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Cal/OSHA Fines LAX Employer $94K For Safety Violations

The Daily Breeze reports that Cal/OSHA has issued citations resulting in fines of $94,550 against U.K.-based Menzies Aviation, a contractor at Los Angeles International Airport, for unsafe working conditions, a union official said Thursday. Jacob Hay of SEIU-United Service Workers West said that the state Department of Industrial Relations’ Division of Occupational Safety and Health, or Cal/OSHA, found the alleged violations during an investigation.

According to Hay, they included an inadequate safety guard on a high-lift industrial truck the company knew about and did not correct, and a failure to train workers on how to properly handle hazardous substances or properly store of hazardous substances in warehouses on airport property. Menzies also was cited for faulty electrical equipment, and for failing to keep an oxygen cylinder safely separated from a fuel gas cylinder, Hay said.

A regional manager for Menzies in Los Angeles said the company had no immediate comment.

The investigation began after Menzies workers filed a complaint with help from the Los Angeles Labor Federation and the Southern California Coalition for Occupational Safety and Health.

Menzies Aviation provides baggage handling, cargo, and cargo-forwarding services to airline clients at more than a dozen major airports in the country.

70% of Americans Now on Prescription Drugs

Mayo Clinic researchers found that nearly 70 percent of Americans are on at least one prescription drug, and more than half take two. The study found that antibiotics, antidepressants and painkilling opioids are most commonly prescribed, Twenty percent of patients are on five or more prescription medications, according to the findings, published online in the journal Mayo Clinic Proceedings.

The statistics from the Rochester Epidemiology Project in Olmsted County, Minn. are comparable to those elsewhere in the United States, says study author Jennifer St. Sauver, Ph.D., a member of the Mayo Clinic Population Health Program in the Mayo Clinic Center for the Science of Health Care Delivery.

“Often when people talk about health conditions they’re talking about chronic conditions such as heart disease or diabetes,” Dr. St. Sauver says. “However, the second most common prescription was for antidepressants – that suggests mental health is a huge issue and is something we should focus on. And the third most common drugs were opioids, which is a bit concerning considering their addicting nature.”

Seventeen percent of those studied were prescribed antibiotics, 13 percent were taking antidepressants and 13 percent were on opioids. Drugs to control high blood pressure came in fourth (11 percent) and vaccines were fifth (11 percent). Drugs were prescribed to both men and women across all age groups, except high blood pressure drugs, which were seldom used before age 30.

Overall, women and older adults receive more prescriptions. Vaccines, antibiotics and anti-asthma drugs are most commonly prescribed in people younger than 19. Antidepressants and opioids are most common among young and middle-aged adults. Cardiovascular drugs are most commonly prescribed in older adults. Women receive more prescriptions than men across several drug groups, especially antidepressants: Nearly 1 in 4 women ages 50-64 are on an antidepressant.

For several drug groups, use increases with advancing age. “As you get older you tend to get more prescriptions, and women tend to get more prescriptions than men,” Dr. St. Sauver says. Prescription drug use has increased steadily in the U.S. for the past decade. The percentage of people who took at least one prescription drug in the past month increased from 44 percent in 1999-2000 to 48 percent in 2007-08. Spending on prescription drugs reached $250 billion in 2009 the year studied, and accounted for 12 percent of total personal health care expenditures. Drug-related spending is expected to continue to grow in the coming years, the researchers say.

This new study demonstrates the statistical likelihood that there are opportunities for apportionment of permanent disability that may be overlooked by employers.

Scientists to Grow Human Organs Within One Year

Regenerative medicine is the “process of replacing or regenerating human cells, tissues or organs to restore or establish normal function”.This field holds the promise of regenerating damaged tissues and organs in the body by replacing damaged tissue and/or by stimulating the body’s own repair mechanisms to heal previously irreparable tissues or organs. Regenerative medicine also empowers scientists to grow tissues and organs in the laboratory and safely implant them when the body cannot heal itself. Importantly, regenerative medicine has the potential to solve the problem of the shortage of organs available for donation compared to the number of patients that require life-saving organ transplantation. Depending on the source of cells, it can potentially solve the problem of organ transplant rejection if the organ’s cells are derived from the patient’s own tissue or cells.

And this technology is advancing at a pace much faster than one would think. The advancement of medical technology should be considered by claim administrators as they set reserves for future medical care for young claimants.

The UK Telegraph reports that a panel of scientists and legal experts appointed by the government in Japan has drawn up a recommendation that will form the basis of new guidelines for Japan’s world-leading embryonic research. There is widespread support in Japan for this research that has raised red flags in other countries. Scientists plan to introduce a human stem cell into the embryo of an animal – most likely a pig – to create what is termed a “chimeric embryo” that can be implanted into an animal’s womb.

That will then grow into a perfect human organ, a kidney or even a heart, as the host animal matures. The organ will then be harvested and transplanted into a human with a malfunctioning organ.

“This recommendation is a very important step forward and one that has taken us three years to achieve,” Professor Hiromitsu Nakauchi, head of the centre for stem cell biology and regenerative medicine at the University of Tokyo, told The Daily Telegraph. Prof Nakauchi’s team have already succeeded in injecting stem cells from rats into the embryos of mice that had been genetically altered. “We can apply the same principles to human stem cells and pigs, although the guidelines have not permitted us to do this yet,” he said.

At present, the Japanese guidelines permit scientists to develop chimeric embryos in laboratory conditions for a maximum of 14 days, but the next stage in the process – the embryos being implanted into an animal’s womb – is prohibited. As soon as government officials agree on the details of the revised guidelines – a process that is expected to take 12 months – Prof Nakauchi believes the first pig carrying a human organ can be produced “quite quickly, because the technique has been established already.”

The scientists plan to initially breed a pig with a human pancreas as it is a relatively easy organ to create, Prof. Nakauchi said, and perfecting the technique will bring relief to millions of people with diabetes. Creating kidneys and a human heart will be far more complicated, he said, but are feasible. He suggested that practical use for the organs may be as little as five years away.

Eventually, he hopes to be able to have numerous human organs within each donor animal that can be harvested all at the same time.

En Banc WCAB Reverses Award in NFL Team Case

Issues concerning former NFL player, Wesley Carrol’s claim for California workers’ compensation benefits initially were tried on December 2, 2008. On March 17, 2009, the WCJ issued a Findings of Fact and Award, finding that Carrol incurred cumulative industrial injury to several body parts in the course of his employment by the Saints and Bengals,causing 46% permanent disability. The Bengals’ petitioned for reconsideration which was granted. On May 24, 2010, the Appeals Board panel issued its Opinion And Decision After Reconsideration in which it rescinded the WCJ’s earlier March 17, 2009 decision, “because the evidence on the issue of section 3600.5(b) is incomplete.” The case was returned by the panel to the trial level for development of the record on that issue.

In this case, the Bengals established at trial that applicant was hired outside of California and that he was only temporarily in California doing work for the Bengals when the team played one game in the state in 1993. The Bengals further showed that as a permissibly self-insured employer under the workers’ compensation laws of the state of Ohio it furnished workers’ compensation coverage that covered applicant’s employment while in California. Ohio law recognizes the extraterritorial provisions of other states, including California, and likewise exempts out-of-state employers and employees who are temporarily doing work within Ohio from the provisions of its workers’ compensation statutes.

After remand, the WCJ again found that Carroll, incurred cumulative industrial injury to numerous body parts while employed as a professional football player by the New Orleans Saints from July 14, 1991 through August 30, 1993, and by the Bengals from September 1, 1993 to April 12, 1994, causing 46 percent permanent disability and a need for future medical treatment. The WCJ further found that the “Bengals are not exempt from workers’ compensation laws of the State of California, with respect to this case, by operation of Labor Code § 3600.5(b).” The WCJ reasoned that “the essential issue in this case is whether the applicant’s employment within the State of California while employed by the Cincinnati Bengals is considered ‘regularly employed,’ as set forth in Labor Code § 3600.5(a).” In this regard it was noted that a “”professional football player in the NFL, such as Mr. Carroll, regularly engages in his employment away from his home city and state. Typically, each NFL team plays one-half of their regularly scheduled games in their home city. The other half are played in the various other states and cities, including California,” For this reason the WCJ concluded “[I]t remains the opinion of the undersigned that Mr. Carroll’s employment with the Bengals while he was in the State of California was regular employment per Labor Code § 3600.5(a)”

The Appeals Board disagreed and reversed the finding of the WCJ in the en banc decision of Carrol v Cincinnati Bengals and held that an employee and his or her employer are exempted by Labor Code section 3600.5(b) from the provisions of the California workers’ compensation law when the employee was hired outside of California and all of the following apply: (1) the employee is temporarily within California doing work for the employer, (2) the employer furnished coverage under the workers’ compensation or similar laws of another state that covers the employee’s employment while in California, (3) the other state recognizes California’s extraterritorial provisions, and (4) the other state likewise exempts California employers and employees covered by California’s workers’ compensation laws from the application of its workers’ compensation or similar laws.

U.S. Approvals of New Drugs Highest Since 1996

After years of disappointing research and development productivity, a new report backed by leading institutional investors sees “early indications of a recovery”, with U.S. approvals of new drugs last year the highest since 1996. The PharmaFutures thinktank said on Wednesday that getting the most out of an improving flow of novel – and costly – drugs in areas such as oncology will require a more flexible approach to developing, licensing, using and paying for medicines. But, the report summarized by Fox News says that pharmaceutical companies need to boost the benefits of drug research by working with regulators and healthcare providers to overhaul the way medicines are approved and paid for, a thinktank backed by investors says. This would allow investors in drug companies to benefit from earlier cash flows, reduced regulatory risk and less uncertainties over whether drugs will be paid for.

The thinktank has the backing of investors such as Fidelity Worldwide Investment, JPMorgan Asset Management, Robeco and Universities Superannuation Scheme Investment Management, as well as drugmakers like GlaxoSmithKline and Johnson and Johnson. PharmaFutures director Sophia Tickell saw scope for change as governments seek to overhaul healthcare and get better value, sometimes prompted by austerity.

“Today’s binary decision-making at the point of regulatory approval and price setting will need to be replaced by iterative, dynamic decision-making that adapts as evidence is accrued, and value determined over time,” the new report said. In particular, regulators should have more flexibility to take into account evidence about a drug’s effectiveness as it is rolled out and used. At the same time, the industry needs to move away from ideas of a fixed price point for medicines to a system where prices are adapted according to changing perceptions of the value of a medicine, based on how it works in clinical practice. On both fronts, there are signs that industry and regulators are starting to change. The U.S. Food and Drug Administration, for example, recently launched a programme to accelerate life-saving therapies designated as a “breakthrough,” opening to door to earlier approval based on quicker studies, where clinical data is compelling.

The European Medicines Agency also has a scheme to allow conditional approval based on good interim clinical trial results, while Britain currently plans to introduce a system of value-based pricing for new drugs in 2014, although details of this measure are still awaited.

DWC Rolls Out Proposed RBRVS Fee Schedule Regulations

The Division of Workers’ Compensation has issued the notice of public hearing for a resource – based relative value scale (RBRVS) based physician fee schedule. A public hearing on the proposed regulations has been scheduled at 10 a.m., July 17, in the auditorium of the Elihu Harris Building, 1515 Clay Street, Oakland, CA, 94612. Members of the public may also submit written comment on the regulations until 5 p.m. that day.

Senate Bill 863 directs DWC’s administrative director to adopt a physician fee schedule based upon the federal RBRVS used in the Medicare payment system.

“I am thrilled that the Division of Workers’ Compensation has issued the proposed physician fee schedule regulations. We believe these regulations will put in place a fee schedule for physicians that will support the right incentives for appropriate care and return to work. We also believe that with these regulations we can more readily keep pace with updates and ensure all the changing technologies are available,” said Christine Baker, the director of the Department of Industrial Relations.

In the RBRVS – based system, relative value units interact with payment ground rules and the conversion factor to determine the maximum fee in light of the resources to provide the service. The new provisions of Labor Code section statute 5307.1 direct the administrative director to “adopt and review periodically an official medical fee schedule (OMFS) based on the resource – based relative value scale for physician services and nonphysician practitioner services.”

“We expect the workers’ compensation system to see many cost saving and efficiency benefits from adopting the RBRVS-based fee schedule, and the benefits will be enhanced by adopting the schedule prior to the ‘default’ fee caps that will automatically apply on Jan. 1, 2014 if a regulation is not adopted,” said Destie Overpeck, acting administrative director. Adoption of the regulations is preferable to the “default” option in Labor Code section 5703.1 that would apply on Jan. 1, 2014 if the administrative director does not adopt a RBRVS-based fee schedule. The proposed regulations differ from Medicare where appropriate for workers’ compensation. Adoption of conversion factors in the regulations improves accuracy over the “default” fee caps, as the proposed conversion factors were derived by RAND with updated and more representative data.

The notice, text of the regulations, and forms can be found on the proposed regulations page.

Supreme Court Approves FTC Suits Against Drugmakers for “Pay for Delay Deals”

The Supreme Court ruled on Monday that federal regulators can challenge deals between brand-name drug companies and generic rivals that delay cheaper medicines from going on sale, which regulators say increase costs to consumers by billions of dollars. But the court, in a 5-3 vote with Justice Samuel Alito recused, declined the Federal Trade Commission’s request to declare the deals to be presumed to be illegal. The regulatory agency has fought the practice for more than a decade.

According to the summary prepared by Reuters Health, the companies in the case were brand-name drug maker Solvay Pharmaceuticals Inc, now owned by AbbVie; generic makers Actavis Inc, previously Watson Pharmaceuticals; Paddock Laboratories Inc, now part of Perrigo Co, and Par Pharmaceutical Cos.Solvay had sued generic drugmakers in 2003 to stop the sale of cheaper versions of AndroGel. In a settlement of the lawsuit, Solvay paid as much as $30 million annually to the generic drug makers to help preserve its annual profits from AndroGel, estimated at $125 million. Under the deal, the three would keep their generic versions off the market until 2015. The patent expires in 2020. Generic drugmakers like the “pay for delay” arrangements because if they bring out their products before patent infringement litigation is over, they run the risk of paying triple damages on sales if they are found to have infringed.

The FTC filed a lawsuit against the companies in 2009, arguing that the companies had simply split up Solvay’s monopoly profits and prevented the generic firms from bringing out a cheaper version of the drug. The FTC lost at the district court level, and that loss was affirmed by 11th Circuit Court of Appeals. The Supreme Court overturned the appeals court ruling and sent the case back to the lower courts for further proceedings.

“This definitely legitimizes the role of antitrust law in these settlements that the FTC has been pursuing for a while,” said Noah Leibowitz, a patent expert with Simpson Thacher and Bartlett. “Any settlement is going to be more difficult and companies will think much more carefully about how they settle these cases,” he said.

FTC Chairwoman Edith Ramirez said the court had “taken a big step toward addressing a problem that has cost Americans $3.5 billion a year in higher drug prices.” “We look forward to moving ahead with the Actavis litigation and showing that the settlements violate antitrust law,” she said in an email statement.

CWCI Sees No Change in Opioid Use

Powerful Schedule II opioid painkillers accounted for about 7% of all outpatient drugs dispensed to California injured workers over the past two years, consuming nearly 20% of California workers’ compensation outpatient prescription dollars, according to new California Workers’ Compensation Institute (CWCI) data.

Using a large sample of prescriptions dispensed to California injured workers from 2002 through 2012, CWCI researchers confirmed major trends noted in earlier research, including a spike in the use of Schedule II opioid analgesics such as Oxycodone, Morphine, and Fentanyl about a decade ago, with the most dramatic increase occurring between 2005 and 2008 when these meds increased from 1.4% to 5.4% of injured worker prescriptions. That growth continued at a more moderate rate from 2008 through 2010, at which point Schedule II opioids hit 6.9% of all workers’ comp outpatient scripts, and 19.7% of prescription payments. The new results indicate that since then, Schedule II opioids have showed little change, hovering around 7% of workers’ compensation prescriptions and 20% of the prescription dollars for the past two years. Unlike CWCI’s 2012 analysis, which showed a potential drop off in the use of Schedule II opioids in the second half of 2011, the latest data reveal no such decline, and as noted last year, rather than signaling a reversal in the trend, the short-term decline in Schedule II opioid utilization suggested by the initial results from the last half of 2011 may have reflected factors such as billing cycles for year-end services, data submission delays due to processing utilization review decisions, and liens.

Whether use of these narcotics to treat injured workers will continue at this level remains to be seen, and a number of factors could affect the trend. For example, a current bill (SB 809) now before the Assembly would fund the state’s CURES prescription monitoring program and require those who dispense Schedule II opioids to report to the Department of Justice whenever they fill a prescription for these meds. Though doctors would not be required to check with CURES before writing a Schedule II prescription, a more robust CURES database and more user friendly program could help curb abuse and doctor shopping to the extent that more physicians voluntarily check the state database before prescribing Schedule II drugs. In any event, CWCI will continue to monitor the prevalence and costs associated with opioid analgesics in California workers’ compensation. In the meantime, the Institute has issued a Bulletin to its members and subscribers summarizing the latest opioid painkiller utilization and payment results in California workers’ compensation and plans to release a more detailed report on the 2002-2012 trends, including breakdowns by drug type, in the next few weeks. That report will be available to CWCI members and subscribers in the Research section of the Institute’s website, www.cwci.org.

Former Oxnard Cop Jailed for Comp Fraud

The Ventura County Star reports that a former Oxnard police officer was sentenced to 120 days in Ventura County jail on Friday after pleading guilty to two counts of felony workers’ compensation insurance fraud.

Ventura County prosecutors said Edward Idukas, 28, told his supervisors on Dec. 29, 2009, that he had hurt his back. Idukas said the injury occurred while he was bending over in the police locker room.

An investigation was launched after authorities were tipped off about his claim. Investigators learned that Idukas was playing baseball on a weekly basis while he was out on disability. Surveillance video showed Idukas engaging in prolonged physical activity without any sign of pain or discomfort. During this time, Idukas told his doctors and physical therapists that he was too disabled to go back to work, prosecutors said.

In addition to being sentenced to jail, Idukas also was ordered to pay $120,702 in restitution. He no longer works for Oxnard police department..

Pharmacy Resolves DEA Oxycodone Probe for $80 Million Penalty

Walgreens Corporation, the nation’s largest drug store chain, has agreed to pay $80 million in civil penalties, resolving the DEA’s administrative actions and the United States Attorney’s Office’s civil penalty investigation regarding the Walgreens Jupiter Distribution Center and six Walgreens retail pharmacies in Florida. The settlement further resolves open civil investigations in the District of Colorado, Eastern District of Michigan, and Eastern District of New York, as well as civil investigations by DEA field offices nationwide, pursuant to the Controlled Substances Act.

The settlement, the largest in DEA history, resolves allegations that Walgreens committed an unprecedented number of record-keeping and dispensing violations under the Act. According to documents filed in the underlying administrative actions, the Registrants negligently allowed controlled substances listed in Schedules II – V of the Act, such as oxycodone and other prescription pain killers, to be diverted for abuse and illegal black market sales.

The settlement agreement covers conduct that was the subject of DEA’s administrative actions and the U.S. Attorney’s Office civil penalty investigation. More specifically, the settlement covers allegations against Walgreens’ Jupiter Distribution Center and six Walgreens’ retail pharmacies. First, the Jupiter Distribution Center failed to comply with DEA regulations that required it to report to the DEA suspicious prescription drug orders that it received from Walgreens’ retail pharmacies. Walgreens’ alleged failure to sufficiently report suspicious orders was a systematic practice that resulted in at least tens of thousands of violations and allowed Walgreens’ retail pharmacies to order and receive at least three times the Florida average for drugs such as oxycodone.

Second, the six retail pharmacies in Florida that received the suspicious drug shipments from the Jupiter Distribution Center, in turn, filled customer prescriptions that they knew or should have known were not for legitimate medical use. In addition, these retail pharmacies and others elsewhere in the United States failed to properly identify and mark, as required by DEA regulations, hardcopy controlled substance prescriptions that were outsourced to a “central fill” pharmacy for filling. Without Walgreens’ retail pharmacies identifying these outsourced prescriptions, DEA could not accurately determine which prescriptions were filled from the retail pharmacies’ own drug supplies and which prescriptions were filled by a “central fill.” Consequently, DEA could not determine the accuracy of the retail pharmacies’ drug records. The DEA’s administrative actions demonstrated millions of violations of this type.

In addition to the $80 million civil penalty for the above violations, Walgreens agreed to surrender the Registrants’ ability to distribute or dispense controlled substances listed in Schedules II – V for two years, ending in 2014. As part of the settlement, Walgreens admitted that it failed to uphold its obligations as a DEA registrant regarding the above-described conduct. Furthermore, Walgreens has agreed to create a Department of Pharmaceutical Integrity to ensure regulatory compliance and prevent the diversion of controlled substances. Walgreens has also agreed to enhance its training and compliance programs, and to no longer monetarily or otherwise compensate its pharmacists based on the volume of prescriptions filled.