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Drugmaker Pays $1.4 B to Resolve Fraud Claims

Global consumer goods conglomerate Reckitt Benckiser Group plc (RB Group) has agreed to pay $1.4 billion to resolve its potential criminal and civil liability related to a federal investigation of the marketing of the opioid addiction treatment drug Suboxone. The resolution – the largest recovery by the United States in a case concerning an opioid drug – includes the forfeiture of proceeds totaling $647 million, civil settlements with the federal government and the states totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million.

Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids.

On April 9, a federal grand jury indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone.

To resolve its potential criminal liability stemming from the conduct alleged in the indictment of Indivior, RB Group has executed a non-prosecution agreement that requires the company to forfeit $647 million of proceeds it received from Indivior and not to manufacture, market, or sell Schedule I, II, or III controlled substances in the United States for three years. In addition, RB Group has agreed to cooperate fully with all investigations and prosecutions by the Department of Justice related, in any way, to Suboxone.

According to the indictment, Indivior promoted the film version of Suboxone (Suboxone Film) as less-divertible and less-abusable and safer around children, families, and communities than other buprenorphine drugs, even though such claims have never been established.

The indictment further alleges that Indivior touted its “Here to Help” internet and telephone program as a resource for opioid-addicted patients. Instead, however, Indivior used the program, in part, to connect patients to doctors it knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in a careless and clinically unwarranted manner.

The indictment also alleges that, to further its scheme, Indivior announced a “discontinuance” of its tablet form of Suboxone based on supposed “concerns regarding pediatric exposure” to tablets, despite Indivior executives’ knowledge that the primary reason for the discontinuance was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug.

The indictment alleges Indivior’s scheme was highly successful, fraudulently converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to the government.

Under the civil settlement, RB Group has agreed to pay a total of $700 million to resolve claims that the marketing of Suboxone caused false claims to be submitted to government health care programs. The $700 million settlement amount includes $500 million to the federal government and up to $200 million to states that opt to participate in the agreement. The claims settled by the civil agreement are allegations only and there has been no determination of liability.

Under a separate agreement with the Federal Trade Commission (FTC), RB Group has agreed to pay $50 million to resolve claims that it engaged in unfair methods of competition in violation of the Federal Trade Commission Act, 15 U.S.C. § 53(b).

Cal/OSHA – $68K in Fines for Confined Space Violations

Cal/OSHA has cited two employers for serious accident-related health and safety violations after workers were poisoned by carbon monoxide while in a confined space at San Francisco International Airport.

Two plumbers from Gladiator Rooter & Plumbing were working in a crawl space replacing underground sewer pipes for airline caterer Gate Gourmet, Inc. on December 22, 2018. The plumbers were using a gasoline-powered saw to cut through concrete when they were overcome by carbon monoxide gas emitted from the equipment, causing one of the workers to lose consciousness. Emergency crews assisted the workers, one of whom was hospitalized for two days.

“These workers were fortunate because performing work in confined spaces can be deadly, especially when oxygen levels are reduced or when deadly gases are present,” said Cal/OSHA Deputy Chief of Enforcement Debra Lee. “Employers must identify and evaluate potential hazards before workers enter confined spaces so they can ensure workers are trained and a rescue plan is in place in case of emergency.”

Cal/OSHA’s investigation found that Gate Gourmet, Inc. did not inform Gladiator Rooter & Plumbing that the crawl space was a permit-required confined space, and did not provide information on the potential hazards posed by entering the space. Cal/OSHA also found that Gladiator Rooter & Plumbing did not have a safety and health program and did not train workers. In addition, the employer did not develop a confined space program, take steps to mitigate the hazards and did not have a rescue plan.

Cal/OSHA cited Gladiator Rooter & Plumbing $50,850 for eight violations, including two serious accident-related, two serious, and four general in nature.

The serious accident-related violations were cited for the company’s failure to implement a permit-required confined space program and its failure to train its employees on working safely in confined spaces. The serious violations were cited for the company’s failure to develop and implement a written permit space program and failure to obtain information about permit space hazard and provide that information to the workers entering the space.

Cal/OSHA cited Gate Gourmet $18,000 in proposed penalties for one serious accident-related violation for failing to communicate with Gladiator Rooter & Plumbing about confined space hazards and precautions.

Construction industry employers should review and follow confined space guidance detailed on pages 26-29 of the updated Cal/OSHA Pocket Guide for the Construction Industry. Cal/OSHA has other confined space resources available for employers in the general industry. All employers in California are required to have an effective written injury and illness prevention program, a safety program to identify, assess and control hazards in the workplace. Cal/OSHA has online tools and publications to guide employers on how to establish an effective safety program.

$6M Fraud Verdict Against “Sham” Attorneys Affirmed

Christine Suh was not an attorney and was not otherwise authorized to represent Allstate’s insureds. She overcame that obstacle by creating and, with help from Christina Chang (Suh’s mother), and others, operating eight sham law offices.

Suh paid several individual attorneys a monthly fee of $3,000 to use their names and state bar numbers. Suh and Chang procured Allstate’s insureds as “clients,” filed 318 insurance claims on their behalf (not authorized by and without the knowledge of the individual attorneys), and diverted insurance proceeds to their personal use.

Allstate Insurance Company and several related companies (collectively, Allstate) brought this action under Insurance Code section 1871.7 (Insurance Fraud Prevention Act) on behalf of the People of the State of California against Christine Suh, Christina Chang (Suh’s mother), and others for insurance fraud in violation of Penal Code section 550 (section 550), which makes it unlawful to submit false or fraudulent claims to an insurance company.

A jury found in favor of Allstate and imposed over $6 million in civil penalties. Suh appeals from the ensuing judgment, arguing the trial court should have stayed this action pending the resolution of a criminal investigation of her conduct. Suh, joined by Chang, also argues that the insurance claims they submitted to Allstate were not fraudulent because, although the insureds were not actually represented by attorneys, the information in the claims forms was accurate.

The Court of Appeal affirmed the judgment in the published case of People v Suh.

Suh argues the trial court’s ruling in response to her ex parte motion for stay “forced [her] to have to choose between asserting her Fifth Amendment privilege and risking substantial monetary jeopardy in the civil action on one hand, and waiving her Fifth Amendment privilege and subjecting herself to criminal jeopardy on the other hand.”

Suh made her request for a stay, not in a regularly noticed motion, but in an ex parte application. A court will not grant ex parte relief in any but the plainest and most certain of cases. The rules governing ex parte applications in civil cases require that “[a]n applicant . . . make an affirmative factual showing . . . of irreparable harm, immediate danger, or any other statutory basis for granting relief ex parte.”

The trial court here acted well within its discretion in denying Suh’s application. Suh did not make a showing of irreparable harm, immediate danger, or any other basis for ex parte relief.”

Suh and Chang argue Allstate’s theory that the insurance claims they submitted “were false or fraudulent was based solely on the testimony that the claims submitted to it were submitted by a [sic] ‘sham law firms.’ No evidence was presented that the claims were ‘false or fraudulent’ in any other regard.

“Suh and Chang read the insurance fraud statutes too narrowly. Unlawful conduct under section 550 does not require a misstatement of fact in the insurance claim.”

An insurance claim is fraudulent under section 550 and section 1871.7, subdivision (b), when it is “characterized in any way by deceit.”

Feds Withdraw Proposed Drug Rebate Rule

The Trump administration will no longer move forward on a proposed rule to eliminate the arcane rebates that flow from drugmakers to middleman pharmacy benefit managers, a significant reversal on one of the White House’s most sweeping actions to-date to curb rising treatment costs.

“Based on careful analysis and thorough consideration, the president has decided to withdraw the rebate rule,” spokesperson Judd Deere said in a statement. “The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline.”

In recent weeks, Politico and other publications reported that the White House and Health and Human Services Secretary Alex Azar disagreed over the rule.

And the proposal had faced resistance from domestic policy chief Joe Grogan and other fiscal hawks on grounds that it was too expensive – costing the government nearly $180 billion over a decade.

Some lawmakers also worried the rule would raise seniors’ Medicare Part D premiums.

The death of the proposal is also bad news for drug companies in that it is a sign that other Trump administration efforts could move forward, some of which the companies fiercely oppose.

Most prominently, the administration has proposed tying some Medicare drug prices to lower prices in other countries, a proposal currently under review at the White House.

Democrats, including Speaker Nancy Pelosi (D-Calif.), also opposed the rebate rule, favoring more direct actions against drug companies. White House staff has been in talks with Pelosi’s office for months on Medicare negotiating drug prices.

Judge Blocks HHS Drug Price TV Ads Disclosure Rule

The Trump administration suffered a blow when a federal judge blocked a key rule about drug price disclosures just hours before it was scheduled to take effect.

U.S. District Judge Amit P. Mehta in Washington, D.C., on Monday sided with a coalition of drug companies and blocked the Trump administration from implementing a policy that would require prescription drug manufacturers to disclose list prices in TV ads.

In May of 2019, the U.S. Department of Health and Human Services (“HHS”) published a final rule that regulates the marketing of prescription drugs. The rule requires drug manufacturers to disclose in any television advertisement the list price – also known as the wholesale acquisition cost – of a 30-day supply of the drug (“WAC Disclosure Rule”).

Merck & Co., Inc.; Eli Lilly and Company; and Amgen Inc.- and the National Association of Advertisers, Inc., a membership organization contend in a lawsuit they filed, that the WAC Disclosure Rule is unlawful. Plaintiffs advance two primary arguments.

First, they argue that the Rule exceeds HHS’s authority, because Congress neither expressly nor impliedly granted HHS the power under the Social Security Act to regulate drug marketing. Second, they maintain that the WAC Disclosure Rule is compelled speech that violates the First Amendment. Plaintiffs have asked the court to halt the WAC Disclosure Rule before it goes into effect.

The court found that HHS lacks the statutory authority under the Social Security Act to adopt the WAC Disclosure Rule. Neither the Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The Rule is therefore invalid.

The court went on to conclude that “no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

It is not immediately clear how the administration will proceed, but the ruling threatens to rob President Trump of an important victory in the fight over drug costs.

Drug companies fought the rule from the start, arguing it would confuse consumers because a drug’s list price – which doesn’t reflect the discounts negotiated with insurers or through patient assistance programs – is often higher than what the patient actually pays.

Tricia Neuman, senior vice president of the Kaiser Family Foundation, said the administration and Congress are working on other drug pricing initiatives, but the decision is “certainly a setback for the administration.”

Neuman said drug pricing transparency “in and of itself is unlikely to have a huge impact on prices. There are a number of other proposals the administration and Congress are moving forward with that will have a more significant impact.”

But those initiatives, like tying what Medicare pays for drugs to what other countries charge, or even allowing Medicare to directly negotiate drug prices, are not close to being completed, and it’s not certain they will ever be finalized.

A drug industry lobbyist called the decision a “Pyrrhic victory,” because it would likely spur Congress to act.

“They won the battle and got the rule defeated, but now it’s likely going to be in legislation,” the lobbyist said, adding that it’s an easy bipartisan issue for lawmakers to support.

Bipartisan legislation introduced by Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Sen. Dick Durbin (D-Ill.) would codify the HHS regulation into law. The bill could be added to a legislative package that Grassley is trying to push through the committee.

A companion bill in the House is sponsored by Rep. Francis Rooney (R-Fla.).

Psychiatric Diagnosis are “Scientifically Meaningless”

A new study conducted at the University of Liverpool has raised eyebrows by concluding that psychiatric diagnoses are “scientifically meaningless,” and worthless as tools to accurately identify and address mental distress at an individual level.

Researchers performed a detailed analysis on five of the most important chapters in the Diagnostic and Statistical Manual of Mental Heath Disorders (DSM). The DSM is considered the definitive guide for mental health professionals, and provides descriptions for all mental health problems and their symptoms. The five chapters analyzed were: bipolar disorder, schizophrenia, depressive disorders, anxiety disorders, and trauma-related disorders.

Researchers came to a number of troubling conclusions.

First, the study’s authors assert that there is a significant amount of overlap in symptoms between disorder diagnoses, despite the fact that each diagnosis utilizes different decision rules. Additionally, these diagnoses completely ignore the role of trauma or other unique adverse events a person may encounter in their life.

Perhaps most concerning of all, researchers say that these diagnoses tell us little to nothing about the individual patient and what type of treatments they will need.

The authors ultimately conclude that this diagnostic labeling approach is “a disingenuous categorical system.”

“Although diagnostic labels create the illusion of an explanation they are scientifically meaningless and can create stigma and prejudice. I hope these findings will encourage mental health professionals to think beyond diagnoses and consider other explanations of mental distress, such as trauma and other adverse life experiences.” Lead researcher Dr. Kate Allsopp explains in a release.

According to the study’s authors, the traditional diagnostic system being used today wrongly assumes that any and all mental distress is caused by a disorder, and relies far too heavily on subjective ideas about what is considered “normal.”

Perhaps it is time we stopped pretending that medical-sounding labels contribute anything to our understanding of the complex causes of human distress or of what kind of help we need when distressed.” Professor John Read comments.

The study is published in the scientific journal Psychiatry Research.

July 8, 2019 News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Court Ends Disgruntled Claimant’s 13 Years of Litigation, West Hollywood Doctor Faces Fraud Charges, Senior Care Facility Cited for $708K Wage Theft, Uninsured Security Company Owners Convicted, “Mini” MRI Under Development, 48% of Doctors Considering Career Change, Nurses Suffer Chronic Sleep Disorders, United Insurance Named as Applied Underwriters Buyer.

Sedgwick to Acquire York Risk Services

Sedgwick has signed an agreement to acquire York Risk Services Group. Following the close of the transaction, Sedgwick will gain more than 60 offices across the US and nearly 5,000 employees, taking its total workforce up to nearly 27,000.

Once approved, the deal would mark Sedgwick’s third acquisition of a TPA in five years. The Memphis, Tennessee-based company purchased Cunningham Lindsey in 2018 and T&H Global Holdings, owner of VeriClaim, in 2014.

Sedgwick Group President Michael Arbour said during an interview that the purchase of York will enhance the company’s scope of services and improve its access to talent in the claims industry. He said York is active in some market segments where Sedgwick has little presence, such as with Longshore and Harbor Workers’ Compensation and Defense Base Act claims and the administration of group risk pools.

He noted that York also is in a strong position as a service provider for public agencies and provides managed care services for other claims administrators. Sedgwick also provides managed care services, but only to clients for whom it adjusts claims, he said.

“We’ve admired them as a friendly competitor for years,” Arbour said. “They do a lot of things that we do and they do a lot things that we don’t do.”

“Joining forces with Sedgwick will provide enhanced capabilities for York’s clients and new opportunities for our associates,” said Thomas Warsop, chairman and CEO of York. “It’s great news for all.”

“At Sedgwick, taking care of people is at the heart of everything we do,” North said. “Bringing together the expertise and capabilities of Sedgwick and York will allow us to serve more customers in more places and show an unprecedented number of people how caring counts.”

BofA Merrill Lynch and Morgan Stanley & Co. LLC served as financial advisors to Sedgwick, and Simpson Thacher & Bartlett LLP and Clifford Chance US LLP served as legal advisors. Jefferies LLC and J.P. Morgan Securities LLC served as financial advisors to York, and Fried, Frank, Harris, Shriver & Jacobson LLP served as its legal advisor. BofA Merrill Lynch and Morgan Stanley Senior Funding, Inc. have provided committed debt financing for the transaction.

The closing of the transaction is subject to customary conditions and regulatory approvals. The terms of the agreement were not disclosed.

Sedgwick isn’t the only third-party administrator on a buying spree. Also on Monday, Fairfax Financial Holdings’ Riverstone subsidiary announced that it has acquired Rockville Risk Management Associates and its sister company, ER Quinn Co.

Joe Paduda, owner of the employer consulting firm Health Strategy Associates, said the merger of the two TPAs – both of which adjust workers’ compensation claims – is not surprising.  “There’s no question there will be more consolidation in the industry,” he said in an email. “Worker’s comp is a shrinking business and consolidation is a foregone conclusion.”

LAPD Officer Pleads No-Contest to Comp Fraud

A nine-year veteran of the Los Angeles Police Department, whose last assignment was with the Valley Traffic Division, has pleaded no contest to one misdemeanor count of workers’ compensation insurance fraud.

Jason Gordon, 48, entered the plea, and was immediately placed on three years of summary probation by Los Angeles County Superior Court Judge William N. Sterling. Gordon additionally is required to complete 300 hours of community service and pay more than $12,000 in restitution under the terms of a negotiated plea agreement.

The LAPD’s Special Operations Division Workers’ Compensation Fraud Unit conducted an investigation that began when Gordon filed a medical claim in 2015.

Over several months in 2016, Gordon went on workers’ compensation leave for an on-the-job injury at the Los Angeles Police Department but was found to be engaged in certain physical activities that were inconsistent with his claimed injury.

Investigators worked with the L.A. County District Attorney’s Healthcare Fraud Division and the L.A. City Attorney’s Office to established probable cause to believe Gordon “knowingly engaged” in physical workout activities.

The case was investigated by the LAPD’s Special Operations Division, Workers’ Compensation Fraud Unit. Deputy District Attorney Arunas Sodonis of the Healthcare Fraud Division prosecuted the case.

Congress Pressures FDA for Cannabis Regs

Congress is cranking up the pressure on the Food and Drug Administration (FDA) to draft rules to regulate cannabis-based products.  Lawmakers legalized the use of hemp-based cannabidiol (CBD) products late last year in the farm bill, sending the agency scrambling to figure out new rules around regulating a unique product that is both a drug and a dietary supplement.

But Congress is signaling that it is growing impatient as the FDA looks for a solution and may not wait on the sidelines for much longer.

“In Congress, some are itchy [for action],” said Jonathan Miller, general counsel for the industry advocacy group U.S. Hemp Roundtable.  Miller said some lawmakers have been privately circulating potential legislation, but he doesn’t expect any formal push from Congress until at least later this fall. “If their patience ends [and FDA doesn’t act], there will be an effort for legislation,” Miller said.

The FDA held a public hearing at the end of May, and experts and industry representatives said it was a good start but did not advance the ball much in terms of giving clarity from a federal level. People who attended the meeting said they left without any new sense of the agency’s timing on creating new regulations.

During the 10-hour hearing, acting FDA Commissioner Ned Sharpless made no promises about timing, but FDA officials were clear that they wanted more data from the public. Sharpless said the agency was essentially operating in uncharted waters.

In particular, FDA wants more information about dosing levels, including how much CBD is safe to consume, and any long-term exposure risks. The agency is also focused on the effects CBD has on children, elderly and pregnant women.

Public comments concerning FDA’s role are due July 16, after the agency extended the deadline for an additional two weeks.

CBD is derived from the marijuana plant but doesn’t give users a high. Ever since the farm bill passed, CBD products have been appearing online and on the shelves of convenience stores, coffee shops and nutrition stores in select states.

In the meantime, lawmakers from both parties are trying to nudge FDA to act. A provision in the House appropriations package that passed last month sets aside funding for FDA to study and set specific levels of CBD to put in food and drinks.

Senate Majority Leader Mitch McConnell (R-Ky.) met with Sharpless last week, and urged the agency to speed up the timing on CBD regulation. “Congress’s intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement,” McConnell said in a statement. “Like my constituents, I am anxious to know the FDA’s plans to ensure public access to safe CBD products,” he added.

Sen. Ron Wyden (R-Ore.) did not meet with Sharpless personally, but last week sent a letter to the agency urging FDA to set an interim policy by Aug. 1 that would allow products containing hemp-derived CBD to be manufactured and sold as food and dietary supplements. Wyden said it was “fully unacceptable” for FDA to suggest it may take up to five years to issue rules. “The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time,” Wyden wrote.