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Tag: 2019 News

OCDA Recovers $1.6M For Unsafe Workplace

The Orange County District Attorney’s Office obtained a $1.6 million judgment in the civil case against a plastics manufacturer for willfully endangering employees by maintaining hazardous work environment.

Beginning in 2007, Solus Industrial Innovations operated a plastics manufacturing plant in Rancho Santa Margarita. Solus willfully, knowingly, and intentionally maintained an unsafe and hazardous work environment for their employees.

When the business relocated certain operations from Pennsylvania to Orange County in 2007, the defendants intentionally discarded a commercial boiler to avoid the cost and permitting requirements of proper installation. Solus instead purchased and installed an inexpensive residential water heater, knowing that it was not equipped to function at a commercial level.

In March 2009, the water heater exploded, senselessly killing two employees.

The Division of Occupational Safety and Health investigated and “determined the explosion had been caused by a failed safety valve and the lack of ‘any other suitable safety features on the heater due to ‘manipulation and misuse’ because Solus used a residential water heater instead of a commercial one.”

In March 2012, the OCDA filed a criminal suit against Solus’s plant manager and its maintenance supervisor for felony violations of Labor Code section 6425 subdivision (a) for knowingly operating an unsafe work environment, which resulted in the death of two employees.

The OCDA also filed the present civil action against Solus and its successor corporations.

The first cause of action “allege[d] that Solus’s failure to comply with workplace safety standards amount[ed] to an unlawful, unfair and fraudulent business practice under Business and Professions Code section 17200, and the district attorney request[ed] imposition of civil penalties as a consequence of that practice, in the amount of up to $2,500 per day, per employee, for the period from November 29, 2007, through March 19, 2009.”

The second was a claim that Solus “made numerous false and misleading representations concerning its commitment to workplace safety and its compliance with all applicable workplace safety standards, and as a result of those false and misleading statements, Solus was allegedly able to retain employees and customers in violation of Business and Professions Code section 17500.” The district attorney requested imposition of civil penalties in the same amount for the same period.

On Jan. 29, 2019, the defendants were ordered to pay $1.6 million, $1.5 million of which will go toward civil penalties and $100,000 for additional victim restitution.

Deputy District Attorney Kelly Ernby of the OCDA’s Environmental Protection Unit is the assigned prosecutor on the case.

Congress Questions a Once Free Drug, Now $375K a Year

Both the U.S. House of Representatives and the Senate have begun holding hearings this year on the rising costs of medicines. The government is intensifying its scrutiny of the pharmaceutical industry and rising prescription drug prices, a top voter concern and a priority of President Donald Trump’s administration.

U.S. Senator Bernie Sanders sent a letter to Catalyst Pharmaceuticals asking it to justify its decision to charge $375,000 annually for a medication that for years has been available to patients for free.

The drug, Firdapse, is used to treat Lambert-Eaton Myasthenic Syndrome (LEMS), a rare neuromuscular disorder, according to the letter, made available to Reuters by the senator’s office. The disorder affects about one in 100,000 people in the United States.

In the letter dated Feb. 4, Sanders asked Catalyst to lay out the financial and non-financial factors that led the company to set the list price at $375,000, and say how many patients would suffer or die as a result of the price and how much it was paying to purchase or produce the drug.

Catalyst declined to comment on Sanders’ letter.  Its shares fell nearly 8 percent to $2.31

For years, patients have been able to get the same drug for free from Jacobus Pharmaceuticals, a small New Jersey-based drug company, which offered it through a U.S. Food and Drug Administration (FDA) program called “compassionate use.”  The program allows patients with rare diseases and conditions access to experimental drugs outside of a clinical trial when there is no viable alternative.

Florida-based Catalyst received FDA approval of Firdapse in November, along with exclusive rights to market the medication for several years. The company, which bought rights to the drug from a company called BioMarin in 2012, develops and commercializes drugs for rare diseases.

BioMarin and FDA did not immediately respond to requests for comment.

In December, Catalyst announced it would price Firdapse at $375,000 a year.  “Catalyst’s decision to set the annual list price at $375,000 is not only a blatant fleecing of American taxpayers, but is also an immoral exploitation of patients who need this medication,” Sanders wrote in his letter.

Democratic Representative Elijah Cummings, chairman of the House Oversight Committee, in January wrote to 12 pharmaceutical firms asking for detailed information on how they set drug prices.

Democratic Representatives Frank Pallone and Diana DeGette wrote to the heads of Eli Lilly and Co, Novo Nordisk and Sanofi SA, the long-time leading manufacturers of insulin, requesting information on why the drug’s price has skyrocketed in recent years.

Fake Companies and Employees Filed 725 Fake Claims for $5M

A Ventura County man has been sentenced to 168 months in federal prison for participating in a massive fraud scheme that used dozens of nonexistent companies to collect nearly $5 million in unemployment benefits for phony employees who never performed any work at the fake entities.

Jack Benjamin Hessiani, a.k.a. “Jack Herrera,” 40, of Camarillo, was sentenced today by United States District Judge John A. Kronstadt. Hessiani pleaded guilty in August 2018 to one count of mail fraud.

According to court documents, Hessiani created numerous fictitious businesses for the sole purpose of defrauding the Employment Development Department (EDD), the state agency that administers the federal unemployment insurance program in California.

After he and his co-schemers filed documents with EDD that showed made-up earnings for the fictitious workers, Hessiani and the co-schemers submitted claims for unemployment insurance benefits for laid-off “employees.” In fact, many of the “employees” were people who had agreed to provide their personal identifying information in exchange for a portion of the unemployment insurance benefits. Some of the benefit portions would go to drug users who likely used the funds to enable future drug purchases, while others were poor students who later faced criminal exposure as a result of the actions of Hessiani and his co-schemers, court papers state.

The unemployment benefits were sent in the form of checks and debit cards to “mail drops” that Hessiani and the co-schemers established in the names of other individuals, according to court documents. After EDD began issuing unemployment benefits, Hessiani ensured that documents were filed that falsely stated that the laid-off “workers” were still unemployed, and he later sought “extended benefits” to obtain unemployment insurance benefits for the sham workers beyond the normal six-month period. These extended benefits were ultimately funded by the United States Treasury.

According to court documents, Hessiani and his co-schemers submitted approximately 725 unemployment insurance claims – including 521 original claims and 204 claims for extended benefits – in the names of 384 “employees.” The investigation identified 43 fictitious companies based in Ventura County that were used to further the scheme, which caused EDD to suffer actual losses of $3.96 million and the United States Treasury to suffer actual losses of approximately $900,000. Hessiani enlarged his scheme by inducing the people whose names were already being used to obtain fraudulent benefits to “recruit” others who would be identified as additional false employees at the fictitious companies, and he paid referral fees for each new fake worker brought into the scheme.

Three other defendants in the case have pleaded guilty to criminal charges and are pending sentencing. They are Hessiani’s brother, James Manuel Herrera, 30, of Camarillo; Eduardo Josue Garcia, 27, of Camarillo; and Daniel Ayala-Mora, 29, formerly of Camarillo.

Feds Move to End Drug Rebates

Reuters Health reports that the Department of Health and Human Services proposed a rule to end the industry-wide system of after-market discounts called rebates that pharmacy benefit managers (PBMs) receive from drugmakers, a practice that has been under increased scrutiny.

If finalized, the rule would change a system that has been in place for decades and that has been criticized for obfuscating the real price of prescription medicines.

The administration of U.S. President Donald Trump has been promising to lower the cost of prescription drugs for consumers, who have seen their out-of-pocket expenses rise each year with higher list prices of pharmaceuticals.

The proposed rule from HHS would apply to companies like Cigna Corp’s Express Scripts and CVS Health Corp, as well as companies like Humana Inc that manage Medicare prescription drug benefits, and Medicaid managed care organizations.

“This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter,” HHS Secretary Alex Azar said in a statement.

Eliminating rebates on prescription drug purchases is a key element of the Trump administration’s plan to lower prescription medicine costs. Trump made lowering drug prices a major priority during his 2016 presidential campaign.

PBMs administer drug benefits for employers and health plans and also run large mail-order pharmacies. Drugmakers say they are under pressure to provide rebates to the few PBMs that dominate the market in order to gain patient access to their products by having them included on preferred coverage lists.

Drugmakers say that PBMs do not pass on enough of those savings to patients – a contention the PBMs dispute – and that the rebates force them to raise the list price of medicines over time to preserve their profits. They argue that the net revenue they actually see has little relation to list prices.

The Pharmaceutical Care Management Association, the main PBM trade group, said eliminating rebates would drive up drug costs and out-of-pocket expenses for consumers. The group said drugmakers alone set prices.

But the Pharmaceutical Research and Manufacturers of America (PhRMA), the main U.S. lobbying group for drugmakers, said the proposal, if enacted, would “fix the misaligned incentives in the system.”

The HHS proposal would allow rebates on prescription drugs to be offered directly to patients, and allow PBMs to establish fixed fee service arrangements with drugmakers that could replace lost revenue from rebates.

An anti-kickback law makes it illegal to pay an incentive for drugs or services that Medicare, Medicaid or other federal healthcare programs cover. The government has been considering removing the safe harbor protection for rebates from the anti-kickback law since last year.

DWC Published the 2018 Annual Audit Report

The Division of Workers’ Compensation has posted the 2018 DWC Audit Unit annual report on its website. The annual report provides information on how claims administrators audited by the DWC performed and includes the Administrative Director’s ranking report for audits conducted in calendar year 2017.

The 2018 Audit Unit annual report details the results of audits conducted in 2017 and provides the name and location of each insurer, self-insured employer, and third-party administrator audited during that time.

The DWC Audit & Enforcement Unit completed 41 profile audit reviews (PAR audits). Of the PAR audits, 40 were routinely selected and there was 1 target audit, which would have been conducted based upon failure of a prior audit. The total number of PAR audit subjects included 5 insurance companies, 11 self-administered / self-insured employers, 21 third-party administrators (TPA), and 4 insurance companies / third-party administrators combined claims adjustinglocations.

Thirty-seven audit subjects (90%) met or exceeded the PAR 2017 performance standard and therefore had no penalty citations assessed in accordance with Labor Code section 129.5(c) and CCR, Title 8, Section 10107.1(c)(4). These audit subjects were, however, ordered to pay all unpaid compensation.

Four audit subjects (10%) failed to meet or exceed the PAR standard and their audits expanded into a full compliance audit of indemnity claims (FCA stage 1). One of these audit subjects (25% of those failing to meet or exceed the PAR standard) met or exceeded the FCA 2017 performance standard and therefore had penalty citations assessed for unpaid and late payment of indemnity in accordance pursuant to Labor Code section 129.5(c)(2) and CCR, Title 8, Sections 10107.1(d).

The remaining three of the four audit subjects (75% of those failing to meet or exceed the PAR standard) failed to meet or exceed the FCA 2017 performance standard and their audits expanded into full compliance audit of indemnity claims (FCA stage 2) and added a sample of denied claims to be audited. These audit subjects were assessed administrative penalties for all penalty citations in accordance with Labor Code section 129.5(c) and CCR, Title 8, Section 10107.1(d) and 10107.1(e).

The audit findings, by law, must detail the number of files audited, the number and type of violations cited, and the amount of an undisputed compensation found due and unpaid to the injured worker. The audit findings presented in this report are statistical and do not identify any individual injured worker. The Labor Code provides that contents of the claim files and the Audit Unit working papers are confidential.

The DWC Administrative Director’s 2017 Audit Ranking Report is part of this annual report. The Ranking Report provides the performance ratings for the 41 audit subjects listed in order, from the best to worst performer.

Congratulations to Zenith Insurance Company – Pleasanton for having the best score in the Ranking Report.  The ranking of the remaining 40 organizations are listed by name on the Ranking Report.

Performance of insurers, self-insured employers, and third party administrators subject to profile audit review and full compliance audit is rated in accordance with the performance standards set annually by the Administrative Director. The DWC Administrative Director’s 2018 Audit Ranking Report lists, in ascending order by performance rating, the administrators audited in calendar year 2017.

Insurance Prime Target for Technology Investment

A new report published by Fitch Ratings concludes that the the workers’ compensation segment of the property/casualty (P/C) insurance business is a prime target for technology investment to maintain competitiveness and bolster performance.

“As the largest U.S. commercial lines segment, workers’ compensation is a focal point for insurers’ efforts to leverage new technologies to gain operating efficiency, reduce workplace injuries and improve claims outcomes,” says Jim Auden, Managing Director at Fitch. “Insurers that lag in innovation face the risk of adverse selection in their underwriting portfolio and expense disadvantages–changes that make them more likely consolidation targets given recent market M&A activity.”

Technology enhancements are a consistent theme in the insurance industry’s history. Expanded ability to process, analyze and store large and more diverse volumes of data is creating greater modeling sophistication in risk segmentation and pricing. Data analytics in claims can help speed resolution, uncover fraudulent activity and predict high severity incidents. Further opportunities to improve modeling and risk management capabilities are emerging from the utilization of artificial intelligence (AI) and machine learning to more readily incorporate new information garnered from wearables, sensors and other connected devices into decision making.

Although most workers’ compensation underwriters are operating from a position of strength as 2018 represents a rare fourth-consecutive year of market underwriting profits, the business has also experienced historical instances of very large losses fueled by inadequate pricing and claims volatility. Success of insurers’ technology initiatives is measured in part on generating steadier results over the long term.

Outside insurtech firms, mainly funded by venture capital and focused on providing technology solutions in many operational areas and across multiple business segments, represent a nimble force accelerating the pace of change.

In response, insurers are more actively investing in or creating strategic partnerships with insurtech firms to gain insight or are developing their own innovation labs to foster creative development. Insurers are seeing competition emerge from start-up underwriters and managing general agencies (MGA’s) with direct, data driven on-line platforms including Next Insurance in small commercial lines and Pie Insurance in workers’ compensation. Uncertainty remains as to whether these newer entrants can build a profitable business with sufficient operating scale.

Tawdry Marketing Details Emerge in Drugmaker Trial

Sunrise Lee, an ex-stripper who became a regional sales director at Insys Therapeutics, gave a doctor a lap dance at a Chicago club as part of her marketing plan to convince the doctor to prescribe its addictive fentanyl spray.

Reuters reports that the testimony in federal court in Boston came in the first criminal trial of painkiller manufacturer executives over conduct that authorities say contributed to a U.S. opioid abuse epidemic that has killed tens of thousands of people a year.

Former Insys sales representative Holly Brown told jurors the incident with her boss, Sunrise Lee, took place after Insys began rewarding the doctor for prescribing its opioid product by paying him to speak at educational events about the drug.

That Illinois doctor, Paul Madison, is one of several whom prosecutors say Lee and four other former Insys executives and managers including wealthy founder and ex-chairman John Kapoor conspired to bribe to boost sales of the spray, Subsys.

Lee, Kapoor, Michael Gurry, Richard Simon and Joseph Rowan deny wrongdoing and have pleaded not guilty to racketeering conspiracy.

Drugmakers often retain doctors to speak at events with other clinicians about the benefits of their drugs, and defense lawyers argue the events were legal compensation for the doctors’ educational work.

Yet Brown said Madison’s events, held at a Chicago restaurant Kapoor owned, were attended by his friends instead of clinicians.

“The idea was these weren’t really meant to be educational programs but were meant to be rewards to physicians.” Brown said.

After one dinner in mid-2012, Brown said she, Lee and Madison went to a club, where she witnessed Lee “sitting on his lap, kind of bouncing around.”

Brown testified that at the time, Madison ran a “notorious” medical practice, which in a 2012 email shown to jurors she described as a “shady pill mill.”

Prosecutors say Insys paid Madison at least $70,800 in speaker fees.

Madison was convicted in November of unrelated charges that he defrauded insurers into paying for unperformed chiropractic procedures. His lawyer did not respond to Reuters requests for comment.

Feds Hold First Hearing on Drug Prices

Powerful committees in the U.S. Congress held hearings on Tuesday on insulin affordability and high prescription drug prices, an issue both chambers have said is a top priority for the year.

The House Oversight Committee, chaired by Democratic Representative Elijah Cummings, and the Senate Finance Committee, chaired by Republican Senator Chuck Grassley, brought in patient advocates and health policy experts to discuss the burden of high drug costs on consumers and sky-rocketing prices.

Both committees also focused on insulin, which those with type 1 diabetes and some with type 2 diabetes depend on.

High prescription drug costs have consistently polled as a top voter concern and have been a top priority of the administration of U.S. President Donald Trump.

It remains unclear whether Democrats, who control the U.S. House of Representatives, and Republicans, who control the U.S. Senate, will find a bipartisan way to address rising drug costs.

The annual cost of insulin for treating a type 1 diabetes patient in the United States nearly doubled from 2012 to 2016 to $5,705 from $2,864, according to a recent study.

Cummings earlier this month sent letters to 12 pharmaceutical companies asking for detailed information on their pricing practices. He focused on medicines whose costs rose the most over the last five years, including several diabetes medications.

Democrats in the Senate and House earlier this month, including Cummings, also introduced a series of bills aimed at bringing down drug costs. No Republicans have signed onto the legislation.

Ron Wyden, the ranking member of the Senate Finance Committee, said in a statement that the committee invited the heads of several large drug companies to testify on Tuesday, but none were willing to come.

9th Circuit Clarifies Employer Liability Provision of Comp Policy

In three separate California state civil lawsuits, performers in the pornographic film industry sued Cybernet Entertainment, LLC for negligence, negligence per se, breach of the implied covenant of good faith and fair dealing, negligent supervision, and negligent hiring and/or retention.

They alleged, in essence, that Cybernet did not take adequate steps to protect its performers and prevent the spread of sexually transmitted diseases and HIV during pornographic shoots, causing injury. The plaintiffs alleged that Cybernet did not provide adequate personal protective equipment, such as condoms, to performers; did not test certain performers; and otherwise violated California regulations meant to prevent the spread of STDs and HIV in pornographic shoots.

The state-court plaintiffs’ causes of action for intentional/fraudulent misrepresentation and conspiracy to commit fraud alleged that Cybernet and others made various false representations concerning the safety of Cybernet shoots (e.g., that protection could be used on request) to the plaintiffs to induce them to participate in those shoots.

Cybernet Entertainment filed a third-party complaint in federal court against State Compensation Insurance Fund seeking a declaration that State Fund had a duty to defend Cybernet in the three state court actions filed against Cybernet under a Workers’ Compensation and Employer’s Liability Insurance Policy.

The district court held that State Fund did not have a duty to defend Cybernet. Cybernet appealed. The ruling was affirmed in the unpublished case of Seneca Insurance Company Inc. v State Compensation Insurance Fund.

The court considered whether two policy exclusions bar coverage under the Employer’s Liability portion of the Policy for the claims asserted in the State Court Actions.

Exclusion 4 provides that coverage under the Employer’s Liability portion of the Policy does not extend to “any obligation imposed by a workers’ compensation . . . law.” Exclusion 5 provides that coverage under the Employer’s Liability portion of the Policy does not extend to “damages or bodily injury intentionally caused or aggravated by” Cybernet.

The acts and injuries alleged in the negligence causes of action fall within the compensation bargain because the gravamen of each is that Cybernet did not maintain a safe workplace. The remedy for such workplace-safety claims is workers’ compensation.

Exclusion 5 bars coverage for the intentional tort claims.

Because either Exclusion 4 or Exclusion 5 bars coverage under the Employer’s Liability portion of the Policy for each of the causes of action alleged against Cybernet in the state court actions, State Fund did not have a duty to defend Cybernet in those actions.

CVS, Aetna and Apple Launch “Attain” Health App

Aetna, a CVS Health business, announced the launch of Attain, a unique health experience designed by Aetna in collaboration with Apple.

Using  an Apple Watch, the Attain app will provide Aetna members personalized goals, track their daily activity levels, recommend healthy actions, and ultimately reward them for taking these actions to improve their well-being. Reward opportunities include the ability for eligible users to earn their Apple Watch through their participation in the program.

This launch builds on the 2016 collaboration between Aetna and Apple in which 90 percent of participants reported a health benefit from their use of Apple Watch.

The Attain app claims to be the first of its kind – designed specifically to offer users a personalized experience that combines their health history with the power of the Apple Watch to help them achieve better health and well-being.

After users have joined Attain, they will have the additional option to share their Attain program data and health history with Apple, enabling Apple and Aetna to collaborate, and over time, continue to improve the Attain experience. Through analytics and machine learning, the collaboration will lead to new features for Attain, offering more personalized recommendations designed to give greater context and decrease barriers to health care.

The developers say user privacy and data security are at the heart of Attain. A completely voluntary program, members determine what information they want to share and can discontinue using Attain at any time. All Attain health data is encrypted on the device, in transit, and on Aetna and Apple’s servers, where it will be stored in a highly secure environment using industry-leading practices fully in compliance with HIPAA.

Information from this program will not be used for underwriting, premium or coverage decisions.

Health history data is tightly regulated by the U.S. government, and Apple and Aetna had to enter into what is known as a business associate agreement in order for Aetna to share it with the Apple. Access to regulated data is necessary for some of the functions of the app, such as recommending age-appropriate exercise or a lower-cost option for scheduled lab tests or MRI imaging tests.

The Attain rewards platform builds off a program developed by Vitality Group, a model that has demonstrated that incentives linked to the Apple Watch are associated with increased, sustained activity. A recent study from RAND corporation found an average 34 percent increase in activity levels for participants using the rewards platform incorporated in Attain with Apple Watch, compared to those without these incentives – leading to an additional 4.8 days of activity per month.

Interested Aetna members are encouraged to sign up at www.AttainbyAetna.com to be notified when the App becomes available for download.