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FDA Modifies Approval Process to Limit Superbug Infection

The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. A key change is that when manufacturers submit instructions for disinfecting the devices between uses, the Food and Drug Administration will not take the company’s word that the instructions work, but will demand proof. In the past, the agency essentially took manufacturers at their word when they claimed a procedure worked; now they will have to submit data proving so “with a high degree of assurance,” the agency said. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.

The FDA issued a draft guidance discussing the reprocessing of reusable medical devices in 2011, and considered almost 500 comments before issuing the final guidance. The final guidance provides more clarity about testing protocols and what data should be submitted to the agency for a premarket submission, such as the data FDA needs to evaluate substantial equivalence for a 510(k) premarket submission. Manufacturers seeking to bring to market certain reusable devices, such as duodenoscopes, bronchoscopes and endoscopes, should submit to the FDA for review their data validating the effectiveness of their reprocessing methods and instructions.

FDA’s final guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.

Separately, the FDA also announced in the Federal Register that the agency’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting on May 14 and 15, 2015 to discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States.

The FDA action followed reports last month that hundreds of patients may have been exposed to pathogens, including antibiotic-resistant “superbugs,” after flexible tubes called duodenoscopes were not properly disinfected between patients. Two patients at the University of California-Los Angeles died. The new recommendations apply, however, not only to duodenoscopes but to most medical devices intended for repeated use, including bronchoscopes and endoscopes.

To deal with the thousands of devices already in use, whose disinfection protocols were not subjected to rigorous validation, the U.S. Centers for Disease Control and Prevention released instructions for reducing the risk of transmitting infections. The protocol calls for swabbing the device after it has supposedly been disinfected and seeing if any microbes grow into detectable colonies, much as doctors take throat swabs to determine if a patient has a strep infection, before the device is used again. The duodenoscopes at the center of the recent superbug outbreaks are made by Olympus Corp, Fujifilm Holdings Corp, and Pentax.

As far back as 2009, the FDA believed that transmission of infection by duodenoscopes occurred when hospitals did not properly follow manufacturers’ instructions for “reprocessing,” or disinfecting, the devices between use. Only recently, the agency said, did it conclude that such transmission can occur even when the instructions are followed to the letter, an indication of how difficult it is to clean the complex equipment.

The FDA does not, however, “have the authority to require manufacturers to change their (device’s) design” even if it prevents disinfection, Dr. William Maisel, FDA’s deputy center director for science, told reporters.

CWCI – WCIRB Joint Study Confirms SB863 ASC Cost Savings

In recent years, the increasing cost of treatment at ambulatory surgery centers has been one factor in the escalation of California workers’ compensation medical costs. In 2012, state lawmakers sought to address these escalating costs by including provisions in SB 863 that, among other things, reduced the maximum facility fees for services performed in ASCs to 80 percent of the fee paid by Medicare for the use of hospital outpatient surgery departments. The WCIRB initially projected that this change in the fee schedule would reduce ASC payments by 25 percent. This new WCIRB CIRB joint study is a follow-up to the authors’ initial February 2014 study that measured the extent to which the change in ASC reimbursements achieved its intended goal of reducing these costs. It includes an entire year of additional data, encompassing episodes from January 2012 through June 2014.

Prior to 2004, California workers’ compensation outpatient surgery facility fees were not subject to a fee schedule, and payments varied widely as payers negotiated or paid usual and customary fees. In the absence of a fee schedule, California workers’ compensation paid significantly more than federal health care programs such as Medicare for comparable services, as was noted in a 2002 study by Kominsky and Gardner.

In 2003, California lawmakers amended Labor Code §5307.1(c)(1) in SB 228 to require the Division of Workers’ Compensation (DWC) to promulgate a fee schedule that utilizes the Medicare payment rules for the use of outpatient surgery rooms and emergency rooms. Under Medicare, each Current Procedural Terminology (CPT) code for a specific outpatient surgical procedure is classified into an Ambulatory Procedure Classification (APC). The final fee is calculated using a formula rather than a prescribed dollar amount. Under the fee schedule, which took effect for services on or after June 15, 2004, maximum facility fees could not exceed 120 percent of the Medicare fee. The adoption of the outpatient facility fee schedule had an immediate effect on costs. CWCI research from 2005 compared pre and post SB 228 payments for 239 distinct outpatient procedures performed in ASCs and found that after adjusting for medical inflation and changes in the mix of medical procedures, average outpatient surgery facility fee payments fell 38.9 percent following the adoption of the Outpatient Surgery Facility Fee Schedule in 2004.

By 2012, however, several years of escalating workers’ compensation medical costs and a growing desire to increase injured workers’ permanent disability benefits led state lawmakers to revisit the issue of ASC fees as one cost-saving component of a legislative reform deal (SB 863) hammered out by representatives of labor, employers and the Brown Administration.The final version of that bill called for the DWC to modify the Outpatient Facility Fee Schedule so that maximum facility fees for services performed in ASCs were reduced from 120 percent to 80 percent of the Medicare fee for those services, though hospital-based outpatient facility maximum fees were kept at 120 percent of the Medicare rate.

As found in the prior study, this update on the effects of SB 863 finds that the reduction in payments has been slightly better than the initial predictions, with a 27 percent decrease in payments per episode and a 29 percent decrease in the payments per procedure from the pre-reform to the post- reform period. There was no evidence of significant changes in service mix or intensity or shifts away from the ASC to the hospital setting. The study concludes by saying “These results are similar to the 2014 findings using the identical measures and show that thus far, the change in the ASC Fee Schedule has achieved its intended objective of reducing one aspect of workers’ compensation medical costs.

Orange County Pair Convicted of $71 Million Surgical Center Fraud

A federal jury has convicted two Southern California residents in connection with a scheme to defraud union and private health insurance programs by submitting bills for more than $71 million and receiving over $50 million in payments for medically unnecessary procedures performed on insurance beneficiaries who received free or discounted cosmetic surgeries. A large number of the fraudulent claims were submitted to the International Longshore and Warehouse Union and Operating Engineers Union health insurance plans. Other victim insurers included Aetna and Anthem.

The two defendants found guilty are Theresa Fisher, 45, of Tustin, who was found guilty of five counts of mail fraud; and Lindsay Hardgraves, 30, of San Pedro, who was found guilty of two counts of mail fraud.

The evidence presented during a six-day trial showed that members of the scheme lured insured “patients” to a surgery center in Orange with promises that they could use their union or PPO health insurance plans to pay for cosmetic surgeries, which are generally not covered by insurance. The surgery center was known at various times as Princess Cosmetic Surgery, Vista Surgical Center, and Empire Surgical Center.

Marketers such as Hardgraves referred “patients” to the surgery center, where they were told they could receive free or discounted cosmetic surgeries if they underwent multiple, medically unnecessary procedures that would be billed to their union or PPO health care benefit program. Fisher was a consultant at the surgery center who scheduled procedures after telling the “patients” about the free cosmetic procedures they could receive and coaching them to fabricate or exaggerate symptoms so that their medical procedures would be covered by their insurance.

The unnecessary procedures typically performed on the “patients” were endoscopies (usually sophagogastroduodenoscopies, or EGDs), colonoscopies and cystoscopies. Once the health care benefit program paid the claims, the patients were given free or discounted cosmetic surgeries, including tummy tucks, breast augmentations and liposuction. In some cases, the surgery center simply billed cosmetic procedures (such as tummy tucks) as if they were medically necessary procedures (such as hernia surgeries).

Fisher and Hardgraves are scheduled to be sentenced on May 29. A third defendant in this case – Vi Nguyen, 31, of Placentia, another consultant at the surgery center – pleaded guilty in January to four counts of mail fraud and faces sentencing before Judge Staton on July 10. At sentencing, each defendant faces a statutory maximum sentence of 20 years in federal prison for each count of mail fraud.

Orange County Insurance Agent Sentenced to Seven Years

Jacob Richard Bonzer, 28, formerly of Lake Forest, Calif. was arrested last August in Chicago by a U.S. Marshals Task Force on 96 felony counts including grand theft, forgery and denial of benefits. He pleaded guilty and was sentenced to seven years in prison last Friday for selling fraudulent insurance polices in Orange County to fund a lavish lifestyle.

Between 2009 to 2013, Bonzer, collected more than $900,000 in commissions and premium payments for the fake polices, and created fake insurance companies to defraud customers, a statement from the Orange County District Attorney said.

Before being sentenced, Bonzer pleaded guilty to 49 counts of grand theft, one felony count of forging a California Department of Insurance Examination report, transacting insurance business without a certificate of authority, 45 felony counts of insurance fraud, with sentencing enhancements for aggravated white-collar crime totaling more than $500,000 and taking more than $200,000. He was ordered to pay $918,300 to his victims. Bonzer used the money to pay for fine dining, travel, wine club memberships and to rent luxury high-rise apartments.

Between 2009 to 2010, Bonzer worked at a Farmers Insurance Group office in Brea, before being fired after failing the company’s career program. The Department of Insurance received a complaint alleging Bonzer submitted 128 fraudulent homeowners insurance applications containing bogus information using nonexistent policyholders for real properties, causing valid policies to be issued for phantom homeowners in escrow. Bonzer allegedly received $46,000 in advanced commissions from the insurance company that expected to collect premiums when the properties closed escrow. Since the applicants were bogus, the insurer never received premium payments and Bonzer was eventually fired.

In 2011, he continued his criminal activities and created a fake company and, with another insurance agent to whom he lied, created 800 more homeowner polices that listed fake names. The fake company was called GW Mutual Risk Retention Group, LLC, which was registered in Florida. GW Mutual is not licensed to write insurance in California though Bonzer sold workers’ comp and commercial insurance policies through his agency, Bonzer Insurance Brokerage, located in Orange County.

Bonzer collected roughly $280,000 in premium from 58 California businesses that believed they were purchasing valid coverage.The other agent paid back his half of the $573,242 in commissions. When questioned by a customer about his ability to sell insurance in California, Bonzer provided him with a fake document from the state department of insurance.

Bonzer orchestrated these elaborate scams by using multiple post office boxes, virtual assistants, business entities, office spaces, email accounts, website domains and bank accounts.

National Prescription Drug Spending Increased 13%

The nation’s largest pharmacy benefits manager says prescription drugs spending rose 13 percent last year, the largest annual increase since 2003. Express Scripts says the gains were fueled by pricey specialty drugs that accounted for about 31 cents of every dollar spent on prescriptions even though they represented only 1 percent of all U.S. prescriptions filled.

New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1% increase in U.S. drug spending in 2014 – a rate not seen in more than a decade. The report says that these findings “demonstrate the need for plans to take decisive action and more closely manage the pharmacy benefit to ensure all patients are able to achieve the best possible health outcomes at a price our country can afford.”

Inflammatory conditions, multiple sclerosis and cancer remained the top three specialty therapy classes for the fifth consecutive year, collectively contributing to 55.9% of the spend for all specialty medications billed through the pharmacy benefit in 2014.

Spending on traditional medications continues to rise as a result of compounded drugs, which emerged in the top 10 traditional therapy classes for the first time and accounted for 35% of the increase in spending. However, Express Scripts expects spend on compounded medications to decline sharply in 2015 due to widespread adoption of our compound utilization management solution. Express Scripts’ compound management solution, implemented in mid-2014, will save its clients more than $1.9 billion in 2015 that would have otherwise been wasted on compounded medications that do not provide a proven clinical benefit.

Drugmaker consolidation and drug shortages also led to increases in traditional drug trend, which rose to 6.4% in 2014. Half of the top 10 therapy classes experienced negative trend in 2014 due to generics. While it expects that trend to persist for the next two years, some categories will face challenges from continued drugmaker consolidation, which can lead to price increases from drug shortages and decreased competition.

UCLA Super Bug Victim Sues Medical Device Maker

Antonia Torres Cerda, 48, died at UCLA Ronald Reagan Medical Center after she allegedly was infected with a “superbug” bacteria transmitted into her body by medical equipment. The Fresno Bee reports that the family is now suing the equipment maker for wrongful death, negligence and fraud. Cerda’s family is asking for punitive and exemplary damages of an unspecified amount. The University of California at Los Angeles is not named in the lawsuit.

Cerda had been given a procedure for ERCP, or endoscopic retrograde cholangiopancreatography, before the transplant and a second procedure afterward, said Peter L. Kaufman, a Los Angeles lawyer who is representing Cerda’s husband, Armando Cerda, her four children and her mother. The procedures were done using a duodenoscope manufactured by Olympus Medical System Corp. of Japan and marketed and sold by Olympus Corp. of the Americas and Olympus Medical System Corp. The scopes are flexible tubes inserted down the throat into the small intestines. About 500,000 people in the U.S. undergo procedures with the scopes every year, according to the federal Food and Drug Administration.

Antonia Cerda needed the transplant because she had nonalcoholic liver cirrhosis, said her oldest daughter Cynthia, 18, a freshman at the University of California at Santa Cruz. She said her mother, who was a field worker, became ill seven or eight years ago and was on the transplant list for about five or six years. Following the transplant, her mother had started to recover but then grew ill from the infection and died. The doctors said there were no antibiotic medications that would have killed the bacteria and saved her mother.

Cerda’s is one of two patient deaths that have been connected to an antibiotic-resistant bacterial outbreak at UCLA. The outbreak is believed to have spread through the use of endoscopes. Five others were infected with the bacteria after having procedures to diagnose and treat pancreatic and bile duct problems between October and January, and UCLA notified 179 people that they may have been exposed. UCLA spokeswoman Dale Tate said seven different scopes were used at the hospital during that time but five had no sign of bacteria. “There were only two that were impacted,” she said. Both were made by Olympus.

The lawsuit alleges that Olympus failed to develop and validate an effective way to clean a redesigned Q180V Scope. Kaufman said a device manufacturer that makes and markets a reusable medical instrument has “an obligation to figure out how to clean it, and they have to prove that their cleaning method works.” Otherwise, he said, they would have to sell it as a “single-use device.” According to the lawsuit, Olympus knew the complex design of its duodenoscope “renders some part of the device extremely difficult to access” and as a result, difficult to clean. An elevator mechanism within the scope contains microscopic crevices that can’t be reached with a brush, and material can remain inside, the suit said. Olympus should have known that these “residual fluids contain microbial contamination, multiple patients would be exposed to serious risk of harm, including lethal infection,” the suit alleges.

Olympus redesigned the TJF-Q180V duodenoscope in 2014, the suit alleges, but failed to update cleaning protocols. But before the redesign, the company allegedly knew the devices were difficult to clean. In 2013, Olympus was allegedly informed of infections to patients in the state of Washington, and “at least four patients who were infected as a result of exposure to contaminated duodenoscopes died.” The suit said Olympus continued to aggressively market the devices “with conscious disregard of the extreme risks to the public of serious infection, pain, suffering and death.”

The lawsuit also includes an allegation of fraud and names three Olympus sales and marketing representatives from Southern California. The lawsuit said the three made false representations to UCLA doctors and staff between July 2014 and January 2015 about the device’s safety and risks associated with its reuse. In seeking punitive damages, the lawsuit said the family believes that Olympus “acted with ‘malice’ “.

Olympus officials did not return telephone calls or email requests from the Fresno Bee for comment.

California “Biofrequency” Device Makers Face Federal Charges

Federal law enforcement agents in Medford Oregon arrested a California couple charged with marketing unapproved medical devices that were claimed to treat ailments ranging from ulcers to AIDS.

Special agents from the Medford office of Immigration and Customs Enforcement arrested David Perez and Sandra Perez at an apartment in the 2300 block of Bromley Street in Medford on warrants issued by the U.S. District Court for the Southern District of California. An indictment claims the couple and co-defendant Beth Campbell have sold almost $700,000 worth of “biofrequency” devices under the brand name Energy Wave. Both husband and wife are charged with conspiracy, sale of adulterated devices, the sale of misbranded devices, acting to cause the shipment of adulterated or misbranded devices and making false statements.

The devices, which prosecutors say were manufactured by an un-indicted co-conspirator in his Southern California home, consist of a small computer-controlled generator connected to metal cylinders intended to be held by the user. “Users were provided with an operating manual and a listing of ‘Auto Codes’ that set forth hundreds of digital settings for the device directed to specific conditions such as abdominal pain, AIDS, diabetes, stroke, ulcer and worms,” the indictment says.

The devices apparently were not approved by the Food and Drug Administration, and prosecutors say the Perezes took extra care to hide their activities from the agency, registering their website in the Philippines and uploading the devices’ instructions to the Internet instead of including them in the box. According to the indictment, David Perez had previously been a partner in California-based CGNI Inc., the owners of which were convicted in 2011 of selling a product called the “Detox Box,” which prosecutors say was almost identical to the Energy Wave.

The Perezes were released from custody in Medford after posting $25,000 bonds, court records show.

New Reports Critical of Reduction in Comp Rates

A new ProPublica/NPR report summarized in an article in the Los Angeles Times, claims that , “over the past decade … state after state has slashed workers’ comp benefits, driven by calls from employers and insurers to lower costs. In fact, employers are now paying the lowest rates for workers’ comp than at any time since the 1970s. Nonetheless, dozens of legislatures have changed their workers’ comp laws, often citing the need to compete with neighboring states and be more attractive to business.”

The result, according to the report, is a grim “geographic lottery” in which compensation, including for lost limbs, varies depending on the state in which you were hurt. There are no federal benchmarks, and plenty of state-level political resistance to fix the problems. More broadly, erosion of protections across the states has had a devastating effect on families in which one of the wage-earners can no longer work, or work at full capacity, because of a serious injury on the job. The report claims “The loss of an arm, for example, is worth up to $48,840 in Alabama, $193,950 in Ohio and $439,858 in Illinois. The big toe ranges from $6,090 in California to $90,401.88 in Oregon.” …. “Given their profound impact on people’s lives, how much compensation workers get for traumatic injuries seems like it would be the product of years of study, combining medical wisdom and economic analysis. But in reality, the amounts are often the result of political expediency, sometimes based on bargains struck decades ago.”

A new report by the federal Department of Labor’s Occupational Safety and Health Administration argues that “changes in state based workers’ compensation insurance programs have made it increasingly difficult for injured workers to receive the full benefits (including adequate wage replacement payments and coverage for medical expenses) to which they are entitled. Employers now provide only a small percentage (about 20%) of the overall financial cost of workplace injuries and illnesses through workers’ compensation. This cost-shift has forced injured workers, their families and taxpayers to subsidize the vast majority of the lost income and medical care costs generated by these conditions.”

These criticisms have dated back for decades. The federal Occupational Safety and Health Act was enacted by Congress in 1970 and was signed by President Richard Nixon on December 29, 1970. The new law authorized the National Commission on State Workers Compensation Laws, a group appointed by President Nixon in 1971 to study workers compensation laws. It issued sweeping recommendations to upgrade state workers compensation laws, including higher disability benefits, compulsory coverage, and unlimited medical care and rehabilitation benefits. It recommended that all states pay totally disabled workers at least two-thirds of their salary up to a maximum of the state’s average weekly wage. Still, many states have not complied with the Commission’s recommended standard wage.

California responded to the Commission Report by adopting mandatory vocational rehabilitation. It was argued at the time that by embellishing the California system with this new benefit, the State would head off a threatened federal takeover of workers’ compensation systems adopted in the various states. Mandatory vocational rehabilitation was later proven to be a costly mistake, was modified and ultimately revoked by the California Legislature with little regret.

For some, the response to these studies would be based upon a famous quote from Ronald Regan. “There you go again” was a phrase spoken during the 1980 United States presidential election debate by presidential candidate Governor Ronald Reagan to his Democratic opponent, incumbent President Jimmy Carter. “There you go again” emerged as a single defining phrase of the 1980 presidential election.The phrase has endured in the political lexicon in news headlines, as a way to quickly refer to bringing certain issues up repeatedly.

More Than 80% of LETF Inspections Result in Penalties

California’s Labor Enforcement Task Force (LETF) is cracking down on businesses violating laws designed to protect workers and California’s economy. In the report submitted to the Legislature this month, the task force since its inception in 2012 has inspected nearly 4,300 businesses suspected of operating in the underground economy. During its first three years, LETF joint inspections have found consistently high rates of non-compliance. On average, across all industries, more than 80 percent of LETF inspections have resulted in penalties for non-compliance. In addition, 40 percent of businesses were out of compliance with every agency participating in the inspection. LETF has assessed $4.2 million in wages due to workers.

LETF works in partnership with other agency enforcement programs to share information and draw upon each program’s respective strengths. At the direction of the Governor in 2012, DIR initiated a collaborative relationship with the Employment Development Department’s Joint Enforcement Strike Force (JESF). Similarly, in 2013, Assembly Bill 576 established the Revenue Recovery and Collaborative Enforcement (RCCE) Team to fight criminal tax evasion. In his signing message, Governor Brown directed DIR to lead the RRCE to ensure that the three teams (LETF, JESF, and RRCE) work together and avoid overlapping efforts.

To this end, DIR has worked to facilitate a governance framework among participating agencies to clarify roles and responsibilities. Ongoing implementation activities include establishing a cross-referral protocol and appropriate data-sharing solutions to improve enforcement efficacy. While each remains under the guidance of their respective agencies, coordination of enforcement efforts supports enhanced communication, while leveraging administrative costs, areas of authority, and staff resources across participating agencies. More recently, DIR has facilitated collaboration among local district attorneys’ offices, roofing contractors, and labor groups to form the Roofing Compliance Working Group. This multi-agency coalition combats unsafe and unfair practices in the roofing industry, where the incidence of serious workplace injuries and fatalities is higher compared to other industries.

“Employers in the underground economy are a threat to the financial security of millions of workers in our state who aren’t paid properly and are exposed to dangerous working conditions. These underground operations also have an unfair advantage over legitimate, law-abiding employers,” said Department of Industrial Relations (DIR) Director Christine Baker. DIR administers the multi-agency task force.

“As a result of violations found by our task force, many businesses operating in the underground economy face thousands of dollars in fines and are ordered to stop work due to hazardous working conditions,” said Dominic Forrest, LETF Acting Chief. “We are cracking down on these egregious violators in California.”

LETF focuses on underground employers in high-risk industries known to frequently abuse the rights of low wage workers, rather than geographic sweeps that prove ineffective by burdening compliant businesses in the area. The targeted industries include car wash, restaurant, garment manufacturing, roofing, construction, agricultural and auto repair businesses. Frequent violations among underground employers include the failure to protect workers as required by workplace health and safety regulations, inadequate workers’ compensation insurance coverage, not paying state payroll taxes, and cheating workers on their earnings.

35 L.A. Car Washes Cited by Labor Commissioner

The California Labor Commissioner’s Office last week cited car wash businesses in the Los Angeles area more than $1.3 million for wage theft following a two-day enforcement activity. The majority of the violations were found at 35 car wash businesses that failed to register with the Labor Commissioner’s Office, as required by law. The inspections uncovered numerous violations of state wage and hour laws affecting nearly 400 workers.

“These citations serve as a reminder that wage theft will not be tolerated. The Labor Commissioner’s office targets its enforcement efforts on employers who intentionally skirt the law,” said Christine Baker, Director of the Department of Industrial Relations (DIR), which oversees the Labor Commissioner’s Office.

The 35 unregistered car wash businesses reflect a significant drop in registration from 2013 to 2014.

“When car wash businesses fail to register, it is often an indicator of wage theft. We are also following up with some of the inspected car washes to conduct full wage audits,” said Labor Commissioner Julie A. Su. “We want to make sure car wash workers are paid what they are owed and that employers who follow the law know we are on their side.”

Violations cited included the failure to pay workers minimum wage and overtime, which resulted in $412,200 in penalties and $308,584 in liquidated damages. An additional 17 violations with citations totaling $218,000 were issued to employers who did not carry workers’ compensation insurance coverage.

The Labor Commissioner’s Office, formally known as the Division of Labor Standards Enforcement, inspects workplaces for wage and hour violations, adjudicates wage claims, enforces prevailing wage rates and apprenticeship standards in public works projects, investigates retaliation and whistleblower complaints, issues licenses and registrations for businesses, and educates the public on labor laws. Updated information on California labor laws is available online.

The Wage Theft is a Crime public awareness campaign, launched last year by DIR and its Labor Commissioner’s Office, has helped inform workers of their rights. The campaign includes multilingual print and outdoor advertising as well as radio commercials on ethnic stations in English, Spanish, Chinese, Vietnamese, Hmong and Tagalog.

Employees with work-related questions or complaints may call the toll-free California Workers’ Information Line at (866) 924-9757 for recorded information in Spanish and English on a variety of work-related topics.