TTA’s August-Sept Wrap: how health tech fared in H1 investment, Oracle’s VA EHRM contract $ bump, Verma’s rumors, Cityblock buys Homeward, sensors could save Scots millions, more!

August 28, 2026 | by

28 August-early September 2026

It’s the last of the August Doldrums, so it’s a good time to look back, courtesy of SVB, on What Happened in Healthcare Investing this first half. (For once, health tech didn’t take a beating with its best H1 in years.) Oracle just can’t help being in the headlines, this time with a nice (and expected) budget bump in its extended VA EHRM contract, and with its Oracle Health EVP, the well-known Seema Verma, possibly under consideration by PhRMA. The only notable transaction was another acquisition in the General Catalyst family, Cityblock Health and Homeward Health. DEA may get a controlled substances telehealth rule yet. And the Scots have discovered and tested sensor-based facility monitoring that could save millions. Aye! (Will Harry and Meghan’s Cotswolds lair have it? Save on security!)

Please feel free to comment on the articles and pass along this Alert. Let me know if this is worth it to you! Also check out my personal page on Substack.

For Readers: Your Editor will be on publishing leave to mid-September. ‘Best Of’ Alerts will be out 1x weekly on Fridays after this week till then. I’ll be resting up for what may prove to be an epic September-October!

Silicon Valley Bank’s take on H1 investment: among the “have and have nots”, it was “the best half in years” for health tech

News roundup: Verma’s rumors, DEA’s new (?) telemedicine rule goes to OMB for review, Cityblock Health goes rural with Homeward buy, Scottish housing sensor tech could save millions–study

Revealed: Oracle’s extended VA EHRM contract increased by $17B as original ceiling reached this year; VA Indy EHR goes online

Last week’s headlines 

This Week’s Must Reads: how lack of focus dooms startup financing, Commure’s Sea of Red Flags Flapping, and what happens if OpenAI expires? (Doom…DOOM!)

News roundup: UHS-Talkspace $850M buy final, DocGo to buy Hicuity Health for $52M in stock/debt, R1 to buy Humata Health, PointClickCare EHR to integrate Anthropic’s AI

UK’s Alertacall sold to Constellation Software’s Volaris Group (Happily, remaining independent)

Recent Headlines and Must Reads

Why Readers can be assured that TTA is 100% Written by Humans (A handy guide to detecting AI Copy Slop and why it’s not here)

News potpourri: OpenAI sued for practicing unlicensed medicine”, Cleveland Clinic med drone delivery, Solventum separates out health info systems, Unlimited Technology RCM in 3.8M data breach, Samsung Galaxy Buds FDA cleared for hearing assist

VA moves to secure Oracle for its EHR Modernization through mid-2031 (More reasons beyond Captain Obvious)

Breaking report: Oracle drawing up plans to lay off employees in “double digit percentages” by 1 September (We’re waiting for this shoe to drop next month)

Chutes & Ladders, Oracle Edition: Surprise! Project Jupiter data center build overages, “social costs” multiply. Pentagon inks $7B, 10 year deal for software.

This week’s Must Read: the dangerous financing of AI data center buildouts–and how they resemble the 2020 health tech boom (Remember the SPAC boom that cracked and left nearly all companies and billions in the dust?)

A gloomy view on Oracle going forward: debt, cash flow, and dependence on OpenAI

 

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News roundup: Verma’s rumors, DEA’s new (?) telemedicine rule goes to OMB for review, Cityblock Health goes rural with Homeward buy, Scottish housing sensor tech could save millions–study

August 27, 2026 | by

Oracle’s Seema Verma rumored to be on a list for a new CEO position with a major lobbying group. The EVP and general manager of Oracle Health and Life Sciences is reportedly under consideration for a new job as CEO of PhRMA. A paywalled story in Endpoints News broke that she is among a group of “Republican policy wonks, former lawmakers” in the running, four months in, for this pharmaceutical lobbying organizational chief position. If the Reddit rumor boards are to be believed, she’s already half out the door. If the former Center for Medicare and Medicaid Services (CMS) administrator to 2021 departs Oracle, it will be the sixth Oracle Health senior level departure this year [TTA 3 Mar]. Those departures for various reasons shook Oracle Health. Verma, on the other hand, has had a relatively low profile at Oracle Health, though reporting to COO Mike Sicilia. If she does depart Oracle, enough time has passed since her CMS position to dispel the Federal-private industry ‘revolving door’ tag, though undoubtedly as EHR head she has been working with the VA. Developing

ATA Action was kind enough to flag for this Editor that the Drug Enforcement Administration (DEA) may finally be moving toward a new rule for telemedicine prescribing of controlled substances. Yesterday (25 August) the “Special Registrations for Telemedicine and Limited State Telemedicine Registrations” final rule was submitted to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) for review. While under review, the text is not public, but the OMB pending EO  is here with the limited text under the RIN: 1117-AB40   The text of the RIN includes that “DEA is currently reviewing the over 6,400 public comments submitted on the Special Registration for Telemedicine NPRM (Notice of Proposed Rulemaking) published on January 17, 2025.”meaning that they are still working with a year-old NPRM.  DEA has extended telemedicine prescribing rules several times, most recently at the end of 2025 to cover full year 2026. A final action to determine approval of the rule is due in November, according to the timetable.

ATA Action’s statement, per their email, is “ATA Action is actively engaged as the rule moves through OMB review, pressing the priorities we have consistently advanced: protecting patient access while maintaining safeguards against diversion — without unnecessary in-person mandates, duplicative state-by-state registration requirements, excessive reporting burdens, or implementation timelines that make participation impractical for legitimate clinicians and healthcare organizations.” They also cite geographic “red flags” that pharmacies face when a prescription results from a telehealth visit and state laws that are more restrictive than Federal law. 

Brooklyn’s Cityblock Health’s goes country with Homeward Health acquisition in an all-stock transaction. It is on the surface an odd match: an urban-focused value-based care provider that primarily serves complex needs and provides additional support for Medicaid and Medicare/Medicaid dual-eligible patients expanding into underserved rural markets. What it does promise Cityblock is growth from its present claimed 200,000 members in 10 states and annualized revenue of $2.2 billion, up 77% year-over-year. Homeward serves around 50,000 rurally-based Medicare Advantage (only) members and 5,000 providers in Michigan and Minnesota through a Michigan clinic, mobile clinics and telehealth. It partners with Blue Cross Blue Shield of Michigan and Aetna for Medicare Advantage. Further financial arrangements were not disclosed.

Homeward’s CEO Dr. Jenny Schneider will remain connected with Cityblock as a “trusted advisor” according to a Cityblock spokesperson and Homeward’s brand and operation will remain. According to her LinkedIn post announcing the acquisition, she previously served as a Cityblock board member. She and another Livongo alumnus, Amar Kendale, launched Homeward Health in 2022 to close healthcare gaps in rural America, accounting for over 61% of primary care shortage areas and a 23% higher mortality rate.

Both Medicaid and Medicare Advantage face challenges–funding cuts for Medicaid and with Medicare Advantage, payers reducing reimbursement rates based on rising costs and increased Federal scrutiny of higher costs, upcoding, overpayments, and bonus programs. 23% of Medicare Advantage enrollees are in a special needs plan (SNP) KFF

Cityblock touts its CORE—Care Orchestration and Resourcing Engine—as an AI-based operating system underpinning our outcomes-based care platform to use almost 10 years of member data to close care gaps for specific members, as well as AI tools “handling routine engagement and administrative work that have already freed up 44,599 hours of clinician time this year, including 42,148 calls handled by AI agents.” Homeward Health’s platform is also AI-native.

Cityblock simultaneously announced a Series E of $116 million led by General Catalyst for a total of close to $1 billion. General Catalyst is an investor in both companies. (Is this a return to the General Catalyst ‘portfolio condensation’ strategy that created Commure last year?–Ed.)

Interestingly, Homeward Health is organized as a public benefit corporation (PBC) and a B Corp, certified by B Lab as meeting their standards of social and environmental performance, accountability, and transparency. It’s doubtful that will carry over to Cityblock. MedCityNews, FierceHealthcare, Becker’s, Cityblock’s CEO Toyin Ajayi blog post 

Biggar, Scotland senior housing environmental sensor-based technology test saves thousands, but across Scotland could save millions. The test at the retirement home Langvout Court, part of Bield Housing & Care, was of environmental and activity sensors developed and implemented by Glasgow-based technology company Archangel and the Digital Health & Care Innovation Centre, funded by the UK Government’s Department for Science, Innovation and Technology through the Glasgow City Region 5G Smart and Connected Places Programme. The automated alerts were directed and coordinated with Bield staff. The sensors alerted the staff to a potential boiler breakdown during Storm Éowyn, high humidity levels and faulty extractor fans in buildings, and resident temperature and activity changes that could indicate changes in health. Annualized savings in the six-month test were estimated at £7,670 in heating costs and £2,825 in maintenance costs, along with improved tenant safety, reduced manual checks and stronger regulatory compliance, creating positive ROI in year one. FarrPoint, which independently evaluated the project, extrapolated that applying Langvout Court’s system across Scotland’s retirement housing developments could generate annual savings of £18.5 million. Archangel case study published in TechUK, release in Care Sector Hub

Teleprescriber Zealthy–and CEO Kyle Robertson–accused of asset fraud; DOJ moves to freeze assets and put company in receivership

April 23, 2026 | by | 2 Comments

A two-year+ story about teleprescriber illegalities that isn’t getting near enough attention. The Cerebral saga is far from over. Telehealth prescriber Zealthy, founded by former Cerebral CEO Kyle Robertson, is in deepening ‘hot water’ with the Department of Justice. The DOJ filed a motion last week in Federal Court seeking an immediate asset freeze and receivership for Zealthy. This is to stop what the DOJ called a “runaway campaign of lawbreaking” by both Robertson and Zealthy, “which is actively deceiving telehealth patients, endangering their safety, and raiding their bank accounts.” The asset freeze and receivership is being requested by DOJ because Zealthy’s liquidity is marginal at best.

Zealthy sells weight loss, birth control, ED, hair loss, mental health, and other prescription medications online. The DOJ is citing them for using the names and licenses of doctors who didn’t work there to fill thousands of prescriptions without the physicians’ knowledge or clinical supervision. The amended DOJ complaint states that both Zealthy and Kyle Robertson engaged in “systemic improper and dangerous telemedical practices,” including “the routine ordering of prescriptions by foreign call-center contractors and other non-clinicians with no medical license and the systemic misuse of the name and National Provider Identifier (NPI) number of doctors to order many thousands of prescriptions for patients they did not actually treat or order a prescription for, and without their knowledge or clinical supervision—and even when they have not even been employed by Zealthy.” Reportedly, the stolen identity of one doctor was used to write 8,000 prescriptions.

Zealthy lost its medical merchant certification from credentialing organization LegitScript in 2025 after it failed to disclose the DOJ litigation. Ad platforms and payment processors dropped Zealthy, which then created shell companies to get around this. Company executives also used credit cards to buy their own subscriptions, diluting the rate of consumer credit card chargebacks to improve their transaction dispute rates, a move to make them look better for their bankers and lenders.

This is part of the ongoing Federal lawsuit that started in June 2024 around deceptive practices that violated distribution of controlled substances, the FTC Act and Restore Online Shoppers’ Confidence Act (ROSCA). It mainly covered activities during the pandemic. Companies named in the original complaint were Cerebral, Zealthy (renamed Gronk Inc), Bruno Health PA, and also named executives Kyle Robertson, former Cerebral executive Alex Martelli, and executive German Echeverry. The DOJ settled the controlled substances distribution charges against Cerebral in late 2024 [TTA 8 Nov 2024] but not the charges against Mr. Robertson, who departed Cerebral in May 2022 at the start of the company’s DOJ and DEA problems. The amended complaint called out Kyle Robertson specifically: “Robertson’s lawbreaking is only becoming more brazen, and dangerous.” One wonders if Mr. Robertson is considering residences in low extradition countries. Sherwood News, FierceHealthcare, HealthExec, HIStalk

Perspectives: How the DEA Telehealth Extension Impacts Patient Access to Opioid Use Disorder Treatments & Buprenorphine Prescriptions

March 11, 2025 | by

TTA has an open invitation to industry leaders to contribute to our Perspectives non-promotional opinion and thought leadership area. Telehealth extensions, including those for controlled substances, are hot topics and before the US Congress today. Today’s contribution is from Dr. Beth Dunlap, a board-certified addiction medicine and family medicine physician and the medical director at Northern Illinois Recovery Center. With extensive experience in addiction medicine at all levels of care, her clinical interests include integrated primary care and addiction medicine, harm reduction, and medication-assisted treatment. She completed medical school, residency, and fellowship at Northwestern University, where she continues to serve on the faculty of the Department of Family and Community Medicine.

Telemedicine flexibilities for buprenorphine, the controlled substance recognized for its high safety profile in treating opioid disorder (OUD), will live to see another year after being re-extended through December 31, 2025. That is, for now.

Federal regulators first leveled the access playing field to buprenorphine in 2020, in response to the COVID-19 Public Health Emergency. The pandemic-friendly policy change allowed buprenorphine administrators to prescribe the substance via telehealth, waiving the previously required in-person patient evaluation.

Renewals granted by the Drug Enforcement Administration (DEA), and the Department of Health and Human Services (HHS), have since kept telemedicine flexibilities for controlled substances alive.

With these protections in place, the treatment landscape for opioid use disorder looks bright, but one overturned ruling from the incoming Trump Administration could change everything.

Buprenorphine hasn’t always been as widely accessible as it is today.

It wasn’t too long ago when buprenorphine prescribers had their hands tied, with regulations like the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, a previous DEA-enforced statute that prohibited them from prescribing buprenorphine over the internet.

Things changed once the DEA dialed back on their telemedicine restrictions in March 2020, permitting providers to prescribe buprenorphine via telehealth platforms and waiving the required initial in-person visit.

Later-released studies that analyzed patient data for “low-threshold” buprenorphine treatment programs, many of which were offered at COVID-19 isolation sites and out of mobile vans, revealed that telemedicine showed much promise in successfully engaging patients from different socioeconomic backgrounds. This included rural residents, veterans, and homeless individuals seeking continued buprenorphine-based treatment.

Such telehealth programs were reported to have high patient engagement numbers in the areas of acceptability and feasibility. For instance, many feasibility studies reported a 60% or higher rate of continued engagement after 30 days of initial prescription.

There are a couple of downsides to telehealth-administered buprenorphine, and that’s patient selection and monitoring. Telemedicine is most appropriate for patients who do not have a lot of unmet psychosocial needs, and who can stabilize, manage meds appropriately, and otherwise have more recovery-related resources.

It may also not be a good option for patients who are struggling with multiple substances or have unmet medical or psychiatric needs.  So, it is not the appropriate care setting for everyone.  However, there are many pros to it, including accessibility, convenience, and lower access barriers than some in-person options.

Policy extensions have bought the DEA more time to rethink telemedicine’s future.

After receiving public feedback on a set of newer proposed telemedicine rules, the DEA and HHS have since worked diligently to release more permanent regulatory updates.

To justify their decisions on how to regulate buprenorphine prescriptions moving forward, these federal agencies have largely leaned on evidence-based studies published in scientific journals. Expanded access to treatment services through telehealth is likely one of the reasons why the country has seen a recent drop in overdose death rates, among other factors.

In one study that assessed patient retention rates for an urban buprenorphine treatment program, the patient show rate increased from 74.1% for prior routine in-person visits to 91.7% for telehealth visits. In another study that focused on patient experiences with buprenorphine telehealth treatments, 84.5% of participants reported having overall positive outcomes.

I am hopeful that DEA will recognize that the current rules have allowed greater access for patients seeking treatment for substance use disorders and mental health, and move to make permanent access to buprenorphine via telehealth.

For Perspectives editorial and additional opportunities such as supporting TTA through advertising, contact Editor Donna.

Updates: ATA on telehealth policy priorities, UHG investor group demands denied care report, DOJ sues Walgreens on illegal Rx dispensing, VA nominee supports Oracle EHR deployment, RFK Jr. HHS nomination hits Senate

January 24, 2025 | by

ATA urges nine telehealth priorities for the Trump Administration’s consideration. Acknowledging that HHS expanded Medicare telehealth flexibilities at the start of the pandemic in 2020 in the previous Trump Administration, the American Telemedicine Association’s list is long and detailed.

#1 was to withdraw last week’s Drug Enforcement Administration’s (DEA) proposed rule, “Special Registration for Telemedicine and Limited State Telemedicine Registrations”. This would create a framework for the remote prescribing of controlled substances that in ATA’s view, would create “untenable restrictions and significant barriers to care”.

The remaining eight include flexibilities that were part of the 2020 rules.

  1. Permanently Allow for the Remote Prescribing of Controlled Substances
  2. Work with Congress to Make Permanent the Medicare Telehealth Flexibilities
  3. Ensure Affordable Telehealth Services for the Commercially Insured
  4. Ensure Affordable Telehealth Coverage for Part-Time, Contracted Workers Who Don’t Qualify for Health Care Coverage
  5. Ensure All Provider Home Addresses Remain Confidential
  6. Expand the Medicare Diabetes Prevention Program
  7. Reinstate Virtual Cardiopulmonary Rehabilitation Programs
  8. Release Updated Regulatory Guidance on Medicare Telehealth Flexibilities

Additional details are in the ATA Action letter to President Trump and Vice-President Vance and the ATA release.

An institutional investor interest group demands a report on delayed and denied care from UnitedHealth Group. This takes the form of a proposal for the 2025 proxy that the UHG board of directors prepare a report on these practices that create increased costs and ‘macroeconomic risks’.  The proxy is usually filed in April for a meeting that is typically in June. UHG will respond at that time it files the proxy.

The group proposing the report is the Interfaith Center on Corporate Responsibility (ICCR). ICCR represents 300 faith-based institutional investors, such as asset managers, pension funds, and foundations, with over $4 trillion in invested capital. This institutional shareholder action is in the aftermath of the Brian Thompson assassination, which revealed widespread consumer anger about UnitedHealthcare’s practices in high rates of claims denials, including their use of AI in the review process, and prior authorizations to restrict utilization. UHG ignores this at its peril. By the time proxies are released and the shareholder meeting occurs in June, the trial of the assassin may be underway, putting this issue back in top news.  ICCR release, Healthcare Dive

Walgreens’ Mound of Misery gained a few hundred cubic yards with a lawsuit filed 16 January by the Department of Justice (DOJ) over improper dispensing of opioids and and other unlawful medications over more than a decade. The civil lawsuit filed in the US District Court for the Northern District of Illinois alleges that Walgreens and subsidiaries dispensed millions of unlawful prescriptions, violating the Controlled Substances Act (CSA). Since Walgreens then sought reimbursement from Federal healthcare programs, they violated the False Claims Act (FCA). The time frame is from August 2012 to the present. Specific allegations include that Walgreens pressured pharmacists to fill prescriptions despite clear ‘red flags’, in excessive quantities, and lacking a legitimate medical purpose and that they ignored the pharmacists and their own internal data. One of the red flags were prescriptions for the ‘trinity’ of an opioid, a benzodiazepine and a muscle relaxant. There are also four different whistleblower actions against Walgreens under the qui tam (on behalf of the government) provisions of the FCA that have been consolidated. If successful, Walgreens could face civil penalties of up to $80,850 for each unlawful prescription filled in violation of the CSA, plus treble damages and applicable penalties for each prescription paid by Federal programs in violation of the FCA. Timing and Walgreens’ response are not yet available. This lawsuit could be a massive stumbling block to the rumored Walgreens/WBA sale.  DOJ release, Healthcare Finance 

The VA Secretary nominee recommits to resuming the 2026 rollout of the Oracle Cerner EHR. Former House Representative for Georgia Doug Collins told members of the Senate Veterans’ Affairs Committee at his nomination hearing Tuesday that he would look at the Oracle Cerner EHR deployment with ‘fresh eyes’ and that “there’s no reason in the world we cannot get this done.” On 20 December, the VA formally stated that they were starting planning now for deployment in four Michigan facilities — Ann Arbor, Battle Creek, Detroit, and Saginaw–for implementation by mid-2016. He was critical of what has transpired to date in the limited deployment as ‘not acceptable’ and pointing out that VA facilities needed modernization of their computer systems. But perhaps a little overoptimistically, he’d like to see a faster implementation in 2016, though it should be done properly and not rushed. NextGov/FCW, Healthcare IT News

And in the Warp Speed World that is now DC, Robert F. Kennedy Jr. is scheduled to testify next Wednesday (29 January) before the Senate Finance Committee on his nomination as Health and Human Services Secretary. At HHS, he would supervise the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). He has promised major reforms including food safety and chemical additives, as well as the relationships between FDA and pharmaceutical companies. Healthcare Dive  Meanwhile, during the transition, HHS froze external communications or work-related appearances by staff. This is fairly standard procedure until review procedures are set up, but apparently no one planned for this in advance. This has derailed two conferences (AFCEA HIT Summit and the HHS Industry Summit) that were scheduled for this month and February. Exceptions to this are ‘mission critical’ and emergency communications. NextGov/FCW

News roundup: CVS Health cedes 4 new board seats to Glenview, Oscar’s strong Q3, telehealth controlled substance prescribing in 3rd extension, new Revere Medical to buy CareMax assets (updated), Oura picks up $75M Dexcom financing and partnership

November 19, 2024 | by

This pre-Thanksgiving week stuffs the turkey, not with giblets and savory fillings, but with Big Developments on the Big Stories of the past few weeks.

CVS feeds the crocodile, gives Glenview Capital four new seats on the board. CVS’ startling move with the hedge fund Glenview Capital Management that adds Leslie Norwalk, Glenview CEO Larry Robbins, Guy Sansone, and Doug Shulman, expands their board of directors to an unwieldy 16. According to the CVS release, Norwalk, from Epstein Becker Green, will join the Health Services Committee. Sansone, CEO of H2 Health, will join the Audit Committee.  Shulman, chairman/CEO of OneMain Holdings, will join the Management Planning and Development Committee. It’s unknown whether Robbins will need to join a committee given his prime position.

Despite CVS’ lack of confirmation after their reported breakup/spinoff discussions that kicked off October [TTA 1 Oct], it’s apparent to anyone with clean glasses that Glenview is driving multiple changes at the company including the ouster of CEO Karen Lynch even after she took direct control of Aetna. She was replaced by a CVS ‘lifer’, David Joyner, head of CVS Caremark. Glenview owns 1% of CVS stock as of last report in October, 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.

The board appears to be looking towards maximizing performance now, not later. The new executive chair of CVS Health, Roger Farah, from the release: “In our discussions with the leadership at Glenview, we agreed that we can deliver greater value from our integrated businesses to all of our stakeholders, including our customers, consumers, colleagues, and shareholders.” New faces tasked with quick turnarounds include group president Prem Shah and at the head of shaky Aetna, Steve Nelson from ChenMed [TTA 8 Nov]. That means achieving profitability and cash flow at a very tough time for nearly all insurers. CNBC, Becker’s

How Centene did it after a similar move by Politan Capital Management. Since early 2022, Centene has been selling off in pieces what turned out to be an abundance of ancillary, only partly digested businesses, such as Ribera Health, Magellan, Apixio, and most recently their MSO/ACO organizer Collaborative Health Systems [TTA 13 Nov, 5 May 2023, 30 July 2022], along with a deep portfolio of real estate such as a projected Charlotte HQ, all bought by the late CEO Michael Neidorff. These ‘fat pads’ were easy cuts along with several thousand people. CVS Health, however, may not have the padding that Centene had to generate ready cash from willing buyers as it has the reputation of being fairly lean. Their big missteps may have been in 2022 (FOMO Time) pursuing a management-led Big Objective of entering brick-and-mortar and buying never-profitable Oak Street Health primary care for $10 billion, buying home health’s Signify Health for $8 billion, and investing $100 million in Carbon Health, all at inflated post-pandemic prices with the latter two having significant issues within their lines of business. 

The proposal of splitting up the company sounds drastic to achieve profitability. It may be a ‘worst case scenario’ thrown out to keep the crocodile sated. Much depends on how both Glenview Capital and Mr. Market behave next year with the opportunities presented, while facing a new administration and HHS and CMS heads without ties to or fondness for payers. 

Meanwhile, Oscar Health, helmed by Aetna’s former and ousted head Mark Bertolini, posted a strong Q3 closing September 30. Versus prior year, their revenue went up 68% to $2.4 billion, medical loss ratio remained fairly stable at 84.6%, up 80 basis points (bps=.01%), and expenses improved by 3.6%, but importantly they narrowed their net loss to $54.6 million, or $(0.22)  of earnings per share, a $10.8 million improvement. Revenue for the year was adjusted upward to the $9.2 billion to $9.3 billion range, $200 million above the prior range of $9.0 billion to $9.1 billion. It’s quite a turnaround from the dancing-with-disaster Oscar of only 18 months ago. Look hard, there’s a schadenfreude-ish smile on the middle guy’s face….  Oscar release

DEA extended telehealth prescribing of controlled substances for a third round. The kicking the can down the road was easily predicted last month. The “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” exited the registry of the White House Office of Management and Budget (OMB) 14 November. On the 15th, the rule was posted to the Federal Register and officially published today (19 Nov). It gives the Drug Enforcement Administration (DEA) a clean extension of the pandemic time flexibilities on Schedule II-V remote prescribing. The industry will wait and see if the incoming Trump 47 administration will bring this up to Congress to repeal, as by a whisker the extension fell outside the 60-day vacate window. But it’s not a hot button issue and is very likely to continue into 2025. FierceHealthcare, ATA release

CareMax goes into Chapter 11, agrees to sell to the new Revere Medical. The senior healthcare provider based in Miami filed Chapter 11 on 17 November but already has entered an agreement to sell assets to Revere Medical, formerly Stewardship Health, sold out of Steward Health’s bankruptcy to Brady Health Buyer, an entity of Rural Healthcare Group-Kinderhook Industries [TTA 8 Nov]. The sale that had to be planned for some time is part of a restructuring plan approved by the company’s secured lenders, commonly called a pre-packaged bankruptcy. Revere is acquiring CareMax’s management services organization (MSO) and ACO assets, including the Medicare shared savings program (MSSP) part of its MSO business that supports about 80,000 Medicare beneficiaries. CareMax will wind down and exit their Medicare Advantage and ACO REACH businesses which will take some time, likely 2026. The operating clinic business assets will go to a third-party buyer. Further restructuring is part of a restructuring support agreement (the “RSA”) with lenders holding 100 percent of the Company’s secured debt obligations, according to the 17 November release. Becker’s  Update: CareMax was related to Steward Health as the exclusive value-based managed service organization (MSO) for Steward Health Care’s Medicare network. Steward’s failure was the final crack that broke CareMax’s back, as it had been losing money for several years, according to Paul Rundell, CareMax’s chief restructuring officer. Not helpful was their leasing many of their properties from real estate investment trust Medical Properties Trust, same as Steward.  HealthcareDive   And where in the world is Dr. de la Torre, Steward’s CEO?

Finland’s Oura health tracker ring now discloses where the money’s coming from. Oura picked up $75 million from Dexcom in a Series D funding round, their first since a $100 million Series C in May 2021 and an undisclosed venture round the following year. Their total financing is $223 million and the valuation at $5 billion. Dexcom and Oura are also in partnership to integrate Dexcom glucose data with vital signs, sleep, stress, heart health, and activity data from Oura Ring. The two-way integration will flow data between Dexcom and Oura products, including Dexcom glucose biosensors, Dexcom apps, Oura Ring and the Oura App. Oura release, FierceHealthcare Oura purchased Sparta Science earlier this month and metabolic tracker Veri in September. Veri, however, works with the Abbott FreeStyle Libre to guide users to the right foods, habits, and timing versus common health metrics such as sleep for their bodies. 

News roundup 16 Oct: Walgreens shuts 1,200 stores–500 in ’25, CVS exiting core infusion biz, Masimo v. Apple update, DEA recommends 3rd telehealth extension, Change hack costing UHG $705M, Owlet back in NYSE compliance

October 16, 2024 | by

A roundup of chickens coming home to roost? But some chickens are just happy to come home.

Walgreens’ Mound of Misery just grew a little higher. The headlines today were all about Walgreens’ closing 1,200 stores over the next three years. Their current store location roster is about 9,000, according to their website. 500 of these will be closed during their upcoming FY2025.  Their release stated this would be “immediately accretive to adjusted EPS and free cash flow”. (Were they making any money at all?) This helped to give their share price a nice bump from $9 to above $10 at market close today. Last year, Walgreens’ shares were priced above $22.

Q4 (closing 31 August) closed with a 6% boost in retail sales. However, losses were $3.0 billion versus a net loss of $180 million in the prior year’s Q4. The reasons cited in their release were a higher operating loss, a $2.3 billion non-cash charge for valuation allowance on deferred tax assets primarily related to opioid liabilities recognized in prior periods, and a non-cash impairment charge related to equity investment in China. The operating loss related to a non-cash goodwill impairment charge for CareCentrix. 

The full year was not cheery. Sales were $147.7 billion, an increase of 6.2% from a year ago (in constant currency, 5.7%). But losses in their FY2024 were $14.1 billion, a stunning increase of 104.5% compared to prior year.

VillageMD is being monetized along with other assets. “CEO Tim Wentworth said in the earnings call that the company is focused on “monetizing non-core assets to generate cash,” naming VillageMD as an example, to focus on its core retail pharmacy business.” HIStalk 16 Oct Can Walgreens shrink itself to profitability? Fierce Healthcare

Over at CVS, they’re doing their own shrinking. CVS is closing its core infusion services business, with plans to either close or sell 29 related regional pharmacies. Infusion services were bought from Coram LLC in 2013 for $2.1 billion. This Reuters exclusive was based on an 8 October memo and confirmed by a CVS press representative. Patients relying on antibiotics, drugs supporting muscular health, and intravenous nutrition services will be transferred to other providers. CVS will continue to provide certain services: specialty medications and enteral nutrition, or tube feeding, at pharmacies in Minnesota, Pennsylvania and San Diego, with nationwide nursing services. Hat tip to HIStalk 16 Oct.

Masimo wins one big patent challenge, loses one (or four), to Apple. 

The Win: Apple had sued Masimo in the US District Court of Delaware for patent infringement of Apple’s utility patent 10,942,491 B2 (“the ‘491 patent”). Masimo was charged as violating Apple’s patent on 19 features. Masimo appealed to the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO) for an inter partes review (IPR) of the patent on the grounds of ‘unpatentability’, a very high proof. Masimo succeeded in this, rendering Apple’s ‘491 patent useless. Apple can appeal but the likelihood of success against the PTAB ruling that required three administrative patent judges to review, at this level of proof, is low. In this Editor’s view, this may spur other developers to come up with innovations now that these 19 features have been deemed unpatentable.

The Loss (I think): In review in the Delaware District Court are four complicated lawsuits between the two combatants, with Apple’s premise that Masimo has infringed upon other patents. Masimo alleged “inequitable conduct” by Apple in their patent filings with the PTO, essentially alleging fraudulent filings on multiple patents. Apple has been granted a summary judgment on Masimo’s claims, throwing them out.

Interestingly, Masimo–never shy to announce wins versus their foe Apple under the prior leadership of Joe Kiani–has remained strangely mum. (Perhaps everyone is waiting for the takeover dust to settle?) Will the ‘new’ Masimo be so combative against Apple? A far more detailed analysis for the patent mavens is in Strata-gee. A very large hat tip and bow to their editor, Ted Green, who writes about marketing primarily in the audio/visual business but has been 100% on top of The Masimo Saga–thank you!

To no one’s surprise, DEA kicks the telehealth waiver can down the road–for the third time. The Drug Enforcement Administration (DEA) sent to the White House’s Office of Management and Budget (OMB) a proposed rule to extend telehealth prescribing of Schedule II and higher controlled substances without changes. 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. In September, reports indicated that DEA not only wanted to restore prior restrictions but also wished to introduce additional ones. However, their timing (September!) given Federal standards of publishing draft rules and lengthy comment periods before a final rule was impossible to be achieved by year’s end. [TTA 13 Sept]

Whether OMB will approve the extension (to a date that cannot be confirmed since the text is unavailable, but reportedly one year) is not certain, as it may be disputed by the Department of Health and Human Services (HHS). Since the waiver is due to expire at the end of the year, this may help to assure the multitude of mental health and other telehealth companies dependent on legal remote diagnosis and prescribing controlled substances that their businesses can continue. FierceHealthcare

UHG didn’t have a happy quarter either due to Change. The total hit to UnitedHealth Group of the Change Healthcare hack is now estimated at $705 million, or 75 cents a share. Their 2025 guidance on profit is a lackluster $30 per share–below Wall Street estimates of $31.18. Government plans’ cuts in payments for Medicare Advantage plus and low state payment rates for Medicaid are affecting UHG as well as nearly every other payer. UHG’s share price on the news reacted negatively, falling 9% and dragging down other payers as well. UHG must rue the day they bought Change Healthcare, as it has been largely bad news ever since. CNBC

And winding up on a happy note–Owlet is back in good graces with the NYSE. Last year, they faced a NYSE notification that they were out of compliance with the $50 million minimum valuation of the company over a consecutive 30-day trading day period. They are now in compliance and their Class A shares can trade without the ‘BC’ black mark and no longer be listed as such on the NYSE website. The NYSE will be following its standard procedure of a 12-month follow-up on compliance. Release, Mobihealthnews

The baby sock and baby monitoring company has had a rough couple of years between a cracked SPAC (2021), FDA notifying them at the end of 2021 that they considered the Smart Sock a medical device, forcing the company to pull it from distribution [TTA 4 Dec 21], mounting losses, layoffs, and rebuilding with an FDA-cleared BabySat and enhanced Dream Sock [TTA 21 June 23]. Usually, this concatenation of events means the company either shuts or sells, but Owlet has done neither and bootstrapped itself. Revenue in their Q2 ending 30 June was up 58% year over year with a narrower operating loss of $2.2 million, compared with $6.7 million in prior year. It recently expanded their European distribution of the Dream Sock after CE Mark certification in May to a total of 11 countries [TTA 18 Sep]. 

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

September 13, 2024 | by

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

Short takes: follow up on Cano Health’s survival moves, eMed transitioning Babylon Health UK but Babyl Rwanda shuts, DEA extends telehealth prescribing for controlled substances thru 2024

October 11, 2023 | by

Cano Health takes the reverse stock split option to stay solvent. In Cano’s latest telenovela episode, a familiar stratagem for companies to drive up a dangerously low share price is to reverse stock split, usually in a large ratio. Cano is facing delisting on the NYSE as its shares traded, as of 11 September, below the $1 minimum for 30 days. [TTA 29 Sept]  Shareholders are being asked to approve a 1 for 60 ratio with the board having the right to adjust it down to 1-for-5 and up to 1-for-100, for both Class A and B common stock. At the current share price of $0.21, a new share’s value would be $12.60. No meeting date has been set, though the press release bluntly states that 30% shareholder ITC Rumba, LLC and the 20% held by current and former members of management and the board intend to vote in favor of it, achieving the necessary simple majority. 1:60 does sound last-ditch, reminiscent of Babylon Health’s late 2022 moves in a 1 for 25 exchange, before attempting to go private–and we know how that turned out. Release

eMed transitioning Babylon Health services in the UK. A check on Babylon Health’s UK website provides FAQs for current users. It leads with promises to expand digital-first primary care services on this registration page for visits, and to develop a chronic care management service starting with medical weight management using Wegovy. The FAQs also state there will be no disruptions to GP at Hand. There is a rebranding (left/above) that sunsets the Babylon name but retains the stylized heart. 

Babyl Rwanda‘s separate website and the eMed pages for Babyl Rwanda are still up, but a local report from 24 September states that the company has ceased operations in Rwanda. As of August, the government was scrambling to find buyers and to maintain operations to 2.4 million Rwandans. “According to Julien Mahoro Niyingabira, the Rwanda Health Communication Centre (RHCC) Division Manager, the Ministry of Health is in discussions with Babyl Rwanda to ensure continuity of services despite the closure of Babylon Health.” How that will be possible without a buyer to pay employees and maintain the operation is debatable. The New Times (Rwanda)

As for the US, the Babylon Health US site also remains up and intact with a small disclaimer at the top that US services are no longer available and to contact your health plan. It is the same as on our last visit on 14 September. It is odd to see, after another month, that no one has disabled the US services or corporate pages such as Investors. This is possibly because the architecture for the US pages are off the UK site (the tab at top has the eMed logo) and nobody is in the US operation to take down the pages. The US operation, in Chapter 7 bankruptcy liquidation, is now in the tender hands of the US bankruptcy courts, where filings, documentation, and processes move slowly indeed with no further public news.

And when you can’t decide, extend. The Drug Enforcement Administration (DEA) and Health and Human Services (HHS) once again are extending Covid-time flexibilities for prescribing controlled substances through 2024.  After 38,000 comments on the proposed changes to rules after the last extension in May, DEA and HHS punted again on reimposing Ryan-Haight Act restrictions that would require in-person evaluations/visits prior to prescribing. This allows clinicians to prescribe Schedule II–V controlled medications via audio-video telemedicine encounters, including Schedule III–V narcotic controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder. Final rules will be timed for Fall 2024. Another year’s breathing room for  6 Oct DEA announcement, Federal Register 10 October “Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”, Healthcare Dive

Mid-week roundup: DEA extends telehealth prescribing waiver to November; telehealth usage continues to erode; NextGen EHR hacked, 1M records breached

May 11, 2023 | by

The answer: 11 November. The question: how long was the Drug Enforcement Administration (DEA) planning to extend their telehealth waiver of in-person prescribing requirements on Schedule II and higher controlled substances?  Both the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”rule on 9 May before the Public Health Emergency (PHE) expired on 11 May. It’s a six-month reprieve for the beleaguered telemental health providers/prescribers and their patients–and sure to be hotly debated over the next few months as a final rule must replace the temporary extension rule and the Ryan-Haight Act isn’t going away. DEA release, TTA 4 May

FAIR Health’s tracking of telehealth medical claims has languished in the Fives–as in 5%–since last year. February is the latest month of tracking and it declined from 5.9% in January to 5.5% in February. Again, the vast majority of claims are for mental health codes (66.7%) far ahead of diagnosis #2, acute respiratory diseases and infections, where Covid-19 once resided. However, the latter accounted for 25.6% of asynchronous (store and forward) telehealth diagnoses. A new metric on the report is audio-only telehealth, which is only slightly more popular in rural versus urban areas. The greatest difference from the national norm is in the West, where February telehealth claims were 7.6%. Monthly national summary, FAIR Health main page for monthly and regional summaries.

NextGen’s EHR/practice management system hacked, 1.05 million patient records breached. Information stolen included patient name, dates of birth, addresses, and Social Security numbers. This was revealed in a filing with the Maine attorney general’s office since it included over 4,000 Maine residents. The hack of the NextGen Office system took place between 29 March and 14 April 2023. It’s been a bad year for NextGen’s IT and security teams, as it also experienced a short-term ransomware attack in January by AlphV/BlackCat. (The two couldn’t be related…could they?) No word yet on class action lawsuits or Federal penalties.  TechCrunch

Mid-week roundup: CVS-Oak Street closes, DEA extends controlled substance telehealth waiver, Bright Health selling CA MA plans, Talkspace, Teladoc turnarounds? (updated)

May 4, 2023 | by

CVS closed its $10.6 billion deal for Oak Street Health, well before the anticipated end of 2023. It picks up 169 primary care offices in 21 states–and an unprofitable operation that clocked a loss last year of $510 million without much of a change till 2025. The quick closing was likely spurred by both the Department of Justice (DOJ) and the Federal Trade Commission (FTC) letting their antitrust challenge period expire at the end of March with nary a whimper. DOJ and FTC, the latter which has been remarkably ‘pixelated’ of late on privacy issues with GoodRx and Teladoc’s BetterHelp, evidently passed on ‘egg on the face’ and let the ovoid land squarely on Elizabeth Warren’s Senate desk. She had asked FTC to ‘carefully scrutinize’ the deal. Shareholders received a tidy $39 per share. OSH will remain a multi-payer practice and now-former CEO Mike Pykosz will lead the company under CVS’ new healthcare delivery arm. This follows on CVS’ closing of Signify Health [TTA 30 March].  CVS release, FierceHealthcare Our prior gimlety coverage of CVS/OSH: 16 Feb, 2 March, Unlike OSH, CVS had a strong Q1 with $2.1 billion in profit, slightly down from 2022’s $2.4 billion, and an 11% boost in revenue. FierceHealthcare

DEA in-person prescribing requirements on Schedule II and higher controlled substances postponed indefinitely. The proposed rule would have added back in-person requirements for telehealth prescribing of controlled substances after the official end of the Public Health Emergency and its in-person waivers on 11 May. On 25 April, the DEA filed a draft temporary rule with the Office of Management and Budget for the extension. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that Schedule II medications and narcotics (including Adderall and Ritalin) require an in-person prescription, while Schedule III or higher medications, including buprenorphine, Ambien, Valium, Xanax and ketamine can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. The DEA was deluged with 38,000 comments and advocacy pressure from ATA. The change has also thrown a wrench in the works of online mental health companies which prescribe many of these drugs. FierceHealthcare  Updated–The ATA has weighed in favorably about the DEA postponement. Kyle Zebley, executive director of ATA Action, stated in their release that “Our hope is that the DEA will use the time of an extension to be responsive to the concerns of telehealth advocates, patients, and the American people to create rules that ensure access to clinical care that is not inappropriately restricted.”

Bright Health put its California Medicare Advantage plans up for sale. The company, staring down at bankruptcy [TTA 7 Apr, 20 Apr] does not yet have a buyer for the MA plans. When they are sold, it will be Bright’s exit as a health insurer, as it has exited MA plans in Florida and exchange plans everywhere else–in a flurry of state investigations ranging from Tennessee to Texas. Bright plans to focus on its provider arm, NeueHealth. Healthcare Dive

Talkspace narrowed its loss, increased revenue. The telemental health provider narrowed its Q1 net loss to $8.8 million compared to 2022’s $18.3 million in Q4 2022 and $20.4 million in Q1. Revenue increased to $33.3 million versus last year’s Q1 of $30.2 million. Their source of business has shifted to B2B with a 71% increase, a sharp departure from their formerly dominant consumer segment which has declined 40%.  Their 2023 forecast revenue is $130-135 million. It is still facing a Nasdaq delisting as trading below $1.00 per share and a class action lawsuit on subscription renewals. Mobihealthnews

Teladoc also waxed positive, ‘beating the Street’ with Q1 revenue growth of 11% to $629 million. This was powered as expected by BetterHelp, Teladoc’s direct-to-consumer mental health business. Their revenue grew to $279 million, a 21% increase. Teladoc’s enterprise business also had a 5% boost to almost $350 million. Their weight loss business is expected to be another net positive income generator, but not affecting results until 2024 as it won’t be introduced until Q3 [TTA 21 April]. The road to profitability will be a long one, as losses this quarter were $69.2 million, but compared to last year’s $6.7 billion writedown of Livongo, it’s positively smooth. Healthcare Dive

Mid-week roundup: Pear Therapeutics’ Chapter 11; Workit Health pinkslips 100; Outcome Health principals convicted of $1B fraud

April 13, 2023 | by

Pear Therapeutics ran out of runway and is in the drink. On Friday, CEO Corey McCann announced in a post on LinkedIn that the company filed for Chapter 11 bankruptcy and has laid off 170 employees, including him. Dr. McCann will continue on the board and as a compensated consultant, while chief operating and financial officer Christopher D.T. Guiffre will remain through the Chapter 11 process along with about 15 employees to manage the asset sale process, limited operations, and transition on behalf of the debtors.

According to their Securities & Exchange Commission (SEC) 8-K filing, terminated employees were paid through April 7, 2023, received two weeks’ salary as severance, and were asked to sign a separation agreement, which includes a general release of claims against the company resulting in a $1.2 million charge.

Only last month, Pear announced that it was exploring ‘strategic alternatives’ including a sale or being acquired. According to the release, the debtors are still seeking a sale of the whole business or to part out specific assets. Now such sales and the bidding process must be approved by the US Bankruptcy Court in Delaware. Release  The sale is anticipated for May.

Another behavioral health casualty in a model that proved unworkable. Pear developed and marketed Prescription Digital Therapeutics (PDTs) concentrated in behavioral health and substance use including opioid use disorder. While these seemed to be accepted by providers, patients, and some payers, payment didn’t materialize from the last, according to Dr. McCann’s LinkedIn post. According to Forbes, “There were more than 45,000 prescriptions written for Pear’s products in 2022, but only around half were filled and the company was able to collect payment for only 41% of those.” The other factors were price and reimbursement. Pear’s products averaged $1,195, which took them out of private payment. Only a limited number of commercial insurers and Medicaid plans would pay for them. Medicare did not. In 2022, Pear reported an operating loss of $123.4 million on $12.7 million in revenue, which doesn’t fly in 2023.

This is quite a change from the heady days of 2021, when Pear went public on Nasdaq via a SPAC in December, raising about $175 million in additional funding. A sign of trouble was that the raise was far less than the anticipated $400 million. At that time, Pear was valued at about $1.6 billion. Prior to the SPAC, they had raised about $284 million through Series D funding (Crunchbase)  Mobihealthnews, MedCityNews

Another virtual behavioral health company facing loss of business is Workit Health, This is due to the Drug Enforcement Administration’s (DEA) planned return to the in-person visit requirement for Schedule III-V non-narcotic controlled medications. Workit is a virtual therapy/treatment company for alcohol, stimulant, and opioid abuse, a crowded field. The company, rationally, is cutting 100 staff in anticipation of a drop in activity. To date, it has over $130 million in funding through a Series C, not a lot.  Behavioral Health Business  Also TTA 15 March on the DEA rule debate

Outcome Health–the other late 2010’s scandal after Theranos–had its denouement in a Federal court in Chicago yesterday (11 April). Convicted of $1 billion in fraud were:

  • Rishi Shah, 37, the co-founder and former CEO of Outcome Health: five counts of mail fraud, 10 counts of wire fraud, two counts of bank fraud, and two counts of money laundering
  • Shradha Agarwal, 37, the former president of Outcome: five counts of mail fraud, eight counts of wire fraud, and two counts of bank fraud
  • Brad Purdy, 33, former chief operating officer and chief financial officer: five counts of mail fraud, five counts of wire fraud, two counts of bank fraud, and one count of false statements to a financial institution

Each count carries specific maximums of between 10 to 30 years which are usually served concurrently. Sentencing for the three executives and for three other employees who had pleaded guilty to lesser charges will be at a date to be determined. SEC charges are pending against the executives, along with Ashik Desai, former chief growth officer, who testified against his former bosses in the criminal trial and was one of the three who pleaded guilty.

Outcome delivered patient education on screens in doctor’s offices and circa 2016 was one of the hottest companies in Chicago. During the pandemic, it merged with PatientPoint. Their problem was inflating their ad delivery numbers to their sponsors such as Pfizer, Biogen, and Sanofi. This puffery included third-party analyses of the ads’ effectiveness, e.g. for prescriptions written. This was exposed by the Wall Street Journal in October 2017. Advertiser makegoods and clawbacks from lenders in the millions resulted. TTA 29 Jan 2018   But the executive crew above plus the other three employees concealed the under-delivery problem, faked revenue numbers, and presented them for debt financing plus equity funding in 2016-17 that rewarded them richly–thus the Federal fraud charges. Mobihealthnews, FierceHealthcare, DOJ release  TTA’s coverage from that time here

Let’s hope for more cheerful news out of HIMSS next week.

News from ATA 2023: debate over DEA in-person prescribing requirement, winners of Telehealth Innovators Challenge, 2024 board chair announced

March 15, 2023 | by

The American Telemedicine Association’s annual conference, ATA2023, which wrapped two weekends ago, had some major debates, awards, and some board changes.

Special ‘listening’ session on DEA’s proposed changes on telemedicine prescribing of controlled substances. This would resume the in-person visit requirement for Schedule III-V non-narcotic controlled medications. A 30-day limit on a prescription would be permitted for a telehealth remote visit and prescription, but an in-person visit would be required during that period or thereafter before any renewal. The DEA proposed rule issued 24 February (draft here) includes allowing care to be delivered uninterrupted for 180 days after the end of the public health emergency (PHE) ending 11 May, but then requires an in-person physician visit. ATA opposes this new requirement for patients who were prescribed these medications solely during telehealth during the PHE (release 25 Feb). Public comment on the proposed rule is open for 30 days (27 March). A representative of the DEA was in the audience for the Monday 6 March discussion moderated by Kyle Zebley, ATA’s senior vice president of public policy. Other telehealth measures were extended for two years in last year’s passage of the 2023 Federal budget bill [TTA 4 Jan]. Healthcare Finance

Winners were announced for ATA’s Telehealth Innovators Challenge. The four categories and winners were:

Femtech and Women’s Health Winner: SimpliFed. SimpliFed is a virtual breastfeeding and baby feeding provider network that improves access to professional lactation support.

In-patient Care Solutions Winner: Great Speech. Great Speech provides speech therapy through a network of 200+ therapists and adds artificial intelligence (AI) technology and proprietary algorithms.

The Patient Experience: Clearstep Health. Clearstep guides healthcare consumers to the best next steps for care based on their symptoms, insurance, location and preferences via a virtual triage system set up for providers. 

Tools That Deliver Care: Strados Labs. The Strados Cardiopulmonary Platform, using the RESP Biosensor, captures wheezing, coughing, and other lung sounds plus respiratory dynamics, then to a clinician portal supported by machine learning algorithms.

SimpliFed also won the overall Judges’ Choice Award. Oshi Health, a virtual-first gastrointestinal care clinic integrating evidence-based medical care and behavioral health support into a convenient, high-touch, data-driven care model, received the overall People’s Choice Award. Release

Sree Chaguturu, MD, has been named Chair-elect of ATA’s Board of Directors for a two-year term starting May 2024. Dr. Chaguturu is executive vice president and chief medical officer, CVS Health. He has served on the ATA Board of Directors since December 2020. He will follow Kristi Henderson, DNP, CEO, MedExpress and senior vice president of the Center for Digital Health and Innovation for Optum Health, who is now Immediate Past Chair. Release

News roundup: DDoS attacks may be ‘smokescreen’, DEA slams Truepill with ‘show cause’, telehealth claims stabilize at 5.4%, Epic squashes patent troll, Cerner meeting exits KC, MedOrbis, Kahun partner on AI intake

December 22, 2022 | by

Readers won’t get out of 2022 without one last cybercrime…article. DDoS attacks–distributed denial of service–escalated worldwide with Russia’s invasion of Ukraine in February. (Ukraine and military aid is a hot topic this week with President Zelenskyy’s visit to the US and Congress speech.) Xavier Bellekens, CEO of Lupovis, a cybersecurity company and a cyberpsychologist (!), postulates that DDoS attacks, as nasty as they are, may be a smokescreen for far more nefarious and damaging attacks. While IT goes into crisis mode over the DDoS, other attacks and information gathering on systems preparing for future attacks are taking place. Russian cyber groups focus on large organizations and move down the line into the most vulnerable, using both manual and automated approaches. Worth reading given the vulnerability and IT short staffing in healthcare organizations. Cybernews

The fallout from Cerebral and Schedule 2 telehealth misprescribing expands. The Drug Enforcement Agency (DEA) issued a ‘Show Cause’ to online pharmacy Truepill for inappropriate filling of ADHD Schedule 2 medications, including Adderall. A ‘Show Cause’ order is an administrative action to determine whether a DEA Certificate of Registration should be revoked, which could put Truepill out of business. The red flag for the DEA: 60% of  Truepill’s prescriptions–72,000–filled between September 2020 and September 2022 were for controlled substances, including generic Adderall. Truepill was Cerebral’s primary mail order provider, though they also used CVS and Walmart. The company stopped filling Cerebral’s ADHD prescriptions in May 2022.

In the order, the DEA cites that “Truepill dispensed controlled substances pursuant to prescriptions that were not issued for a legitimate medical purpose in the usual course of professional practice. An investigation into Truepill’s operations revealed that the pharmacy filled prescriptions that were: unlawful by exceeding the 90-day supply limits; and/or written by prescribers who did not possess the proper state licensing.”

The company stated in an emailed statement that they were fully cooperating with the investigation. If it does move to a hearing, Truepill’s chances of a successful defense are statistically low.

Truepill also fills prescriptions for Hims & Hers, GoodRx and Mark Cuban Cost Plus Drug Company. It was valued in its 2021 funding round at $1.6 billion. Companies in telemental health and prescribing of Schedule 2 ADHD medications, such as Cerebral and Done Health, are under enhanced scrutiny over their business practices [TTA 1 June]. Mobihealthnews, DEA press release, HISTalk, Digital Health Business & Technology

Telehealth medical claims stabilize. FAIR Health’s latest reports for August and September report that the percent of medical claims coded as telehealth are back up to 5.4%. June and July dropped slightly to 5.2% and 5.3% respectively. Also steady are that the vast majority of claims are for mental health services. In September, they were 66% of diagnoses far ahead of ‘acute respiratory diseases and infections’ at 3.1%. In procedure codes, psychotherapy accounts for over 43%.

A patent troll Epically bites the dust. Back in the early to mid-2010s [TTA’s index here], patent trolls (technically non-practicing entities which have no active business) presented a significant threat to early and growth-stage health tech companies. One, MMR Global (which apparently no longer exists), was notorious for buying up EHR and PHR-related patents and then filing patent infringement lawsuits against both small and large healthcare organizations with similar patents–and their users–that were generally monetarily settled. But NPEs are still active. One in south Florida, Decapolis Systems, used the same techniques as MMR Global had, suing in this case multiple Epic customers for patent infringement. Epic not only defended its customers but also sued Decapolis in the US District Court, Southern District of Florida. The court found that both Decapolis patents were invalid, ending what Epic termed ‘vexatious patent litigation’. Decapolis had successfully sued 24 other entities, including other EHRs, which settled. Owned by an inventor, this company will have to find another line of honest business. Epic release, Thomson Coburg

Oracle’s message to Kansas City: no more Cerner meetings for you. And maybe more. Cerner’s site for its annual customer/partner conference since 2007 has been in Kansas City, attracting about 14,000 visitors. Not only will it be integrated into Oracle CloudWorld in Las Vegas, 18-21 September, it’s been retitled Oracle Health with no mention of Cerner. The loss to local KC business is substantial–estimated to be in the $18 million range. While it’s logical to integrate it into the massive CloudWorld conference, it’s also another message to KC after Oracle’s sudden real estate downsizing that Cerner’s presence there will shrink…and shrink..as it’s absorbed into Oracle Health, and further confirmation that the Cerner name is gradually being sunsetted. KansasCity.com, HISTalk

A new (to this Editor) specialty care telehealth company, MediOrbis, is partnering with Kahun for an AI-enabled digital intake tool. This is a chatbot capable of conducting an initial medical assessment. Based on the patient’s answers and Kahun’s database of about 30 million evidence-based medical knowledge insights, it provides a summary for the physician before the telehealth visit and highlights areas of concern. Mobihealthnews  MediOrbis also has partnered with remote care/engagement Independa to add its capabilities to Independa’s HealthHub on their LG TVs.

Ousted Cerebral CEO may sue company, accuses management of scapegoating on Schedule 2 prescribing

November 18, 2022 | by

Troubled telemental health provider Cerebral may face a lawsuit from former CEO Kyle Robertson. Ousted in May when the company’s prescriptions for ADHD patients started to be excluded from pharmacies such as Truepill, CVS, and Walmart for Schedule 2 (potential for abuse and misuse) medications such as Adderall, Ritalin, and Vyvanse [TTA 6 May], Robertson has written a letter to Cerebral demanding access to documents. The types of documents requested, according to (paywalled) Insider, include “possible breaches of fiduciary duty, mismanagement and other violations of law.” Usually, these are a setup to determine whether others on the company board and leadership were the real culprits in business mismanagement, and a prelude to a legal filing.

CBS News obtained a copy of the Robertson letter, in which “Robertson says he was pressured by the company’s investors to “sell more stimulants” and believes his ouster was an effort to “scapegoat” him as these investigations arose.  He was urged by one board member  that “the easier you make it for people to get stimulants, the better for the business and its customers.” and also claimed that an investor told Robertson’s partner the company’s “ADHD business is crushing and it’s a cash cow … Kyle’s got to push this thing further.” Other documents obtained by CBS allegedly detail clinical safety issues, staff “practicing with expired (or) suspended license(s),” and duplicate accounts which could set the stage for overprescribing. Other documents allege lack of training, pushing prescriptions to 95% of patients, and disregarding state regulations putting licenses at risk. [TTA 29 June] The current management, led by David Mou, has denied this all.

Multiple investigations are proceeding. From May on, Cerebral came under investigation by the Federal Trade Commission (FTC) on deceptive advertising and marketing practices, the Drug Enforcement Agency (DEA) as part of increased scrutiny of telehealth providers and pharmacies possibly overprescribing telehealth-generated prescriptions, and most significantly, the Department of Justice (DOJ) subpoenas on allegations of overprescribing. A prior wrongful dismissal lawsuit by Matthew Truebe, Cerebral’s former VP of product and engineering, alleged that the company put growth before patient safety, including prescribing ADHD drugs to 100% of diagnosed patients as a retention strategy. The concatenation of evidence from multiple sources makes a lawsuit by Robertson, who also cites other factors, probable–unless this is being used as a tablespoon to sweeten his severance.

Prior to that, Cerebral was one of the leaders in the still-hot digital mental health category. In December 2021, their $300 million Series C raise led by Softbank boosted their valuation past $4.8 billion, employed 4,500, and had 210,000 patients. In October, they released 400 staff but other reports indicate far more. Also FierceHealthcare

DOJ investigates telemental Cerebral on over-prescribing of controlled medications

May 10, 2022 | by

DOJ dropped an anvil on Cerebral’s head Friday night. Last week’s reports on the Drug Enforcement Agency (DEA) investigation of telemental health provider Cerebral were confirmed on Friday with the official notification that the US Attorney’s Office for the Eastern District of New York had subpoenaed the company as part of their investigation into possible violations of the Controlled Substances Act. According to the Wall Street Journal, the subpoena was issued to Cerebral Medical Group, the corporation it uses to contract with clinicians and provide healthcare services. The company is fully cooperating with the investigation by the Department of Justice, which includes turning over records pertaining to their prescribing of controlled substances such as Adderall and Xanax. This has been reported by FierceHealthcare which is citing (paywalled) Insider.

Last week, Cerebral announced that it would stop prescribing controlled substance prescriptions for new ADHD patients as of 9 May. However, they would continue prescribing controlled substances for other mental health conditions, according to a memo from their chief medical officer to their clinician network.

Cerebral’s Saturday statement in response to the subpoena maintains (from FierceHealthcare):

“To be clear, at this time, no regulatory or law enforcement authority has accused Cerebral of violating any law”

and

“Cerebral has dedicated significant time, energy, and resources to ensuring that its policies and procedures regarding the prescription of controlled substances and other medications both are medically appropriate and comply with all applicable state and federal law,” the statement also said. “As a responsible company, Cerebral is continuously improving its systems and practices. The foundation of this company is built on evidence-based, ethical, and compliant practices so that our patients can receive the highest quality of care and achieve the best clinical outcomes.”

The company has done well with the increased demand for mental health services provided via telehealth including remote evaluating and prescribing. In December, their $300 million Series C raise boosted their valuation past $4.8 billion.

Darkening this rosy picture is, as TTA noted last week, that a former VP of product and engineering, Matthew Truebe, has sued Cerebral for wrongful dismissal. According to him, the company put growth before patient safety, including overprescribing medications for ADHD. Other reports indicate that the DEA interviewed other former Cerebral nurse practitioners who felt pressured to prescribe ADHD medication after a short video call. The Verge

Cerebral has also gained notoriety for dodgy advertising claims pertaining to ADHD and other conditions. In January, advertising on TikTok and Instagram was pulled for claims that obesity is “five times more prevalent” among adults with ADHD, and stated that getting treatment for the mental health disorder could help patients “stop overeating.” These followed inquiries by Forbes and NBC News. Also pulled was their Facebook advertising around prescribing Type 2 diabetes medications, GLP-1 agonists, as a “wonder drug” for weight loss. 

Will this put a damper on the burgeoning area of telemental health and remote prescribing? Stay tuned. Also Becker’s.