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.

News roundup: Omada Health files S-1 for IPO in 2025–and a look at 2024 healthcare IPOs, Philips debuts new smart baby monitor, ActiveAlert launches in UK, ATA Nexus 2025 calls for speakers, abstracts

Omada Health plans exit into the public markets. Omada, which has virtual health diabetes and hypertension management programs, reportedly filed an S-1 with the Securities and Exchange Commission (SEC), according to a Business Insider source. The IPO may be planned for 2025. Omada has been on a hot streak lately, inking deals with Amazon for their health condition programs, adding GLP-1 management, plus accreditation from NCQA and URAC.

Unlike the bare shelves of 2023, 2024 has racked up a few healthcare and digital health IPOs. Waystar’s IPO landed in June and closed today at $26.80, above its $21.50 opening price. This is for a decidedly unglamorous but revenue-generating part of healthcare–RCM and payments management. Tempus AI, in the far glammier AI in precision medicine sector, also IPO’d in June at $37, and after some initial summer sag recovered to $48.96 today. But June also saw yet another formerly hot healthcare tech company, Sharecare, go private after three years of a cracked SPAC. It was bought at 13% of its peak valuation. [TTA 26 June] Another supersonically sad summer story was Tel Aviv-HQ’d Nuvo, which developed and markets a digital pregnancy monitoring system. It went public on Nasdaq via a SPAC on 1 May–then filed for Chapter 11 reorganization by 22 August. Has this finally, finally put paid to SPACs? Bloomberg News, The Middle Market

Virtual MSK provider Hinge Health reportedly is testing the IPO market, having hired Morgan Stanley to start the process. [TTA 3 Oct]

Omada investors since 2011 have poured $525 million into the company over 11 rounds, ending with a debt financing in January 2023. There are 33 investors, including eight lead investors such as Fidelity, Cigna, and Andreessen Horowitz. Crunchbase

If one is to believe the analyst and investor quotes in this Business Insider article, once we get past 2024 and into Q1 2025, the ‘clogged pipe’ of waiting IPOs will roar back into the market like a hungry beast. Aside from wincing at the heckuva mixed metaphor, this Editor tends to be a lot more sanguine about next year. She believes that there are a lot of hungry investors waiting, all right–to offload years of risk to the public and other investors and recoup some if not all of their investment money. Mr. Market may, or may not, feel the same. Hat tip to HIStalk 4 October

On a lighter note, Philips is introducing its most advanced monitoring system to date, the AI-assisted Avent Premium Connected Baby Monitor. The system includes a camera/mic, ‘parent unit’, and app. The camera/mic tracks the baby’s chest motions in sleep and breathing without a wearable. It also has Cry Detection + Translation, which uses AI-assisted and machine learning to interpret baby’s cries. Parents can set up notifications via the parent unit or the app to better understand if baby is tired, gassy, hungry, uncomfortable, or irritated. Release, Mobihealthnews

At the other end of the age spectrum, the Taking Care personal alarm (PERS) company in the UK is introducing ActiveAlert. It adds an AI-assisted twist to personal assistance by triggering a wellbeing check-in call when it detects changes in the frequency, timing, or nature of alarm calls. Their models use 30 years of alarm call data. If there is a change, families are notified. According to their release (PDF), the patterns of alarm call usage can be used to take a more proactive approach to elder care in alerting for concerns or red flags to families before emergency scenarios arise. 

Planning ahead to 2025, the American Telemedicine Association will be returning south–to New Orleans. ATA Nexus–Redefining Care Delivery will be 3-5 May at the New Orleans Convention Center. Deadline is 1 November for speakers and general content proposals, as well as research abstracts for oral and poster presentations. Information for applications is here. The form for requesting the sponsorship and exhibit prospectus is here. Release

Breaking: another exit at Teladoc, with COO resigning effective 31 December

The corporate exits and reorganization at Teladoc continue. Mike Waters, chief operating officer (COO) of Teladoc since mid-2022, has handed in his resignation effective 31 December. The reason given by Teladoc in an SEC 8-K regulatory filing (see item 5.02) is “a change in the Company’s executive reporting structure” which under US law is a resignation ‘for good reason’ as explicitly specified in his employment agreement. He is off the executive leadership webpage.

The parting will not be a difficult one. Mr. Waters will have:

  • nine months of continued base salary
  • up to nine months of premiums for continued medical, dental or vision coverage pursuant to COBRA
  • any earned but unpaid annual bonus in respect of 2024
  • accelerated vesting of all time-based equity awards granted to Mr. Waters prior to the Separation Date, which are unvested as of the Separation Date and are scheduled to vest in the nine months following the Separation Date
  • continued eligibility to vest in awards subject to performance-based vesting conditions if and to the extent the performance conditions are satisfied during that nine-month period.

In return, Mr. Waters will remain an employee through the 31 December separation date. He also has to execute a separation and release agreement that releases any further claims against Teladoc. It also includes a post-termination nine-month non-compete and non-solicit agreement. General non-compete agreements are controversial with new laws limiting them but if baked into an older employment agreement are likely spelled out.

Mr. Waters’ business operational roots are in health systems and practices. He was previously with the Providence health system in Washington, first with Swedish’s practice groups, then in senior executive positions with the system, for a total of over 14 years. 

Teladoc’s top-level executive churn has been substantial this year. At the CEO level, Chuck Divita replaced ousted Jason Gorevic in June after a short under two-month vacancy. Richard Napolitano, the chief accounting officer, departed in May and joined Thomson Reuters where he is now chief accounting officer (LinkedIn). He was replaced by Joseph Catapano from Pitney Bowes in September.  Laizer Kornwasser, the president of enterprise growth and global markets, formerly president of CareCentrix prior to its acquisition by Walgreens, was terminated in July in another reorganization and apparently has not been replaced.  Healthcare Dive

Industry news short takes: fundings for Qure.AI, Centivo, Rippl, Surescripts; M&A closings for GE Healthcare-Intelligent Ultrasound, LetsGetChecked-Truepill. And is Hinge Health going public soon?

The waning days of summer wrapped with a few moderate-sized fundings:

India’s Qure.AI scored a $65 million Series D, bringing their total funding to $125 million. Leading the raise: Lightspeed and 360 ONE Asset, followed by Merck Global Health Innovation Fund, Kae Capital, Novo Holdings, Health Quad, and TeamFund. Qure.AI uses AI to analyze radiology images and ultrasound scans, against billions of clinical image datasets. It currently is used in over 90 countries and 3,100 locations including NHS Trusts. While headquartered in India, Qure.AI has international HQs in NYC, London, and Dubai. The fresh funding will be used to expand its US presence, invest in foundational AI models, and interestingly, acquire medtech companies. Another emphasis of the company is to expand skilled radiology to locations which are resource-constrained, such as healthcare facilities in developing nations or in global rural areas. It is also being used in clinical trials by Johnson & Johnson, Astra Zeneca, and Viatris. MedCityNews 

Centivo added $75 million in equity and debt financing, bringing their total funding to $226.4 million. Centivo provides a primary-care centered health plan directly to employers in all 50 states by partnering with local health systems and direct contracts with ACOs in 18 markets. Centivo replaces traditional health plan and broker relationships. What they offer to employers is an advanced primary care centered model through Centivo Care, an in-house virtual primary care practice. They claimed as of 2023 results of 71% reduction in member out-of-pocket costs compared to commercial plans offered to employers, saving employers 15% or more, and increasing utilization of primary and specialty care. Whether this will “fix America’s broken healthcare model” (a meme we’ve heard many times before) is debatable, but the siren song of reduced healthcare costs for employers is evidently attractive to a raft of funders. It attracted new strategic investors Cone Health Ventures and MemorialCare Innovation Fund, plus existing financial investors including B Capital, Cox Enterprises, F-Prime Capital, Ingleside Investors, and Morgan Health (a division of JPMorgan Chase). Debt financing was provided by Trinity Capital and ongoing banking partner, JPMorgan Chase.  Release, Mobihealthnews, MedCityNews

It’s a $23 million Series A for Rippl to advance virtual on-demand dementia and senior-focused behavioral care. The new funding will be used to expand the company’s geographic footprint, currently Washington, Texas, Illinois, and Missouri, to California, Florida, and Arizona. The company’s key partners are the Alzheimer’s Association, Medicare Advantage Plans, ACOs and other payors and payviders. Rippl is also a participant in the Centers for Medicare & Medicaid Services’ (CMS) eight-year alternative payment model, the Guiding an Improved Dementia Experience Model (GUIDE Model). It started in July with 390 healthcare providers. The Series A was led by Tina Hoang-To, Kin Ventures Founding General Partner, with participation from Rippl’s seed investors ARCH Venture Partners, General Catalyst, GV (Google Ventures), F-Prime, Mass General Brigham Ventures, and 1843 Capital. JSL Health also joined the round. Release 

E-prescriber Surescripts now has a majority investment from private equity TPG Capital. The investment amount was not disclosed and regulatory approval is pending. Its current ownership is 50% by the National Community Pharmacies Association and the National Association of Chain Drug Stores, with the other half Express Scripts and CVS Caremark. It was not disclosed how the ownership shares would be adjusted among the five entities, as CEO Frank Harvey said that all will remain. Surescripts brought in Triple Tree to explore a sale back in April. This Editor noted then that Surescripts has about 95% of the e-prescribing market, enabling it to obfuscate their real business in the vagueness of “health intelligence sharing”. Certainly the PBM owners can use the cash, if cash they’ll get. Release, FierceHealthcare 

Closing M&A deals kick off the fall:

On Tuesday, GE Healthcare closed their $51 million purchase of Intelligent Ultrasound’s clinical AI business [TTA 25 July]. Intelligent already partnered with GEHC on its ScanNav Assist AI technology to power its SonoLystlive and SonoLyst X/IR for GEHC’s Voluson Expert and Voluson Signature ultrasound devices, plus the Voluson Swift. GEHC plans to incorporate Intelligent’s solutions across its ultrasound portfolio through improving workflows and enhancing ease of use for clinicians and patients. MassDevice

And the Optum-arranged ‘marriage’ of LetsGetChecked and Truepill wasted no time in closing on Tuesday. Truepill, a digital/mail order pharmacy, will operate as a subsidiary of LetsGetChecked, an at-home diagnostic with testing kits. Earlier reports indicated that Truepill would be the surviving entity.  Both companies have substantial investments from Optum Ventures and have been losing money for years. Truepill was caught up in the Cerebral and Done Health Schedule II as a fulfillment pharmacy for both and fell under DEA scrutiny with a ‘show cause’ action. TTA extensively analyzed the structure of the “$525 million” acquisition by LGC and the Optum role in it at the time of the announcement TTA 22 August. Interestingly, the closing announcement does not reiterate the acquisition cost. Release, Mobihealthnews

Will virtual MSK provider Hinge Health go public soon? Blake Madden in his Hospitalogy blog 1 October confirms that Morgan Stanley has been hired to run the long-rumored IPO process. Undoubtedly, their management is looking at Sword Health’s nifty recent raise and $3 billion valuation. Investors have been pushing for an exit for some time. In April, the last time that Hinge was on the TTA radar, it had cut 10% of its 1,700 employees yet at that time was rumored to be considering an IPO. Hinge’s last raise was an October 2021 $400 million Series E led by Tiger Global and Coatue Management for a total funding of $826.1 million over 10 raises (Crunchbase). At that time, their valuation was a bubbly $6.2 billion, which despite $400 million in cash reserves (as of April) and its popular niche, in today’s market would be drastically revised downward. Stay tuned….

Two ‘oops’ at VA: OIG finds VA, Oracle performance misalignments, makes 9 recommendations; VP candidates’ EHR records improperly accessed by VA employees

Another OIG audit still finds plenty of inconsistencies between VA and Oracle Health in the EHRM implementation–and makes another set of recommendations. The VA’s Office of Inspector General (OIG) conducted a review of the ongoing EHR Modernization (EHRM) at the VA, and once again found shortcomings in processes not addressed in the May 2023 revision of the 10 year contract.

It’s all about controls and consistency in response. The report identified that VA and Oracle Health still do not have adequate controls to prevent system changes from causing major incidents. Regarding response, both organizations are not uniform nor thorough. Controls were not adequate to mitigate incident impact by providing standard procedures and interoperable downtime equipment. VA lacked a formal process for linking delays to specific major performance incidents.

The auditors analyzed 360 major performance incidents—outages, performance degradations, and incomplete functionality—that occurred between 24 October 2020 and 31 August 2022, plus additional incidents through March 2024. Even though deployments halted in VA facilities except for the joint MHS/VA rollout at Lovell Federal Health Care Center in March, major performance incidents continued, including at Lovell which experienced a major problem in filling 60% of prescriptions.

The OIG made nine recommendations in their report. Grouped together, they include the following actions:

  1. Real-time data sharing to give VA greater awareness of potential problems in system operations
  2. Prioritizing major performance incident response in a clear and consistent manner
  3. Developing and enforcing response and other performance metrics to hold the contractor accountable
  4. Requiring sufficient detail in post-resolution reports
  5. Raising staff awareness of procedures
  6. Acquiring appropriate backup systems for downtime
  7. Better identifying and addressing major performance incidents linked to negative patient outcomes.
  8. Identifying the appropriate backup system and develop a training strategy to ensure clinicians can use the system during downtime.
  9. Assessing facilities’ patient safety reports identified during this audit, determining if additional actions need to be taken and, if so, providing an action plan.

VA release, Healthcare IT News

Some VA employees got very naughty in looking up information on the two VP candidates. Both Ohio Senator JD Vance and Minnesota Governor Tim Walz are both veterans (Marines and Army National Guard, respectively). The breaches were discovered in August during a security sweep of high-profile health accounts held in the VA’s EHR. 

  • 12 employees used their VA computers to access information on Vance and Walz.
  • These included physicians and a contractor viewing for an “extended time”.
  • The curious employees may face charges including dismissal and criminal charges. The length of access and intent will be taken into account.
  • Unknown is whether any of the information was shared outside of VA.

Their respective campaigns were notified and the investigation continues. The VA sent a memo to all employees on 30 August from VA Secretary Denis McDonough with a restatement of official data privacy and conduct directives plus the results of a failure to comply. Original reports were in the Washington Post and CNN. Healthcare IT News, Becker’s

Two follow ups: Steward Health CEO resigns–and sues the Senate HELP committee, Wojcicki will take 23andMe private

Ralph de la Torre MD hasn’t sailed the $40 million boat south yet–but he doesn’t have to go into his office anymore, only the lawyers’. Yesterday (30 September), Dr. de la Torre stepped down from his CEO and board positions of the bankrupt Steward Health. He had submitted his resignation on 19 September, the day that the Senate Health, Education, Labor and Pensions (HELP) Committee voted to hold him in criminal and civil contempt due to his failure to appear before the committee on 12 September. The full Senate voted to refer the contempt charges to the Department of Justice (DOJ) on 25 September. [TTA 26 Sept]

de la Torre filed his own lawsuit on 30 September in the District of Columbia US District Court against each member of the HELP Committee, charging them with violating his Constitutional rights, specifically the Fifth Amendment on self-incrimination, in seeking to subpoena him for a hearing which “was simply a device…to attack Dr. de la Torre and publicly humiliate and condemn him” as part of a “coordinated campaign to villainize and scapegoat him.” The lawsuit seeks to have the subpoena and the contempt referral invalidated and declared unenforceable as a result, seeking declaratory and injunctive relief. He had previously asserted his Fifth Amendment rights before the Committee in view of the company’s Chapter 11 proceedings. Given the threatening and extreme language of several of the committee Members and the actions that de la Torre’s filing singles out, the DC District Court hopefully will give this a fair hearing.

It is unknown if anyone will replace de la Torre as CEO even on an interim basis, as the company is selling its assets via the US Bankruptcy Court for the Southern District of Texas.

“While Dr. de la Torre has amicably separated from Steward on mutually agreeable terms, he will continue to be a tireless advocate for the improvement of reimbursement rates for the underprivileged patient population,” a Steward spokesperson said to Becker’s in a 28 September statement. “Dr. de la Torre urges continued focus on this mission and believes Steward’s financial challenges put a much-needed spotlight on Massachusetts’ ongoing failure to fix its healthcare structure and the inequities in its state system.” (Our Readers will not be blamed for being slightly amazed at this last statement, as most of Steward’s troubled hospitals, including two hospitals that no one would buy, were in that state–and Steward’s interests ranged all the way to London and Malta.) FierceHealthcare, Healthcare Dive 

She’ll do it herself, because nearly 50% of voting shares says she can–No Third-Parties Need Apply. Per an SEC regulatory filing yesterday (30 September), beleaguered 23andMe CEO Anne Wojcicki declared that she is no longer seeking proposals from third parties and is moving forward to acquire the company. “It has become even clearer to me that the best path forward for the (company) is for me to take the company private.” Since the board of directors is vacant–except for her–and she holds effective voting control, it is hard to contradict her. While the company is public via a SPAC that cracked hard, with shares hovering around $0.37, her $0.40 bid per share was rejected by the board in no uncertain terms. However, Wojcicki is the only one who counts here, as she has sole voting power over 9.7 million shares and shared voting power over 101.1 million shares of the company equaling 24.8% of the company’s shares. Replacements have not been made for the seven departed independent directors–and this Editor doesn’t expect any until (and if) Wojcicki buys the company [TTA 17 Sept].

In the SEC filing, Wojcicki said “Importantly, I remain committed to our customers’ privacy and pledge to maintain the (company’s) current privacy policy in effect for the foreseeable future, including following completion of the acquisition I am currently pursuing.” This Editor ironically notes that had that position on site and database security prevailed a year or so ago, none of this would have happened.

Wojcicki may be buying a near-empty shell of a company that preferred to blame users versus clean up its security act, but it will be All Hers. There you go. Reuters, The Business Journals, Yahoo News

Now CVS Health may be reviewing ‘options’–including a possible breakup–report

Perhaps CVS needs to take a medication for Corporate Indigestion. It turns out that CVS did not entirely avoid the agita that is sickening Walgreens. Instead, it has other reasons. Reuters reported that according to their sources (unnamed), their management, board, and financial advisers are exploring ‘options’ that may lead to a partial breakup of the company. Prominently mentioned: a spinoff of their insurance businesses from their retail business. CVS acquired Aetna for this back in 2018 for a pricey $69 billion. Being debated: where the Caremark pharmacy benefit manager (PBM) unit will reside, under retail or insurance. PBM feeds into both retail and the insurance plans.

Glenview Capital Management is reported to be one of the financial institutions in talks with management on an improvement plan. Glenview owns 1% of CVS stock according to the Wall Street Journal, but that 1% accounts for over $700 million of its $2.5 billion war chest. That gives them cause for concern–and leverage.

CVS has confirmed none of this, going to the Boilerplate Folder to pull copy about “driving performance and delivering high quality healthcare products and services enabled by our unmatched scale and integrated model.”

Industry observers aren’t expressing anything more than mild surprise about this, based on a concatenation of recent events and backwash from their 2022-2023 spending binge.

  • CVS cut its 2024 outlook again in August for the third quarter running…and has lost 25% in share value YTD.
  • The kneejerk of a $1 billion cost-cutting plan is being implemented; this week, about 2,900 corporate jobs will be cut. This is after a 5,000-employee layoff that was announced in October 2023, taking place into 2024.
  • Aetna’s Brian Kane was booted in August after less than one year on the job due to his numbers going the wrong way–and his job filled in and not replaced [TTA 8 August]. Who’s next?
  • The outlook for Medicare Advantage is glum into 2025 and later, with utilization costs soaring, new lower Federal reimbursement rates for diagnoses, and Federal clawbacks on overpayments from 2018 on. 2025 plan exits have multiplied with CVS’ affecting about 10% of their membership.
  • PBMs are under attack. The latest is a 20 September FTC administrative complaint (= suit) against the Big Three (CVS Caremark, Express Scripts/Cigna and Optum/UHG plus their respective group purchasing organizations for inflating insulin drug pricing. Insulin is the prime example of inflated drug costs in the FTC view. The latest action doubles down on FTC’s mid-year report. MedCityNews  Readers should note that drug costs have been consistently under attack in Washington not only with this administration, but the prior one, which makes the current election a continuation of the same negative atmosphere.
  • In May, CVS openly sought private equity partners to expand their Oak Street Health locations to a promised 300 by 2026. No partner nor expansion has been announced to date. OSH was bought for a stunning $10.6 billion only 17 months ago.at the very tail end of the ‘buy anything/FOMO’ boom.  This Editor noted that this summer, there were direct response TV commercials to rustle up members airing on various cable channels that target the mature demographic. OSH was regarded as the runt of the litter of primary care practice groups since the larger ones had already been bought by Walgreens and Amazon. Its drawbacks in addition to small size: its model was overly wedded to Medicare value-based (ACO REACH) and Medicare Advantage models, and it had never turned a profit nor was about to. Even at the time, CVS was heavily criticized as making “a deal that made no sense” and “CVS better have a plan they implement in 18 months or they’ll get slaughtered” by an industry figure. [TTA 2 Mar 2023,16 Mar 2023We’re at 18 months. Is OSH quietly on the block?
  • Signify Health was another expensive 2022 buy that sounded good on calls to support the “integration” objective ($8 billion, cash). It put CVS into burgeoning home health and practices–but cost not only the inflated purchase price but also part of the cost of unwinding Remedy Health’s failed Episodes of Care model. CVS also put $100 million into Carbon Health which had to unwind several lines of business including public health before their Series D [TTA 11 Jan 2023], and earlier this year had both their CEO and their president depart. Biotech Networks

Is it time to call healthcare the Sick Man of the American Economy? Or just these big pillars? Crain’s Chicago Business. FierceHealthcare, Healthcare Dive

What’s next for: Steward CEO now in criminal contempt of Congress; Walgreens’ Pessina’s fortune vanishes by 97%; Masimo’s Kiani now a man without a company

Senate unanimously votes to hold Steward Health CEO in contempt. The resolution passed on Wednesday 25 September refers the contempt charges against Dr. Ralph de la Torre, the CEO of Steward Health, to the Department of Justice (DOJ). The Senate Committee on Health, Education, Labor and Pensions (HELP) voted on 19 September to recommend two contempt charges–criminal and civil–to the full Senate. It is the first time since 1971 that a criminal contempt charge has been passed. The DOJ’s actions can include prosecution by the District of Columbia’s US Attorney which can mean arrest and possible incarceration, with a fine that doesn’t exceed $100,000, or civil contempt which usually involves a fine and another subpoena to appear. FierceHealthcare, Becker’s

The threatening language of the HELP committee members such as Bernie Sanders and Ed Markey surely did not encourage de la Torre or his legal counsel to appear on 12 September, with the anger across the board among all members regardless of party. All that it promised to be was, in street language, the worst kind of beatdown. Formally, the appearance was rejected because of Steward’s bankruptcy in adjudication in the US Bankruptcy Court for the Southern District of Texas supervising the sale of Steward assets. There is also a court order that prevents de la Torre from commenting during the sale process. To the press, his legal counsel depicted the HELP committee hearing as “a pseudo-criminal proceeding in which they use the time, not to gather facts, but to convict Dr. de la Torre in the eyes of public opinion.” TTA 14 Sept

Steward Health’s spectacular collapse opens even more Pandora’s Boxes for de la Torre. He possibly faces additional lawsuits attempting to ‘pierce the corporate veil’ to claw back his bank and personal, sizeable maritime and aviation assets–or hold him criminally liable, far more complicated, long-term, and damaging. A cynical view would be that de la Torre would be well advised to get on his $40 million yacht or one of his private aircraft–and depart for a destination that is reluctant to extradite to the US. 

Walgreens Boots Alliance’s troubles drastically shrink executive chairman Stefano Pessina’s personal fortune. Chairman Pessina, who holds 17% of WBA stock and is the single largest shareholder, has seen his holdings shrink in value by 97%, from $12 billion in 2015 to a current $1.3 billion, according to Bloomberg data. The 83-year-old WBA head has seen hard times before. He pulled a rabbit out of the proverbial hat in 2007 by going private with Boots and then merging it with Walgreens in 2015, but time and Mr. Market are not on his side with taking on the debt load necessary.

Is WBA or Walgreens attractive to an acquirer? With stock trading at a record low of around $8 and a market capitalization of about $7.5 billion, it may be a bargain if an investor ignores or doesn’t blanch at the debt load. But those who understand the business cannot buy due to US antitrust regulations, which rules out any retail competitor or PBM. Or the company could be parted out to healthcare providers or a health insurer, but that ignores their miseries, such as reduced Medicare Advantage reimbursements. Their mistakes such as VillageMD and unprofitable locations are in the middle of being worked out and the company is shrinking. Meanwhile, their 15 October full-year earnings report will be dripping with red ink, as their Q1-3 lost $314 million versus prior year earnings of $1.2 billion. Crain’s Chicago Business

Vanishing for Joe Kiani is his day job at Masimo after a dramatic proxy fight. The founder of the audio and health monitor company was voted out of his board seat by shareholders. He followed by resigning as CEO after founding the company 35 years ago. Michelle Brennan, a board member (from Politan) has been appointed as interim CEO. Previously, she was a senior executive at Johnson & Johnson’s companies, including international experience in business development, for over 30 years. She also is on the board of Cardinal Health. Korn Ferry is coordinating the search for a permanent CEO.

The proxy battle wasn’t even close, according a CNBC report reported by Strata-gee. Quoting an inside source, the Politan slate of two directors, Darlene Solomon and William Jellison, received twice as many votes as Joe Kiani and Christopher Chavez on the Masimo slate. 

The company is continuing ‘strategic alternatives’ (read: sale) of its consumer health and audio businesses, the latter mostly acquired in the utterly snakebit 2022 acquisition of Sound United’s consumer audio brands. Masimo is using Centerview Partners and Morgan Stanley as financial advisors and Sullivan & Cromwell as a legal advisor. Presumably, the Kiani-arranged sales to or joint ventures of these units with unnamed investors is off. Masimo will be retaining their professional healthcare and pulse oximetry products. For Q3 2024, Masimo reiterated its financials from early August, with earlier guidance here.

Whether others will depart with Kiani is too soon to tell. During the proxy fight in July, Masimo’s chief operating officer, Bilal Muhsin, promised to resign if Kiani was forced out, specifically citing that he would refuse to work with Quentin Koffey, a Masimo director and chief investment officer of Politan Capital. Other managers signed similar letters around the same time.  However, in the Masimo release on the Kiani resignation, financials, and management changes, CFO Micah Young and Muhsin stated that would provide more details on an earnings call in October.

The Strate-gee view was that shareholders got tired of hearing promises about Sound United and that Kiani was high-handed with them–treating it as his personal company and not theirs. Healthcare Dive

News roundup: Owlet expands to EU, mPulse buys Zipari, New Mountain PE merges 3 payment integrity firms in $3B smush, Candid Health’s $29M raise, Oura buys Veri, Bloomer Tech’s cardio bra

It’s a dogpile of catchup news.

Owlet announced that it’s expanding its European distribution of the Dream Sock. The new countries are Greece, Poland, the Czech Republic, Romania, Slovakia, Hungary and Bulgaria. It is currently, according to its website, available in France, Belgium, the Netherlands, and Luxembourg. It received its CE Mark certification in May. The Dream Sock is a non-prescription device that reports, for babies 1-13 months and 6 to 30 pounds, pulse rate, oxygen, wakings, and sleep trends in real-time via the Owlet Dream App. The app also allows alerts outside of range to be set. Owlet’s financials have improved substantially, though still in the loss column, as detailed in the Mobihealthnews article.

mPulse acquired Zipari for an undisclosed price. Both companies are in the healthcare ‘consumer experience (CX)’ segment which broadly includes using consumer information to ‘personalize health journeys’ that enhance the consumer experience for its health plans. Zipari is apparently more the back end of CX software solutions for insurers, third party administrators, and healthcare payers. There was no disclosure of sale price nor of transition of Zipari staff or the brand name. mPulse now covers 400+ leading healthcare organizations, including 29 of the 30 largest health plans in the country. mPulse is private and controlled by PSG. Release

Private equity company New Mountain Capital, in a $3 billion move, merges three payment integrity companies. New Mountain merged The Rawlings Group, Apixio’s Payment Integrity business, and Varis into a single $3 billion, 2,000 employee company around payment accuracy using various technologies. Rawlings is the largest with over 1,400 employees. It identifies third parties responsible for paying medical claims and is over 40 years old. Apixio provides administration, clinical, and financial program services for payers, previously part of Centene. The remainder of the company–its connected care platform and value-based care services–will be acquired by Datavant. Varis provides overpayment identification solutions including diagnosis-related groups (DRG) and ambulatory payment classification (APC) prospective payments. ‘Smushing’ makes sense if there is one controlling investor and the services dovetail with each other; from the description, the main company will be Rawlings. One hopes that they work out the ‘big bang’ details. FierceHealthcare

In a rare fairly large Series B funding, Candid Health scored $29 million. Candid is a revenue cycle automation and integration platform that simplifies billing for providers through API integrations with current system. The raise was led by 8VC with participation from existing investors First Round Capital, BoxGroup, and Y Combinator. Their total funding since 2019 is $47 million. Release

The Oura ring from Finland is not only still around, but is acquiring a metabolic health company, Veri. One of those ‘neat ideas’ which this Editor thought was gone is still around, having sold 2.5 million rings both direct and through Best Buy currently for $69.99 annually plus local tax, and now tracks over 20 biometrics around sleep, activity, heart health, and stress. Oura has had $148 million of funding since 2013, with its last big $100 million Series C back in the Palmy Days of 2021, with a small venture round in 2022. Veri is also Finnish, already partners with Oura, and has an app that via CGM (Abbott FreeStyle Libre) guides users to the right foods and habits for their bodies. Oura will be launching in conjunction with Veri a new feature, Meals, to help members to see how meal timing affects health metrics like sleep, stress, and recovery. Many of Veri’s team will be joining Oura, including their three founders. Release, Mobihealthnews 

An ECG that looks and wears like a bra. That is the device designed by Bloomer Tech, a MIT spinout. This wearable violates the “smaller and less obtrusive is better” dictum to collect more and more accurate data. The bra design places sensors all around a woman’s torso, the best position for heart data, in an accustomed way to collect data on heart function, lungs, hormones, and metabolism. It connects to an app that collects information and sends it to the wearer’s health provider. Bloomer Tech’s market will be women at risk or with heart disease, with the bra as a prescription item. Its first clinical trial was launched in March, funded by a $1.9 million grant from the National Institutes of Health. It comes in 12 sizes from 32B to 44C, Axios Boston

The two women founders, Chong Rodriguez and Aceil Halaby met in the MIT’s masters degree program, founding it in 2018. They named it after Amelia Bloomer, a 19th Century American suffragette, social reformer, publisher/writer, and advocate for less restrictive forms of dress than the whalebone corsets and tight dresses customary of the period. MedCityNews

23andMe settles 6.9M data breach lawsuit for $30M. Breaking–all seven independent directors quit

23andMe settles, not fights. And their independent directors just quit. The troubled (understatement) company is paying $30 million to settle a massive class action lawsuit around the 6.9 million data breach that started a year ago. This infamous data breach that TTA timelined here was discovered last October, with 23andMe claiming it only affected 14,000 records. Reality dawned as it rapidly grew to millions through the 23andMe databases of over 14 million. By December, 23andMe then resorted to blaming users reusing previously breached passwords (credential stuffing) which was easily disproved. It was one of the worst corporate faux pas since Bud Light.

The hackers had also specifically targeted people with Chinese or Ashkenazi Jewish heritage which wasn’t disclosed until February, though part of the October 2023 hack. It added to the suspicion that those of Jewish heritage were specifically targeted.

Users as a group will receive $30 million along with three years of credit monitoring called Privacy & Medical Shield + Genetic Monitoring. The settlement reached 13 September requires approval by the Federal District Court in the Northern District of California, San Francisco division.

Notably, 23andMe spokesperson Katie Watson confirmed to The Verge that $25 million will be covered by cyber insurance, so most of the cash is there. The settlement document also refers to the extremely uncertain financial condition of the company and asks that the judge halt any further arbitrations by tens of thousands of other class members. 23andMe’s parlous financial status is publicly well known, but no other buyer since the board’s turndown in August of Anne Wojcicki’s offer of $0.40 per share has stepped up to make an acceptable offer. (Perhaps the board was premature–it closed today at $0.34.) Reuters 

Breaking: Wojcicki won’t have to worry about her independent directors anymore. They’ve resigned, effective today, leaving a board of one. The seven directors sent a letter today (Tuesday 17 September) to CEO Wojicki citing that the Special Committee of the board, after months of work, never received from Wojcicki a “fully financed, fully diligenced, actionable proposal that is in the best interests of the non-affiliated shareholders”. It was quite an ask, given that Wojcicki controls the company through a supervoting arrangement. She reportedly holds 22.5% of the company’s outstanding Class A common stock and 59.2% of outstanding Class B common stock (according to analyst TD Cowen)–other reports state that she has in total 49.99% of the voting power. In their letter, they made it clear that the differences were irreconcilable: “Because of that difference and because of your concentrated voting power, we believe that it is in the best interests of the Company’s shareholders that we resign from the Board rather than have a protracted and distracting difference of view with you as to the direction of the Company.” Your move, Anne. Release

(An examination of the board posted online reveals that only one of the resigning members, Richard H. Scheller, ever worked at 23andMe. According to his online bio, he joined 23andMe in 2015 as Chief Scientific Officer and Head of Therapeutics. According to his Caltech board of trustees bio, he retired from 23andMe in 2019.)

Rounding up follow ups: Walgreens shareholder suit on pharmacy performance, Steward CEO no-shows Senate committee, Masimo-Politan proxy fight has court win for Politan–vote on for 19 September

Another shovelful topping Walgreens’ Mound of Misery. Filed in the US District Court for the Northern District of Illinois, this shareholder lawsuit points to the poor performance of Walgreens’ pharmacy division. The fault is assigned to Walgreens management, specifically CEO Tim Wentworth and CFO Manmohan Mahajan plus 10 other executives including chairman Stefano Pessina, in overstating the division’s performance between 12 October 2023 to 26 June 2024 . It charges that they “falsely and materially claimed confidence in the brand inflation, volume growth, cost execution, discipline, and overall contributions of [Walgreens’] pharmacy division”, leading to an overvaluation of Walgreens’ share price. In addition, Walgreens “veiled the reality: that (Walgreens’) pharmacy division was not actually equipped to adapt to ongoing hurdles within the industry”.

The shareholder is Mark Tobias, a shareholder since late 2022. Key to the suit is the 12 October 2023 earnings conference call that contained positive comments about the pharmacy operation made by Wentworth, new at that time to Walgreens, and Mahajan. Their tune changed by the 27 June 2024 conference call where they admitted that the pharmacy model was “not sustainable”. Walgreens’ share price on 12 October 2023 was $24.19.  As of 4pm New York time today, 13 September, Walgreens closed at $9.21.

From the Crains Chicago Business article, the lawsuit demands restitution and reforms:

  • Walgreens should be awarded damages and restitution from the individual defendants
  • The company and defendants take steps to reform and improve corporate governance and internal procedures
  • Those reforms may include
    • Strengthening the board’s supervision of operations
    • Permitting Walgreens shareholders to nominate at least five candidates for election to the board
    • Ensure the establishment of effective oversight of compliance with applicable laws, rules and regulations

The Crains article also includes a Scribd copy of the filing.  Also Healthcare Dive

Another very large Mound of Misery buried Steward Health…but CEO Ralph de la Torre doesn’t plan to comply with a Senate committee subpoena. His testimony before the Senate’s Health, Education, Labor and Pensions committee was scheduled for 12 September but last week on 4 September, his attorneys informed the committee that Dr. de la Torre would not appear. They cited the ongoing US Bankruptcy Court for the Southern District of Texas sale of Steward assets (Healthcare Dive update) and a court order that silences him from comment during the sale process. The committee, chaired by Senator Bernie Sanders, is also accused by the CEO’s attorneys of using the bankruptcy and de la Torre’s marine possessions (a $40 million yacht and $15 million fishing boat) and private jets as “a pseudo-criminal proceeding in which they use the time, not to gather facts, but to convict Dr. de la Torre in the eyes of public opinion.”

The committee plans to decide on 19 September among two options: whether Dr. de la Torre will be brought up on criminal contempt charges that would be referred to the District of Columbia US Attorney, or civil contempt which usually involves a fine and another subpoena to appear. Several Senators on the committee–Sanders, Elizabeth Warren, and Edward Markey–have called de la Torre’s no-show “outrageous”. Sanders has issued threats of de la Torre being held accountable for his greed, but exactly how much of this is for the press and what the committee will do is unclear.  More of concern to the CEO would be whether further lawsuits would attempt to ‘pierce the corporate veil’ and claw back his bank and personal assets–or hold him criminally liable. Healthcare Dive, AP

The ugly Masimo-Politan Capital proxy fight continues–with a win for Politan. The attempt by Masimo, a consumer audio company that branched out into professional healthcare and pulse oximetry products–and last year won a big patent infringement decision against Apple on pulse oximetryto further postpone a shareholder vote on giving control to activist shareholder Politan Capital ended in a loss yesterday. The US District Court, Central District of California denied Masimo’s request for a preliminary injunction to block Politan’s nominees for the Masimo board. Unless Masimo’s motion asking the same court to find Politan in contempt due to breaking the court’s sealing order on the decision, and the court grants a further delay, the shareholder vote will be held next Thursday 19 September. The likely outcome, according to Strata-gee which is covering this from the consumer audio perspective, is that shareholders will turn the board over to Politan by electing their representatives to the two open seats, booting CEO Joe Kiani–and total corporate chaos will ensue. Strata-gee has all the gory details. Background in TTA 8 August and prior.

US telehealth controlled substances prescribing waiver may expire at year’s end; DEA may further restrict

Current waivers end 31 December without DEA, Congressional action. The Drug Enforcement Administration (DEA) apparently through inaction, will allow the current virtual prescribing flexibilities impacting Schedule II and higher drugs to expire at the end of year. These waivers which removed the in-person examination requirement under the Ryan-Haight Act were instituted during the Covid pandemic and extended twice [TTA 11 Oct 23, 11 May 23] with a final expiration of 31 December 2024.

Reportedly, the DEA is not only wishing to reinstate the status quo ante, but also reportedly wants to institute additional restrictions. However, any draft rule that would reimpose or changes restrictions has not been put out for the public comment period, review, and final rule implementation which typically takes anywhere from 60 to 120 days, well past year’s end. Last year, when a draft rule was released for comment, nearly 40,000 comments were received.

At the time of the 2023 extension that kicked this particular can down the road into the end of a presidential election year, DEA had stated that they would use 2024 to finalize telemedicine prescribing rules, but no action has been taken. Since then, the Department of Justice has filed multiple charges of Medicare and Medicaid fraud and illegal distribution of controlled substances against seven Done Global employees [TTA 3 July and prior], with investigations pending on practices by provider Cerebral and pharmacy Truepill

Under the aegis of the American Telemedicine Association (ATA), a coalition of 330+ organizations have again written as of Tuesday 10 September to the current administration and both houses of Congress to 1) extend the waivers for two years, as part of the end of the Federal fiscal year (starting 1 Oct) package, and 2) use the time for DEA to “to fulfill its congressional mandate to establish a special registration pathway that balances access to medically necessary care with appropriate enforcement.” The rationale centers on the lack of time, but strongly around the availability of psychiatrists throughout most of the US–there are none in half of US counties especially in rural areas. (The average MD psychiatrist is well over 50, nearing retirement, and not well reimbursed for his or her time–which is why med school grads in heavy debt don’t gravitate to the specialty.) What is not stated is that many if not most telepsychiatry providers do not have models that will support in-person evaluations as required without waivers.

There are no public actions or responses either by Congress or by the DEA as of today (13 September).

ATA press release, Biden Administration letter, House letter, Senate Leadership letter, Healthcare Dive

ATA Action, ATA’s trade organization and advocacy arm, has also formed a political action committee (PAC), ATA Action PAC. Its stated purpose is to support incumbent Federal candidates including Congressmembers who support their goals in virtual care policy. Candidates on the Federal or state levels will not receive support.  Release

Evolent Health talking major acquisition by payer Elevance, private equity

Management services organization Evolent Health moving down the road in selling itself. Another deal perking below the Labor Day wire to brew into September or October coffee is a full or partial buyout of Evolent Health.  Potential buyers or partners include Elevance Health (the former Anthem), to position against Optum/UHG, and several private equity companies: TPG, KKR, and Clayton, Dubilier & Rice (CD&R). Evolent provides organizational and administrative services for primary plus specialty care physicians and payers for patients with complex conditions, within and outside of value-based care models such as ACOs, utilizing connected care and workflow automation technologies. In June, it agreed to acquire many of the AI utilization management assets of Machinify, not yet closed. 

Evolent’s (EVH, NYSE) current market capitalization is about $3.65 billion; stock price closing yesterday was $31.62 (Yahoo Finance). Industry analyst Jailendra Singh of Truist projected earlier this month, before this news dropped, that the stock was underpriced at the time in the ~$20 range and justified a target price at $33, citing their ability to manage utilization trends and rate adjustments for FY 2024. Seeking Alpha went so far as to state that at an acquisition price of $35, it would still generate a profitable internal rate of return (IRR).

A buyout won’t be cheap. With an estimated $114-116 billion shares outstanding, an outright purchase price at $35/share could approach or top $4 billion. Which means that the buyout lift could be shared. Projections with the information available range from PEs negotiating a leveraged buyout (LBO), a tuck-in by Elevance, or possibly a PE/Elevance partnership. Elevance already works with CD&R in the Mosaic Health care delivery platform partnership.  The shape of the buyout will develop over the next few weeks. FierceHealthcare

Another activist shareholder forcing a sale? Medical Buyer added to the above reports that long-time shareholder Engaged Capital pushed for this, to the degree that the board of directors needed to settle with them by forming a strategy committee focused on “value creation initiatives”.  As far back as 2021, Evolent was courting suitors or partners–at that time, Walgreens Boots Alliance, which may have been a far better but more complex buy than VillageMD. Hat tip to HIStalk 8/26

Evolent’s potential sale complicates the outlook for other MSOs such as Aledade, Optum, Privia Health, Health Catalyst, Accolade, Alignment Health, and Collaborative Health Systems (now part of Centene–disclaimer, CHS was this Editor’s former employer). In addition, a payer buying a large MSO with provider contractual relationships may pique the interest of FTC and DOJ, which already have Optum on their radar.

Sidebar: Revealed yesterday was Evolent’s CEO Blackley Seth cleaning up his stock option portfolio. According to Investing.com, he “sold shares totaling approximately $5.6 million at an average price of $30.00, with transactions ranging from $30.00 to $30.02. Additionally, the CEO acquired shares worth roughly $1.6 million through option exercises with prices between $6.87 and $10.27.” The sales were prearranged on 29 February under SEC Rule 10b5-1 to avoid insider trading charges. Both the sale and buy were over 100,000 shares.

Truepill to be acquired by LetsGetChecked for $525 million

When is $525 million not $525 million?  Ireland’s LetsGetChecked and California-based Truepill have two things in common: backed by Optum and burning through cash. The deal went under the Labor Day wire:

  • How the buy is structured: $25 million in cash, another $200 million in possible earnouts tied to revenue milestones, and $150 million via a convertible note offering to finance the deal….which doesn’t add up to $525 million.
  • While LetsGetChecked is technically is doing the buying, it is creating a merger NewCo to unify both businesses. Truepill will be the surviving trade name as it has the slightly healthier business.
  • This creates a digital pharmacy to market and fulfill LetsGetChecked’s at-home testing kits.
  • Most of Truepill’s senior management, including their CEO, Paul Greenall, will remain. Greenall also received a $7.25 million forgivable loan. (The reason why is unstated, but these loans usually cover stock option purchases.)

No closing date nor required regulatory reviews are disclosed.

According to Axios, both businesses are in the red. “Truepill lost $15 million on $64 million in revenue for the first four months of this year (increased revenue run rate), while LCG lost $32 million on $39 million in revenue over the first five months of 2024 (declining revenue run rate)”. Truepill was valued in 2021 at $1.6 billion and had acquired $370 million in VC funding. 

As projected at the beginning of the year, health tech M&A are either tuck-ins or throwing in together to survive. Truepill had been shopped since March but received only one other offer. During the Cerebral and more recently developing Done Schedule II drug prescribing scandal in mid-2022, Truepill, as a mail-order pharmacy for both, found itself in the middle of it and under DEA scrutiny with a ‘show cause’ action. LetsGetChecked was also deeply underwater and not looking like it was surfacing. With the NewCo, it seems like an Optum Ventures-engineered ‘shotgun wedding’.  TTA 19 June19 Dec 2022

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.

Are patients and physicians ready for generative AI? How will it be most acceptable?

As the flood of news will ebb over the next two to three weeks or so (and your Editor takes annual leave), some reading for your pondering.

Gimlet EyeBain and Company, the well-known (and well-feared when they come to your company) management consultants (and investors), recently published results from March’s US Frontline of Consumer Healthcare Survey taken from 500 (undefined) respondents. Unfortunately, with the article, there is no opportunity to download the full survey or review the methodology. From their featured toplines, though, we can savvy that there are still many patient and clinical doubts around generative AI. 

Bain’s article generally spins positives from the results. For instance, their lead is that patients are ‘more comfortable with generative artificial intelligence (AI) analyzing their radiology scan and making a diagnosis than answering the phone at their doctor’s office.’  Their second lead is that clinicians generally have ‘a positive view, recognizing generative AI’s potential to alleviate administrative burdens and reduce clinician workload”.

Your Editor takes a more Gimlety view. First, let’s review consumer comfort with generative AI in five functions:

  • No ‘comfortable’ response is above 37%. Adding in ‘neutral’ at 18%, the only area breaking 50% is “taking notes during appointments to send follow-ups” at 55%. Consumers are not comfortable with generative AI “providing medical advice, treatment plans, and prescriptions” at 21% (11% and 10% respectively).
  • ‘Not comfortable’ is lowest for notes for follow up at 45%. The highest is for medical advice at a eye-blinking 79%. In between, the range is 52% to 68%–indicating strong consumer resistance across the board.
  • As to analyzing radiology scans, there is a lot more comfort with that report going to the doctor for review than AI making a diagnosis. For reports to the doctor, the ‘comfortable’ response is 31% but falls to 21% for diagnosis. ‘Not comfortable’ notches from 52% to 62%
  • For answering calls for providers or insurers, there is definite unacceptance at 68% with only 33% ‘neutral’ or ‘comfortable’.

Provider perspectives are split between physicians and (undefined) administrators. (No neutral in these responses)

  • They both believe that administrative burden and workload will be reduced, with admins far more hopeful than physicians at 43% and 35% by area respectively.
  • What neither group likes is the potential to undermine the patient-provider experience: 19% negative for the physicians and the admins not far behind at -17%.

The takeaway: Generative AI is following the telehealth curve in initial low acceptance. The responses and proportions resemble the early days of telehealth and to a lesser degree, remote patient monitoring. Information didn’t fit into workflows, wasn’t seen as critical, and increased administrative burdens. With acceptance languishing for over a decade, it took a black swan event called the Covid Pandemic to overcome–and in the end it reshaped telehealth, as Teladoc and Amwell have learned.

But in present time, if your Editor as a consultant were presenting this to an AI developer, a physician group, or investors, she would advise preparing for a long, hard road. A road which needs validation, real revenue models, demonstrated accuracy, acceptances, and proven value in solving crucial problems and cost reductions. Natural-language processing (NLP) is being touted as a tool for most of this–but it is only part of the picture. 

Views at variance: Healthcare IT News (NLP interest), MedCityNews (LLMs losing to humans on medical knowledge), MedCity News (on proving value)