Follow up roundup: Amwell to reverse stock split to avoid delisting (updated), Amazon Clinic folded into One Medical, Amedisys divesting to close UHG deal, latest on Steward Health’s antics and $7M spying, Masimo’s shareholder fight (latest)

July 2, 2024 | by

Amwell will reverse stock split to fix their pending delisting on the NYSE. The board of directors approved on 28 June a 1 for 20 reverse split. This will remedy their non-compliance with NYSE regulations requiring an average closing price of above $1.00 over a consecutive 30 trading-day period [TTA 5 Apr]. Shareholders approved the move at their meeting on 18 June. The NYSE notice was given on 2 April and the reverse split will happen at the market open on 11 July, well within the six-month window. Amwell Class A shares closed yesterday at $0.27 so that condensing 20 shares will bring the share price around $5.40. Amwell’s 2024 is forecast with revenue in the range of $259 to $269 million and adjusted EBITDA in the (less) red between ($160) million to ($155) million, with no breakeven in sight until 2026. Their Q1 posted a $73.4 million net loss. Amwell has also released 10% of staff since the palmier days of 2023. Amwell, like Teladoc, continues to struggle in a stand-alone urgent care model that is now obsolete. Release, Healthcare Dive

Update 11 July: Amwell shares opened today at $6.52, and as of midday were trading at $7.51. So short term, the reverse split is working to plump up the shares.

Amazon says goodbye to Amazon Clinic by folding it into One Medical. This should come as no surprise to Readers who noted the  May departure of Clinic’s general manager Nworah Ayogu, MD to VC Thrive Capital with no replacement or search. Amazon’s announcement on 27 June was typically upbeat in renaming the service as One Medical’s Pay-per-visit telehealth. The improvements they claim are:

  • Pay-per-visit telehealth for 30+ common but minor conditions, like pink eye, the flu, or a sinus infection
  • A One Medical monthly or annual membership plan that includes on-demand virtual care and same or next-day appointments at 150+ One Medical primary care offices
  • More affordable–messaging/asynchronous visits are now $29, formerly $35, and video visits at $49, formerly $75. 

The catch–existing Clinic members have to log into One Medical to access their records and the service. Amazon is also propping up One Medical through Prime membership, offering a better deal at $99/year and non-Prime individuals for $199 per year. Amazon does not disclose users, growth, or revenue for either Clinic or One Medical. Healthcare Dive

The long-delayed UnitedHealth-Amedisys home health deal moves closer to closing. Amedisys and UHG’s home health operation under Optum will be divesting some of their locations to VitalCaring Group to avoid Department of Justice anti-trust concerns. The divestiture is contingent on the acquisition closing, now projected in second half of this year. The number of locations was not disclosed though earlier speculation had estimated it at 100. UHG’s offer to acquire Amedisys was made in June 2023 for $3.3 billion in an all-cash deal. It would be additive to its earlier $5.4 billion buy of LHC Group, now part of Optum. With the divestiture, analysts do not see any impediments to a closing, though it had faced opposition in Oregon in March and DOJ opposition since it was announced. This Editor remains sanguine about a successful closing. After UHG won versus DOJ in the Change Healthcare acquisition, “DOJ has a long memory, a Paul Bunyan-sized ax to grind, and doesn’t like losing.” Expect a few more impediments tossed in their direction over the next months. FierceHealthcare , Zack’s Research

The latest episodes in the continuing soap opera of Steward Health involve both Optum and James Bond moves on their critics. Optum had offered back in March to buy their practice groups under Stewardship Health, which stalled with first the Massachusetts Health Policy Commission (HPC), then their bankruptcy. That offer is now off, leaving Steward in the lurch. It was critical to $75 million of Steward’s debtor-in-possession (DIP) financing as recently as 13 June [TTA 14 June]. The deal would have been problematic anyway for Optum as they are under DOJ scrutiny not only for Amedisys but also because Optum controls or has arrangements with 10% of US physicians, 90,000 to date. Healthcare Dive They also settled recently with DOJ for $20 million on Optum Rx’s filling orders from a mail-order pharmacy in Carlsbad, California between 2013 and 2015 for Schedule II drugs: opioids, benzodiazepines, and muscle relaxants. Healthcare Dive

Adding to Steward’s piles of misery are the latest revelations that Steward financed a $7 million spy operation on their critics. This loony aspect to the Steward endgame involved contracting with UK investigators on surveilling a critical former executive, a British financial analyst, and a Maltese politician to find compromising actions between 2018 and 2023. The investigations were allegedly authorized and prioritized by Steward’s top executives while Steward struggled to pay bills for its hospitals and practices. Payments to the investigators were routed through Steward’s Malta operation against their critics in Malta and elsewhere. Steward at the time was embroiled in a dispute around their management of hospitals in Malta, which was eventually investigated and terminated by a Maltese court last year.

One example: the UK firm Audere “collected embarrassing personal information and photographs of a former Steward employee after Steward feared he would leak financial information to its auditor.” Another was the investigation and harassment of a British financial analyst, Fraser Perring, critical of Steward’s actions in its dealings with Medical Properties Trust (MPT). He was followed, his home CCTV was disabled, his home was broken into, family members and his partner were followed. Perring was also being smeared on Twitter through an account set up by Audere. There is much more on this in OCCRP’s report, published (paywalled) in the Boston Globe and Times of Malta. OCCRP’s full report and findings are here. FierceHealthcare

Electronics, audio, and medical device company Masimo continues to fight a hostile activist investor, Politan Capital Management. In December 2023, Masimo notched a significant win via the International Trade Commission versus Apple’s Series 6 and later Watches that forced Apple to disable its pulse oximetry (SpO2) sensors and software that violated Masimo’s smartwatch patents [TTA 28 Dec 2023]. Politan descended on Masimo in April accusing CEO and chairman Joe Kiani and others of mismanagement, including the 2022 acquisition of Sound United’s audio brands. It won two seats on the Masimo board of directors at the last shareholders’ meeting and is demanding two more seats at this year’s meeting on 25 July which would give it effective control.

The latest in the proxy fight is that the chief operating officer, Bilal Muhsin, will depart after 24 years at Masimo if Joe Kiani is forced out. The brief conditional resignation was sent to Masimo’s lead independent director, Craig Reynolds. Mentioned in the resignation was that he would refuse to work with Quentin Koffey, a Masimo director and chief investment officer of Politan Capital. More letters like this may be coming as reportedly Masimo management has urged employees to sign similar letters. Strata-gee, MedTech Dive  

Politan was the investment group that upended Centene Corporation and ousted most of Centene’s board plus 25-year CEO Michael Neidorff in 2022 shortly before his death on 7 April 2022 [TTA 18 Dec 2021]

Update: 300 engineers in Masimo’s healthcare division expressed specific support for Joe Kiani against Politan and Quentin Koffey in an open letter. “We wish to convey our deepest concern if Quentin Koffey and Politan Capital take control and Joe Kiani is removed. We are committed to Masimo because of the vision and innovation he pushes and drives us to deliver. The prospect of losing our founder and CEO threatens to derail the progress we have made and jeopardize the future of Masimo.” They also expressed that they may leave. “We, the undersigned from Masimo Healthcare Engineering, wanted you to be aware that we may not continue with the company if Joe Kiani is replaced by Quentin Koffey and Politan Capital.” This follows on other letters written by international regional managers and presidents in June also stating their support and warning that they may leave if Kiani leaves. The annual shareholder meeting is scheduled for 25 July.   MedTech Dive

However, Masimo is also embattled on other fronts: earlier in June, DOJ and FDA announced their investigation of problems with their Rad-G and Rad-97 SpO2 devices leading to a recall and the SEC is investigating potential accounting irregularities and internal control deficiencies. MedTechDive

News roundup: Transcarent raises $126M; 98point6 lays off; Oscar notches first profit; Steward Health’s Ch. 11; Amazon Clinic GM leaves; Amwell’s down but hopeful Q1; Hims founder gets political

May 8, 2024 | by

A study in contrasts

Already well-funded Transcarent gains another $126 million in a Series D round. Total outside funding is $424 million that boosts its valuation to $2.2 billion. This round will fund expansion and development efforts plus enhancing the platform’s AI capabilities. The Series D round was led by General Catalyst and Glen Tullman’s 7wireVentures, with participation from new investors Memorial Hermann Health System and Geodesic Capital, along with existing investors. As noted in our Rock Health analysis (but not in the company’s release), this raise had a ‘sweetener’ of a 2.5x return should the company IPO or M&A.  Transcarent is an enterprise health navigator that enables employees to use a single platform to navigate their needs for medical, surgery, pharmacy, and mental health care. Transcarent’s differentiator in this space for large self-insured employers is that Transcarent steers employees to higher quality, lower cost care settings. Their pricing is also based on actual users only in risk-based agreements, versus the more common per member per month (PMPM) care management model. Transcarent also pays health systems up front for surgical procedures.

Tullman, who is also Transcarent’s CEO, is well known for creating high profile companies that eventually are sold or IPO’d for high valuations. These deals make his followers money, but often not the buyers (ask Teladoc) or the employees left in the lurch. This Editor does wonder, given the state of US business right now, how this competitive enterprise care management niche earns this kind of investment and valuation. Release, Mobihealthnews 

One of Transcarent’s buys last year was 98point6’s virtual care and related assets that included 98point6’s physician group, self-insured employer business, and an irrevocable software license in a deal worth potentially $100 million according to publicity. 98point6 then had a well publicized and $32 million-financed pivot to being a software company and licensor, acquiring remaining assets from asynchronous telehealth provider Bright.md this past January for 55% in equity and 45% in cash. Despite all this, little noted was that at the end of April was that 98point6 laid off an undisclosed number of its estimated 100 US-based staff. One wonders if this affects service to Bright.md’s provider customers. GeekWire

On the health plan side, rebooted insurtech Oscar Health finally got into the black with $177.4 million in net income for Q1 and beat earnings per share estimates. It’s no surprise to those of us who’ve followed the modus operandi of Mark Bertolini, who took the reins a year ago March [TTA 30 Mar 2023] and stated at the time that his focus was moving Oscar to profitability. Total revenue was $2.1 billion, a 46% increase versus Q1 2023, driven primarily by higher membership, rate increases, and lower risk adjustment as a percentage of premiums. Release. Becker’s, FierceHealthcare Their full 2024 is projected at $8.3 to $8.4 billion in revenue, $125 to $175 million in adjusted EBIDTA. Oscar solely offers ACA exchange plans for individuals and small groups, having exited Medicare Advantage after 2022. Release

Steward Health Care filed Chapter 11 bankruptcy on 6 May. As forecast when the company moved to sell its provider group Stewardship Health to Optum [TTA 18 Apr], Steward’s debt load in its 31 hospitals and operations forced the restructuring on Monday. What’s owed: $1.2 billion in total loan debts, about $6.6 billion in long-term lease payments, north of $600 million to 30 of its largest lenders (Change Healthcare, Philips North America LLC, Medline Industries, AYA Healthcare and Cerner). There’s $289.8 million in unpaid compensation obligations: $68 million to its own workers in unpaid employee salaries, $105.6 million in payments for physician services and $47.7 million owed to staffing agencies. Topping it off–$979.4 million outstanding in trade obligations, of which approximately 70% are over 120 days past due.

Debtor-in-possession is now Medical Properties Trust (MPT) which will finance $75 million up front extending to $225 million more if Steward’s asset selloff milestones are completed on time. MPT will need to be far more forthcoming about Steward’s finances than Steward has been. The Stewardship Health sale to Optum now has to pass through the US Bankruptcy Court for the Southern District of Texas as well as Massachusetts regulators. Becker’s, Healthcare Dive 6 May, 7 May

Amazon Clinic loses its general manager, Nworah Ayogu, MD. He departed for Thrive Capital, a secretive VC (based on its website) that invests in technology, internet, and software companies. Dr. Ayogu, who doubled as chief medical officer of Amazon Pharmacy, stated the move will enable him to focus “exclusively on healthcare” after nearly four years with Amazon. He launched Clinic in November 2022 to a full 50-state rollout of the asynchronous and synchronous telehealth service last August, after a privacy challenge that escalated to the Senatorial level and forced a rollout delay [TTA 1 Aug 2023]. It sounds more like the doctor needs to go on a break. Amazon has not announced a replacement nor has Thrive issued any information. Becker’s, Modern Healthcare

Amwell’s soft Q1 reflective of telehealth as a whole. Its Q1 revenue of $59.5 million was 7% below Q1 2023’s $64 million, and missed Mr. Market’s forecasts. Where there was improvement was that net loss narrowed considerably to $73.4 million from prior year’s $398.5 million, when it took a hefty non-cash goodwill impairment charge. The bright spot Amwell is forecasting is that their Federal contract with Defense Health Agency, jointly with Leidos, will impact by Q4. Their part of the Digital First initiative for the Military Health System (MHS) will replace the current system, MHS Video Connect, with Amwell Converge [TTA 15 May]. Their pending NYSE stock delisting they plan to remedy with a reverse stock split to be announced.  Healthcare Dive, Amwell’s SEC Form 10-Q

Hims CEO and founder Andrew Dudum Does a Dumb. Mr. Dudum made a statement that on X that was interpreted by most to be encouraging the disruptive anti-Israel university and elsewhere protests which have roiled cities like New York and Los Angeles for weeks and are canceling graduations at Columbia University and University of Southern California. A statement like “If you’re currently protesting against the genocide of the Palestinian people & for your university’s divestment from Israel, keep going. It’s working.” and went on to say that companies would be eager to hire them is plain and clear. It immediately garnered criticism from investment group, industry, and software heads, as well as conservative and moderate media. This Editor will put on her marketing cap and remind Mr. Dudum of Marketing 101–be memorable, but do not offend the customer or investors who give you money. You have, after all, a company that depends upon appealing to a wide spectrum of people with easy and recurring telehealth prescriptions for hair loss, weight loss, skin problems, women’s health concerns, and erectile dysfunction. Your statement was not only completely unnecessary but also inflammatory at a bad time–it offended many customers no matter what religion or beliefs. Stock dropped. Customers canceled. Note to Mr. Dudum: if you want a thriving business, don’t live up to your name. FoxBusiness

Has Amazon lost its ‘edge’ in healthcare? Or finally seeing reality?

December 1, 2023 | by

Amazon’s long and winding road to Healthcare Reality is no surprise to those tracking Amazon’s moves over the past few years. And Bloomberg agrees. In the eyes of many of the industry, Amazon was one of the top companies revolutionizing healthcare in a consumer-focused, tech-driven model. They were making The Big Moves along with giants CVS and Walgreens with an open wallet, with Walmart lagging and tagging behind. But when you turn a Gimlet Eye to the track record, The Big Moves were marked by hubris, uncertainty, lack of focus, lack of healthcare expertise, and just plain bad judgment.

  • First, there was the sinkhole known eventually as Haven, 2018-2021. This partnership with JP Morgan and Berkshire Hathaway (RIP to the legendary Charlie Munger) generated truckloads of 50,000-foot quotes by JPM’s Jamie Dimon and B-H’s Warren Buffett about the ‘hungry tapeworm’ of healthcare costs and the need to simplify it for their million-odd employees. It was clear that Amazon was relegated to the ‘junior partner’. Their reaction was to go their own way well before the shutdown and make its own acquisitions, acquiring PillPack in mid-2019 as the first move towards a PBM, Amazon Pharmacy, then pushing Amazon Care for large employers. TTA 6 Jan 2021
  • Then there was the brief and mysterious life of Amazon Care, 2019-2022. Their mix of virtual care, in-home, and telehealth services signed up large employers such as Hilton and (of course) Amazon with the eventual vision of delivering in-home care of visits and medications via mobile providers. Despite plenty of pivoting behind the scrim but eventually going nationwide with some, not all, of their services, their vision wasn’t attractive to most large employers. Even before One Medical was acquired in July 2022, Amazon decided to ditch Care by end of 2022. TTA 25 Aug 2022
  • And $3.9 billion later, there is One Medical, acquired earlier this year. It has never made money and won’t for at least two fiscal years. It doesn’t resemble an Amazon-style delivery model either. It’s a membership model practice group with individual paying members plus 9,000 corporate service contracts and telehealth. Of course, memberships including telehealth are being offered to the millions of Amazon Prime members at a drastically discounted rate starting earlier this month.
  • Bubbling under this is Amazon Clinic, an asynchronous virtual consult service leaked in November 2022, formally announced in June 2023 but delayed until August on data privacy issues that attracted Senatorial scrutiny on whether information would be passed to other Amazon services for merchandising [TTA 27 June]. Visits cost an average of $50. Amazon is surprisingly mum on Clinic’s status.

From the collection of articles linked above, plus TTA’s ongoing chronicle of FTC’s (and DOJ’s) consistent scrutiny (some call it vendetta) re Amazon [TTA 24 Aug, 27 Oct], one cannot conclude that Amazon has lived up to its publicity, dominating coverage earlier this year, that it would be a leading Healthcare Transformer. In that last article, this Editor’s obvious doubts were summarized as “What we view as a juggernaut is facing more than their share of distractions and changing circumstance.”

It is awfully nice to know that Bloomberg has taken our small ball of misgivings and run with it. Their article describes, through interviews with current and former employees, patients, competitors, and industry analysts, a “culture of hubris”, believing that “Silicon Valley-style invention could outsmart industry incumbents” and management not listening to the industry people they did hire. The hubris goes back to the very beginning. Even transitioning a young but deep in the red company like PillPack, bought for a truly ridiculous amount of money but that fit easily into the Amazon model, took an inordinate amount of time–about two years. Amazon Pharmacy, built on the PillPack bones, doesn’t seem to be meeting expectations, running headlong into local retailers such as CVS, Walmart, and Walgreens, discounters such as GoodRx, and deliverers such as Mark Cuban Cost Plus. No surprises there when you waste two years. Wall Street doesn’t like it much either, despite the promises from CEO Andy Jassy that healthcare is their long-term growth area, carrying through the vision of former CEO and now chairman Jeff Bezos.

It also doesn’t help to be the corporate target of the FTC, not mentioned in the Bloomberg article.

This Editor will quote herself from a recent article. While it was in the context of learnings from Olive AI, it applies equally to those with lots of success in other businesses or even other parts of healthcare. Know that healthcare, no matter what the conferences say, is an entrenched, over-regulated, risk-averse, and thus extremely slow-moving business. The risk level is high, the reward may be incremental, at best. And the big guys–the payers, big health systems, and their vendors, will always have it all over you.

Amazon Clinic announces 50-state rollout 1 August. Were the privacy issues fixed?

August 1, 2023 | by | 2 Comments

At least the disclaimers are new and improved. Amazon today, on its news page, announced that Amazon Clinic was being rolled out to all 50 US states from the previous 33. You will be paying in cash (no insurance accepted) for services, which now include live 24/7 telehealth (via two ‘white-labels’, Wheel and SteadyMD) in addition to asynchronous (messaging) telehealth, for treatment of about 30 common mild and chronic conditions such as rosacea, gout, eczema, UTIs, and the ever-popular erectile dysfunction and hair loss. Access is provided through the Clinic website or the Amazon app. Providers set fees on a one-time and ongoing basis. Prescriptions can be filled individually or through Amazon Pharmacy. The service is not available to those below 18 or above 64, which is a mystery as those 65+ are perfectly capable of paying in cash and suffer from the same maladies. (Age discrimination, anyone?)

As to the reported delay from 27 June on the service expansion [TTA 27 June], an Amazon spokesperson denied that privacy concerns expressed by two US senators (Warren and Welch) and in the Washington Post had any effect and in fact, denied that there was any delay.  FierceHealthcare.

It is unknown whether Amazon replied to the senators’ letter that cited where consumer information went, that it may be redisclosed, and denial of service (inability to complete registration) if a user during registration did not agree to waive HIPAA and give Amazon access to the patient’s personal information file.

Looking at the news, website and privacy disclosures, there are multiple disclaimers wherever one looks that seem to address these concerns.  On the news release, there is a link labeled Read more about how privacy is built into Amazon Clinic’s core. Excerpts below (main points in red):

We do not sell customer information.

Amazon doesn’t sell customers’ personal information. Amazon Clinic also doesn’t use a customer’s personal health information to market or advertise other products in the Amazon.com store.

We ask for HIPAA authorization to make things easier for customers.
One of the complaints we hear a lot about traditional health care is how many times customers are asked to fill out forms over and over again. To solve this problem, Amazon Clinic asks customers for permission (through the HIPAA authorization) to allow us to save their information and patient records if their health care provider leaves Amazon Clinic. This supports continuity of care and makes it easier for customers to work with different provider groups, because they won’t have to fill out the same form multiple times or lose access to their visit history. Customers have the option to accept or decline the HIPAA authorization before getting treatment—customers who decline can still receive care from Amazon Clinic.

Privacy disclosure on the Amazon Clinic site is the same in consumer-oriented language and with a revocation notice:

What we do (and don’t do) with your information
We use your information to make your healthcare experience easier. We send it to your healthcare providers and pharmacies when you’re being treated, and we save it so you won’t have to fill out the same forms over and over again—even if your healthcare provider were to leave Amazon Clinic. We’ll never sell your information to anyone and we don’t use your personal health information to market or advertise other products available on Amazon.com.
We respect your preferences
If you don’t want us to save your health information, you can still get care through Amazon Clinic. However, you should know that if the healthcare provider(s) you’ve used leave Amazon, we’ll be required by law to delete your health information and you’ll have to re-enter it if you visit us again.
You can change your mind
If you give us permission to save your health information, then change your mind, that’s OK. To revoke your HIPAA Authorization, just email your request to clinic.privacy@amazon.clinic. Make sure to include your name, date of birth, address, and phone number, or download the HIPAA revocation form, fill it out, and send it as an attachment to your email.

Unless this is not operating reality, Amazon may have come to its senses and installed proper guardrails on this service. Amazon is making a massive bet on healthcare by building Clinic, Amazon Pharmacy, and paying $3.9 billion for One Medical which is currently unprofitable. They are betting that to their captive audience, basic healthcare can be delivered like merchandise and that more complex primary care can be folded into the Amazon continuum. In Amazon Clinic, it’s betting that it can one-up established players like Ro and Hims as well as Teladoc and Amwell.

A hard look at Amazon reveals that the strategy compensates for losses in other areas, such as their basic businesses with layoffs of 27,000, including Amazon Pharmacy and the Washington Post, and shuttering Amazon Care last year. Technology hasn’t been much of a winner, with Halo terminated yesterday and with privacy concerns (again) around Alexa, Kindle, and Ring security cameras. AWS is no longer the cash cow mooing in the meadow that subsidizes various ventures, with growth down by half and plenty of competition [TTA 16 June]. Amazon has few friends in DC, not even at the Washington Post. The Federal Trade Commission (FTC) and the Department of Justice (DOJ) have held up their $1.7 billion buy of iRobot for one year as of this month, and are still scrutinizing One Medical.

If the guardrails are made of Silly Putty and there are consumer complaints, Senator Warren, who has a long history of sparring with Amazon, will be issuing more letters. She will huddle with FTC and DOJ, where there’s a dartboard with Amazon’s name on it. Note to Amazon: Senator Warren is up for reelection in 2024, and she needs a high-profile issue.

FTC, HHS OCR scrutiny tightens on third-party ad trackers, sends letter to 130 hospitals and telehealth providers

July 27, 2023 | by

If you’ve checked on your legal department, they may resemble Pepper (left). Hospitals and telehealth companies have been put on notice by letter agencies HHS Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) that personal health information–not just protected health information (PHI) covered by HIPAA–that can be transmitted to third-parties by ad trackers like Meta Pixel is now forbidden, verboten, not permitted. In the joint statement by OCR and FTC, hospitals, providers, and telehealth providers were explicitly told that use of these online trackers is being equated with violations of consumer privacy. Their release specified “sensitive information” such as health conditions, diagnoses, medications, medical treatments, frequency of visits to health care professionals, and where an individual seeks medical treatment. Hospitals and telehealth companies also cannot plead ignorance of what their developers did, as the responsibility is being put squarely on them to monitor the data going to third parties out of websites and apps. 

“The FTC is again serving notice that companies need to exercise extreme caution when using online tracking technologies and that we will continue doing everything in our powers to protect consumers’ health information from potential misuse and exploitation.” Samuel Levine, Director of the FTC’s Bureau of Consumer Protection, said. At OCR, which historically had its hands full with HIPAA violations and data breaches, their scope has broadened. “Although online tracking technologies can be used for beneficial purposes, patients and others should not have to sacrifice the privacy of their health information when using a hospital’s website,” said Melanie Fontes Rainer, OCR Director. “OCR continues to be concerned about impermissible disclosures of health information to third parties and will use all of its resources to address this issue.” Both HHS and FTC can take action without the time-consuming legal actions that DOJ must undertake.

True to FTC’s renewed use of the 2009 Health Breach Notification Rule, the letter sent to 130 hospital systems and telehealth providers came down hard on anything that could be interpreted as personal health information. Even for health organizations not covered by HIPAA, the letter is explicit on their obligation to protect against disclosure to third parties and to monitor the flow to third parties even if not used for marketing. Without explicit consumer authorization, it can “violate the FTC Act as well as constitute a breach of security under the FTC’s Health Breach Notification Rule.” Previous TTA coverage on third-party trackers and FTC actions here. Health IT Security

Between the DOJ and FTC alone, with actions on ad trackers and changes to antitrust guidelines, they have made the spring and summer of 2023 a most interesting and busy one for hospital and healthcare company legal departments. It’s even more amazing that given this background and on notice, Amazon just keeps flouting basic regulations about health information usage, such as for Amazon Clinic–which to date has not rolled out. TTA 27 June

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

June 29, 2023 | by

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…)

Amazon Clinic delays 50-state telehealth rollout due to Federal data privacy, HIPAA concerns on user registration, PHI–is it a warning?

June 27, 2023 | by

Amazon delaying Amazon Clinic national rollout from today (27 June) to 19 July. Amazon Clinic, which debuted last November as an asynchronous, message-based telehealth consult or prescription renewal referral platform [TTA 16 Nov 2022], has run once again into Federal scrutiny. This time, it’s two Senators from New England–the well-known Elizabeth Warren (D-MA) and the little-known Peter Welch (D-VT)–who are poking Amazon with the stick of whether sensitive health and personal data are flowing into Amazon’s other databases.

Their letter to CEO Andy Jassy was fair warning that, as this Editor predicted last February (see the list of open issues) after the One Medical buy closed to high-fives all around, the government is nowhere near finished with scrutinizing Amazon and how personal data, including health data, flows between their units and is monetized. 

In a two-page letter dated 16 June based on reporting in the Washington Post (100% owned by Amazon’s 12.6% shareholder and controller, Jeff Bezos–the irony runs deep here), the two senators believe that they have caught Amazon but good–and with some of the goods. 

  • Users of the Amazon Clinic service are asked, in the registration form, to authorize the “use and disclosure of protected health information.” They are told that agreement to this gives Amazon access to the “complete patient file” and that this information “may be re-disclosed,” after which it will “no longer be protected by HIPAA”. By agreeing to this, users waive any HIPAA personal health information protections.
  • If the user declines to agree, they are redirected and unable to complete Amazon Clinic registration and denied care. HIPAA regulations specifically prohibit conditioning care on agreement to disclose patient information. (This is known by anyone who has taken required training or certification on HIPAA when working for health plans or other regulated healthcare providers including RPM and telehealth vendors.)

The letter raises the sensible, usual questions on why personal data is being collected and what Amazon is doing with it. For instance, it requests responses on how patient data is used by Amazon, what data is shared with third-party entities, and what data is used in any analytics or algorithms. It cites as a non-compliance example the $1.5 million that GoodRx paid in an FTC penalty on their past Meta Pixel usage for ad tracking. (Interestingly avoiding the $7.5 million Teladoc paid for similar ad tracker misuse by BetterHelp.)

The $30/visit service has been available in 33 states since last year and currently through asynchronous messaging, provides care for minor conditions such as UTIs, herpes, and skin infections. The expansion will cover all 50 states and add synchronous video telehealth.

One would think that with billions on the line with One Medical, Amazon would be more cautious about poking the Antitrust Bear. They have already been put on notice by the Federal Trade Commission, the Department of Justice (DOJ), Congress, and multiple states. For Amazon Clinic, requiring individuals to waive their right to protect their PHI in registering for the service is downright brazen. How this got past their legal and compliance departments boggles the mind. Why Amazon is not ‘hiving off’ PHI collected through this small service is another question. Doing so would show to FTC and DOJ that Amazon can play by the rules. Instead, it confirms the widely held belief of those in healthcare that Amazon culturally cannot deal with the restrictions that come with the territory. Are they deliberately ‘playing chicken’ with the Feds? Pollo loco? This up-to-the-line behavior tends not to end well, as the telemental health providers that over-prescribed controlled substances found out.  POLITICO, The Hill, mHealth Intelligence

Amazon gets all tangled up on their $3.9B One Medical buy as FTC widens antitrust scrutiny

February 7, 2023 | by

Amazon’s ride towards being the #1 threat to healthcare hits an oncoming train. A report in stock analysis newsletter Seeking Alpha, picked up from other sources (the subscription Dealreporter), states that the Federal Trade Commission (FTC) hired outside economists to scrutinize Amazon’s $3.9 billion purchase of provider network One Medical (1 Life Healthcare). In a little-noticed action in early December, FTC also sent out subpoenas to current and former One Medical current and former customers as part of its investigation.

Both the Wall Street Journal and Bloomberg (paywalled) are reporting that this appears to be part of a larger FTC action in developing a wide-ranging antitrust lawsuit against Amazon on multiple anticompetitive business practices. In a recent example, FTC held up Amazon’s acquisition of iRobot (Roomba) during the summer, and in September, requested information from 1 Life and Amazon above and beyond the usual required Hart-Scott-Rodino Act (HSR) reports reviewed by the FTC and DOJ [TTA 15 Sept 2022]. This examination has been going on for some years, across two administrations, but may come to fruition as early as this spring. The main investigation is around Amazon favoring its own products, how it treats outside sellers on its platform, and copycatting the products of outside sellers. It may also cover Amazon Prime bundling practices. Prime also plays into its healthcare strategy. FierceHealthcare

Another factor: the highly profitable growth of Amazon Web Services (AWS) has taken a nosedive along with the cloud market, killing Amazon’s growth and value, according to Seeking Alpha’s analysis (may be paywalled). Amazon is also closing or pausing already built-out food stores–Fresh supermarkets and Go convenience shops–ending a long-term commitment to developing them.

When all of these factors are combined with Amazon’s 18,000 layoffs and huge 2022 net loss of $2.7 billion, it’s hard to believe that Amazon now has enough blue sky fisc to make the huge investment and long-term commitment that a largely new and cash-intensive business, delivering healthcare through real live providers in offices, will require. Amazon’s current health business is either transactional virtual retail (Pharmacy and the new non-face-to-face Amazon Clinic for virtual medical referrals) or hardware+subscription (Halo)–areas that Amazon knows well. But managing an entirely new and complex area that provides expensive and regulated provider services?

This Editor will go out on a wintry limb and predict that Amazon, facing FTC and state anticompetitive actions plus plenty of shareholder profit pressure , will cancel the deal with One Medical–leaving One Medical on another limb.

CVS works their plan in Oak Street Health buy talks, Carbon Health $100M investment + clinic pilot; VillageMD-Summit finalizes (updated)

January 11, 2023 | by

CVS, Walgreens, Amazon, Walmart all chasing the same type of companies to expand their service continuum. During their Q2 2022 earnings call, CVS Health announced that they were determined to enhance their services in three categories: primary care, provider enablement, and home health. And CVS’ CEO Karen Lynch was pretty blunt about it: “We can’t be in the primary care without M&A” (sic). So CVS’ latest moves should come as no surprise.

Oak Street Health: CVS is in talks with this value-based care primary care provider for primarily older adults in Medicare and Medicare Advantage plans. With 100 offices nationally, it’s not too small, not too large to combine with other operations. As a public company traded on the NYSE but puttering along in the $13-$22 per share range since the fall from a high of $30 in August, the news of CVS’ interest has boosted them above $28 and a market cap of just under $7 billion. Although Oak Street has previously maintained that they have no interest in a sale, it has never been profitable and is on track to lose $200 million this year. That is not a good look for CVS but they are working a strategy. Previously, CVS walked away from primary care group Cano Health [TTA 21 Oct 22]. Bloomberg News (paywalled) reported that CVS could pay $10 billion which would be over $40 a share. Healthcare Dive, Reuters

Carbon Health: CVS leads their Series D with a $100 million investment plus piloting Carbon Health operations in primary and urgent care clinics in their retail stores. However, the deal came at a price. Last week, prior to the investment announcement, Carbon announced that it would wind down lines of business in public health, remote patient monitoring, hardware, and chronic care programs, cutting 200 jobs in addition to a June cut of 250, at the time about 8% of their workforce. Carbon will now concentrate on their clinic core business. 100 are presently located across Arizona, Nevada, Colorado, Kansas, Florida, Massachusetts, and California (San Francisco, Bay Area, and San Jose).

In the last two years, Carbon raised $350 million and grew by acquiring four clinic chains. It diversified by buying Steady Health (chronic care management in diabetes) and Alertive Health (remote patient management)–both businesses they are departing. Reportedly last month they bought Inofab Health, an Istanbul-based digital health platform for patients with asthma, chronic obstructive pulmonary disorder, and cystic fibrosis. Crunchbase, FierceHealthcare, Mobihealthnews, SF BizJournal,

CVS is still working its Signify Health acquisition past the Department of Justice (DOJ) and the Federal Trade Commission (FTC). It went into a Second Request for information in late October under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR), which adds 30 days to the review timetable after the Second Request has been complied with. There is some competitive overlap between CVS and Signify in home health management and accountable care organization (ACO) operations, and some divestitures may be necessary. A closing in Q1 as planned seems optimistic. Acquiring Oak Street may complicate matters since their clinics operate as a Direct Contracting Entity (DCE, now ACO REACH). This present administration is not friendly towards healthcare consolidation of any type, especially with entities participating in Federal programs. (See UHG’s acquisition of Change Healthcare, with court approval being appealed by DOJ.) Reaching (so to speak) deep into CMS programs could be a red flag.

Walgreens’ VillageMD finalized their Summit Health acquisition for $8.9 billion yesterday (9 Jan) (updated). Now with 680 provider locations in 26 markets and 20,000 employees, the group adds to VillageMD’s primary care practices specialty practices in neurology, chiropractic, cardiology, orthopedics, and dermatology plus 150 City MD urgent care locations. 200 VillageMD locations are already adjacent to Walgreens locations. Walgreens Boots Alliance (WBA) and Evernorth, the health services business of Cigna, were the two investors. WBA raised full-year sales guidance from $133.5 billion to $137.5 billion. The current chair and former chief executive officer of Summit Health, Jeffrey Le Benger, MD, will be the interim president until VillageMD finds a permanent president reporting to VillageMD CEO Tim Barry. Release, RevCycleIntelligence, Forbes  At this point, Walgreens hasn’t moved forward with the rumored acquisition of ACO management services organization Evolent Health [TTA 1 Oct 22], which would be far more complex. 

Amazon is still awaiting Federal approval for One Medical as well as in multiple states (Oregon only the first; expect scrutiny). It is also closing Amazon Care and opening asynchronous non-face-to-face telehealth service Amazon Clinic.  Walmart continues on an internal strategy of opening Walmart Health clinics in underserved areas. Earlier in 2022, they announced the opening of more health ‘superstores’ in Florida, having established 20 in Arkansas, Illinois, and Georgia starting in 2019. Walmart’s approach to retailing health services and products, since getting serious about it in 2018, has wavered with multiple changes of strategy and executive departures [TTA 22 Nov 22]

Yes, Virginia, there is an Amazon Clinic, after all; stripped down, non-face-to-face consults for common conditions

November 16, 2022 | by

On the move while Care is shutting down and OneMedical is not yet onboard as awaiting Federal approvals, Amazon Clinic’s premature leak generated press for the service’s formal debut on Tuesday. The leak was remarkably accurate [TTA 11 Nov] in describing it for the New York Minute it was up. According to their introductory blog, Amazon Clinic will operate in 32 US states (not specified, but a quick check indicates it’s not available in Alaska and New Hampshire). It provides message-based virtual care for more than 20 common health conditions, such as allergies, acne, eczema, UTIs, and hair loss. (The website lists conditions covered and prescription renewals for previously diagnosed conditions such as asthma, hypothyroidism, high cholesterol, and migraine.)

What it is: a stripped-down, questionnaire-driven provider referral platform, enabling a non-face-to-face telehealth consult or prescription renewal. It’s not clear from available information whether the messaging is synchronous, asynchronous (delayed), or a combination of both. This certainly sounds less ambitious than the home-based delivery/enterprise membership model of Amazon Care. How Clinic works:

  • Select your condition
  • Pick your preferred provider from a list of licensed and qualified telehealth providers. Costs and if available in your state are disclosed in the selection process.
  • Complete intake questionnaire
  • Connect with clinician through a secure message-based portal
  • After the message-based consultation, the clinician sends a personalized treatment plan via the portal, including any necessary prescriptions to the customer’s preferred pharmacy including Amazon Pharmacy. Here, costs may be covered by insurance.

As Care was, payment is upfront as Amazon doesn’t accept insurance. The cost of consultations will vary by provider and condition but tend to be in the $40 – 50 range. This includes ongoing follow-up messages with the clinician for up to two weeks after the initial consultation. Some conditions, such as rosacea, require a prior diagnosis.

In addition, the services provided are available only to those aged 18-64, which strikes this Editor as discriminatory for those 65 and over who can well pay cash and might prefer a ‘visit lite’.

No mention of whether those laid off at Amazon Care or through the rest of Amazon (10,000 announced) can apply for jobs with this new service; it sounds largely referral, highly automated, manageable, and not requiring heavy oversight. The last can be a problem all its own. TechCrunch, Mobihealthnews, CNBC

Short takes: Will there be an Amazon Clinic?, Transcarent and Teladoc, perfect together?, Get Well partners with Palomar Health, expands with Veterans Health Administration

November 11, 2022 | by | 1 Comment

Did Amazon prematurely leak an initiative? Or was it an error? The Verge reports that a video was uploaded to Amazon’s YouTube page on Tuesday–then taken down–describing a new service that would offer assessment, diagnosis, and treatment of common conditions such as allergies. The Amazon Clinic video depicts a user taking an online questionnaire about their symptoms, After paying a fee, a clinician reviews it, diagnoses, and prescribes as needed, sending to the patient’s pharmacy. The disclaimer: “Telehealth services are offered by third-party healthcare provider groups.” The video directs to amazon.com/clinic which is not live. Another Amazon Mystery. Amazon Care is shuttering and the company is jumping through Federal hoops to get approval to close their buy on OneMedical. Hat tip to HISTalk today.

HISTalk also pointed to a Forbes article on health navigator companies such as Castlight and Firefly Health, with a bit of a ‘sting’ at the end. Transcarent, a health navigator that takes on risk integrating its services into employee benefits, is the latest enterprise founded by Glen Tullman, a serial entrepreneur who founded Livongo, investor group 7Wire Ventures, and built up Allscripts as CEO. The writer speculates that Tullman should buy Teladoc to give Transcarent a distribution system–a built-in network of physicians and health system relationships. Yes, this is the same Teladoc that Tullman sold Livongo to for a tidy $18.5 billion, then earlier this year wrote off $6.6 billion as an impairment. This one drips with irony. With its stock down nearly 90% from its January 2021 high, it’s never been cheaper!

Get Well, an RPM, patient care management, and workflow automation company, announced new and expanding partnerships. The new one is with Palomar Health, a health system in Escondido, California. This will implement Get Well services in four phases in five areas to improve patient experience: digital care management (GetWellLoop), inpatient experience (Get Well Navigator and a workflow automation for hospital staff), emergency department experience, care gap closure, and health equity through additional features. Becker’s  The second is an expansion with the Veterans Health Administration (VHA) into 70 Veterans Affairs Medical Centers (VAMC) and a fifth Veterans Integrated Service Network (VISN) with nine facilities. They also now have a FedRAMP “In Process” designation for cloud services which is enabling expansion of GetWellLoop care plans with a VAMC. Release (Business Wire)