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Trilogy of WCAB Decisions Find Valley Fever Presumptively AOE-COE

Coccidioidomycosis, commonly known as Valley Fever, is a fungal infection caused by the fungus Coccidioides. It primarily affects the lungs but can also spread to other parts of the body, such as the bones, skin, and central nervous system.

Coccidioides fungi are found in soil in certain arid and semiarid regions, particularly in the southwestern United States, Mexico, and parts of Central and South America. When the soil is disturbed, such as through construction, farming, or wind, the fungal spores can become airborne and be inhaled by humans and animals.

Ernest Sanchez was a correctional officer for the State of California. He filed a claim for injury to the respiratory system and musculoskeletal system in the form of coccidioidomycosis. The WCJ issued a Findings and Order of March 30, 2021 finding that he did not sustain the injury as alleged.

The WCAB granted reconsideration, rescinded the WCJ’s decision, and return this matter to the trial level for further development of the medical record and analysis in order for the parties, the reporting physician(s), and the WCJ to consider the applicability of Labor Code section 3212.10 in the panel decision of Sanchez-I v State of California – ADJ12021219 (June 2021).

After further proceedings, the WCJ again issued another Findings and Order on March 3, 2023 finding that the valley fever was again not industrial. And again the WCAB panel granted reconsideration, rescinded the WCJ’s decision and issued a new decision reflecting that applicant sustained presumptive industrial injury in the form of coccidioidomycosis in Sanchez-II v State of California ADJ12021219 (May 2023)

The panel cited Labor Code section 3212.10 as authority for this decision which states: “In the case of a peace officer of the Department of Corrections who has custodial or supervisory duties of inmates or parolees … the term “injury” as used in this division includes … pneumonia, … that develops or manifests itself during a period in which any peace officer covered under this section is in the service of the department or unit.” And that “the … pneumonia … so developing or manifesting itself shall be presumed to arise out of and in the course of employment.

The panel then cited Lee v. State of California (2017) 2017 Cal. Wrk. Comp. P.D. LEXIS 543 [Appeals Bd. panel]; and Thomas v. State of California (2021) 2021 Cal. Wrk. Comp. P.D. LEXIS 62 [Appeals Bd. panel]),as “previous cases in which valley fever has been found to constitute pneumonia.”

In Lee v State of California the panel noted that “The statutory language in section 3212.10 does not identify or designate a specific type of pneumonia nor does it limit the applicability of the presumption to a specific type of pneumonia. If the Legislature had intended to limit the presumption, it would have done so.”

It then quoted from the AME report from AME Gerald Markovitz, M.D. that stated “”Mr. Lee presented today for AME evaluation in the field of internal medicine. He developed a case of primary pulmonary coccidiomycosis [coccidioidomycosis] (Valley Fever). There is a Presumption for pneumonias in Correctional Officers and he developed a pneumonia, so there is no reason to deny industrial responsibility for his Valley Fever.” From this reporting the panel commenced this trilogy of cases equating valley fever as within the definition of “pneumonia” for purposes of the presumption in Labor Code 3212.10 .

In Thomas v State of California, the second case of the trilogy, PQME Paul J. Grodan, M.D., testified that valley fever constitutes pneumonia. “Therefore, applicant had pneumonia that developed or manifested itself during his service in a custodial role at CDCR. The burden thus shifted to defendant to show that applicant did not develop industrial pneumonia.”

Turning then to Sanchez II v State of California, the third case in the trilogy, after citing Lee and Thomas as authority for application of the “pneumonia” presumption in valley fever cases, the panel noted that the burden of proof shifted to the employer.

The record was developed with two short supplemental reports from qualified medical evaluator Jeffery M. Freesemann, M.D. “However, Dr. Freesemann never states, let alone provides substantial medical evidence, that applicant’s valley fever was probably not contracted at work. Rather, he states that the cause of the injury is “impossible to determine.” Defendant thus did not meet its burden of overcoming the statutory presumption.”

DHS Ends Form I-9 Requirement Flexibility on July 31, 2023

In 1986, Congress reformed U.S. immigration laws by passing the Immigration Reform and Control Act of 1986 (IRCA). IRCA prompted the creation of the Form I-9, Employment Eligibility Verification, which was designated as the means of documenting that the employer verified an employee’s identity and U.S. employment authorization.

Since the Form I-9 became a requirement for all U.S. employers hiring new employees, one key rule has remained unchanged. Within three business days after the first day of employment employers must “physically examine” the documentation presented by new employees from the Lists of Acceptable Documents to ensure that the presented documentation appears to be genuine and to relate to the individual who presents them.

In March 2020, ICE announced that it would defer the requirement that employers review employees’ identity and employment authorization documents in the employees’ physical presence, instead allowing that to occur remotely, with the expectation that physical inspection would occur within three business days after normal operations resumed.

In follow-on guidance, ICE noted that employers could continue to implement the flexibilities until affected employees undertake non-remote employment on a regular, consistent, or predictable basis, or the extension of the flexibilities related to such requirements is terminated, whichever is earlier.

In October 2022, DHS and ICE announced that the flexibilities would be extended until July 31, 2023.  

However, on May 4, 2023 the U.S. Department of Homeland Security (DHS) and U.S. Immigration and Customs Enforcement (ICE) announced that employers will have 30 days to reach compliance with Form I-9 requirements after the COVID-19 flexibilities sunset on July 31, 2023.

As noted in the March 2020 announcement, under the flexibilities, employers with employees taking physical proximity precautions due to the COVID-19 pandemic were allowed to temporarily defer physical examination of employees’ identity and employment authorization documents. Instead, employers could examine the employees’ documents remotely (e.g., over video link, fax, or email) and enter “COVID-19” as the reason for the physical examination delay in the Section 2 Additional Information field when physical examination took place in the future.

Once the employees’ documents were physically examined, the employer would add “documents physically examined” with the date of examination to Section 2 Additional Information field on the Form I-9, or in Section 3, as appropriate.

However, on Aug. 18, 2022, DHS issued a proposed rule that would allow alternative procedures for the examination of identity and employment eligibility documents. The public comment period closed on Oct. 17, 2022. DHS is currently reviewing public comments and plans to issue a final rule later this year.

This proposed rule would create a framework under which the Secretary of Homeland Security could authorize alternative options for document examination procedures with respect to some or all employers.

Such procedures could be implemented as part of a pilot program, or upon the Secretary’s determination that such procedures offer an equivalent level of security, or as a temporary measure to address a public health emergency declared by the Secretary of Health and Human Services pursuant to Section 319 of the Public Health Service Act, or a national emergency declared by the President pursuant to Sections 201 and 301 of the National Emergencies Act.

This proposed rule would allow employers (or agents acting on an employer’s behalf) optional alternatives for examining the documentation presented by individuals seeking to establish identity and employment authorization for purposes of completing the Form I-9.

4th Largest Drug Distributor Suspended From Controlled Substance Sales

Morris & Dickson Co., LLC is a pharmaceutical wholesaler based in Shreveport, Louisiana. It is one of the largest privately held wholesale drug distributors in the country. The company was founded in 1841 by Alexander Dickson and William Morris, and it has been in continuous operation for over 180 years.

It has since become the nation’s fourth-largest wholesale drug distributor, with $4 billion a year in revenue and nearly 600 employees serving pharmacies and hospitals in 29 states.

In October 2017, DEA became aware of the high-volume sales of Oxycodone and Hydrocodone from Morris and Dickson Company to five of the top ten purchasing pharmacies within the state of Louisiana. DEA records indicated that Morris and Dickson Company had not filed any suspicious order reports on any of the pharmacies in question in Louisiana.

A review of the purchases made by these high-volume independent pharmacies showed that these pharmacies were purchasing quantities which were not indicative of the pharmaceutical market. Not only were numerous “independent” retail pharmacies purchasing more Oxycodone and Hydrocodone than the largest chain pharmacies operating within the state, they were purchasing more narcotics than several of the largest chain pharmacies combined within the same zip code. In some instances, DEA noted these “independent” pharmacies were purchasing more than ten times the amount of narcotics the average Louisiana pharmacy purchased per month.

While Morris & Dickson wasn’t the only drug distributor who the DEA accused of fueling the opioid crisis, it was unique in its willingness to challenge those accusations in the DEA’s administrative court. In a scathing recommendation in 2019, Administrative Law Judge Charles W. Dorman said Morris & Dickson’s argument that it has changed its ways was too little, too late.

This month DEA announced it has suspended the DEA Certificate of Registration as a drug distributor pursuant to Title 21, United States Code, Sections 823 and 824. The DEA’s investigation of Morris and Dickson Company determined that the continued registration of this company constitutes a substantial likelihood of imminent danger to public health and safety. This action only applies to the distribution of controlled substances and will not affect non-controlled pharmaceutical drugs distributed by the company.

Morris and Dickson Company received written notice of the factual and legal basis for this action. In addition, they will be given the opportunity for an administrative hearing within the next 60 days. After the hearing, the DEA Acting Administrator will make a final decision on whether Morris and Dickson Company’s registration should be permanently revoked.

DEA Administrator Anne Milgram said in the 68-page order that Morris & Dickson failed to accept full responsibility for its past actions. Milgram specifically cited testimony of then-president Paul Dickson Sr. in 2019 that the company’s compliance program was “dang good” and he didn’t think a “single person has gotten hurt by (their) drugs.”

Those statements from the president of a family-owned and operated company so strongly miss the point of the requirements of a DEA registrant,” she wrote. “Its acceptance of responsibility did not prove that it or its principals understand the full extent of their wrongdoing … and the potential harm it caused.”

In a statement, the company said it has invested millions of dollars over the past few years to revamp its compliance systems and appeared to hold out hope for a settlement.

“Morris & Dickson is grateful to the DEA administrator for delaying the effective date of the order to allow time to settle these old issues,” it said. “We remain confident we can achieve an outcome that safeguards the supply chain for all of our healthcare partners and the communities they serve.”

The DEA has been highly criticized in the delay it has taken to conclude this investigation.

AI Used to Discover New Antibiotic for Deadly Superbug

Scientists used artificial intelligence to identify a new antibiotic that might be useful to fight a deadly drug-resistant bacteria commonly found in hospitals and medical offices. The study has just been published in the journal Nature Chemical Biology. The newly discovered drug – Abaucin is a narrow-spectrum antibiotic that is effective against Acinetobacter baumannii, a superbug that is resistant to many antibiotics. Abaucin works by inhibiting the transport of lipoproteins, which are essential for the growth and survival of bacteria. It has now also been shown to be safe in animal studies

Abaucin was developed by a team of researchers led by James J. Collins at the MIT Jameel Clinic and Jonathan Stokes at McMaster University. The team used an artificial intelligence algorithm to screen thousands of compounds for potential antibiotic activity. Abaucin was one of the compounds that was identified by the algorithm.

Abaucin works by inhibiting lipoprotein transport, which is essential for bacterial growth. It is a narrow-spectrum antibiotic, which means that it is only effective against a few types of bacteria. This makes it less likely to cause resistance to develop. Abaucin is still in the early stages of development, but it has the potential to be a valuable new tool for treating infections caused by Acinetobacter baumannii.

There’s a lot of trepidation around AI and I genuinely understand it,” said Jonathan Stokes, lead author on the paper and an assistant professor of biomedicine and biochemistry at at McMaster University in Ontario, Canada. “When I think about AI in general, I think of these models as things that are just going to help us do the thing we’re going to do better.

According to a report by USA Today, Stokes teamed up with researchers from the Broad Institute of MIT and Harvard to screen for potential antibiotics to use on Acinetobacter baumannii, a superbug that can cause infections in the blood, urinary tract and lungs. This bacteria usually invades hospitals and healthcare settings, infecting vulnerable patients on breathing machines, in intensive care units and undergoing operations.

This type of bacteria, resistant to the potent antibiotic carbapenem, infected 8,500 in hospitals and killed 700 in 2017, according to the Centers for Disease Control and Prevention.

Stokes said the lab team developed AI models to predict which ones would have the highest likelihood of antimicrobial activity, narrowing the field to 240 drugs or active ingredients. Researchers then narrowed the field again through testing before discovering a molecule RS102895, renamed abaucin, that appeared to be potent against the superbug.

“It’s important to remember right when we’re trying to develop a drug, it doesn’t just have to kill the bacterium,” Stokes said. “It also has to be well tolerated in humans and it has to get to the infection site and stay at the infection site long enough to elicit an effect.”

Researchers said they can screen a much larger volume of potential drugs by using machine-learning techniques. The study said while existing high-throughput screening can evaluate a few million drugs or chemical ingredients at once, algorithms developed from machine learning can assess “hundreds of millions to billions” of drug molecules.

There are other examples of AI being used to develop new drugs:

– –  Exscientia is a pharmaceutical company that uses AI to design new drugs. The company has developed several drugs that are now in clinical trials, including a drug for Alzheimer’s disease and a drug for cancer.
– –  Insilico Medicine is another pharmaceutical company that uses AI to develop new drugs. The company has developed several drugs that are now in preclinical trials, including a drug for Parkinson’s disease and a drug for HIV.
– –  Atomwise is a company that uses AI to design new drugs for infectious diseases. It has developed several drugs that are now in preclinical trials, including a drug for malaria and a drug for tuberculosis.
– –  BenevolentAI is a company that uses AI to develop new drugs for rare diseases. It has developed several drugs that are also now in preclinical trials, including a drug for Duchenne muscular dystrophy and a drug for cystic fibrosis.

These are just a few examples of the many companies that are using AI to develop new drugs. AI has the potential to revolutionize the drug discovery process, and it could help to develop new treatments for a wide range of diseases.

California Supreme Court Expands Employee Whistleblower Protections

A.C.R. worked as a bartender at Kolla’s, Inc., a nightclub in Orange County. In 2014, A.C.R. complained to Gonzalo Estrada that she had not been paid wages owed for her previous three shifts of work. Estrada responded by threatening to report A.C.R. to immigration authorities, terminating her employment, and telling her never to return to the club.

In June 2014, A.C.R. filed a complaint against Estrada and Kolla’s with Department of Labor Relations, Division of Labor Standards Enforcement (DLSE), which opened an investigation.

After determining that Estrada’s immigration-based threats and termination of A.C.R. violated California law, DLSE notified Estrada and Kolla’s of proposed remedies, including payment of lost wages to A.C.R., reinstatement of A.C.R.’s previous position, and payment of civil penalties to A.C.R. and DLSE. After Estrada and Kolla’s declined to accept DLSE’s proposed remedies, the Labor Commissioner sued them for violations of the Labor Code, including retaliation in violation of section 1102.5(b).

The trial court entered an order granting in part the Labor Commissioner’s application for default judgment but ruled against the Labor Commissioner on the section 1102.5(b) claim. The court held that the Labor Commissioner did not state a valid cause of action under section 1102.5(b) because A.C.R. reported her complaints to her employer rather than a government agency. The Labor Commissioner appealed.

The Court of Appeal held that the trial court had relied on an outdated version of section 1102.5(b) and that the current version of the law protects disclosures made to one’s employer. The Court of Appeal nonetheless affirmed the trial court’s judgment on the section 1102.5(b) claim, concluding that a private employee’s report of unlawful activity directly to his or her wrongdoing employer is not a protected disclosure under section 1102.5(b).

The Court of Appeal explained that Estrada, as the owner of the nightclub, “was at least aware of – if not responsible for – the non-payment of wages” and that an ” ’employee’s report to the employee’s supervisor about the supervisor’s own wrongdoing is not a “disclosure” and is not protected whistleblowing activity, because the employer already knows about his or her wrongdoing.’ ”

The California Supreme Court reversed and remanded, and held that a protected disclosure under section 1102.5(b) encompasses reports or complaints of a violation made to an employer or agency even if the recipient already knows of the violation. It further concluded that complainant A.C.R. made a disclosure protected by section 1102.5(b) in the case of P. ex rel. Garcia-Brower v. Kolla’s, Inc. – S269456. (May 2023).

The Legislature enacted section 1102.5 in 1984 to provide whistleblowers with protection from employer retaliation. In 2003, in the wake of a “recent spate of false business reports and other illegal activity by Enron, WorldCom and others,” the Legislature amended section 1102.5(b) to include several additional employee protections.

In 2013, the Legislature again amended section 1102.5(b), expanding its protections to include an employee’s disclosure made “to a person with authority over the employee or another employee who has the authority to investigate, discover, or correct the violation or noncompliance.”

The Supreme Court has repeatedly held that section 1102.5(b) “reflects the broad public policy interest in encouraging workplace whistle-blowers to report unlawful acts without fearing retaliation.” (Green v. Ralee Engineering Co. (1998) 19 Cal.4th 66, 77 (Green); Lawson v. PPG Architectural Finishes, Inc. (2022) 12 Cal.5th 703, 709 (Lawson); Soukup v. Law Offices of Herbert Hafif (2006) 39 Cal.4th 260, 287.)

It is undisputed that the employer’s conduct was prohibited by the Labor Code. The question here is whether a report of unlawful activities made to an employer or agency that already knew about the violation was a protected “disclosure” within the meaning of section 1102.5(b).

The Supreme Court concluded that it was, noting that “Applying the Court of Appeal’s reasoning here would result in outcomes contrary to the Legislature’s purpose.”

And it disapproved Mize-Kurzman v. Marin Community College Dist., 202 Cal.App.4th 832 to the extent it is inconsistent with its opinion. Mize-Kurzman rested on federal precedent subsequently abrogated by Congress. In 2012, Congress passed the Whistleblower Protection Enhancement Act of 2012 (WPEA) (Pub.L. No. 112-199 (Nov. 27, 2012) 126 Stat. 1465), an update to the Whistleblower Protection Act (WPA), that “clarif[ied] the broad meaning” of disclosure to correct Federal Circuit precedent that had “wrongly accorded a narrow definition to the type of disclosure that qualifies for whistleblower protection.”

NSC Publishes Research on Improving Workplace Safety with Robotics

A new report by the National Safety Council builds on the Work to Zero Safety Innovation Journey to help organizations assess risks, identify technology solutions and ready workplaces for implementation.

Specifically, this white paper, which analyzes academic journals, vendor interviews and company case studies, evaluates the benefits of robotics and autonomous mobile robots, or AMRs, on reducing injuries and fatalities in the workplace. It also outlines best practices employers can follow to implement robotic technology across a range of workplaces.

For this white paper, Work to Zero identified the five most common robot configurations available to employers – AMRs, Automated Guided Vehicles or AGVs, Articulated Robots, Humanoid Robots and Cobots – to assess their key benefits and applications. In addition to concluding this technology can be ideal for manufacturing applications, where repetitive, high-volume production is necessary, the report identified several other examples in which employers can use robots to create safer outcomes for their workers, including:

– – Inspecting confined spaces and industrial facilities. Organizations in the construction, mining and logging industries may especially benefit from using wheeled AMRs to remove human workers from on-site hazards.
– – Transporting parts, goods and materials. Used alongside sensors and computer vision, AMRs and AGVs can minimize the risk of human-machine collisions.
– – Using robotic arms for precision cutting and welding, as well as the safe handling of toxic, high-temperature or explosive materials.
– – Machine tending and parts repositioning by using robotic arms and AMRs to reduce risks associated with manual machine handling.

Work to Zero also found adopting robotic technology can help employers mitigate the risk of workplace musculoskeletal disorders, prevent falls from heights and reduce worker muscle fatigue. However, several barriers to widespread robot adoption exist.

While recent advancements have reduced the price and increased the viability of robotics for common industrial applications, costs of implementation and ongoing maintenance may still be prohibitive for smaller industrial operations.

Additionally, Work to Zero found AVG and AMR configurations may be disruptive to some work environments or need to be coupled with additional safety technologies to effectively mitigate risk. This underscores that, despite the many benefits, employers must tailor their robotic technology to meet their unique safety needs and drive the return on investment.

There is also an enduring concern that robotics or other technology may eventually replace human workers, but the report noted that, in addition to robotics having the potential to improve efficiency and safety, increased automation may help businesses reduce costs overall, which can lead to increased investments and the creation of new jobs in other areas, especially in engineering, maintenance and programming.

Ultimately, this white paper found the importance in having a proactive approach to addressing the potential consequences of automation, such as retraining and reskilling programs for displaced workers, and ensuring the benefits of automation are shared equitably across organizations.

Santa Clara Jury Awards $2M to Deaf Package Handler for Discrimination

Late Friday, a Santa Clara County jury awarded $2 million to Younes Mchaar, a deaf, low-wage, former FedEx Ground part-time package handler who was repeatedly denied reasonable accommodations and the interactive process at the company’s San Jose facility.

The jury verdict also found that FedEx failed to prevent this discrimination against him despite FedEx Ground having previously been sued by the U.S. Equal Employment Opportunity Commission (EEOC) on behalf of deaf package handlers nationwide.

According to a press release by his attorneys, Mr. Mchaar, who has been deaf since birth, began working at FedEx Ground in 2011 as a part-time package handler in Virginia.

Mchaar alleged in his lawsuit, filed in 2020, that after FedEx in Virginia denied him promotions and proper interpretive services from 2011 to 2017, he moved to the San Jose position – anxious, stressed and frustrated but seeking a better workplace and higher pay.

Mr. Mchaar transferred to the company’s San Jose, California facility in April 2017, anticipating reasonable accommodations to assist in routine communications. But it took until December 2017 for the company to arrange a meeting with him about reasonable accommodations.

At that point, FedEx agreed to provide American Sign Language (ASL) interpreters for all safety meetings and Video Remote Interpreting VRI for daily meetings. Nonetheless, the ASL interpreters were often not present at safety meetings, and the VRI did not even arrive at the facility until June 2018 – after which, it was glitchy.

He also discovered that just as in Virginia, “FedEx promoted and assigned important projects to less-qualified, non-deaf employees,” according to his lawsuit.

After Mr. Mchaar vigorously complained about denied reasonable accommodations, he was written up 10 times in 2 ½ months and proposed for termination, at which point he resigned.

According Mercury News, FedEx said in an emailed statement Tuesday that it disagreed with the verdict and was reviewing its options for an appeal. The firm said it “remains committed to the fair and equal treatment of all team members, including our employees who are deaf and hard of hearing, for whom we strive to provide every opportunity for success.”

Throughout Mchaar’s employment in San Jose, the package-delivery titan had been fighting the U.S. Equal Employment Opportunity Commission in federal court over its treatment of deaf package handlers.

“Shipping giant FedEx Ground Package System, Inc., (FedEx Ground) violated federal law nationwide by discriminating against a large class of deaf and hard-of-hearing package handlers and job applicants for years”, the U.S. Equal Employment Opportunity Commission (EEOC) charged in a lawsuit it announced.

The EEOC says that FedEx Ground failed to provide needed accommodations such as American Sign Language (ASL) interpretation and closed-captioned training videos during the mandatory initial tour of the facilities and new-hire orientation for deaf and hard-of-hearing applicants. The shipping company also failed to provide such accommodations during staff, performance, and safety meetings. Package handlers physically load and unload packages from delivery vehicles, place and reposition packages in FedEx Ground’s conveyor systems, and scan, sort and route packages.  

The EEOC charges that, in addition to failing to provide communications-based accommodations for mandatory meetings, FedEx Ground refused to provide needed equipment substitutions and modifications for deaf and hard-of-hearing package handlers, such as providing scanners that vibrate instead of beep and installing flashing safety lights on moving equipment.  

The EEOC, after a nationwide investigation, sued FedEx in 2014 (No. 2:15-cv-00256 (W.D. Pa. May 18, 2020) ) under the Americans with Disabilities Act. The agency alleged the company failed to provide reasonable accommodations for deaf and hard-of-hearing package handlers that would let them perform essential job functions, communicate with managers, and participate in meetings. The agency further alleged that FedEx failed to provide flashing lights for safety on motorized moving equipment.

In 2020, to resolve the nationwide lawsuit, FedEx agreed to pay $3.3 million to up to 229 people, and agreed in a consent decree to provide deaf and hard-of-hearing package handlers with live and video American Sign Language interpreting, and scanning equipment with non-audible cues, such as vibration. The company also agreed to put warning lights on motorized equipment such as forklifts.

The company said Tuesday it has fully complied with the terms of the EEOC settlement agreement, which enabled the deal to expire in May 2022.

The lawsuit is Santa County Superior Court Case No. 20CV366270.

AI Device Restores Function so Paralyzed Patient Can Walk

Grégoire Courtine, a French-born neuroscientist at École Polytechnique Fédérale de Lausanne in Switzerland, is the International Paraplegic Foundation chair in spinal cord repair at the Center for Neuroprosthetics and the Brain Mind Institute at the Swiss Federal Institute of Technology in Lausanne.

Courtine and Jocelyne Bloch of HBP partners EPFL and CHUV have created a device that allows patients with total spinal cord injuries to stand, walk, and even participate in recreational activities such as swimming, cycling, and canoeing. The device is called a “digital bridge.”

The “digital bridge” device is a breakthrough study that could represent a quantum leap in the treatment of certain brain and central nervous system injuries. The device uses artificial intelligence to decode brain signals that enable the patient to move around independently.

“When there’s a spinal cord injury, the brain is disconnected from the spinal cord, so the communication is interrupted,” said Courtine during a press call Tuesday. “And what we’ve been able to do here is to reestablish the communication between the brain and the region spinal cord that controls leg movement with a digital bridge.”

That so-called “digital bridge” can effectively turn thought into actions – or, as Courtine put it, it can “capture thoughts” and translate them into a stimulation of the spinal cord.

According to the study published in the Journal Nature, the experimental treatment has been tried just once. Gert-Jan Oskan is a 40-year-old Dutch man who suffered a spinal cord injury in a bicycle accident. For nearly 12 years, he was unable to walk, step or stand. Courtine’s team implanted two devices, one into Oskan’s brain, and another into his spinal cord. The two devices communicate wirelessly, hence the digital bridge, or as the paper calls it, the “brain-spine interface,” or BSI.

Now, Oskan, whom Courtine calls the first “test pilot” of the newly invented system, has regained function in his knees, hips and ankle joints. He can walk – slowly, with the help of crutches – for about 300 to 600 feet. He can stand, with support from his hands, for two to three minutes at a time. He can even climb a few stairs.

Perhaps most remarkably, the treatment appears to work even after the system is shut off.

The implant has been life-changing, says Oskam. “Last week, there was something that needed to be painted and there was nobody to help me. So I took the walker and the paint, and I did it myself while I was standing,” he says.

When Oskam thinks about walking, the skull implants detect electrical activity in the cortex, the outer layer of the brain. This signal is wirelessly transmitted and decoded by a computer that Oskam wears in a backpack, which then transmits the information to the spinal pulse generator.

After around 40 rehabilitation sessions using the brain-spine interface, Oskam had regained the ability to voluntarily move his legs and feet. That type of voluntary movement was not possible after spinal stimulation alone, and suggests that the training sessions with the new device prompted further recovery in nerve cells that were not completely severed during his injury. Oskam can also walk short distances without the device if he uses crutches.

Bruce Harland, a neuroscientist at the University of Auckland in New Zealand, says that this continued improvement in spinal function is great news for anyone with a spinal-cord injury, “because even if it’s a longer-term chronic injury, there’s still a few different ways that healing could happen”.

“It’s certainly a huge jump” towards improved function for people with spinal-cord injuries, says neuroscientist Anna Leonard at the University of Adelaide in Australia. And, she says, there is still room for other interventions – such as stem cells – to improve outcomes further. She adds that although the brain-spine interface restores walking, other functions such as bladder and bowel control are not targeted by the device. “So, there’s certainly still room for other areas of research that could help progress improvements in outcomes for these other sort of realms,” she says.

Antonio Lauto, a biomedical engineer at Western Sydney University, Australia, says that less-invasive devices would be ideal. One of Oskam’s skull implants was removed after about five months because of an infection. Nevertheless, Jocelyne Bloch, the neurosurgeon at the Swiss Federal Institute of Technology who implanted the device, says that the risks involved are small compared with the benefits. “There is always a bit of risk of infections or risk of haemorrhage, but they are so small that it’s worth the risk,” she says.

Courtine’s team is currently recruiting three people to see whether a similar device can restore arm movements.

CWCI Studies Low-Volume – But High-Cost Driver Drugs

Part II of a California Workers’ Compensation Institute research series on low-volume/high-cost drugs used to treat California injured workers identifies three Dermatological drugs, three Opioids, and three Antidepressants that represent a relatively small share of the prescriptions within their therapeutic drug group, but due to high average reimbursements, have become cost drivers, consuming a disproportionate share of the payments.

The report reveals that Dermatologicals were the fourth most prevalent drug category in 2021, with 9.3% of the workers’ comp prescriptions, but ranked second (behind Anti-Inflammatories) in total drug spend, consuming 17.3% of all prescription drug payments. That was up from 12.8% in 2012, which the study ascribes to increased utilization and the emergence of high-priced topical analgesics. Diclofenac sodium topicals jumped from 0.5% of all workers’ comp prescriptions in 2012 to 5.4% in 2021 – fourth among all drugs dispensed that year, and they represented 58.1% of the 2021 Dermatological prescriptions, but with inexpensive generics widely available, their average reimbursement was a relatively low $65, so they consumed only 23.5% of the Dermatological dollars. In contrast, the study notes three other low-volume/high-priced drugs that have become Dermatological cost drivers:

– – Diclofenac sodium and adhesive sheets (dispensed as Xrylix kits, in 2021 these kits accounted for just 0.3% of the Dermatological prescriptions, but with an average payment of $4,126, they consumed 7.2% of the dermatological drug spend).
– – Lidocaine/menthol (this drug was dispensed in various forms, but NuLido gel and Terocin patches were key cost drivers. Lidocaine/menthol represented only 1% of the Dermatologicals dispensed in 2021, but at an average of $1,050 per prescription, it accounted for 6.2% of the Dermatological payments.
– – Diclofenac epolamine (dispensed as Flector patches at an average of $570 per prescription, or as generic equivalents at an average of $577, diclofenac epolamine comprised just 1.7% of the 2021 Dermatological prescriptions, but 5.9% of the payments within the group).

Opioid use in workers’ comp has been falling for more than a decade and with the adoption of Opioid and Pain Management Treatment Guidelines in late 2017 and a Formulary in 2018, Opioids’ share of the prescriptions continued to drop, falling to 9.4% in 2021 (down from 29.4% in 2012), while their share of the total drug spend fell to 5.8% (down from 26.7% a decade earlier). At the same time, the mix of Opioids used to treat injured workers shifted. The study noted three low-volume/high-priced Opioids that have become cost drivers within their group:

– – Buprenorphine, typically used to treat Opioid Use Disorder for patients in Medication-Assisted Treatment plans, in 2021, it accounted for 5.2% of the workers’ comp Opioids, and with an average payment of $363, it consumed 35.4% of the total Opioid reimbursements – more than any other Opioid.
– – Tapentadol HCl, used when other pain medications do not work well or cannot be tolerated, but only available as a brand drug (Nucynta or Nucynta Extended Release) it represented just 0.6% of the Opioid prescriptions, but at $590 per prescription, it accounted for 6.4% of the total Opioid drug spend.
– – Oxycodone, prescribed for moderate to severe pain, is available in a variety of generic and brand formulations, including extended-release and abuse-deterrent varieties. In 2021, 5.9% of Opioid prescriptions were for oxycodone, and at $145 per prescription, it consumed 16.0% of all Opioid payments.

The top four Antidepressants dispensed to injured workers in 2021 represented nearly 2/3 of the Antidepressants used, but all four were relatively low-cost drugs, so they accounted for only 42.5% of the payments in this drug group. In contrast, the study identified three low-volume/high-priced drugs that consumed a disproportionate share of the Antidepressant drug spend:

– – Vortioxetine HBr, used to treat Major Depressive Disorder, remains under patent and is only available as brand-name Trintellex. Available in 5, 10, and 20 mg tablets, this drug carries a black box warning noting an increased risk of suicidal thoughts and behaviors. In 2021, only 1.0% of the Antidepressant prescriptions in California workers’ compensation were for Vortioxetine HBr, but with an average reimbursement of $476, this drug comprised 12.4% of all Antidepressant payments.
– – Desvenlafaxine, an extended-release tablet that comes in various strengths, is used to treat major depression. It is available as a brand drug (Khedezla, Pristiq), with average payments as high as $642 per prescription, but since the introduction of generic versions in 2017, brand versions have declined to 14 to 15% of the prescriptions. Payments for generic desvenlafaxine averaged $58 to $66 from 2019 to 2021, which helped drive down the average reimbursement for this drug. In 2021, desvenlafaxine represented 1.0% of workers’ comp Antidepressants, but the average payment was still $131, so it accounted for 3.5% of the Antidepressant payments.
– – Bupropion HCl is used to treat depression, anxiety, and other mood disorders, and to aid smoking cessation. Available as a brand drug (Wellbutrin, including an extended-release version that tends to be very expensive), or in generic versions, which accounted for 98% of the Bupropion HCl dispensed to injured workers in 2021. Unlike generics, where the average payment declined from $121 in 2012 to $25 in 2021, over that same decade average reimbursements for brand versions of bupropion HCl increased nearly 10-fold from $267 to $2,614. The dominance of generic buproprion HCl has helped contain the total payments for this drug, but the 2% of the prescriptions dispensed as high-cost brand drugs drove the average payment up to $77 in 2021 — more than three times the $25 average paid for generics. As a result, bupropion HCl, which accounted for 7.6% of the Antidepressant prescriptions in 2021, consumed 16.3% of the Antidepressant payments.

CWCI has published more details and analyses on these drugs in a Spotlight Report, Cost-Driver Medications in the Top California Workers’ Comp Therapeutic Drug Groups: Part II, Dermatologicals, Opioids, and Antidepressants. Institute members and subscribers can log on to www.cwci.org and access the report under the Research tab, others can purchase a copy from the CWCI’s online store. Part III of CWCI’s research on low-volume/high-cost medications will focus on medications found in the Musculoskeletal and Ulcer drug categories.

Sunnyvale Company Announces AI Underwriting for Work Comp

Mulberri is a software company that provides a cloud-based platform for small and medium-sized businesses (SMBs) to purchase and manage insurance.The company was founded in 2016 by Hamesh Chawla and is headquartered in Sunnyvale, California.

Mulberri’s platform uses artificial intelligence (AI) to automate the insurance buying process, making it easier and faster for SMBs to find the right coverage at the best price. The company’s customers include businesses in a variety of industries, including retail, healthcare, and technology.

Mulberri just announced the launch of its Risk Engine, a first of its kind risk assessment offering for workers compensation underwriters. The Risk Engine, which is already being deployed by customers like Paychex’s PEO department, uses machine learning models to put the information underwriters need at their fingertips, making it possible to make fast, accurate decisions.

Workers’ comp is a multi-billion-dollar market, but most existing underwriting processes have not taken full advantage of the power of data, especially AI. Mulberri designed its Risk Engine to meet the needs of underwriters and their customers, extending Mulberri’s existing portfolio of insurance products for payroll businesses, HR providers, brokers and small-medium businesses.

“Our mission from day one has been to leverage technology to complement underwriters’ judgment so that the business insurance process can be simple, efficient, and transparent,” said Hamesh Chawla, CEO and cofounder of Mulberri. “The Risk Engine is a transformative step forward.”

Mulberri trained its Risk Engine to determine factors that impact claims based on millions of pieces of information including firmographic information, previous loss experience and workers compensation information. The cloud-based product allows intuitive access to predictions on demand from any SaaS application as well as easy deployment. It also enables users to analyze and score prospects one at a time or in bulk. All data is obfuscated, so PII remains safe.

It allows underwriters to make predictions for:

– – Claim Propensity – Likelihood of an insured filing a claim in twelve months
– – Claim Frequency – Claim repetition in twelve months
– – Claim Severity – Severity of the claim should it occur
– – Loss Ratio – Likelihood of the loss ratio getting worse than a profitable level

Mulberri has won the following awards from Insurtech:

– – 2023 Insurtech Innovation Award for Best Insurtech Solution for PEOs and Brokers
– – 2023 Insurtech Rising Star Award
– – 2023 Insurtech Best of Show Award

To learn more about the Mulberri Risk Engine and get a demo , sign up at mulberri.io