Weekend news roundup: GE Healthcare spins off, adds CTO; Allscripts now Veradigm; NHS Brainomix AI stroke trial success; Withings home urine scanner; Careficient buys Net Health EMR; CommonSpirit’s class action suit on data breach

January 7, 2023 | by

GE Healthcare now trading on its own. On Wednesday, GEHC rang Nasdaq’s traditional opening bell virtually on its first day of trading Wednesday (4 Jan). The bell ringing was unique as the first company in Wisconsin to do so from their plant in Waukesha. GE retained approximately 19.9% of the outstanding shares of GE HealthCare common stock with the remaining 80.1% distributed to current GE shareholders. Today it closed at $58.95 and remains headquartered in Chicago. (It moved from Amersham UK back in 2016.) Management is now independent, with Peter Arduini as CEO and adding yesterday a new chief technology officer, Taha Kass-Hout MD, MS, from Amazon’s health AI area to lead the company’s new science and technology organization through their four areas: Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics. Release, Yahoo Finance  Also Mobihealthnews

Remember back in 2019 when problematic EHR Practice Fusion was renamed Veradigm? Allscripts has now renamed the entire company as Veradigm, after expanding it to analytics and research. After two years of reorganizing and downsizing (plus paying off Practice Fusion fines), selling off their hospital/large practice EHRs to Constellation Software/N. Harris Group for $700 million last May, the slimmed-down Veradigm Network encompasses electronic health records, practice management systems, and patient communication platforms. Interestingly, a search first leads you to a main corporate website under Allscripts and doesn’t forward automatically to Veradigm, making this a softer-than-usual name change. Now Veradigm can pick up a few companies on the market, as they announced last year. Release    Hat tip to HISTalk

NHS using Brainomix AI to diagnose stroke faster, tripled near-full recoveries to 48%.  The key finding: patients diagnosed using AI made near full recoveries increased from 16 to 48%. The trial of e-Stroke Suite took place in 22 hospital trusts in England across 111,000 suspected stroke patients. The AI in the e-Stroke Suite cut average diagnosis to treatment time by an hour from 140 to 79 minutes. The AI technology was developed by UK company Brainomix. Daily Mail, Oxford Academic Health Science Network case study (Note: Oxford AHSN, Brainomix, and Royal Berkshire NHS Foundation Trust (RBH) are partners in the National Consortium of Intelligent Medical Imaging (NCIMI).)

Withings is debuting the U-Scan, an in-home urinalysis device, at CES. The 90 mm device sits in the toilet bowl and uses cartridges to analyze urine components, sending results to the Withings Health Mate app. Cartridges for Europe so far are Cycle Sync for menstrual period tracking and ovulation windows, and Nutri Balance for hydration and nutrition. Nutri Balance analyzes specific gravity, pH, vitamin C, and ketone levels. The U-Scan will debut in Europe at the end of Q2, with the U-Scan starter kit priced at €499.95.  Both await FDA clearance. Withings U-Scan page, Mobihealthnews

Careficient buys Net Health’s home health/hospice EMR. Careficient already is present in the home health, hospice and home care cloud EMR market. Net Health is selling its home health, hospice, home care and palliative solutions EMR, marketed under HealthWyse and Hospicesoft, as well as its revenue cycle management (RCM) division, to concentrate on wound care and rehabilitation therapy. This expands Careficient’s client base by 750 locations in 39 states. Transaction cost was not disclosed. Release

Add to the cost of hacking multiple class action lawsuits. CommonSpirit Health, based in Chicago and the second largest health system in the US covering 21 states under CHI and Dignity Health names, not only has to remedy a massive 600,000 patient data breach discovered last October [TTA 3 Dec], but also fight a class action lawsuit filed 29 December by a patient in the US District Court for the Northern District of Illinois. Financial, health insurance, and medical information were all breached. The suit requests damages exceeding $5 million and injunctive relief, including stronger data protection practices. It will be the first of many as a quick search indicates multiple law firms seeking claimants. FierceHealthcare, WGNRadio

Amazon-One Medical gains conditional OK in Oregon–a preview of coming scrutiny?

January 6, 2023 | by

Amazon has approval for the $3.9 billion One Medical acquisition from the Oregon Health Authority (OHA)–but with conditions.  OHA’s task is to review transactions such as these in how they affect patient cost, access, quality, and equity. OHA’s key comments were positive on cost and access, equivocal on quality, and expressed concern on equity (28 December PDF here):

Cost: “…the transaction will not meaningfully change Amazon and One Medical’s market share for primary care services in Oregon. Commercial insurance payment rates for One Medical are negotiated through the partnership with Providence [Health & Services].” In the Conclusions, they noted that “Amazon, with its advanced supply chain and purchasing power, may generate efficiencies and savings for One Medical, though any savings would not necessarily be passed to consumers.

Access: The few One Medical clinics were found to be in urban areas where there is good access to healthcare. “The entities have also stated that they plan to expand One Medical’s network of clinics, which may provide additional access to services.”

Quality: “OHA has limited insight into quality for One Medical locations, since its [five] Portland clinics opened in 2020 and 2021 and One Medical does not participate in some programs that require regular quality reporting.” However, they noted that “Amazon’s business model also has the potential to impact quality.”

Equity: concern on “One Medical siphoning off commercially insured patients with higher payment rates from clinics that serve more Medicaid and Medicare-covered patients.”

Conditions for approval are in reporting on these areas. Amazon is to report on the services it provides and the quality of care, plus any governance or organizational changes, every six months for five years after the acquisition closes. OHA then must perform follow-up analyses on the impact of the transaction on the commitments Amazon makes on cost, access, and quality of care. 

One Medical’s limited Oregon footprint proved to be helpful to Amazon in gaining OHA approval–but may be a Preview of Coming Difficulties. One Medical operates in 29 markets including NYC, Los Angeles, Boston, and Atlanta, with 815,000 members and 8,000 company clients. States like New York, Massachusetts, Connecticut, and California are not exactly pushovers for approval, with California alone having two approval entities. Then there are the Feds. Back in September, Amazon disclosed the Federal Trade Commission (FTC) was scrutinizing the acquisition, with no resolution announced yet. One Medical also owns Iora Health, which has a full-risk value-based care model for patients in Medicare Advantage (MA) and Medicare shared savings across seven states–HHS and CMS territory. Two more shoes yet to drop: the SEC and the Department of Justice (DOJ). DOJ of late casts a gimlet eye on any healthcare merger–just ask UnitedHealth Group and Change Healthcare, which they are still fighting.

This Editor will stand by last year’s prediction: Iora will be sold either before or immediately after closing. The higher cost/higher care needs Medicare market doesn’t fit with Amazon’s monetization model. It is less profitable and requires advanced risk management, a skill set that Amazon doesn’t have and likely doesn’t want. MA and MSSP (Medicare Shared Savings Program) routinely face regular Federal scrutiny, which Amazon doesn’t do well either. Amazon can use the cash; it is facing major league bad press with its planned layoff of 18,000 workers, about 6% of its 300,000-person corporate staff. One wonders if many of its shareholders (other than Jeff Bezos) approve of this massive investment in a relatively small provider organization.  Reuters 

Mobihealthnews, FierceHealthcare

Telehealth extensions signed into US law with Federal FY 2023 omnibus bill

January 4, 2023 | by

Jammed into the final moments of the now-ended 117th Congress before Christmas was the passage of the FY2023 ‘omnibus’ $1.7 trillion Federal budget bill. This bill did at least several good things for those of us concerned with US telehealth, as it extended provisions for Medicare reimbursement that become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery. There is also a tax provision that affects high-deductible health plans. 

Their passage is important as the Covid-19 Public Health Emergency (PHE) is set to expire on 11 January and no movement has been publicly discerned for its renewal. In the fall, the Department of Health and Human Services (HHS) notified US state governors that there would be at least a 60-day notice before the PHE ends. It is unknown whether this notice has been given.

To summarize the two-year extensions that go to the end of 2024:

  • Expanding originating and geographic site to include anywhere the patient is located, including the patient’s home
  • Expanding eligible practitioners qualified to furnish telehealth services, including occupational therapists, physical therapists, speech-language pathologists, and audiologists
  • Extending the ability for federally qualified health centers (FQHCs) and rural health clinics (RHCs) to furnish telehealth services
  • Delaying the in-person requirement for mental health services furnished through telehealth, including the in-person requirements for FQHCs and RHCs
  • Extending coverage and payment for audio-only telehealth services
  • Extending the Acute Hospital Care at Home (AHCAH) initiative, pioneered by Johns Hopkins two decades ago. It also requires the HHS Secretary to publish a report comparing AHCAH programs with traditional inpatient care delivery. 
  • Extending the ability to use telehealth services to meet the face-to-face recertification requirement for hospice care
  • Extending high deductible health plan (HDHP) safe harbor exceptions for telehealth services in high-deductible health plans.

The final bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances. As mentioned in our earlier article, this is a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. ATA/ATA ACTION release.

The HHS Secretary will be required to submit a report to Congress on the utilization of the above services. The interim report is due in October 2024 and the final report in April 2026, according to the American Hospital Association. Affecting hospitals and practices in the bill:

  • It delayed the statutory Pay-As-You-Go (PAYGO) Medicare 4% sequester for two years, preventing the $38 billion in Medicare cuts that otherwise would have taken effect in January.
  • Partial relief from a 4.5% reduction in physician reimbursement rates starting on 1 January. The legislation reduced the cut to 2% for 2023 and around 3% for 2024.

HealthcareFinance

Other features of this bill having an effect on healthcare and telehealth (from Infrastructure Report Card):

  • $455 million for the expansion of broadband service, including $348 million for the ReConnect program, a series of grants administered by the US Department of Agriculture for the construction, improvement, or acquisition of facilities and equipment needed to provide broadband service in eligible rural areas. This could help rural areas and hospitals in provider-patient and provider-to-provider consults.
  • $1.65 billion for the National Institute of Standards and Technology (NIST), an increase of $424 million, or 34%, above the FY 2022 enacted level. Specific funding is allocated for the measurement labs and research at $953 million, a $103 million or 12% increase above the FY 2022 enacted level. The goal is to spur research advances in cutting-edge fields like carbon dioxide removal, artificial intelligence, quantum information science, and cybersecurity.

The bill was signed into law by the president on vacation in St. Croix, USVI. Given the bumpy start of the 118th Congress today, these are at least not up for grabs.

Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal

January 3, 2023 | by

David v. Goliath slugfest continues. The International Trade Commission (ITC) confirmed its Initial Determination [TTA 28 June] that Apple Watches infringed AliveCor patents on ECG readings. This Final Determination counters the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) December ruling that found not only in favor of Apple’s patents but also invalidating AliveCor’s three patents in question [TTA 8 Dec].  

The ITC’s findings come under a 60-day presidential review from 22 December. The penalty on Apple comes under a Limited Exclusion Order (LEO), a cease and desist order. It sets a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during this review period. However, enforcement of the ruling will be delayed until the review of AliveCor’s appeal of the PTAB ruling wends its way through that process in the Northern District of California, which is expected to take place in early 2024, a year from now.

A running dispute since 2020. Once upon a time, AliveCor and Apple worked together to give ECG functionality to the Apple Watch. This ended after the Apple Watch 4 incorporated ECG readings. This resulted in court actions related to patents starting in early 2021 [TTA 29 Apr 21, 9 July 21]. Apple is now up to the Watch 8, incorporating more and more cardiac and health monitoring features. AliveCor has also moved on with financing with a GE Healthcare-backed Series F this past August, the KardiaMobile 6L, and the KardiaMobile Card. As of today, it has over 170 patents.

As this Editor remarked in December, going after a rival’s patents is an often necessary but risky business that can backfire. Right now, David has moved Goliath to a draw now, with further matchups this year into next. AliveCor release, Mobihealthnews      Hat tip to Dr. Dave Albert, founder and Reader.