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Tag: 2021 News

Eli Lilly FDA Approved Drugs Cut COVID Hospitalizations and Death

A combination of two Eli Lilly antibody drugs cut the risk of COVID-19-related hospitalizations and deaths by 87%, the company announced Wednesday, further upholding dosing already authorized by the Food and Drug Administration.

New data from the randomized, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrates that bamlanivimab 700 mg and etesevimab 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19.

These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the U.S. Food and Drug Administration and a positive scientific opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

This new Phase 3 cohort of BLAZE-1 included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19. Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on key secondary endpoints. These results are consistent with those seen in other data sets from BLAZE-1: in the previous Phase 3 cohort, bamlanivimab 2800 mg with etesevimab 2800 mg reduced the risk of hospitalizations and deaths by 70 percent and in the Phase 2 cohort, bamlanivimab alone reduced the risk of hospitalizations and ER visits by approximately 70 percent.  

In this new Phase 3 cohort, there were four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together.

These positive results reinforce our previous findings and support the authorized dose of bamlanivimab 700 mg with etesevimab 1400 mg. These compelling data – in addition to the recent EUA from FDA, the decision from EMA and the recommendation for the therapy in the National Institutes of Health’s COVID-19 Treatment Guidelines – give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories.

“The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the U.S.”

Lilly continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world.

Bamlanivimab alone and bamlanivimab with etesevimab together are authorized under special/emergency pathways, in the context of the pandemic, in the U.S. and the European Union. In addition, bamlanivimab alone is authorized for emergency use in Canada, Panama, Kuwait, the UAE, Israel, Rwanda, Morocco and numerous other countries.

Through Lilly’s work with the Bill & Melinda Gates Foundation, Lilly is providing doses of bamlanivimab free of charge in Rwanda and Morocco.

Court of Appeal Affirms Prison Nurse Conviction for Comp Fraud

In 2013, Ndiawar Diop, while working a licensed vocational nurse at the California Institution for Men in Chino, provided insulin to inmate George Philpott. After Philpott injected himself, he returned the needle through an opening in a window. Diop then placed the used needle into a container used for disposing of needles.

Philpott observed Diop put his hand into the container and get poked. Philpott called for a correctional officer to avoid getting in trouble. Upon seeing Diop prick himself, Philpott exclaimed, ‘I have Hep C.’ Philpott admitted that he did not like Diop, but claimed that he never attacked, injured,or threatened him.

Diop was treated for the needle stick, and completed an intake form at U.S. Healthworks stating that after and inmate injection he got poked by his needle on his right index finger while taking the needle back from him 2 hours ago.

Seven months later, Diop was evaluated and treated by mental health professionals. At this point the history morphed into an attack by the prisoner. Then later during a permanent and stationary evaluation the story morphed even more to a claim that he was “attacked by this inmate with a syringe” and for the first time, he claimed the inmate tried to stab him in the neck.

The change from an accidental to an intentional mechanism of injury affected the claim’s monetary value because, beginning in 2013, a claimant could not receive permanent disability for a stress-related claim unless it was the result of a “violent act” and stress was originally claimed as an injury.

A jury convicted him of five counts of insurance fraud and one count of attempted perjury in connection with his workers’ compensation claim. The Court of Appeal affirmed in the unpublished case of People v. Diop.

Diop contended on appeal that: (1) the evidence fails to support his convictions; (2) the trial court made many evidentiary errors; (3) the court erred in failing to unseal juror identification information; (4) the court erred in failing to instruct on the defense of mistake of fact; and (5) the court erred by denying his motion for new trial.

The Court of Appeal reviewed, and then rejected each one of these arguments. It then concluded the “evidence demonstrates that defendant’s account of how he was injured by an inmate’s dirty needle changed from accidental to intentional. From this evidence, it was reasonable for the jury to conclude that defendant knowingly made a false material statement for the purpose of obtaining greater workers’ compensation benefits.” Cited for $6.4M So. Cal. Delivery Driver Wage Theft

The Labor Commissioner’s Office has cited Green Messengers Inc. and Services LLC $6.4 million for wage theft violations affecting 718 workers. The Santa Ana-based contractor delivered packages for Services in Los Angeles, Orange and San Bernardino counties.

The Labor Commissioner’s Office opened an investigation in June 2019 after receiving a report of labor law violations indicating Green Messenger workers were experiencing wage theft because they were not paid properly and did not receive correct pay statements.

Green Messengers provided delivery services for

The investigation found that from April 2018 to January 2020, delivery drivers were scheduled to work 10-hour workdays and required to finish an Amazon delivery route in those 10 hours using Green Messenger or Amazon vehicles.

Due to the number of deliveries, drivers often had to work through their meal and rest breaks, and were not paid properly for the extra time when they had to work 11 or more hours to complete the route. This resulted in frequent minimum wage, overtime, meal break, rest period and split-shift violations.

The citations total $6,454,110, with $5,304,768 owed to the 718 workers. The amount payable to workers includes $3,377,988 in liquidated damages and waiting time penalties, $762,850 in penalty assessments for not providing proper wage statements, $882,735 for split-shift, meal and rest break premiums, and $281,195 for minimum wage, overtime and contract wages.

Green Messengers and Services are responsible for the amounts due to workers according to California’s client-employer liability law, in effect since 2015. The law holds client-employers that obtain labor from a subcontractor liable for their workplace violations.

The citations issued to Green Messengers Inc. include $1,149,342 in civil penalties payable to the state.

The companies have appealed the citations. Under the appeal procedure, the Labor Commissioner’s Office will hold a hearing before a Hearing Officer who will affirm, modify or dismiss the citations.

DA Files Felony Charges for OSHA Violations in Deadly Injury

The Contra Costa County District Attorney’s Office filed a felony complaint against Segundo Collazos, the owner of Amazon’s Landscaping Company based out of Concord.

The charges relate to the 2018 death of Manuel Peralta, then 68, of Antioch, California, who died while operating a rented tree stump grinder in San Ramon.

According to the OSHA report, Collazos and Peralta were working at the 3700 block of Segovia Court in San Ramon on April 9, 2018. Peralta had a rope tied around him and was tied to a Dosko stump grinder. The owner of the company was operating the stump grinder.

Peralta’s rope became entangled in the cutting wheel of the stump grinder, resulting in his being pulled into the grinder’s cutting wheel killing him.

Collazos, the company owner who had been operating the machine, was fined $54,750 for six workplace violations.

At the time of the incident, Collazos had a suspended license with the Contractors State License Board. The investigation began from the California Department of Industrial Relations’ Division of Occupational Safety & Health Bureau of Investigations.

The first felony alleges that defendant Collazos permitted the victim Manuel Peralta to use a stump grinder in a manner contrary to manufacturer recommendations and to work in the danger zone of the cutting wheel, resulting in his death.

The second felony alleges that Collazos failed to properly train Peralta on the proper and safe use of the stump grinder, also resulting in his death.

“Employers must be made aware that disregarding the requirement to train and supervise workers using dangerous equipment can lead to tragedy and possible jail time,” said Cal OSHA Chief Doug Parker in a statement.

The District Attorney’s Office reminds homeowners to check that a contractor is currently licensed and insured before hiring them for residential construction work. Homeowners can check the validity of a license number on the Contractors’ State Licensing Board website or call (800) 321-CSLB (2752).

Deputy District Attorney Ryan Morris is prosecuting the case on behalf of the People. DDA Morris is assigned to our Office’s Special Operations Division.

Employer COVID Plans Shown in National Survey

More than a third of employers have fielded complaints from workers related to COVID-19, and claims involving the Americans with Disabilities Act have jumped since last summer, according to a survey of employers released by Blank Rome LLP on Wednesday.

Blank Rome’s report, based on a February survey of 130 executives, human resources leaders, and in-house and general counsel, said that 34% of respondents had gotten COVID-19-related complaints. That’s up from 21% in July and just 12% in March 2020, the firm said, adding that ADA claims climbed from 4% in July to 8%.

And while the overwhelming majority of the company leaders – 87% – are in favor of taking the COVID-19 vaccine themselves, only 15% said they would require workers to get the jab. Meanwhile, 39% of respondents said they would not require employees to be vaccinated, and the rest were undecided.

When it comes to asking workers if they have been vaccinated, 41% answered that they plan to do so, though half remained unsure.

When it comes to the potentially risky practice of incentivizing the shots, just 10% of respondents said they would, while 34% said they won’t and the rest had yet to decide, according to the report.

“Employers are waiting to see how it all shakes out,” Susan Bickley, a Blank Rome partner and study co-authors aid, adding that employers might be able to encourage workers to get vaccines without instituting mandates or structured incentive programs. “There’s been some conflicting signals.”

While the report showed a steady rise in complaints from employees, it also showed that nearly three-quarters of them don’t fall into traditional categories for employment claims, such as discrimination, retaliation, and Occupational Safety and Health Administration complaints.

Employers have widely adopted medical screening requirements for on-site workers, which could be a driver of the increasing employee complaints, the report said. The majority of the surveyed employers have increased cleaning, social distancing requirements and associated signage. Roughly 97% require masks, a figure that has risen since the summer.

Three-quarters of employers allow their employees to work from home, and only 28% have three-quarters or more of their employees on site. Most continue to refrain from instituting workplace liability waivers.

Additionally, 78% of employers have faced increased requests for paid time off. And around 40% have seen increased requests for time off under the Family and Medical Leave Act or unpaid leave.

But those requests haven’t had too much of an impact on typical time-off eligibility. Around 60% of the employers haven’t made changes to PTO offerings, and just 6% have given parents of young children more PTO.

In April, more than half of employers had avoided taking employee-related cost-cutting measures, such as layoffs and furloughs. That number has dropped as the pandemic has raged on; now, just 31% have managed to evade those outcomes.

“This was the first survey where employers are feeling somewhat hopeful,” Iley said. “We got some positive comments. People are coming out of the difficult decisions.”

Exclusive Remedy Ends Suit for Employee Suicide

John Coffman, a longtime employee of the California Department of Transportation, died by suicide in 2015.  He began working for Caltrans doing landscape maintenance work in the early 2000s.

Since at least May 1998, Caltrans has had a “zero tolerance” policy for workplace violence, including threats, harassment, verbal abuse, bullying, and intimidation. He began reporting incidents of verbal abuse, intimidation, and threats of physical harm starting in 2002. He documented incidents nearly every year until 2015.

The October 2, 2015 incident caused him to be “extremely stressed out.” The following day, Coffman went to the hospital; his blood pressure was elevated, and he was prescribed medication to “help [him] cope.” He was placed on leave due to emotional distress. He was scheduled to return to work on January 4, 2016, however he committed suicide on December 30, 2015.

His wife and son sued Caltrans and Coffman’s supervisor, Michael Nelson, for wrongful death. They allege that Coffman was bullied, ridiculed, and harassed at work by a number of coworkers and that Caltrans and Nelson failed to prevent those acts, causing Coffman’s death.

Caltrans and Nelson moved for summary judgment on the basis of their affirmative defense that the Coffmans’ claims are barred by workers’ compensation exclusivity. The trial court granted that motion.

The Court of Appeal affirmed the dismissal in the unpublished case of Coffman v. Dept. of Transportation.

The issue was whether the conduct of Nelson and Caltrans fell outside the compensation bargain such that workers’ compensation exclusivity does not bar appellants’ action. Coffmans advance two arguments for why their claims are not barred.

First, they maintain that the conduct of Coffman’s coworkers amounted to harassment, which they assert falls outside the compensation bargain. They further argue that Caltrans and Nelson ratified that conduct by failing to prevent it, such that they may be held liable for it. Second, appellants contend that Caltrans and Nelson’s failure to enforce Caltrans’s workplace violence prevention policy violated a fundamental policy of this state.

Analyzing the incidents individually reveals that the majority of the complained-of conduct by Coffman’s coworkers was within the compensation bargain. The incident in which Flores battered Coffman is an obvious exception, but that incident was investigated, Flores was found to have violated Caltrans’s workplace violence policy, and he was fired. Accordingly, Caltrans and Nelson cannot be said to have ratified that conduct and thus cannot be held liable for it.

Retaliation in violation of the FEHA, which count 2 does allege, likewise is outside the compensation bargain.

How Medicare Rates Overpay Physicians

Medicare reimbursement policies for outpatient services have encouraged physician integration with hospitals, according to a new study and commentary published in Health Services Research.

An article on MedPageToday claims that’s in part because Medicare reimbursement for physician services, on average, would have been $114,000 higher per physician per year for those who were integrated with a hospital, researchers found.

For primary care alone, reimbursement would have been $63,000 higher per physician per year for those who were integrated with a hospital. For medical specialties, the average reimbursement difference was $178,000, and for surgical specialties, it was $150,000.

The reimbursement difference per specialty ranged from $363,000 for urology to $15,000 for psychiatry, according to the study.

These numbers are astonishing,” healthcare technology consultant Dan O’Neill, MA, MS, tweeted. O’Neill is the former senior vice president and general manager of Change Healthcare and a former Robert Wood Johnson Foundation health policy fellow.

The incentives and waste here are just … incredible. As in, incredibly destructive,” O’Neill tweeted. “Just imagine how much worse this is for commercial payers, given the 200% to 400% markups (over Medicare) in hospital outpatient departments.”

Post and colleagues also found a modest association between a higher payment differential and the probability of integrating with a hospital. The effect was larger among primary care physicians and medical specialists, but not statistically significant among surgeons, they found.

Post also tweeted about the potential effects of vertical integration: “While integration is associated with higher prices, current evidence suggests a limited association with quality,” he wrote. “As a result, we’re not crazy about encouraging more of it.”

There are several reasons the study has garnered attention, Michael Chernew, PhD, professor of healthcare policy at Harvard Medical School and author of the study’s corresponding commentary, told MedPage Today.

“There’s an enormous amount of concern about healthcare prices in this country,” Chernew said. And much of the concern about high prices is because of consolidation.

Additionally, there is interest in Medicare spending, he said. One issue that has an impact on that is site-neutral payments.  “This study links them together in a way that is both interesting and policy-relevant,” Chernew said.

Merced Claimant Faces Fraud Charges for False History

Kia Lor, 54, of Merced, was arraigned on four counts of insurance fraud after an investigation by the Department of Insurance found that she allegedly lied about the extent of prior injuries in an attempt to receive nearly $7,000 in undeserved workers’ compensation payments.

On October 5, 2018, Lor, a former Nutrition Assistant at the Merced Community Action Agency, injured her lower back while lifting a cooler at a company picnic.

During the course of treatment, Lor denied any prior injuries to her lower back when completing paperwork and while talking with the workers’ compensation insurance carrier and the Qualified Medical Examiner.

However, during the course of the investigation, it was found that Lor had submitted multiple motor vehicle accident claims between 1999 and 2016 where she suffered injuries to her back.

Additionally, she filed a workers’ compensation claim in 2008 reporting a back injury.

Lor’s misrepresentations about the extent of her prior injuries could have resulted in her being paid $6,960 for permanent disability, but the investigation prevented the payment.

Lor was arraigned at the Merced County Superior Court. This case is being prosecuted by the Merced County District Attorney’s Office.

Employer’s Vendor Has No Duty to Injured Worker

Robert Piontkowski, an employee of Chevron, was seriously injured on the job at the company’s El Segundo refinery when he was splashed with super-heated materials. Plaintiff subsequently received workers’ compensation benefits for the injuries he sustained.

Piontkowski claims he was injured because a pipe that would normally have drained those materials in a different manner was plugged.

Chevron had a services agreement with Veolia Environmental Services, Inc. to hydroblast such pipes at Chevron’s direction. Plaintiff also alleged that a few days prior to the accident, Chevron requested that Veolia unplug the drain line. At the time of the accident, Veolia had not yet reported to unplug the line.

Plaintiff filed this negligence action against Veolia alleging Veolia owed him a duty, as a third-party beneficiary of the services agreement, to timely respond to a request from Chevron to clean the drainpipe at issue and, further, that Veolia’s failure to clean the pipe caused the condition that led to his injury.

The trial court granted Veolia ES Industrial Services, Inc.’s motion for summary judgment, finding as a matter of law that plaintiff could not establish that Veolia owed him a legal duty of care. Plaintiff appealed. Finding no error, the court of appeal affirmed the judgment of the trial court in the unpublished case of Piontkowski v. Veolia ES Industrial Services, Inc.

In considering whether a party has a legal duty in a particular factual situation, a distinction is drawn between claims of liability based upon misfeasance and those based upon nonfeasance.

Misfeasance exists when the defendant is responsible for making the plaintiff’s position worse, i.e., defendant has created a risk. Liability for misfeasance is based on the general duty of ordinary care to prevent others from being injured by one’s conduct.

Conversely, nonfeasance is found when the defendant has failed to aid plaintiff through beneficial intervention. Liability for misfeasance is based on the general duty of ordinary care to prevent others from being injured by one’s conduct. Liability for nonfeasance is limited to situations in which there is a special relationship that creates a duty to act.

The basic idea is often referred to as the “no duty to aid rule,” which remains a fundamental and long-standing rule of tort law. As a rule, one has no duty to come to the aid of another. A person who has not created a peril is not liable in tort merely for failure to take affirmative action to assist or protect another unless there is some relationship between them which gives rise to a duty to act.

The services agreement was not intended to benefit Chevron’s employees nor was it focused on providing a safe work environment for them. Rather, it is plain from the agreement that Veolia’s services were intended to benefit Chevron by keeping its refineries and equipment operating smoothly.

Hawthorne Physician Settles Kickback Case for $215K

A Hawthorne-based physician has settled allegations that he violated the False Claims Act by receiving kickbacks and other improper payments in exchange for referring patients to Memorial Hospital of Gardena.

Dr. Ashok Kumar paid $215,228 on March 1 to settle the allegations brought against him in a whistleblower lawsuit that Memorial Hospital of Gardena provided compensation to Kumar, whom they hired as a medical director, that both exceeded the fair market value of his services and was an attempt to incentivize him to refer patients to their hospital.

The lawsuit alleged that Kumar violated the federal Anti-Kickback Statute as well as the Physician Self-Referral Law. The Anti-Kickback Statute imposes civil liability on those who willingly offer, solicit, receive or pay any sort of compensation in exchange for the referral of services provided by a federal health care program, including Medicare. The Physician Self-Referral Law, commonly known as the Stark Law, bans doctors from referring patients to receive designated health care services payable by Medicare or Medicaid from entities with which the doctor or an immediate family member has a financial relationship.

The settlement resolves allegations originally brought in a lawsuit by Dr. Joshua Luke, the former chief executive officer of Memorial Hospital of Gardena, against Kumar and other defendants under the whistleblower provisions of both the federal and California False Claims acts. Both statutes permit private parties to sue on behalf of the state and federal governments for false claims for government funds, and to receive a share of any recovery.

Dr. Luke will receive $42,529 from the federal government as his share of the recovery announced today. His allegations against the other defendants were resolved in 2018 when they agreed to pay the federal government an $8.1 million settlement. The allegations brought on behalf of the State of California have been resolved pursuant to a separate agreement.

This case was handled by Assistant United States Attorney Frank D. Kortum of the Civil Fraud Section, who worked closely with the U.S. Department of Health and Human Services – Office of Inspector General. Tips and complaints from all sources about potential fraud, waste, abuse and mismanagement can be reported to the Department of Health and Human Services, at 800-HHS-TIPS (800-447-8477).

The case is United States of America ex rel. Luke, State of California ex rel. Luke v. Gardena Hospital, L.P. DBA Memorial Hospital of Gardena, Avanti Hospitals, LLC, et al., CV 15-8732-MCS.