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EU to Ban 300 “Unreliable” Generic Drugs

Europe’s medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to “unreliable” tests conducted by Indian contract research firm Micro Therapeutic Research Labs.

The decision, announced by the European Medicines Agency (EMA) on its website, is the latest blow for India’s drug-testing industry, which has run into a series of problems with international regulators in recent years.

Nobody at the Chennai-based company was immediately available to comment.

A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. … CROs range from large, international full-service organizations to small, niche specialty groups.

According to the report in Reuters Health, the EMA said European officials had been investigating Micro Therapeutic’s compliance with good clinical practice after Austrian and Dutch authorities raised concerns in February 2016.

“The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling,” the agency said.

However, there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers.

The EMA’s recommendation on the suspension of the medicines tested by Micro Therapeutic will now be sent to the European Commission for a legally binding decision valid throughout the European Union.

Drug tests carried out at Indian contract research organizations (CROs) have been key in getting a huge array of generic medicines approved for sale around the world over many years.

In 2015, Europe banned around 700 medicines that had been approved based on clinical trial data provided by GVK Biosciences, then India’s largest CRO. Other smaller Indian CROs have also been found to have fallen short of required standards.

In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years, according to consultants and industry executives.

Anthem Accuses Express Scripts of Price Gouging

A legal battle has pitted a major national insurer and its pharmacy benefit manager (PBM) against each other in dueling legal actions in litigation that seeks class action status that could include tens of thousands of claimants.

Anthem is one of the nation’s largest health insurers with more than 38 million members. Express Scripts handled more than 175 million claims for Anthem in 2015 alone, according to the complaint.

The saga starts when Anthem sued Express Scripts last March, accusing it of excessive pricing and operational failures. It also sought the right to terminate its 10-year contract with Express Scripts, which began in 2009.

Express Scripts was contracted as Anthem’s exclusive provider of PBM services for Anthem-administered health insurance plans for a ten year period. Part of the agreement was a “periodic pricing review” to ensure that Anthem was receiving competitive benchmark pricing for drugs. However, when Anthem engaged Health Strategy, LLC. as a private consultant to conduct a comprehensive market analysis Anthem discovered that Express Scripts did not provide competitive benchmark pricing.

Based on the Health Strategy’s analysis, ESI’s current pricing to Anthem exceeded competitive benchmark pricing by more than $3 billion annually, and $13 billion over the remaining term of the Agreement. This was the basis of the March Anthem v Express Scripts litigation.

In its counterclaims against Anthem, Express Scripts said the insurer rejected several proposals to renegotiate prices. In addition, Express Scripts’ legal document says Anthem was offered a choice of “less money up front but lower pricing” or a bigger upfront payment “with higher pricing for Express Scripts’ services.”

It chose the higher prices over the course of the contract in exchange $4.6 billion more in upfront fees, according to the PBM’s counterclaim. That money, Express Scripts’ documents allege, was then used by Anthem to buy back its own stock, rather than passing it along to health plan members. The stock buyback “applied upward pressure to Anthem’s stock price, thereby enriching shareholders and management,” the filing alleges.

Two months later, two health plan participants sued both companies under the Employee Retirement Income Security Act challenging Express Scripts’ alleged overbilling.

Express Scripts Inc. and Anthem Inc. are accused in a proposed class action of breaching their ERISA fiduciary duties by entering into the 10-year, multibillion-dollar prescription-drug agreement that caused plan participants to overpay for benefits ( Burnett v. Express Scripts, Inc. , S.D.N.Y., No. 1:16-cv-04948, complaint filed 6/24/16 ). “This action seeks to recover losses suffered by the plaintiffs…who overpaid and continue to overpay for the portions of the costs of prescription drugs…they are responsible for paying as plan participants,” says the lawsuit.

Express Scripts spokesman David Whitrap said the firm denies “the allegations and will defend ourselves vigorously.” Anthem, too, denied the allegations and said it would fight the charges. However, the “denied” allegations echo those in Anthem’s March lawsuit against Express Scripts, and counterclaims filed shortly thereafter by Express Scripts against Anthem.

The court has not yet decided if the suit will have class action status.

The federal judge has dismissed two of the six counterclaims that Express Scripts raised in Anthem $15 billion lawsuit. In a decision recently made public, U.S. District Judge Edgardo Ramos in Manhattan dismissed Express Scripts’ claim that Anthem breached an implied covenant of good faith and fair dealing, saying it duplicated a breach of contract claim. He also dismissed an unjust enrichment claim filed by Express Scripts.

Express Scripts has contracts with insurers and other administrators of workers’ compensation benefits in California. It is unclear if any of Anthem’s allegations apply to any of the California workers’ compensation pharmacy benefit contracts.

“Medical” Marijuana Annual Market to be $50 Billion

The biggest marijuana market for now is the United States, with estimates that it will surpass $20 billion by 2020.  And the workers’ compensation industry is carefully watching the evolving trend, which some say will soon reach its doorstep. The momentum is increasing with billions of dollars now pushing the momentum to yet higher levels of energy.

But importing cannabis to the United States is illegal under federal law. The only way to get around the ban is to receive approval from the U.S. Food and Drug Administration (FDA).

Britain’s GW Pharmaceuticals’ Epidiolex – an experimental cannabis-based drug to treat epilepsy – could be the first to get the green light.

“The medical cannabis industry is much larger than the U.S.,” said Matthew Ginder, whose Florida-based law firm represents cannabis businesses, including in Israel. Growing acceptance of medical marijuana creates opportunities in countries that have legalized medical marijuana but have not developed the infrastructure, he said.

Canada, for instance, exports medical cannabis to Australia, Croatia and Chile.

And now Reuters Health reports that Israel, a leader in marijuana research and health technology, is attracting international investment as it tries to position itself as a cutting-edge exporter in the rapidly-growing market for medical-grade cannabis.

With estimates that the global market for medical marijuana could reach $50 billion by 2025, the Israeli government is set to allow the local industry to start exporting and projects annual revenues in the hundreds of millions of dollars.

Medical cannabis is a relatively new field with no universal clinical standard. Israel aims to fill the void by combining its expertise in agriculture, technology and cannabis-based medicine, said Yuval Landschaft, head of the health ministry’s medical cannabis unit (IMCA).

“In the United States, for example, they use recreational marijuana for medical use – that’s like making chicken soup when you have a cold,” Landschaft told Reuters. “We’re the ones making the antibiotics.”

The strategy is to create medical-grade cannabis with quality and efficacy ensured along the entire supply chain from cultivation to manufacture and distribution.

In contrast to the United States, which is currently the biggest legal marijuana market, authorities in Israel are liberal in their support of research and development.

Licensed marijuana growers work with scientific institutions in clinical trials toward the development of cannabis strains that treat a variety of illnesses and disorders.

There are about 120 studies ongoing in Israel, including clinical trials looking at the effects of cannabis on autism, epilepsy, psoriasis and tinnitus.

The health ministry wants to share its acquired knowledge and train doctors from abroad. Talks are underway with Australia, Germany, Brazil and others, Landschaft said.

The government gave the go-ahead in February to legislation that would allow export.

More than 500 Israeli companies have applied for licenses to grow, manufacture and export cannabis products, according to government officials, and some are already capitalizing on the booming U.S. market.

In the past year, U.S. and other firms have invested about $100 million to license Israeli medical marijuana patents, cannabis agro-tech startups and firms developing delivery devices such as inhalers, said Saul Kaye, chief executive of iCAN, a private cannabis research hub in Israel.

Kaye expects investment to grow ten-fold and reach $1 billion over the next two years.

Tikun Olam, Israel’s largest grower, has partnered with U.S. companies to cultivate marijuana in four U.S. states, chief executive Aharon Lutzky said. Pending government approval, it hopes to export to Europe and South America.

Convicted Employer Faces Premium Fraud Claims Again!

A Maine woman has filed suit in federal court against a California security services firm, saying the company retaliated against her when she complained about allegedly illegal acts being committed by one of its executives, Ousama Karawia.

Karawia was convicted in Los Angeles in 2012 for grand theft, insurance fraud and possession of an assault weapon for offenses committed at a security service he co-owned at the time that had provided security for sites in California and the Statue of Liberty in New York.

He was found guilty in 2012 of setting up a shell company to hide the true number of his employees as a way to avoid paying higher workers’ compensation premiums.

The trial court sentenced Karawia to five years in state prison on the fraud by misrepresentation count, suspended execution of that sentence, and placed him on probation for a period of five years on the condition that he serve 240 days in custody, which could be served by electronic monitoring.

According to the report in the Portland Press Herald, Pamela Treadwell, who worked for Vescom from 1988 until she resigned in March 2014, said in court documents that many of the problems began when Vescom, her employer, hired a man named Ousama Karawia to help with management of the firm.

Vescom is a part of Worldwide Sourcing Group, or WWSG, which also owns the security firms Vets Securing America, American Guard Service and Professional Building Maintenance, a property management company. The company says it is one of the largest privately owned security firms in the country.

Vescom had an office in Hampden Maine that has since been closed, and the company is now based in California. Treadwell’s lawsuit was filed in Maine state court and subsequently moved to the U.S. District Court in Portland because Vescom is located out of state.

According to the 2017 lawsuit, Karawia allegedly committed insurance fraud while at Vescom by getting a policy that covered employees of WWSG’s other companies at a low rate, but using Vescom’s claims history rather than the higher claims rate of the other companies.

Treadwell said in the lawsuit that she told the company’s owners that Karawia was getting kickbacks from the insurer and that having him involved in the company ran afoul of state licensing regulations that bar felons from having management positions in a security firm. Karawia had of course been convicted in the above California criminal case before he was hired at Vescom, and his appeal of his sentence was turned down by the California Court of Appeal in 2014.

After forwarding those concerns to the company’s owners, the lawsuit claims, Treadwell was shunned by the top management in the company and told she had to pay for insurance coverage for her husband on her employer-provided health care policy at a cost of $7,800 a year.

Finally, Karawia moved money out of the company’s payroll account, meaning that employees’ checks would bounce, according to the lawsuit. Treadwell said Karawia reminded her that as the company vice president, her name was on the checks, suggesting she might be liable if they bounced.

At that point, Treadwell said she resigned so as not to be implicated in the check-bouncing and accused of submitting false documents to state regulators.

CWCI Studies Spine Fusions

A new study on the use of spinal fusion surgeries in California workers’ compensation finds that in 60% of all spinal fusion claims the initial report of injury was for a sprain or strain; a majority of the fusions occurred within two years of the injury; and as the claims aged, more than 20% involved at least one subsequent fusion surgery.

The analysis by the California Workers’ Compensation Institute (CWCI) is based on data from more than 18,266 California work injury claims from accident years (AY) 2000 through 2014 in which one or more spinal fusions were performed. Using claims data from the Institute’s Industry Research Information System database, CWCI Senior Research Associate Stacy L. Jones identified spinal fusion claim characteristics (cause and nature of injury, part of the spine that was fused and the number of spinal segments involved); patient demographics; the presence of comorbidities; and the average amounts paid in indemnity and medical benefits.

In addition the study measured the timing of the initial fusion and the presence and timing of any subsequent fusions; independent medical review outcomes for spinal fusion requests; utilization trends for MRIs, pre- and post-surgery physical therapy, and the level of pre- and post-surgical opioid use. Among the findings:

– Men accounted for more than 64% of the spinal fusion claims in each of the 15 years studied, and average amounts paid across the entire span were higher for males than females (15.5% more for temporary disability; 27.1% more for permanent disability; and 16% more for medical).
– 62% of the claims that involved a spinal fusion were initially reported as strain and sprains; followed by cumulative traumas (including mental stress), which comprised 14%.
– Lumbar fusions accounted for nearly half of the workers’ comp spinal fusions; while fusions involving additional vertebral segments (i.e., multiple-level fusions) represented 1/3 of all fusions.
– Mental health disorders were the leading comorbidity (noted in 37% of spinal fusion cases), while 29.9% involved circulatory problems, and 17.1% listed substance abuse as a comorbid condition.
– Loss payments on medical back diagnoses without spinal cord involvement averaged as much as $378,392 in AY 2003, or 6.7 times the average for similar claims without a spinal fusion.

The Institute has published a full report on the study, including additional results, background information, tables, and commentary as a CWCI Report to the Industry, “Spinal Fusion Claims in California Workers’ Compensation.” CWCI members and subscribers may log on to the Research section to access the report, while others may purchase the report for $32.

DWC Extends Deadline for RTW Supplement Program

An amendment that extends the deadline to file for the Return-to-Work Supplement Program (RTWSP) has been approved by the Office of Administrative Law (OAL) and filed with the Secretary of State, effective March 20, 2017.

The regulation amendment extends the deadline to file for RTWSP benefits for certain individuals who received the Supplemental Job Displacement Benefit (SJDB) voucher between April 13, 2015 and December 1, 2015, and who may not have received notice of their eligibility to apply for the RTWSP benefit.

The amendments to 8 CCR section 17304 are shown below with new language underlined and deleted language struck through:

(a) An application for the Return-to-Work Supplement must be received by the Return-to-Work Supplement Program within one year from the date the Voucher (DWC-AD Form 10133.32 (SJDB) Rev: 10/1/15, or later version) was served on the individual.

(b) Notwithstanding subdivision (a) of this section, an application for the Return-to-Work Supplement from any individual who was issued a Voucher prior to December 1, 2015, for an injury occurring on or after January 1, 2013, must be received by the Return-to-Work Supplement Program no later than or within one year from the effective date of this subdivisionese regulations, whichever is later.

Applicants who were previously denied due to the eligibility deadline due to the eligibility deadline do not need to reapply. Their case will be reopened, reviewed, and a new determination made within 60 days.

The amended regulations can be found on the DIR website.

Chubb Comp Coverage – There’s an App for That!

A new online system from Chubb will help independent agents quote and issue a comprehensive workers’ compensation policy for small businesses.

“Our new workers’ compensation system is efficient and fully automated, making it easier for our agents to place and service small business accounts,” said Jim Williamson, Division President, Small Commercial Insurance, Chubb North America.

Chubb’s workers’ compensation policy for small business owners is designed to meet the needs of a wide range of industries, and includes the following coverage highlights:

– Provides coverage for small businesses with as few as one employee up to businesses with revenues of $10M
– Includes small business protection for medical expenses and lost wages to employees, providing security and peace of mind for employers
– Incorporates versatile coverage options including waiver of subrogation and various employer liability limits
– Easy, 24/7 automated system access with the ability to generate a quote and issue a policy in just minutes

When combined with Chubb’s business owner’s policy (Chubb BOP), Chubb’s workers’ compensation policy for small businesses provides customers an insurance solution with broad coverage and Chubb’s policy and claim service capabilities.

Williamson added, “At Chubb we understand that employees are a small business’ most valuable asset and are often like family. Our goal is to provide small business owners the confidence of knowing if an injury or illness occurs on the job, they’ll have the right coverage in place to ensure their employees, and their businesses, will return to normal as quickly and cost-effectively as possible.”

Chubb is the world’s largest publicly traded property and casualty insurance company. With operations in 54 countries, Chubb provides commercial and personal property and casualty insurance, personal accident and supplemental health insurance, reinsurance and life insurance to a diverse group of clients.

Parent company Chubb Limited is listed on the New York Stock Exchange (NYSE: CB) and is a component of the S&P 500 index. Chubb maintains executive offices in Zurich, New York, London and other locations, and employs approximately 31,000 people worldwide.

As IMR Volume Grows – 90% of UR Upheld

A CWCI analysis of the California workers’ comp independent medical review (IMR) process used to resolve medical disputes finds that in 2016, IMR physicians once again upheld about 90% of utilization review (UR) physician’s modifications or denials of treatment, yet IMR volume continued to grow, climbing 6.5% last year.

The California Workers’ Compensation Institute (CWCI) analysis is based on a review of data from 477,045 IMR decision letters issued in 2014, 2015, and 2016 in response to applications submitted to the state after a UR physician modified or denied a requested medical service.

State lawmakers who included IMR in the 2012 workers’ comp reforms expected the process would reduce workers’ comp treatment disputes once doctors, attorneys and other participants came to understand which services could be approved because they meet evidence-based medicine standards. Three years in, however, IMR volume is at a record high, as the Division of Workers’ Compensation reports there were 10,477 more cases in 2016 than in 2015.

The 2016 IMR outcomes data show that IMR physicians upheld the UR doctor’s modification or denial of a requested service 91.2% of the time, which was up from an 88.4% uphold rate in 2015 and matched the rate noted in 2014.

The mix of services reviewed by IMR physicians in 2016 showed little change from the two prior years, as prescription drug requests (28.5% of which were for opioids) again accounted for nearly half of all IMRs, with UR modifications or denials of pharmaceutical requests upheld 92.5% of the time.

Notably, requests for compounded drugs (typically gels or creams) did represent a declining share of the 2016 prescription drug IMRs, as they fell from 8.0% of the 2015 determinations to 6.2% last year, which may have to do with their consistently low IMR overturn rate (IMR physicians deemed them not medically necessary 99% of the time in 2014, 2015, and 2016).

Requests for physical therapy, injections and durable medical equipment together represented about 24% of the 2016 IMRs, while no other medical service category accounted for more than 5% of the disputed requests.

Among the medical service categories, uphold rates in 2016 ranged from 78.9% for evaluation and management services (primarily referrals for consultations) to 93.6% for acupuncture.

As in the prior 2 years, the analysis found that most of the disputed medical services that went through IMR in 2016 were requested by a small number of physicians. The top 10% of physicians named in the 2016 IMR decision letters (1,248 physicians) accounted for 85% of the disputed service requests, while the top 1% (125 providers) accounted for 44%.

Significant geographic variation was again evident as well, as 32.8% of the IMR decision letters were addressed to Los Angeles County recipients even though the region only accounted for 23.6% of all workers’ comp medical services in the state.

IMR volume also was disproportionately high in the Bay Area, which accounted for 20.1% of the IMR letters vs. 15.2% of the medical services; while less populated regions of the state had a disproportionately small share of the IMRs, as did the Inland Empire, Orange County and San Diego.

A complete analysis of the latest IMR results has been released in a CWCI Spotlight Report, “Independent Medical Review Decisions: January 2014 Through December 2016.”

LA Rite Aid Pharmacies Settle Fed Drug Charges

Rite Aid Corporation has paid $834,200 in civil penalties to the United States to settle claims stemming from alleged violations of the Controlled Substances Act.

Rite Aid paid the civil settlement as part of an agreement reached last week to resolve allegations that certain Rite Aid pharmacies in Los Angeles dispensed and/or recorded controlled substances using a medical practitioner’s incorrect or invalid DEA registration number. The government alleged that the incorrect or invalid registration numbers were used at least 1,298 times as a result of Rite Aid’s failure to adequately maintain its internal database.

The settlement also resolves allegations that Rite Aid pharmacies dispensed, on at least 63 occasions, prescriptions for controlled substances written by a practitioner whose DEA registration number had been revoked by the DEA for cause.

In 1970, the United States Congress passed the Controlled Substances Act (CSA), which created “a closed system” of distribution for controlled substances. The CSA established a regulatory framework to control every facet of the handling of the substances, from their manufacture to their consumption.

The CSA became law against the backdrop of increasing diversion and abuse of legitimate controlled substances, but the law was also designed to ensure an adequate supply of those substances needed to meet the medical and scientific needs of the United States.

“Accurate record keeping at retail pharmacies helps ensure that authorities can keep track of how many controlled substances a pharmacy should have and does have on hand,” said United States Attorney Eileen M. Decker. “These federal regulations were put into place to prevent the abuse of powerful drugs that are dispensed by pharmacies and should only be used under the careful watch of a medical professional.”

In entering into and paying the settlement, Rite Aid did not admit liability. Prior to entering into the agreement, Rite Aid implemented a DEA registration validation program designed to verify DEA registration numbers for medical professionals who prescribe controlled substances.

“This settlement demonstrates DEA’s commitment to monitoring and holding accountable all potential sources of diversion for controlled substances and maintaining the safety of our communities,” said DEA Special Agent in Charge Steve Comer

This case was investigated by the Drug Enforcement Administration’s Office of Diversion Control, Los Angeles Field Division.

The settlement was negotiated by Assistant United States Attorney Donald W. Yoo of the Civil Fraud Section.

Can Employers Subrogate Against Opioid Drugmakers?

This January, the city of Everett, in Washington filed a first-of-its-kind lawsuit against Purdue Pharma alleging the drug maker “supplied OxyContin to obviously suspicious physicians and pharmacies,” ultimately failing “to prevent the illegal diversion of OxyContin into the black market.”

While other suits against the company by states and municipalities have accused Purdue Pharma of deceptive marketing – allegedly playing up OxyContin’s effectiveness while playing down its addictiveness – Everett’s lawsuit is the first to claim the company knew its drugs were being diverted and did nothing to stop it.

In particular, the complaint outlines a drug ring that began with a sham clinic in Los Angeles and ended with a kingpin running OxyContin on the streets of Everett. The unravelling was detailed in a Los Angeles Times investigation that triggered the idea for Everett’s lawsuit.

The so-called Los Angeles pill mill was ultimately shut down and the cadre of physicians, pharmacists, and dealers that kept it churning were prosecuted.

In Everett, Washington, the jail is overflowing with addicts, the detox facility is set to double in size, and the city spends a fortune clearing its streets and parks of needles and tiny plastic bags.Those are the hallmarks of a heroin epidemic that began, city officials said, as a crisis dating back to the late 2000s that involved different drugs: opioid prescription painkillers.

Nearly a decade after the opioid onslaught, Everett is still struggling with the cost. And now the city wants the company that manufactured OxyContin to pay the bill.

Key to the complaint are internal Purdue emails outlined by the Los Angeles Times, including a 2009 excerpt from an exchange between the company’s compliance director and a sales manager who had become suspicious of the number of OxyContin prescriptions traced back to the clinic’s doctors.

After paying the clinic a visit, the sales manager wrote that “the line was out the door, with people who looked like gang members. I feel very certain that this is an organized drug ring.”

Purdue Pharma disputes the allegations in the lawsuit. In a statement to NBC News, the company said the city “paints a flawed and inaccurate portrayal of events that led to the crisis in Everett.”

The company said it has been a leader in developing abuse-deterrent medications, “which the FDA and National Institute on Drug Abuse have said are making a difference in the fight against abuse.” The company also said that OxyContin accounts for less than 2 percent of all opioid prescriptions in the United States.

The first Oxycontin lawsuit to successfully procure a settlement came in 2007. The federal Oxycontin lawsuit alleged that the company had fraudulently encouraged over-prescription of the drug.This Oxycontin lawsuit distributed $130 million to victims of Oxycontin addiction. The “settlement” of the civil case was however part of a package settlement of criminal charges also pending against the company, and may not have been accomplished otherwise.

Private Oxycontin lawsuits concerning side effects have not been widely successful; however, a large number of Oxycontin lawsuits were settled out-of-court.

Santa Clara and Orange counties filed a case in 2015 in Orange County Superior Court. They alleged that Purdue Pharma, Cephalon, Janssen Pharmaceuticals, Endo Health Solutions and Actavis violated California’s false advertising and unfair competition laws and created a public nuisance. The case was placed on hold in 2015 pending the outcome of FDA investigations that were underway at the time.

Chicago sued Teva Pharmaceuticals, Purdue Pharma Inc. and other drugmakers in 2014, saying they misled doctors and the public about the addictive nature of opiates and pushed prescriptions despite known dangers of addiction. A defense request for a stay order pending FDA investigations was denied in September 2016, and the Chicago case is still active.

The case is City of Chicago v. Purdue Pharma LP et al., case number 1:14-cv-04361, in the U.S. District Court for the Northern District of Illinois. The current federal court docket shows the case to be in the discovery stage with 439 documents filed in the case so far. The Third Amended Complaint filed on October 25, 2016 contains 341 pages of specific allegations against the defendant drugmakers (not counting exhibits) and reads like an organized crime fiction novel laced with intrigue. The information in this document would certainly steer a competent subrogation lawyer in the right direction to find evidence to make a case.

The outcome of these pending cases, and certainly more to follow, will weigh heavily on the answer to the question about the subrogation potential against opiate drugmakers for recovery of the costs of some of our most costly and protracted injury claims.