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Tuesday, December 6, 2022

Med malpractice lawsuits, delayed by pandemic, hitting hospitals harder than expected

 Carlos David Castro Rojas was a healthy 27-year-old engineering student when he fell off a ladder hanging Christmas lights in 2017, breaking his leg and injuring his knee. 

What was supposed to be a relatively routine surgery at a Baylor Scott & White Health hospital in Dallas ultimately ended with Rojas sustaining a severe brain injury. His mother’s lawsuit alleges he wasn’t properly cared for while under general anesthesia, and the lack of blood flow and oxygen to his brain landed him in a permanent vegetative state. He’s now unable to speak or walk and requires round-the-clock care. 

Like so many medical malpractice lawsuits filed before the Covid-19 pandemic, the case filed by Rojas’ mother, who moved to Dallas to care for her son, was held up as court dockets ground to a halt and jury trials were postponed. Recently, though, a jury issued a $21 million judgment against the clinicians who provided Rojas’ care, as well as their employer, U.S. Anesthesia Partners. Baylor Scott & White settled separately ahead of the trial. 

The delay put “incredible pressure” on Rojas’ family, said Bruce Steckler, the attorney representing Rojas’ mother.

“It’s unfortunate that these folks had to wait,” Steckler said, “but it’s really unfortunate that they had to go through what they went through. My belief is it happened because people were putting profits ahead of their patients and not providing the quality of care they needed to provide.” 

Now that courts have resumed normal operations after the pandemic-related delays of 2020 and 2021, many health systems are shouldering higher medical malpractice expenses than they otherwise might expect. The payouts, while a lifeline for the patients and families harmed by medical errors, have added significant strain onto what’s already a challenging time for hospitals facing ballooning labor and supply expenses. 

“It’s a big thing,” said Ed McGrath, managing director with the consultancy VMG Health. “When you’re getting hit on labor and you’re getting hit on supply costs and then you start getting hit on medical malpractice, that’s a triple whammy.”

Throughout much of the pandemic, jury trials weren’t happening or were very limited, said Kathleen Nastri, a medical malpractice attorney with the firm Koskoff. When trials resumed, criminal cases took precedence. That meant civil cases, which include malpractice, remained dormant, she said. 

“We were out for so long,” Nastri said. “The civil docket was essentially shut down.”

Typically, health systems are able to plan ahead for any legal costs they might incur and build that into their insurance reserves, but a recent report from VMG Health said some are seeing malpractice costs rise to levels they didn’t anticipate. The authors interviewed executives from 21 not-for-profit health systems, more than half of whom said they’re struggling with higher than expected malpractice costs. 

So far, the higher expenses are being felt primarily at health systems that self-insure for malpractice liability, meaning they cover the cost of claims, often through offshore captive insurance companies, McGrath said. They’ll also typically have some form of catastrophic coverage for payouts that exceed certain thresholds. McGrath thinks the effects will extend to all health systems next year, even among those that do buy liability insurance. 

“I think 2023 will still be a pretty tough year when it comes to this particular topic,” he said. 

Major health systems like Baylor Scott & White Health, CommonSpirit Health, UPMC, Mass General Brigham, and Cleveland Clinic all reported larger self-insurance reserves or professional and general liability funds, which include malpractice, in their latest financial statements.

St. Louis-based Ascension’s professional and general liability loss reserve grew more than 6% year-over-year in fiscal 2022, reaching $932 million as of June 30, 2022. 

Ascension could be on the hook for billions in legal fees after a judge determined last month that the jury can award punitive damages once a consolidated lawsuit against Ascension St. Vincent in Florida goes to trial next year. Hundreds of people have sued the hospital over injuries they say were caused by an impaired surgeon who should not have been practicing. Ascension did not respond to a request for comment. 

Cleveland Clinic’s insurance expenses grew 66% in the quarter ended Sept. 30 year-over-year. A spokesperson said that reflects higher malpractice premiums, but also cybersecurity, property, and auto premiums.   

“The judgments are all coming through now at much higher rates than they had been for the last two years,” said Mike Ramsay, CEO of the patient safety advocacy group Patient Safety Movement Foundation. “Unfortunately for the hospitals, a number of the judgments are against the hospitals and so they have to find the cash to pay on the suits.”

While many delayed cases were filed before the pandemic, there’s reason to believe more will result from the staff shortages and reassignments that took place during the crisis, Ramsay said. To quickly attend to the crush of Covid-19 patients, hospitals placed clinicians in intensive care units without the proper training, he said. 

The effects are already showing up in hospital safety scores. Compared with pre-pandemic 2019, central-line associated bloodstream infections were up 45% in the first half of 2021. Rates of the superbug MRSA were up 39% in that time. 

Nastri, the Koskoff attorney, said her current slate of cases leads her to believe hospitals have become less safe than they were before the pandemic. It could be because protocols designed to prevent sepsis or infections aren’t being followed as closely. Poorly trained staff or contract workers who aren’t familiar with a particular hospital’s protocols could also be contributing. 

“I can tell you in general I have not seen as many clear errors in my 30 years of practice as I have probably in the last 18 months,” Nastri said. 

https://www.statnews.com/2022/12/05/medical-malpractice-hospitals-covid-pandemic-insurance/

Mesoblast cut to Hold by Jefferies

 From Buy

https://finviz.com/quote.ashx?t=MESO&ty=c&ta=1&p=d

Anavex cut to Neutral from Overweight by Cantor

 Target to $11 from $16

https://finviz.com/quote.ashx?t=AVXL&p=d

Esmo IO – Mirati struggles to keep the first-line dream alive

 When it comes to adagrasib's chances in the potentially lucrative first-line lung cancer setting, Mirati still has some convincing to do. Amgen set a low bar earlier this year at World Lung: adding its rival Kras inhibitor, Lumakras, to checkpoint inhibition came with worrying levels of liver toxicity and a meagre 29% overall response rate. Standard-of-care Keytruda presents a much bigger challenge, and topline data in an abstract, released ahead of a full presentation at the Esmo Immuno-Oncology conference tomorrow, point to adagrasib coming up short. SVB analysts described a 49% ORR for adagrasib plus Keytruda as “relatively modest” and in-line with Keynote-189, which tested the Merck & Co MAb plus chemo. Adagrasib needs to do much better for any hope of justifying front-line usage; Stifel analysts described a 56% ORR generated in six patients treated for more than six months as “trending in the right direction”. Responses stratified by patients’ PD-L1 expression levels will be scrutinised tomorrow, and perhaps point to a way forward. Mirati plans to launch a phase 3 trial in patients with low PD-L1 expression “soon”, according to Reuters. But with Mirati shares opening down 17%, it seems the market was expecting a lot more.

Cross-trial comparison of combination first-line non-small cell lung cancer trials
 ORR ORR in TPS >50%ORR in TPS 1-49%ORR in TPS<1%
Krystal-7 (ph2, adagrasib + Keytruda) 49% (26/53)*???
Krystal-1 (ph1b portion, adagrasib + Keytruda)57% (4/7)**???
Keynote-189 (ph3, Keytruda + chemo) 48% (184/387)***61%48%32%
*In patients with at least one on-study scan, median treatment duration two months, includes 5 unconfirmed partial responses. **median follow-up 19.3 months. ***median follow-up 10.5 months Source: Esmo-IO 2022 abstract, NEJM Gandhi et al, 2018.

https://www.evaluate.com/vantage/articles/events/conferences-snippets/esmo-io-mirati-struggles-keep-first-line-dream-alive

Evaxion, ExpreS2ion Ink Research Pact For Cytomegalovirus Vaccine Candidate

 

  • Evaxion Biotech A/S  has signed a Vaccine Discovery Collaboration Agreement with ExpreS2ion Biotech Holding AB for the joint development of a novel cytomegalovirus (CMV) vaccine candidate.
  • During the discovery phase of the collaboration, Evaxion will use its proprietary AI platform, RAVEN, to design a next-generation vaccine candidate that elicits both cellular and humoral/antibody responses. 
  • The antigen constructs derived from Evaxion's AI platform will be produced by ExpreS2ion, followed by assessments in Evaxion's preclinical models. 
  • The joint discovery project will be included in Evaxion's development pipeline under EVX-V1.
  • Under the terms of the collaboration, ExpreS2ion will have the exclusive right to license the CMV vaccine candidate. The research and intellectual property licensing costs will be divided 50/50 between the parties until 2025.
  • A potential future Development and Commercialization Agreement for the jointly discovered CMV vaccine candidate is expected to include an upfront payment and future milestone payments to Evaxion from ExpreS2ion not exceeding a six-digit USD amount, as well as sub-licensing royalty.

Ra Medical: Catheter Precision System Used in Over 800 Procedures in US, Euro Hospitals

 -Catheter Precision, Inc., a medical device and technology company focused on cardiac electrophysiology, announces that more than 800 procedures have been performed in a number of leading U.S. and European hospitals utilizing the VIVO System that enables physicians to noninvasively identify an area of ventricular arrhythmia onset. On September 12, 2022 privately held Catheter Precision announced a definitive merger agreement with Ra Medical Systems (NYSE American: RMED), which, if completed, will result in a combined publicly traded company focusing on the cardiac electrophysiology market.

https://www.businesswire.com/news/home/20221201005454/en/Catheter-Precision%E2%80%99s-VIVO%E2%84%A2-System-Used-in-More-Than-800-Procedures-in-Leading-U.S.-and-European-Hospitals

High-Intensity Billing for 'Treat and Release' ED Visits Has Shot Up Since 2006

 High-intensity billing during "treat and release" emergency department (ED) visits rose dramatically over the last two decades, according to an observational study.

From 2006 to 2019, the share of treat-and-release visits at the ED (those where patients were not admitted) that included high-intensity billing jumped from 4.8% to 19.2%, reported researchers led by Alexander Janke, MD, MHS, of the VA Ann Arbor Healthcare System and University of Michigan.

Also, the share of visits by patients with more comorbidities, older patients, and those with "nonspecific but potentially serious diagnoses" also went up, they stated in Health Affairs.

"Mechanistically, there is a tug of war between physician groups and payers for reimbursement, and one of the places where that tug of war plays out is in high-intensity billing," Janke, who is a fellow in the VA National Clinician Scholars Program, told MedPage Today in a phone call.

His group found that only 47% of the increase in high-intensity billing was "expected" due to changes in administrative measures related to the patient case-mix and kinds of services available in claims data. "High-intensity billing" was defined as ED visits that included a CPT code signaling "high complexity" (99285) or "critical care" (99291 or 99292).

"Upcoding," or submitting codes for more expensive procedures and diagnoses than were performed, was one possible reason for the upward trajectory of high-intensity billing, the researchers said. Janke's group suggested that other reasons could be "a correction for historical downcoding" when coding practices were more simplistic, or "broader changes" in the evolution of care in the ED. For example, Janke recalled a senior colleague telling him that, when she began practicing, any very elderly patient who presented to the ED after passing out would be admitted to the hospital.

But emergency medicine has evolved and continually seeks ways to manage patients safely, while using fewer resources and minimizing hospital admission, he explained.

Now, an older adult with multiple chronic comorbidities who presents with a nonspecific complaint and is evaluated in the ED may receive a careful risk stratification and plan to manage their condition safely at home, without requiring hospital admission, he said.

"That's sort of the most dramatic way in which emergency care's underlying complexity has changed over the past two decades, and that's what plays out in the data in the paper," Janke stated.

He noted that the "expected" increase in high-intensity billing was based on information gleaned from basic claims data such as sex, age, and diagnosis codes in a patient's chart. What isn't included are the patient's social determinants of health and the clinical complexity involved in their care, he explained.

"As we move in the direction of alternative payment models [APM] for emergency care, we have to be sensitive to how the complexity of emergency care has changed, Janke stated. For that reason, claims data alone are likely insufficient for understanding that evolution of care, he argued."

"Any health policy work to better calibrate emergency care billing with value must account for what's missing in these simple measures," Janke noted in a follow-up email. "That includes things like the comprehensive management of older adults with social or functional barriers to safe discharge, the growth of risk stratification tools to safely avoid expensive hospital admissions, or the expanding toolkit of acute care providers to link patients experiencing homelessness to community resources."

Janke said his group's future research includes building out data sets to better characterize the complexity of emergency care. That will be "essential" to informing policy conversations of billing codes and developing APMs that "truly improve how we take care of patients," he stated.

For the current study, the authors used the Nationwide Emergency Department Sample (NEDS) focusing on the period of 2006 to 2019, looking at variables such as age, sex, insurance status visit disposition and ED site region, among others. The analysis excluded patient visits that led to hospital admissions, to transfers to other short-term facilities, or to death. They cautioned that, because data on observation care are not reliably captured in the NEDS database, some visits in the treat-and-release sample may have included patients receiving observation services.

Disclosures

Janke disclosed support from an Emergency Medicine Foundation Resident Research Grant, the Department of Veterans Affairs (VA) Office of Academic Affiliations/VA National Clinician Scholars Program, and the University of Michigan.