardner), Healthcare Finance News

Cigna-Humana deal fizzles after two weeks after term discussion fails, shareholders nix

That was mercifully fast. After all the speculation and rumors [TTA 2 Dec], Cigna and Humana called off their talks on 10 December after not coming anywhere near terms on the financials. According to the Wall Street Journal, it was also evident that shareholders disliked it nearly immediately by driving down the share prices of both companies by 10%.

Their sources indicated that it would be a share and cash deal by Cigna for Humana, which added to shareholder displeasure. Cigna will be instead buying back up to $10 billion in stock to drive up their valuation. Reportedly, the repurchasing of least $5 billion of stock will take place between now and H1 2024. Cigna will also concentrate on smaller ‘bolt-on’ acquisitions and the sale of its Medicare Advantage business as previously announced. In the past five days, Cigna shares plumped by nearly $50 and Humana’s by about $10.

The WSJ‘s sources stated that Cigna continues to believe in a combination with Humana, something that the two companies have danced around for years, dating back even before the proposed payer megamergers of 2015 which saw Humana’s acquisition by Aetna (and Cigna’s by Anthem, now Elevance) disapproved both by states and at the Federal antitrust level. The two would, at least on paper, be a good fit, with Cigna’s strength in commercial plans plus Evernorth’s services added to Humana’s in Medicare Advantage, Medicaid, and home health services under CenterWell. It would have created a strong rival to UnitedHealth Group and CVS Health at $300 billion in revenue. What may have proved to be the antitrust stumbling block were their respective strengths in pharmacy benefit management (PBM) though with different focuses.

Even more than the increasingly hostile Federal antitrust environment between DOJ and FTC, it also points to the paucity of funding for mergers and acquisitions–M&A down 14% so far this year to about $1.2 trillion according to Dealogic.

In about three years, healthcare funding has gone from money thrown by VC and PE investors at what we recognize now as shaky propositions (Cerebral, Babylon Health, Olive AI, Pear) to no interest (or funds available) in what would be quality matchups. The pendulum swings–and swings back. We hope. Healthcare Dive

Short takes: a rumor of merger/buy with Cigna and Humana–what are the odds? (updated) And what’s up with the low number of HIMSS 24 exhibitors?

crystal-ballCigna and Humana, perfect together? Only if they can get the deal through the Feds and the states. Late this week, the Wall Street Journal revealed that Cigna and Humana were exploring either a merger or, as some theorize, a buy of Humana ($93 billion in revenue, $60 billion valuation) by much-larger Cigna ($181 billion in revenue, $78 billion valuation). Between them, it is estimated that they would have 35 million members. No transaction cost has been estimated, but the WSJ sources indicate it will be a stock-and-cash deal that could be finalized by the end of the year if all goes well.

On paper, industry observers like it but point out the overlap in one significant area.

  • Cigna earlier announced that it wants to sell its relatively small Medicare Advantage business, concentrating on its leadership in the commercial business and with its service businesses under the Evernorth umbrella.
  • Humana is exiting its commercial health plans to focus on MA and Medicaid, as well as its large footprint in the home health business with CenterWell.
  • Humana’s CEO Bruce Broussard is retiring next year, with newcomer to Humana Jim Rechtin joining as COO in January 2024 as his replacement. Cigna’s CEO David Cordani is a sprightly 57 and likely not to go anywhere.
  • The overlap area that could be problematic is pharmacy benefit management (PBM) with each having about 17-18 million in Express Scripts (Cigna), the second largest in the US, and Humana Pharmacy Solutions. 

Liking it on paper is one thing–FTC, DOJ, and 50 states may not feel so enthusiastic. It’s established through their actions that both Federal agencies are reining in M&A with new and restrictive merger guidelines scheduled to go into effect next year [TTA 20 July]. Healthcare is a major political hot button for this administration for cost–especially drug costs. That is where the reportedly equally sized in revenue PBM operations present the most major conflict to a merger or a buy, both in service and valuation. Both serve their own plan members as well as others, notably Express Scripts with 24% of claims, whereas Humana’s serves primarily its own plan members with 8% of claims. Neither are easy to divest without creating antitrust questions for acquirers and a major dent in Humana’s services. The final factor: Lina Khan, chair of the FTC, has never seen a merger that she’s liked based on her own statements [TTA 24 Aug].

Doomed to repeat history? In 2015, two payer mega-mergers involving these same companies were concocted: Cigna with Anthem and Humana with Aetna. They hit the buzzsaws of DOJ and before that, state approvals. The DOJ pursued them on antitrust in the Federal courts which derailed both by January 2017. Running up to that, every state got an approval vote through review by each state’s Department of Banking and Insurance or equivalent. Many did not approve or with conditions. The other factor is corporate. In the runup to the merger, Anthem-Cigna was marked by escalating animosity from the management suites to the worker cubes. After the deals were scuppered in the Federal District Court, Anthem and Cigna bitterly fought over damages and cancellation fees in Delaware Chancery Court. Aetna and Humana took their lumps and breakup fees, and went on. Aetna went on to merge with CVS, a deal that avoided most of the antitrust flak. Humana went on to acquisitions in other areas.

Our betting line. Both insurers will look at the financials in this hard-to-get-arrested year. Both will feel out the Feds before going forward. Both will calculate whether it’s best to start now or wait till next year and a possible change in administration. Neither company wants to be a political target in an election year. Defensively, Cigna may make noises about other combinations–Centene and Molina have been mentioned–which present their own difficulties and troubles, to strategically try to force the issue. Stay tuned! MedCityNews, Axios

Update: Other analysts suddenly are on board with this Editor’s gimlety view of the matchup, citing antitrust and how Federal regulators are primed to challenge major deals. The FTC is specifically probing the PBM business. The fact that the deal, according to JP Morgan, could take 12 to 24 months is no surprise as par for the course, but Mr. Market didn’t like it, dragging down both companies’ share prices every day since the rumor broke. (Hmmmm….do they read TTA?)  But a small lamp was lit by one analyst: a Cigna-Humana combo could present real competition to the 9,000 lb. elephant of healthcare, UnitedHealth Group, and that might help to put it over. FierceHealthcare

Another concern that occurred to your Editor: Cigna’s international footprint could mean additional approvals by UK and EU regulators.

According to Healthcare Dive’s analysis, the combined entity would have a PBM market share of 32%, right up against CVS Health-Caremark at 33% and UHG’s OptumRx way behind at 22%. It’s a small group with big barriers to entry which makes it a slam-dunk to antitrust regulators.  A whistle in the dark might be UHG’s long-drawn-out buy of Change Healthcare, but there were divestitures of business before closing and both parties managed to prove to the satisfaction of a US District Court that the separation to Optum Insight would not affect business relationships with other health plans. But here, both are health plans, and both have PBMs.

HIMSS 24 exhibitors, where are you? An item in today’s HIStalk on the ‘interesting’ choice as closing keynoter of football coach Nick Saban (U of Alabama Crimson Tide) at a healthcare IT conference went on to compare the number of booked HIMSS exhibitors to date with HIMSS 23’s floor total. This Editor, who for a few years booked the least expensive HIMSS space for the company she worked for back then well in advance, could not believe the low number of exhibitors three months from show time in March. Checking the HIMSS show website, there are 501 exhibitors listed. In 2023, according to HIStalk, there were 1,216. Many of these exhibitors have multiple booths in the Orange County (Orlando) Convention Center, but it still indicates the uncertain state of healthcare, pullbacks in marketing budgets, the rise of real competition in HLTH and ViVE, and perhaps some concerns about the show management transition from HIMSS itself to Informa. Are industry and IT influentials skipping HIMSS next year? Stay tuned or comment below!

Healthcare M&A hit a 3 year low in Q2 2023, to the surprise of none: KPMG

“Is deal making ready to rebound?”–KPMG tries to find the bright side in their new study of healthcare activity. If Q2 reflects the trend, it won’t be this year. See below for what this Editor sees that KPMG doesn’t.

  • There were 245 deals in Q2 2023, 7% below deal volume in Q2 2022 and 41% below the bull market of Q2 2021.
  • Buyers shifted from the financial buyer (e.g. a long-term investor), now at 29% of deals, to strategic buyers who look to expand or augment their businesses at 71%. This is a complete flip from the prior year, where strategic buyers were 37% (98) of a total of 264 transactions.
  • Sectors have also shifted:  42% of deals included physician groups, 27% were IT/digital health sector, 16% were in post-acute care, and 15% involved health systems. The shift away from digital health is pronounced from the palmy pandemic days of 2021 where 737 deals raised $29.1 billion.

There aren’t many big deals on the board in Q2, mostly announced and not closed: CVS Health-Oak Street (closed), Optum-Amedisys, TPG and AmerisourceBergen-OneOncology, Molina-BrightHealthcare’s CA plans, Froedert Health-ThedaCare, and Kaiser Healthcare-Geisinger (forming Risant Health). The last is still to be structured.

KPMG’s reason why for the paucity of deals were the Fed and the continuance of interest rate hikes to supposedly slow inflation (which hasn’t worked much and instead is depressing the economy), the US political situation (turmoil), and what they politely term “uncertainty about the valuations of potential acquisition targets.” Healthcare Dive, Becker’s

“Uncertainty about the valuations of potential acquisition targets” is an understatement. This Editor looks back at that time of  2020 to perhaps Q1 2022 as a binge of insane proportions and self-reinforcing FOMO. Rivers of free-flowing money for any company in digital health–who can blame founders and funders for grabbing their buckets and filling them? The hangover? Equally insane. Of SPACs alone, which were treated like the future of IPOs, nearly all cracked. Valuations of established telehealth companies plunged 70-90%. The money? The river bed is largely dry except for a few puddles and branches. The call for profitability is late.

Racking up reasons why from this Editor’s POV that aren’t in the KPMG analysis:

  • Investors such as VCs and providers no longer have the money because 1) they spent it and 2) can’t raise it. Those who have ‘dry powder’ are either reserving it for a brighter day, cutting back themselves, or deploying it to what they perceived as safer bets such as fintech and biopharma. The deals being made especially in digital health are small. Private equity, family offices, and high net worth investors are mostly staying out of healthcare, or being extraordinarily cautious about both where they invest and how much. More on this: TTA 5 April.
  • A four-bank collapse–Silicon Valley Bank’s failure most notably was a dagger in the heart of West Coast VCs. Add to it First Republic, Silvergate, and Signature in NYC (a favorite of Silicon Alley), plus Credit Suisse being taken over by UBS, all in fairly short order in late winter, ant that will tend to curb anyone’s enthusiasm. It also affected companies that located their cash, investments, and payables/receivables in these banks.
  • High valuations seem to have an inverse relationship to survival. This past year has seen the total ‘hull loss’ of the following former ‘industry darling’ companies: Pear Therapeutics, SimpleHealth, The Pill Club, Hurdle, Quil Health [TTA 11 July], and now Babylon Health.  Teetering on the edge are Bright Health Group and possibly 23andMe. Insurtechs Clover and Oscar are cleaning up frantically, trying to recover. Established companies such as Teladoc and Amwell have taken it in the shins and talk a lot about profitability after years almost proudly not being profitable. Onetime ‘too hot for their shirts’ telemental health is still trying to survive the scandals around Cerebral and Truepill. What remains isn’t favorable: too many companies chasing the same younger group of people who want virtual mental health, plus DEA confusion around Schedule II medication telehealth prescribing [TTA 14 June]. 
  • Big acquirers CVS Health (Oak Street Health, Signify Health) and Walgreens Boots Alliance (VillageMD) are posting down numbers, retrenching, selling units, closing stores, and laying off staff in a matter of months to a year post-acquisition.

And to wrap…there are six letters may sink any revival of M&A: DOJ (Department of Justice) and FTC (Federal Trade Commission), with a commission relishing their activist role. 

  • Draft Merger Guidelines that update corporate merger guidelines originally from 1968 but updated many times since. The 13 Guidelines drafted by DOJ Antitrust and the FTC have the intent to prevent mergers that threaten competition or create monopolies. But reading them, nearly every merger or acquisition other than in a horizontal or conglomerate model will be in violation of one of the 13. [TTA 20 July
  • Earlier, the Premerger Notification changes to the filing process covered under the Hart-Scott-Rodino (HSR) Act for transactions over $111.4 million. Again, it raises the height of the mountain and the time required for all transactions other than the smallest. [TTA 29 June]
  • FTC reviving the 2009 Health Breach Notification Rule to clamp down on ad trackers, fining Teladoc’s BetterHelp and GoodRx millions, and sending letters to 130 hospitals and health systems to put them on notice that they are on the radar [TTA 27 July].

This Editor is shocked that this concatenation of Federal actions have not gained the attention they deserve, especially the first–or maybe the legal departments are just working verrry verrry qwietly to register their objections.

Perhaps there will be a bounce in M&A–companies moving to acquire under the wire of both the merger guidelines and the premerger notification changes–akin to what Wall Street calls a ‘dead cat bounce’ (apologies to felines). After they’re in effect, watch for another dead stop in M&A and investor exits until everyone adjusts to the new rules and figures out new workarounds. No one wants to be the first out of the gate in this situation.

(Edited for clarifications)

Another antitrust shoe drops: FTC, DOJ publish Draft Merger Guidelines for comment–what are the effects?

The Department of Justice (DOJ) and the Federal Trade Commission (FTC) have published for public comment a draft of revised corporate merger guidelines. These update prior guidelines from 1968 which have been revised six times since. These are stated as incorporating comments from hearings and comments that started in January

The Draft Merger Guidelines on FTC.gov are open for comment for the next 60 days (18 September), cleverly during a time when most of Washington DC is repairing to cooler climes for summer holidays. They are centered on what DOJ Antitrust and FTC loftily call The 13 Guidelines. These will be used singly or in combination for these agencies to determine “whether a merger is unlawfully anticompetitive under the antitrust laws.” 

  1. Mergers should not significantly increase concentration in highly concentrated markets;
  2. Mergers should not eliminate substantial competition between firms;
  3. Mergers should not increase the risk of coordination;
  4. Mergers should not eliminate a potential entrant in a concentrated market;
  5. Mergers should not substantially lessen competition by creating a firm that controls products or services that its rivals may use to compete;
  6. Vertical mergers should not create market structures that foreclose competition;
  7. Mergers should not entrench or extend a dominant position;
  8. Mergers should not further a trend toward concentration;
  9. When a merger is part of a series of multiple acquisitions, the agencies may examine the whole series;
  10. When a merger involves a multi-sided platform, the agencies examine competition between platforms, on a platform, or to displace a platform;
  11. When a merger involves competing buyers, the agencies examine whether it may substantially lessen competition for workers or other sellers;
  12. When an acquisition involves partial ownership or minority interests, the agencies examine its impact on competition; and
  13. Mergers should not otherwise substantially lessen competition or tend to create a monopoly

Assistant Attorney General Jonathan Kanter of the Antitrust Division stated in the DOJ/FTC release, “Today, we are issuing draft guidelines that are faithful to the law, which prevents mergers that threaten competition or tend to create monopolies. As markets and commercial realities change, it is vital that we adapt our law enforcement tools to keep pace so that we can protect competition in a manner that reflects the intricacies of our modern economy. Simply put, competition today looks different than it did 50 — or even 15 — years ago.” Not to be outspoken, FTC Chair Lina M. Khan, got her dibs in: “With these draft Merger Guidelines, we are updating our enforcement manual to reflect the realities of how firms do business in the modern economy.” Here the DOJ Antitrust Division takes the communications lead but the draft is published by FTC. These guidelines require no ratification by Congress as they are administrative in nature.

To this Editor, it is hard to see that any merger or acquisition of like companies or even complimentary organizations could pass. Consider the following scenarios: a leading telehealth or remote patient monitoring company offers to buy a struggling early-stage AI/ML or data analytics company to expand its capabilities, a larger health system buys a failing community hospital, one hotel looks to buy another down the street, VCs or equity investors look to exit just about anything through a sale. Every one of these situations triggers one or more of these guidelines.

Coupled with the proposed changes to the Premerger Notification under the Hart-Scott-Rodino Act (HSR Act) [TTA 29 June] now published in the Federal Register (29 June), open for comment until 28 August, we may be looking at the last few years as the Last Good Time for M&A, even with current restrictions in place.

As your Editor said last month, “For those surprised that FTC is taking the lead on this, this once-sleepy agency woke up late last year in a heckuva bad humor and is now taking a far more activist role in corporate oversight in areas such as privacy.” This was powered by a 2021 executive order by the current president for any and all mergers to be scrutinized. Earlier, FTC and DOJ withdrew antitrust policy statements that they now feel are overly permissive. FierceHealthcare

Already industry machers such as the American Hospital Association, Federation of American Hospitals, Pharmaceutical Research and Manufacturers of America (PhRMA) have asked the FTC mildly and politely for a further 60-day extension of the comment period. This includes non-healthcare organizations such as the American Hotel & Lodging Association and the Consumer Technology Association which runs CES. (Don’t hold your breath) FierceHealthcare

crystal-ballIn the cloudy crystal ball, this Editor sees a rush to complete acquisitions 1) below the HSR threshold ($111 million) and 2) in general before the new antitrust guidelines are adopted–and they will be as they are administrative measures and not laws. To reiterate previous comments, overall it will further depress M&A and investor exits, especially in healthcare and with mid-size private and public companies, funding beyond Series A/B, and valuations.  If you start a business, inherit one, or are trying to turn around one that has lost its markets or unprofitable–but can’t sell it in the future, what you have is a ton of frozen value and uninterested lenders. Will a thousand flowers bloom, like they did in airline deregulation 1980-1995–drive businesses to friendlier countries like Ireland or Poland–then lead to stagnation? Perhaps a new era of conglomerates of unrelated businesses a lá LTV and Gulf+Western in the 1960s? Tell your Editor and fellow Readers below.

FTC, DOJ float enhanced information requirements for HSR premerger notification filing process–what will be M&A effects?

FTC, DOJ are now coming after M&A–and you thought they were tough before? New information disclosure requirements proposed by the US Federal Trade Commission (FTC) and the Department of Justice (DOJ) Antitrust Division for mergers and acquisitions that fall under the Hart-Scott-Rodino Act (HSR) may put a damper on an already stagnant business area. On Tuesday 27 June, FTC, notably taking the lead with the concurrence of DOJ, released multiple proposed changes to the premerger notification filing process, the most extensive since they were first published in 1978 after HSR was passed in 1976. HSR premerger notification is required for transactions that exceed the threshold currently set at $111.4 million.

These changes will be formally submitted for the standard 60-day public review and comment later this week in the Federal Register. Changes are typically made after that time before final rules are published, a process that may take months.

From FTC’s release, the proposed changes fall under these areas.

  • Provision of details about transaction rationale and details surrounding investment vehicles or corporate relationships.
  • Provision of information related to products or services in both horizontal products and services, and non-horizontal business relationships such as supply agreements.
  • Provision of projected revenue streams, transactional analyses and internal documents describing market conditions, and structure of entities involved such as private equity investments.
  • Provision of details regarding previous acquisitions.
  • Disclosure of information that screens for labor market issues by classifying employees based on current Standard Occupational Classification system categories.
  • These proposed changes also address Congressional concerns that subsidies from foreign entities of concern [North Korea, China, Russia, and Iran–Ed.] can distort the competitive process or otherwise change the business strategies of a subsidized firm in ways that undermine competition following an acquisition.

The National Law Review goes into far more detail on exactly what additional information will be required. This includes disclosure of what foreign jurisdictions are reviewing the deal. The rationale for the changes is that transactions have become far more complex since the original requirements were set and that the additional information will “more effectively and efficiently screen transactions for potential competition issues within the initial waiting period, which is typically 30 days.” According to FierceHealthcare, the FTC said it expects the proposed changes will take merging entities 144 hours per filing, up from the current 37-hour average. It’s clear that the mountain of information already needed to file a pre-merger notification and the time needed to gather such information will be much higher, perhaps to months and reveal far more than perhaps some companies want to disclose.

For those surprised that FTC is taking the lead on this, this once-sleepy agency woke up late last year in a heckuva bad humor and is now (more…)

US/EU 2021 healthcare VC funding soared 65%, but health tech performance slumped 28%–and 2022 surprises

This isn’t the usual Rock Health report of puppies and unicorns. Silicon Valley Bank is a source new to this Editor, but even in topline, the report is pretty bracing. Their coverage is broad and detailed–biopharma, health tech, dx (diagnostic)/tools, and device–on US and European venture capital (VC) funding from 2019 to 2021. There are some warning flags for the health tech sector through their report (summary page; report available for free download here).

What you’d expect: total health care soared in 2021 to over $86 billion–a 65% increase over 2020 (not 30%!). This was led by biopharma at $36.3 billion, then health tech at $28.2 billion. Dx/tools and devices had far more modest funding gains. 

For health tech: 

  • Funding was up 157% versus 2020–42 new ‘unicorns’, four times 2020
  • Provider operations companies comprised a record 35% of total seed/series A funding, up from 20% in 2020. The other hot areas were clinical trial enablement and alternative care. Surprisingly, healthcare navigation was next to last, perhaps indicating that these companies are further along in maturity.
  • Investors were numerous, but high frequency investors were Tiger Global, Andreesen Horowitz, General Catalyst, Casdin, and Gaingels.
  • SPACs slowed in 2021, trying to find the right match before their two-year window to complete a merger and reflecting greater SEC scrutiny of blank checks. Of those who ‘de-SPAC’ed in 2021, Talkspace and Owlet led in market losses, 80% and 73% respectively.
  • Post-IPO performance dropped 28%, led by insurtechs Oscar, Bright Health, and Alignment Health
  • There were 122 M&A deals. The $63 million median value was down 25% from 2020. marking a shift to vertical integrations in care continuums or horizontal to capture consumer bases.

2022 The Year of M&A and Acquire-to-Hire? The end of the report sounds a cautionary note to health tech ‘bulls’. Expect “massive” consolidation. Healthy investment will continue, but the opportunities will be for companies seeking expand product offerings, expand to other markets, or acquire to hire talent (!)–the latter something quite new.

Also FierceHealthcare