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Drug Makers Trying AI to Speed Drug Discovery

Reuters Health reports that the world’s leading drug companies are turning to artificial intelligence (AI) to improve the hit-and-miss business of finding new medicines, with GlaxoSmithKline unveiling a new $43 million deal. Other pharmaceutical giants including Merck & Co, Johnson & Johnson and Sanofi are also exploring the potential of AI to help streamline the drug discovery process.

The aim is to harness modern supercomputers and machine learning systems to predict how molecules will behave and how likely they are to make a useful drug, thereby saving time and money on unnecessary tests. “Many large pharma companies are starting to realize the potential of this approach and how it can help improve efficiencies,” said Andrew Hopkins, chief executive of privately owned Exscientia, which announced the new tie-up with GSK.

Hopkins, who used to work at Pfizer, said Exscientia’s AI system could deliver drug candidates in roughly one-quarter of the time and at one-quarter of the cost of traditional approaches.

The Scotland-based company, which also signed a deal with Sanofi in May, is one of a growing number of start-ups on both sides of the Atlantic that are applying AI to drug research. Others include U.S. firms Berg, Numerate, twoXAR and Atomwise, as well as Britain’s BenevolentAI.

“In pharma’s eyes these companies are essentially digital biotechs that they can strike partnerships with and which help feed the pipeline,” said Nooman Haque, head of life sciences at Silicon Valley Bank in London.

But, this is not the first time drugmakers have turned to high-tech solutions to boost R&D productivity. The introduction of “high throughput screening”, using robots to rapidly test millions of compounds, generated mountains of leads in the early 2000s but notably failed to solve inefficiencies in the research process.

When it comes to AI, big pharma is treading cautiously, in the knowledge that the technology has yet to demonstrate it can successfully bring a new molecule from computer screen to lab to clinic and finally to market. “It’s still to be proven, but we definitely think we should do the experiment,” said John Baldoni, GSK’s head of platform technology and science.

Baldoni is also ramping up in-house AI investment at the drugmaker by hiring some unexpected staff with appropriate computing and data handling experience – including astrophysicists. His goal is to reduce the time it takes from identifying a target for disease intervention to finding a molecule that acts against it from an average 5.5 years today to just one year in future.

Earlier this year GSK also entered a collaboration with the U.S. Department of Energy and National Cancer Institute to accelerate pre-clinical drug development through use of advanced computational technologies.The new deal with Exscientia will allow GSK to search for drug candidates for up to 10 disease-related targets. GSK will provide research funding and make payments of 33 million pounds ($43 million), if pre-clinical milestones are met.

Comp Attorney and Kickback Conspirator Face Sentencing

The Department of Justice announced that Daniel J. Rush pleaded guilty in federal court this month to three felony counts: receiving an illegal payment as a union employee; honest services fraud; and conspiracy to commit structuring and money laundering.

In pleading guilty, Rush, 56, of Crescent City, Calif. (formerly of Oakland, Calif.), admitted that between 2011 and 2015 he was employed by the United Food and Commercial Workers International (UFCW International) as the Organizing Coordinator for the unofficial medical cannabis and hemp division. Rush admitted he violated the Taft-Hartley Act when he accepted compensation from employees in, or potentially in, a labor organization.

Rush also admitted he committed honest services wire fraud with the intent to deprive the UFCW of its right to his honest services and he conspired with workers’ compensation attorney Marc Terbeek, 55, of Berkeley, Calif., to launder money and to evade reporting requirements in an effort to conceal the source of the money.

Terbeek, was allegedly involved in a massive corruption case filed by the FBI’s Public Corruption and Civil Rights Squad. The FBI and IRS raided Terbeek’s office in January 2015 and since then he has been cooperating with investigators. The sworn Affidavit signed by FBI Special Agent Roahn Wynar attached to the criminal complaint against Daniel Rush claims the following scenario occurred.

Daniel Rush was an official with the United Food and Commercial Workers Union that had established a “Cannabis Division” to organize dispensary employees. He was also closely involved in Measure D, the process to regulate medical marijuana dispensaries in Los Angeles, and also connected to legalization’s most prominent pitchman: Lt. Gov. Gavin Newsom.

According to the allegations of paragraph 31 of the Affidavit , Tarbeek admitted to the FBI that he had been paying “kickbacks” to Rush for sending Terbeek legal work since 2004. Rush “encouraged” Terbeek to acquire a workers compensation law practice to litigate cases referred by the Insitutio Laboral de la Raza. In exchange Tarbeek gave Rush a credit card associated with Terbeek’s law firm and Terbeek paid it off routinely. Text messages confirmed this practice continued as late as February 2015. From 2010 to 2015, Rush spent $110,000 on Terbeek’s card, about $2,000 per month, for mostly personal expenses.

Also, Terbeek allegedly agreed to share legal fees with Rush derived from Terbeek’s clients seeking permits to operate dispensaries in California, Nevada, and beyond (Affidavit paragraph 34). After creation of this arrangement, Terbeek paid Rush $5000 as his “share” of the medical marijuana legal fees.

For his part in the scheme, on February 15, 2017, TerBeek was charged by information with one count of making a payment to a union employee, in violation of 29 U.S.C. § 186(a), and one count of willful violation of anti-structuring regulations, in violation of 12 U.S.C. § 1956.He pleaded guilty to both counts on February 16, 2017

Terbeek is scheduled to be sentenced by Judge Gilliam on August 21, 2017, and Rush will be sentenced on October 2. . Rush is looking at the possibility of 30 years in prison as well as a $565,000 fine but is currently free on a $100,000 bond

State Bar records reflect that Terbeek remains an active unrestricted member at this time.

O.C. Contractor to Serve Year in Jail for Fraud

The Orange County Register reports that Newport Beach business owner prosecuted for insurance and workers’ compensation fraud and tax evasion finished paying $1.7 million in restitution Friday, June 23, so an Orange County Superior Court judge lessened his sentence from five years behind bars to a year in jail, according to his attorney.

Darrin Shawn Wilson, 52, the owner of American Blacktop Inc. and The Mavrick Company, pleaded guilty Thursday to insurance fraud with a sentencing enhancement for aggravated white-collar crime exceeding $500,000.

Wilson also admitted workers’ compensation insurance fraud, failing to collect or account or pay for taxes, and tax evasion, all felonies. In the negotiated plea with prosecutors, 56 other felony counts were dismissed, according to defense attorney Kate Corrigan.

Wilson paid $1.25 million in restitution on Thursday and came into court Friday to pay the remainder, Corrigan said. He will apply for home confinement and also be placed on three years of probation, Corrigan said.

When he was charged, prosecutors alleged the case was a $5.6 million insurance fraud and tax evasion scheme. Wilson was also accused of failing to pay $384,000 in taxes.

The fraud came to light when a worker fell 12 feet from a ladder and attempted to put in a workers’ compensation claim. Wilson claimed the man was employed by a subcontractor that was unlicensed and uninsured.

Corrigan said Wilson has hired new attorneys and an accountant, “and he’s righted his ship, so to speak – He won’t run afoul of these workers’ compensation insurance issues ever again.”

“He’s a guy who obviously messed up, but at the core he’s a good guy,” she said.

Opioid Prescribing Drops – Illegal Drugs Increase

A new opioid interstate study reports decreases in the amount and frequency of the drug prescribed to injured employees covered by workers’ compensation in several states. However, the Workers Compensation Research Institute’s (WCRI’s) study, Interstate Variations in Use of Opioids, 4th Edition, also found higher opioid use and other patterns of high-risk drug use in other states during the same time period.

The study examined 26 states’ workers’ compensation (WC) systems, which covered more than 430,000 nonsurgical WC claims and about 2.3 million prescriptions connected with those claims. The study also found that New York, Michigan, Kentucky and Maryland had the highest reduction in opioid use among the states with lower average uses by workers injured in 2010 and 2013.

The 26 states included in this study are Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Wisconsin. These states represent over two-thirds of the workers’ compensation benefits paid in the United States.

The WCRI study shows decreases in opioid prescriptions in most of the 26 states it observed. But opioid addiction from pain-killers reportedly has reached epidemic heights.

Between 65% to 75% of injured workers on pain killers had at least one opioid prescription between 2013 to 2015, with the highest incidents in Arkansas (85%), South Carolina (80%) and Louisiana (80%). New York, Pennsylvania and Louisiana had the highest number of opioid claims among the 26 states – though, again, New York did see substantial decreases.

This report serves as a tool to monitor changes in opioid utilization as states implement reforms addressing opioid prescribing and dispensing. Moreover, by comparing variations in the use of opioids across the states, this study can help policymakers and stakeholders be better informed about the level of opioid use in their states and better target future efforts to address issues related to prescription opioids in their states.

But at the same time, more U.S. workers are testing positive for drug use, according to a May 2017 Quest Diagnostics ​study. In fact, addiction to cocaine, marijuana and methamphetamines is at a 12-year high, the study shows. Increases in drug addiction could present more misconduct issues for employers and raise treatment costs.

“This year’s findings are remarkable because they show increased rates of drug positivity for the most common illicit drugs across virtually all drug test specimen types and in all testing populations,” said Barry Sample, PhD, senior director, science and technology, Quest Diagnostics Employer Solutions.

The positivity rate in urine testing for cocaine increased for the fourth consecutive year in the general U.S. workforce and for the second consecutive year in the federally-mandated, safety-sensitive workforce. Cocaine positivity increased 12 percent in 2016, reaching a seven-year high of 0.28 percent, compared to 0.25 percent in 2015 in the general U.S. workforce, and seven percent among federally-mandated, safety-sensitive workers to 0.28 percent, compared to 0.26 percent in 2015.

DWC Answers Lien Claim Filing Questions

The Division of Workers’ Compensation (DWC) June 26 Newsline reminded lien claimants that they are required to file a declaration for any lien filed between January 1, 2013 and December 31, 2016 for which a filing fee was paid by the end of June.

Labor Code section 4903.05(c) provides: lien claimants shall have until July 1, 2017. DWC recommends that lien claimants complete their submission by 5 p.m. on Friday, June 30 in order to ensure a timely filing.

Senate Bill 1160, which became effective January 1, requires all lien claimants who filed a lien between January 1, 2013 and December 31, 2016, and paid a filing fee, to file the “Supplemental Lien Form and 4903.05(c) Declaration” form. Labor Code section 4903.05(c) was amended as part of the bill’s reform measures to combat fraud in the workers’ compensation system.

DWC has received some questions following the Newsline it posted on June 26, 2017. It just published an updated Newsline with additional reminders regarding regulatory requirements.

“Lien claimants should be aware that the submission of electronic lien-related documents through EAMS must comply with long-standing Workers’ Compensation Appeals Board (WCAB) rules and procedures. California Code of Regulations, title 8, section 10324, cited in the June 26 newsline, concerns ex-parte communications and provides that documents must be served and a proof of service filed. The parties that should be served with lien related documents, including the 4903.05(c) Declaration, are addressed in section 10770. DWC has no authority to waive the requirements of a WCAB rule or exempt a party from compliance.”

“Lien claimants electronically filing a Proof of Service for documents previously filed in EAMS should be aware that submission of duplicate documents is prohibited by California Code of Regulations, title 8, sections 10206 and 10206.1. In that instance, the Proof of Service would be filed with DWC and a copy of the previously filed document and Proof of Service would be served on the parties. The declaration should not be refiled in EAMS.”

Those who do not meet the July 1 deadline and comply with the filing and service rules will face potential dismissal of their liens after next Monday.

RAND Reports on Workers’ Comp Fraud

A new report just published by RAND focuses on one particular form of workers’ compensation fraud: the intentional manipulation of rules and procedures by providers, particularly those delivering health care services and supplies.

The report conceptualizes the sources of and remedies for workers’ compensation fraud in California, discusses various data-driven fraud-detection efforts that other governmental programs use, examines specific aspects of the California approach that might need addressing, and offers some high-level recommendations in that light for the consideration of regulators and legislators.

The Report finds that advanced analytics techniques that social welfare programs use for detecting fraud have had generally favorable results. These techniques offer California workers’ compensation similar promise. Shortcomings in how data are currently collected and accessed should not prevent the Department of Industrial Relations from utilizing these tools.

Employers must furnish up to $10,000 in medical treatment after a claim is filed and can limit the employee’s discretion as to the provider; if the employer rejects the claim, the employee can then receive treatment on a lien basis. Postemployment claims have a strong likelihood of denial, and liens that follow are concentrated in certain locations and providers, routinely settling for a fraction of claimed value, which suggests that they remain a significant source of profit.

Lien volume and claimed value in denied postemployment claims would be reduced if medical care were subjected to the cost controls available in nondenied cases.

Many liens are filed by providers who are under indictment or have been convicted. Existing law offers means to stay liens or suspend providers but either require a formal prosecution or affect only a narrow set of liens.

A Medicaid policy that suspends payments when there is an investigation of a credible fraud allegation would apply to providers who are only under suspicion and would cover all of their liens.

RAND recommends that the DIR implement a centralized and permanent workers’ compensation fraud data unit to enhance opportunities for detecting and addressing fraud.

The Report recommends that the California Department of Industrial Relations take immediate steps to incorporate the use of data analytics into its routine fraud-detection work. To target certain employee-selected providers who repeatedly generate liens large in volume and claimed value, give employers the option of denying a questionable postemployment claim while continuing to offer medical care under their control. And use the payment suspension policy adopted by Medicaid as a tool in addition to those already available under Labor Code §§ 4615 and 139.21 to take active fraudsters out of the workers’ compensation system.

Court Rejects Overtime Class Action Against TPA

Tristar’s normal work schedule for claims examiners required them to work 7.5 hours per day, but Tristar also offered several alternative work schedules that allowed claims examiners to work 8.33 or 8.5 hours per day in exchange for receiving every other Monday or Friday off. Most claims examiners elected to work under one of Tristar’s alternative work schedules.

In February 2014, two former examiners filed this putative class action against Tristar alleging it misclassified them and other similarly situated claims examiners as exempt from California’s overtime laws. According to Plaintiffs, Tristar required its claims examiners to work more than eight hours a day and 40 hours per workweek, but paid no overtime based on the exempt classification it applied to its claims examiners.

In November 2014, Plaintiffs filed a motion to certify a class composed of all individuals who are or previously were employed by Tristar as Claims Examiner[s] II and Claims Examiner[s] III in Tristar’s] Workers’ Compensation Division between February 25, 2010 and December 31, 2014.

The trial court denied Plaintiffs’ motion because it found they failed to present substantial evidence establishing their claims were typical of the class or that common issues of law or fact predominated on Plaintiffs’ overtime claims. The court explained Plaintiffs failed to present any evidence of a generally applicable written or de facto policy that required claims examiners to work overtime.

The Court of Appeal affirmed the denial in the unpublished case of Kizar v Tristar Risk Management.

The party advocating class treatment must demonstrate the existence of an ascertainable and sufficiently numerous class, a well-defined community of interest, and substantial benefits from certification that render proceeding as a class superior to the alternatives. [Citations.] ‘In turn, the “community of interest requirement embodies three factors: (1) predominant common questions of law or fact; (2) class representatives with claims or defenses typical of the class; and (3) class representatives who can adequately represent the class.(Brinker, supra, 53 Cal.4th at p. 1021.) The party seeking class certification bears the “burden to support each of the above factors with a factual showing.”

To satisfy the commonality requirement for class certification, Plaintiffs were required to show their liability theory could be established on a classwide basis through common proof. Typically, in overtime claims, plaintiffs show this by presenting evidence of an employer policy or practice that generally required the class members to work overtime.

Plaintiffs presented no evidence of any such policy or practice.

Lien Claimants Face Friday Deadline

The Division of Workers’ Compensation (DWC) is reminding lien claimants that they are required to file a declaration for any lien filed between January 1, 2013 and December 31, 2016 for which a filing fee was paid.

Labor Code section 4903.05(c) provides: lien claimants shall have until July 1, 2017. DWC recommends that lien claimants complete their submission by 5 p.m. on Friday, June 30 in order to ensure a timely filing.

Senate Bill 1160, which became effective January 1, requires all lien claimants who filed a lien between January 1, 2013 and December 31, 2016, and paid a filing fee, to file the “Supplemental Lien Form and 4903.05(c) Declaration” form. Labor Code section 4903.05(c) was amended as part of the bill’s reform measures to combat fraud in the workers’ compensation system.

To comply with SB 1160’s requirements, DWC made available an e-form declaration and the WCAB promulgated regulations requiring the use of this form by e-filers and JET filers.

Liens claimants who fail to file the “Supplemental Lien Form and 4903.05(c) Declaration” will have their liens dismissed.

As with any court document, DWC says that the declaration must be served on the parties in the case. Rule 10324 states: No document, including letters or other writings, shall be filed by a party or lien claimant with the Workers’ Compensation Appeals Board unless service of a copy thereof is made on all parties together with the filing of a proof of service as provided for in Rule 10505.

DWC is currently reviewing and evaluating filed declarations for compliance with the legislation, and will be holding hearings to determine whether the declarations are accurate and comply with the requirements of section 4903.05(c).

Lien claimants should be aware that the filing of a false declaration is grounds for dismissal of the lien. The DWC has posted frequently asked questions on use of the new form, which can be found on the DWC Website.

And some of the lien claimants failed in their efforts to have the new law declared unconstitutional earlier this year.

In the case of the California Workers’ Compensation Interpreters Association et al. v. Workers’ Compensation Appeals Board of the State of California the petition for writ of mandate was denied by the Court of Appeal. The case was filed pursuant to California Labor Code § 5955 challenging the declaration under penalty of perjury provisions of SB1160, part of the new lien law.

The Interpreters unsuccessfully argued that they do not “neatly” fit into any of the seven categories, and that section (G), the only one that mentions interpreters, is limited to interpretations during medical-legal events, but nothing is said about interpreting during treatment events. This they say will limit “thousands” of lien claimants from collecting liens since they cannot sign the declaration “without the risk of filing a false declaration.”

The Court of Appeal denied the petition in a terse docket entry that essentially concluded the case was premature since it assumed events in the future that had not yet happened at the WCAB.

“Because petitioners’ claims depend, at least in substantial part, on speculative future events, they are not appropriate for immediate judicial resolution. (Pacific Legal Foundation v. California Coastal Com., supra, 33 Cal.3d at p. 173 [agency guidelines might inhibit property owners from planning improvements to their land, but “the hardship inherent in further delay is not imminent or significant enough to compel an immediate resolution of the merits of plaintiffs’ claims”]; Wilson & Wilson v. City Council of Redwood City (2011) 191 Cal.App.4th 1559, 1582-1583 [courts will decline to adjudicate dispute if they are asked to speculate on the resolution of hypothetical situations]; see also Concerned Citizens Coalition of Stockton v. City of Stockton (2005) 128 Cal.App.4th 70, 83 [writ petition ordinarily will not be granted to reach issues the trial court has not yet addressed, since such issues are not ripe for appellate court review].) “

“We therefore decline to exercise our discretion to entertain writ review of petitioners’ challenges. (See Landau v. Superior Court (1998) 81 Cal.App.4th 191, 201 [“an appellate court retains discretion to summarily deny extraordinary writ petitions on grounds related to the apparent merits of the action as well as upon grounds related to the formal or procedural sufficiency of the petition”].) The parties’ requests for judicial notice are denied as moot.”

It remains to be seen if this was their final or the first in a series of efforts to pursue this theory in response to SB 1160.

Healthcare Security Breach Settles for $115 Million

Healthcare companies, workers’ compensation administrators, and even law firms who maintain confidential health data on litigated cases should take notice.

Anthem is on the cusp of having to make the biggest payout in U.S. history for a data breach. The $115 million proposed settlement reflects just how valuable patient records and personal information have become.

And the story on ModernHealthCare.com notes that “There’ve been bigger breaches, such as Target, but this one is unique because of the types of the records taken,” said Daniel Marvin, a partner with law firm Morrison Mahoney who specializes in data security and cyber-insurance topics. Almost 80 million records were exposed in the 2015 breach, revealing names, birth dates, Social Security numbers and other information. “The critical and valuable information that most lends itself to identity theft is the type of information that was taken,” he explained. “That’s one of the reasons we’re seeing such a large number in terms of the settlement amount.”

Target and Home Depot, two companies that suffered well-documented data breaches of their own during the past couple of years, each paid less than a fifth of what Anthem is expected to dole out to settle their claims. The Anthem settlement must still be approved by the U.S. District Court in California.

“When comparing the Anthem number to other large retail breaches, keep in mind that in most of those retail breaches it was just credit card information,” said Kenneth Dort, a partner at Drinker Biddle & Reath, a law firm whose clients include Anthem, but was not involved in this settlement. “There isn’t a high level of identity fraud, whereas with Anthem, you’ve got a pretty good foundation for potential identity theft.”

Still, the Anthem settlement may not capture all the company’s total exposure related to the breach, Marvin said. There’s the initial forensic analysis, notification of the people whose information was breached, and possible reputational damage.

“It’s not just insurers,” said David Holtzman, vice president of compliance strategies for CynergisTek and a former senior adviser to HHS’ Office for Civil Rights. “It’s vital that everyone, from the smallest physicians office to the largest health insurer, have some cyber-awareness in place and take appropriate measures to understand what the risk is.”

He pointed to the fact that the Anthem breach happened because an employee opened a phishing email and that it took almost an entire year for Anthem to notice anything was awry. “The big takeaway from this breach,” Holtzman said, “is you have to have technologies in place that allow for audit and review, for monitoring system activity.”

Ethics Committee Finds 6 Cases of WCJ Misconduct

The Workers’ Compensation Ethics Advisory Committee is a state committee independent of the DWC. The EAC is charged with reviewing and monitoring complaints of misconduct filed against workers’ compensation administrative law judges. Anyone may file a complaint with the EAC. Complaints may be submitted anonymously, but all complaints must be presented in writing.

According to its 2016 Annual report, the EAC considered a total of 39 of the 44 new complaints it received in calendar year 2016, in addition to 6 complaints pending from 2015. A large proportion of the complaints alleged legal error not involving judicial misconduct or expressed dissatisfaction with a judge’s decision. Of the 42 resolved complaints, the EAC identified 6 complaints resulting in judicial misconduct for which they recommended further action by the Chief Judge or the administrative director.

In one of the situations finding judicial misconduct, an applicant attorney alleged having raised the right to call the defense attorney as a hostile witness under Evidence Code 776. The judge noted in the minutes of the hearing the view that complainant’s argument was silly. The complainant complained that this comment was made in front of all the witnesses.

After the complainant told the judge about having won a few cases on Medical Provider Network (MPN) access standards violations against this defendant, the judge indicated, “Good for you, but it’s not going to be the case with this judge.” After the complainant indicated that a petition for removal could be filed, the judge replied, “Go ahead – I have friends in the Recon Unit.”

The complainant also alleged that the judge gave legal advice to the complainant’s client, undermining the complainant’s competency and professionalism. The complainant alleged that the judge told the client that a chiropractor is not needed as a Primary Treating Physician; rather, the client needs an orthopedic hand surgeon to treat the hand. The complainant alleged that the judge failed to take a neutral position, stating that the judge would rule against the complainant.

Following its review of the investigation, the committee identified violations of Canons 1, 2, and 3 of the Code of Juridical Ethics and recommended to the CJ that further appropriate action be taken.

An another situation, an anonymous complainant, alleged that the judge failed to respect and comply with the law and failed to act in a manner that promotes public confidence. The complainant alleged that the judge had a reputation for issuing notices, orders, and reports on reconsideration/removal that contain substantially false and misleading statements of facts. The complainant attached a WCAB panel decision reversing the judge’s decision. The complainant complained that the judge’s continuing pattern and practice of disregarding the rights of lien claimants reduced the WCAB to a mockery.

Following its review of the investigation, the committee identified violations of Canons 1, 2, and 3 of the Code of Juridical Ethics and recommended to the CJ that further appropriate action be taken.