The federal court case brought by 38 former National Football League players seeking to force the NFL to recognize chronic traumatic encephalopathy (CTE) as a covered disease under workers’ compensation has been withdrawn.
Instead of pursuing their joint case, the players will file separate workers’ compensation claims in individual states, according to their lawyer.
The U.S. District Court for the Southern District of Florida in Ft. Lauderdale, Judge Beth Bloom dismissed the suit (Gaiter et al. v. National Football League) without prejudice.
The plaintiffs’ lawyers - Tim Howard and Miguel Amador of Howard & Associates in Tallahassee - voluntarily withdrew their complaint. They explained that the players have decided to proceed with filing state claims. "We are going forward aggressively state-by-state as that is the least risky approach to secure the recoveries for our clients," Howard told Insurance Journal.
Earlier, on Dec. 5, Judge Bloom had stayed the case pending a decision on whether it should be transferred to the federal court in Pennsylvania that is handling multidistrict litigation involving concussions and the NFL.
The U.S district court in eastern Pennsylvania, under U.S. District Judge Anita B. Brody, oversaw a consolidation of concussion lawsuits against the NFL and reached a settlement valued at as much as $1 billion in potential benefits for more than 22,000 former players. Earlier this month, the U.S. Supreme Court let stand that concussion settlement, deciding against hearing complaints by some former players that the settlement is inadequate and unfairly treats current versus future brain injuries differently.
The workers’ compensation case brought in federal court did not have a great chance of succeeding, according to lawyers reached after the complaint was filed but before it was withdrawn.
"The first real hurdle here is that it is questionable as to whether a federal court is even the proper forum to determine a state workers’ compensation issue. The answer is most likely no," Justin R. Parafinczuk, a civil trial attorney and partner with the Florida firm Koch Parafinczuk & Wolf, P.A., told Insurance Journal.
He said the complaint essentially asked the federal court to declare CTE a compensable occupational disease under workers’ compensation laws that vary by state.
"This request would basically strip the defendants’ rights to defend themselves at a traditional worker’s compensation hearing, where the plaintiff or, as referred to in worker’s compensation, the claimant would have the burden to prove these allegations to a worker’s compensation judge, and the defendants would be able to present all available defenses," he said. This would require the federal court to do an "extensive analysis of the worker’s compensation laws of every state where a defendant resides," something he said the court would be "highly unlikely" to undertake.
The other hurdle was the players’ Collective Bargaining Agreement, under which CTE is not recognized.
...
Instead of pursuing their joint case, the players will file separate workers’ compensation claims in individual states, according to their lawyer.
The U.S. District Court for the Southern District of Florida in Ft. Lauderdale, Judge Beth Bloom dismissed the suit (Gaiter et al. v. National Football League) without prejudice.
The plaintiffs’ lawyers - Tim Howard and Miguel Amador of Howard & Associates in Tallahassee - voluntarily withdrew their complaint. They explained that the players have decided to proceed with filing state claims. "We are going forward aggressively state-by-state as that is the least risky approach to secure the recoveries for our clients," Howard told Insurance Journal.
Earlier, on Dec. 5, Judge Bloom had stayed the case pending a decision on whether it should be transferred to the federal court in Pennsylvania that is handling multidistrict litigation involving concussions and the NFL.
The U.S district court in eastern Pennsylvania, under U.S. District Judge Anita B. Brody, oversaw a consolidation of concussion lawsuits against the NFL and reached a settlement valued at as much as $1 billion in potential benefits for more than 22,000 former players. Earlier this month, the U.S. Supreme Court let stand that concussion settlement, deciding against hearing complaints by some former players that the settlement is inadequate and unfairly treats current versus future brain injuries differently.
The workers’ compensation case brought in federal court did not have a great chance of succeeding, according to lawyers reached after the complaint was filed but before it was withdrawn.
"The first real hurdle here is that it is questionable as to whether a federal court is even the proper forum to determine a state workers’ compensation issue. The answer is most likely no," Justin R. Parafinczuk, a civil trial attorney and partner with the Florida firm Koch Parafinczuk & Wolf, P.A., told Insurance Journal.
He said the complaint essentially asked the federal court to declare CTE a compensable occupational disease under workers’ compensation laws that vary by state.
"This request would basically strip the defendants’ rights to defend themselves at a traditional worker’s compensation hearing, where the plaintiff or, as referred to in worker’s compensation, the claimant would have the burden to prove these allegations to a worker’s compensation judge, and the defendants would be able to present all available defenses," he said. This would require the federal court to do an "extensive analysis of the worker’s compensation laws of every state where a defendant resides," something he said the court would be "highly unlikely" to undertake.
The other hurdle was the players’ Collective Bargaining Agreement, under which CTE is not recognized.
...
California Labor Commissioner Julie A. Su announced that Santa Rosa taxi company A-C Transportation Services, Inc., has agreed to settle its $522,300 citation for refusing to provide its 30 drivers with workers’ compensation insurance coverage and for misclassifying them as independent contractors.
Owners Kevin and Jennifer Kroh, also doing business as Healdsburg Cab Company, agreed to pay a fine of $200,000 in installments, with final payment in June 2021. If they default on the payments the agreement is void and the full $522,300 judgement will be due. The company also agreed to cease all operations as of December 31, 2016.
The agreement comes after the taxi company was issued a Stop Order judgment in October by a Sonoma County Superior Court judge for continuing to refuse to provide workers compensation insurance as required by law.
The California Labor Commissioner’s Office launched its investigation into A-C Transportation Services in March of 2014 and found that it had failed to provide workers’ compensation insurance coverage as required by law from 2011 through 2014 and was misclassifying drivers as independent contractors.
A citation for $522,300 was issued and appealed by A-C Transportation claiming their drivers were independent contractors who leased taxi cabs from the businesses.
In January 2015, the Labor Commissioner affirmed the citation and determined that the taxicab drivers were employees and not independent contractors.
A-C Transportation Services then filed a petition to review the administrative decision in Sonoma County Superior Court. On September 16, the Court found that there was substantial evidence to support the Labor Commissioner’s determination and denied the petition.
When A-C Transportation continued to operate and refused to secure workers’ compensation insurance, the Labor Commissioner requested the court to intervene and issue a Stop Order. On October 19, a Sonoma County Superior Court Judge issued a Stop Order judgment. On December 7, both parties reached an agreement to resolve the case.
...
Owners Kevin and Jennifer Kroh, also doing business as Healdsburg Cab Company, agreed to pay a fine of $200,000 in installments, with final payment in June 2021. If they default on the payments the agreement is void and the full $522,300 judgement will be due. The company also agreed to cease all operations as of December 31, 2016.
The agreement comes after the taxi company was issued a Stop Order judgment in October by a Sonoma County Superior Court judge for continuing to refuse to provide workers compensation insurance as required by law.
The California Labor Commissioner’s Office launched its investigation into A-C Transportation Services in March of 2014 and found that it had failed to provide workers’ compensation insurance coverage as required by law from 2011 through 2014 and was misclassifying drivers as independent contractors.
A citation for $522,300 was issued and appealed by A-C Transportation claiming their drivers were independent contractors who leased taxi cabs from the businesses.
In January 2015, the Labor Commissioner affirmed the citation and determined that the taxicab drivers were employees and not independent contractors.
A-C Transportation Services then filed a petition to review the administrative decision in Sonoma County Superior Court. On September 16, the Court found that there was substantial evidence to support the Labor Commissioner’s determination and denied the petition.
When A-C Transportation continued to operate and refused to secure workers’ compensation insurance, the Labor Commissioner requested the court to intervene and issue a Stop Order. On October 19, a Sonoma County Superior Court Judge issued a Stop Order judgment. On December 7, both parties reached an agreement to resolve the case.
...
With more attention on the impact of opioid addiction and the role of overprescribing, drug companies have come under more scrutiny for suspicious and sometimes unsavory marketing practices.
A lot of the spotlight has been directed toward Purdue Pharma, the makers of OxyContin. A company that already paid $20 million in a settlement with 27 states, attorneys general across the country many years ago.
Unsealed court documents indicate that the drug manufacturer went to great lengths to stop preauthorization of OxyContin in West Virginia despite concerns from public health officials.
The warning signs of what would become a deadly opioid epidemic emerged in early 2001. That’s when officials of the state employee health plan in West Virginia noticed a surge in deaths attributed to oxycodone, the active ingredient in the painkiller OxyContin.
They quickly decided to do something about it: OxyContin prescriptions would require prior authorization. It was a way to ensure that only people who genuinely needed the painkiller could get it and that people abusing opioids could not.
But an investigation by STAT claims that Purdue Pharma, the manufacturer of OxyContin, thwarted the state’s plan by paying a middleman, known as a pharmacy benefits manager, to prevent insurers from limiting prescriptions of the drug. The financial quid pro quo between the painkiller maker and the pharmacy benefits manager, Merck Medco, came to light in West Virginia court records unsealed by a state judge at the request of STAT, and in interviews with people familiar with the arrangement.
The strategy to pay Merck Medco extended to other big pharmacy benefit managers and to many other states, according to a former Purdue official responsible for ensuring favorable treatment for OxyContin. The payments were in the form of "rebates" paid by Purdue to the companies. In return, the pharmacy benefit managers agreed to make the drug available without prior authorization and with low copayments.
"That was a national contract," Bernadette Katsur, the former Purdue official, who negotiated contracts with pharmacy benefit managers, said in an interview. "We would negotiate a certain rebate percentage for keeping it on a certain tier related to copay or whether it has prior authorization. We like to keep prior authorization off of any drug."
Katsur said prior authorization programs do little to eliminate inappropriate prescribing by "bad doctors" and usually just create needless paperwork for doctors working in the best interest of patients. She said some doctors simply won’t deal with the hassle of a prior authorization program, resulting in some legitimate patients not getting the medication they need.
"You don’t want to make it harder for a doctor to prescribe when they are doing the right thing," she said.
In addition to keeping OxyContin from being subject to prior authorization, the rebates paid to pharmacy benefit managers were used to guarantee favorable status for OxyContin on their listings of approved drugs, Kastur said. PBMs commonly place drugs in different tiers on these lists, called formularies. Some tiers are more restrictive and require higher copayments. Purdue wanted OxyContin placed in the least restrictive tier - and succeeded.
The relationship with Merck Medco was so important that Purdue moved Katsur to New Jersey so she could be close to Merck’s national headquarters, she said.
It is common for drug companies to pay rebates to gain preferential treatment from companies hired by insurance plans to manage prescription drug benefits, but in this case the arrangement removed a key safeguard in the system that may have slowed the growth of OxyContin as it became a national bestseller that eventually peaked at annual sales of $3 billion.
The former Merck Medco was purchased by Express Scripts in 2012. A spokesman for Express Scripts said no one currently at the company had knowledge of the West Virginia contract. A spokesman for Purdue Pharma said the company had no comment.
In McDowell County, where the court records from a state lawsuit against Purdue were unsealed, the local sheriff said prescription pill abuse is so rampant that the county plans to file a new lawsuit against painkiller makers.
...
A lot of the spotlight has been directed toward Purdue Pharma, the makers of OxyContin. A company that already paid $20 million in a settlement with 27 states, attorneys general across the country many years ago.
Unsealed court documents indicate that the drug manufacturer went to great lengths to stop preauthorization of OxyContin in West Virginia despite concerns from public health officials.
The warning signs of what would become a deadly opioid epidemic emerged in early 2001. That’s when officials of the state employee health plan in West Virginia noticed a surge in deaths attributed to oxycodone, the active ingredient in the painkiller OxyContin.
They quickly decided to do something about it: OxyContin prescriptions would require prior authorization. It was a way to ensure that only people who genuinely needed the painkiller could get it and that people abusing opioids could not.
But an investigation by STAT claims that Purdue Pharma, the manufacturer of OxyContin, thwarted the state’s plan by paying a middleman, known as a pharmacy benefits manager, to prevent insurers from limiting prescriptions of the drug. The financial quid pro quo between the painkiller maker and the pharmacy benefits manager, Merck Medco, came to light in West Virginia court records unsealed by a state judge at the request of STAT, and in interviews with people familiar with the arrangement.
The strategy to pay Merck Medco extended to other big pharmacy benefit managers and to many other states, according to a former Purdue official responsible for ensuring favorable treatment for OxyContin. The payments were in the form of "rebates" paid by Purdue to the companies. In return, the pharmacy benefit managers agreed to make the drug available without prior authorization and with low copayments.
"That was a national contract," Bernadette Katsur, the former Purdue official, who negotiated contracts with pharmacy benefit managers, said in an interview. "We would negotiate a certain rebate percentage for keeping it on a certain tier related to copay or whether it has prior authorization. We like to keep prior authorization off of any drug."
Katsur said prior authorization programs do little to eliminate inappropriate prescribing by "bad doctors" and usually just create needless paperwork for doctors working in the best interest of patients. She said some doctors simply won’t deal with the hassle of a prior authorization program, resulting in some legitimate patients not getting the medication they need.
"You don’t want to make it harder for a doctor to prescribe when they are doing the right thing," she said.
In addition to keeping OxyContin from being subject to prior authorization, the rebates paid to pharmacy benefit managers were used to guarantee favorable status for OxyContin on their listings of approved drugs, Kastur said. PBMs commonly place drugs in different tiers on these lists, called formularies. Some tiers are more restrictive and require higher copayments. Purdue wanted OxyContin placed in the least restrictive tier - and succeeded.
The relationship with Merck Medco was so important that Purdue moved Katsur to New Jersey so she could be close to Merck’s national headquarters, she said.
It is common for drug companies to pay rebates to gain preferential treatment from companies hired by insurance plans to manage prescription drug benefits, but in this case the arrangement removed a key safeguard in the system that may have slowed the growth of OxyContin as it became a national bestseller that eventually peaked at annual sales of $3 billion.
The former Merck Medco was purchased by Express Scripts in 2012. A spokesman for Express Scripts said no one currently at the company had knowledge of the West Virginia contract. A spokesman for Purdue Pharma said the company had no comment.
In McDowell County, where the court records from a state lawsuit against Purdue were unsealed, the local sheriff said prescription pill abuse is so rampant that the county plans to file a new lawsuit against painkiller makers.
...
Last year, the European Medicines Agency banned about 700 medicines across Europe after an investigation revealed data tampering in some trials of generic drugs in India. The questionable trials were conducted by "contract research organizations" or CROs in India on behalf of major international durgmakers located in other countries around the world.
International medical experts said that volunteers undergoing back-to-back clinical trials endangers the health of patients participating. It can also compromise clinical data gathered through these trials, on the basis of which drugmakers seek approval to sell generic medicines around the world.
"The time gap between participation in two different trials should be 90 days minimum," said Stephanie Croft, a lead inspector at the WHO. "When [data] is incomplete or incorrect it could pose a serious risk to patients."
Yet, some of the "volunteers" in India who participate in drug studies for international drugmakers who use Indian CROs are "addicted" to the money and find ways to violate the rules and do not wait the required 90 days between participating in clinical drug trials.
Half of more than a dozen volunteers interviewed by Reuters across four cities - Chennai, Hyderabad, Bengaluru, and New Delhi - said they waited much less than 90 days between trials. In the past three-to-four years, they said they spent several months at a time in different cities so that they could participate in as many studies as possible.
One volunteer, Vasudeva Prakash, a former mechanic, said he was never asked by CROs, and their ‘agents’ who approached him for studies, about whether he had recently taken part in another trial.
"Everybody does it. Once you start getting the money, it's very hard to quit. It's like an addiction," said Prakash.
He said after the first study, he began to regularly receive messages on his phone and Facebook, often from agents working on behalf of CROs, informing him about ongoing clinical trials where volunteers were required. Such messages included three key things: the city where the trial was being conducted, the total pay offered, and the "blood loss", or the amount of blood the volunteer will need to provide.
Prakash provided Reuters with documentation proving he underwent trials with short gaps at Apotex Research Pvt Ltd, owned by Canadian drugmaker Apotex Inc; Lotus Labs, owned by U.S. generics giant Actavis; Ethics Bio Lab, owned since last year by U.S. drugmaker Par Pharmaceutical Inc; and India’s Semler Research Center Pvt Ltd, among others.
In addition to the questionable status of volunteers, several CROs have been accused of outright data tampering. For example, CRO, Quest Life Sciences, was found last year to have manipulated clinical data on certain trials, according to inspection reports from the WHO and the UK’s medicines authority.
Several large international drugmakers, including Teva Pharmaceutical Industries Ltd and Mylan NV, rely on CROs in India to carry out tests on cheaper versions of branded drugs. The aim of these so-called "bioequivalence" studies is to gauge whether non-branded drugs are equally safe and effective. The faster the trials are undertaken, the faster the drugs can come to market.
In the wake of trial data manipulation scandals at CROs in the past three years, many large drugmakers including Swiss firm Novartis, have been shifting more critical trials back to the United States and Europe, according to consultants and industry executives.
International and local regulators have struggled to keep its oversight in line with the growth of an industry that expanded rapidly in the 2000s, as drugmakers shipped clinical trial work to India to save money. The market is estimated to have crossed $1 billion in 2016, according to consultants Frost and Sullivan ...
International medical experts said that volunteers undergoing back-to-back clinical trials endangers the health of patients participating. It can also compromise clinical data gathered through these trials, on the basis of which drugmakers seek approval to sell generic medicines around the world.
"The time gap between participation in two different trials should be 90 days minimum," said Stephanie Croft, a lead inspector at the WHO. "When [data] is incomplete or incorrect it could pose a serious risk to patients."
Yet, some of the "volunteers" in India who participate in drug studies for international drugmakers who use Indian CROs are "addicted" to the money and find ways to violate the rules and do not wait the required 90 days between participating in clinical drug trials.
Half of more than a dozen volunteers interviewed by Reuters across four cities - Chennai, Hyderabad, Bengaluru, and New Delhi - said they waited much less than 90 days between trials. In the past three-to-four years, they said they spent several months at a time in different cities so that they could participate in as many studies as possible.
One volunteer, Vasudeva Prakash, a former mechanic, said he was never asked by CROs, and their ‘agents’ who approached him for studies, about whether he had recently taken part in another trial.
"Everybody does it. Once you start getting the money, it's very hard to quit. It's like an addiction," said Prakash.
He said after the first study, he began to regularly receive messages on his phone and Facebook, often from agents working on behalf of CROs, informing him about ongoing clinical trials where volunteers were required. Such messages included three key things: the city where the trial was being conducted, the total pay offered, and the "blood loss", or the amount of blood the volunteer will need to provide.
Prakash provided Reuters with documentation proving he underwent trials with short gaps at Apotex Research Pvt Ltd, owned by Canadian drugmaker Apotex Inc; Lotus Labs, owned by U.S. generics giant Actavis; Ethics Bio Lab, owned since last year by U.S. drugmaker Par Pharmaceutical Inc; and India’s Semler Research Center Pvt Ltd, among others.
In addition to the questionable status of volunteers, several CROs have been accused of outright data tampering. For example, CRO, Quest Life Sciences, was found last year to have manipulated clinical data on certain trials, according to inspection reports from the WHO and the UK’s medicines authority.
Several large international drugmakers, including Teva Pharmaceutical Industries Ltd and Mylan NV, rely on CROs in India to carry out tests on cheaper versions of branded drugs. The aim of these so-called "bioequivalence" studies is to gauge whether non-branded drugs are equally safe and effective. The faster the trials are undertaken, the faster the drugs can come to market.
In the wake of trial data manipulation scandals at CROs in the past three years, many large drugmakers including Swiss firm Novartis, have been shifting more critical trials back to the United States and Europe, according to consultants and industry executives.
International and local regulators have struggled to keep its oversight in line with the growth of an industry that expanded rapidly in the 2000s, as drugmakers shipped clinical trial work to India to save money. The market is estimated to have crossed $1 billion in 2016, according to consultants Frost and Sullivan ...
A new study published in the American Journal of Epidemiology and summarized in Ruters Health says that regular use of pain relievers over many years may increase the risk of hearing loss.
Researchers analyzed long-term data on almost 56,000 U.S. women and found using non-steroidal anti-inflammatories (NSAIDS) like naproxen (Aleve) and ibuprofen (Motrin) as well as acetaminophen (Tylenol) for six years or more was tied to a greater risk of hearing problems than taking these drugs for a year or less.
"Hearing loss is extremely common in the United States and can have a profound impact on quality of life," said senior study author Dr. Gary Curhan, a researcher at Harvard University and Brigham and Women’s Hospital in Boston.
Risks of the painkillers in the study go beyond hearing loss and patients should do their best to avoid long-term use, Curhan added by email.
"Even though these medications are sold without requiring a prescription, they do have potential side effects, one of which is a higher risk of hearing loss; they have also been shown to be associated with a higher risk of hypertension (high blood pressure) and other important medical conditions," Curhan said.
"They are generally safe when taken in usual doses for short periods of time," Curhan noted. "However, there should be strong justification for long-term use."
Women in the study who used NSAIDs at least twice a week for six years or more were 10 percent more likely to report hearing loss than participants who used these drugs for less than one year.
With acetaminophen, regular users for at least six years were 9 percent more likely to report defective hearing than short-term users, researchers report in the American Journal of Epidemiology.
Researchers did not find a statistically meaningful association between hearing loss and the duration of aspirin use.
Aspirin has been linked to ringing in the ears in the past, and Vicodin, a painkiller that contains acetaminophen, has been tied to hearing loss with overuse, noted Dr. Jennifer Derebery of the House Ear Clinic and the University of California, Los Angeles.
Ibuprofen is less commonly recognized by the public as a potential cause of hearing damage, Derebery, who wasn't involved in the study, said by email.
Previous research has found a similar link between painkillers and hearing loss in men, though studies to date have yet to explain how the drugs might impact hearing, said Dr. Wilko Grolman, a researcher at the University of Utrecht in the Netherlands who wasn’t involved in the study.
However, the study is observational and doesn’t prove these painkillers cause hearing impairment.
"The hearing loss was self-reported and not measured objectively with hearing tests," Dr. David Haynes, a researcher at Vanderbilt University Medical Center in Nashville who wasn’t involved in the study, said by email ...
Researchers analyzed long-term data on almost 56,000 U.S. women and found using non-steroidal anti-inflammatories (NSAIDS) like naproxen (Aleve) and ibuprofen (Motrin) as well as acetaminophen (Tylenol) for six years or more was tied to a greater risk of hearing problems than taking these drugs for a year or less.
"Hearing loss is extremely common in the United States and can have a profound impact on quality of life," said senior study author Dr. Gary Curhan, a researcher at Harvard University and Brigham and Women’s Hospital in Boston.
Risks of the painkillers in the study go beyond hearing loss and patients should do their best to avoid long-term use, Curhan added by email.
"Even though these medications are sold without requiring a prescription, they do have potential side effects, one of which is a higher risk of hearing loss; they have also been shown to be associated with a higher risk of hypertension (high blood pressure) and other important medical conditions," Curhan said.
"They are generally safe when taken in usual doses for short periods of time," Curhan noted. "However, there should be strong justification for long-term use."
Women in the study who used NSAIDs at least twice a week for six years or more were 10 percent more likely to report hearing loss than participants who used these drugs for less than one year.
With acetaminophen, regular users for at least six years were 9 percent more likely to report defective hearing than short-term users, researchers report in the American Journal of Epidemiology.
Researchers did not find a statistically meaningful association between hearing loss and the duration of aspirin use.
Aspirin has been linked to ringing in the ears in the past, and Vicodin, a painkiller that contains acetaminophen, has been tied to hearing loss with overuse, noted Dr. Jennifer Derebery of the House Ear Clinic and the University of California, Los Angeles.
Ibuprofen is less commonly recognized by the public as a potential cause of hearing damage, Derebery, who wasn't involved in the study, said by email.
Previous research has found a similar link between painkillers and hearing loss in men, though studies to date have yet to explain how the drugs might impact hearing, said Dr. Wilko Grolman, a researcher at the University of Utrecht in the Netherlands who wasn’t involved in the study.
However, the study is observational and doesn’t prove these painkillers cause hearing impairment.
"The hearing loss was self-reported and not measured objectively with hearing tests," Dr. David Haynes, a researcher at Vanderbilt University Medical Center in Nashville who wasn’t involved in the study, said by email ...
The Food and Drug Administration released its recommendations for how medical device manufacturers should maintain the security of internet-connected devices, even after they’ve entered hospitals, patient homes, or patient bodies.
First issued in draft form last January, this guidance is more than a year in the making. The 30-page document encourages manufacturers to monitor their medical devices and associated software for bugs, and patch any problems that occur. But the recommendations are not legally enforceable - so they’re largely without teeth.
The FDA has been warning the health care industry for years that medical devices are vulnerable to cyberattacks. It’s a legitimate concern: researchers have managed to remotely tamper with devices like defibrillators, pacemakers, and insulin pumps. In 2015, FDA warned hospitals that the Hospira infusion pump, which slowly releases nutrients and medications into a patient’s body, could be accessed and controlled through the hospital’s network. That’s dangerous to patients who could be harmed directly by devices altered to deliver too much or too little medication. It also means poorly secured devices could give hackers access to hospital networks that store patient information - a situation that’s ripe for identity theft.
"In fact, hospital networks experience constant attempts of intrusion and attack, which can pose a threat to patient safety," says Suzanne Schwartz, the FDA’s associate director for science and strategic partnerships, in a blog post about the new guidelines. "And as hackers become more sophisticated, these cybersecurity risks will evolve."
The FDA issued an earlier set of recommendations in October 2014, which recommended ways for manufacturers to build cybersecurity protections into medical devices as they’re being designed and developed. The current guidance focuses on how to maintain medical device cybersecurity after devices have left the factory. The guidelines lay out steps for recognizing and addressing ongoing vulnerabilities. And they recommend that manufacturers join together in an Information Sharing and Analysis Organization (ISAO) to share details about security risks and responses as they occur.
Most patches and updates intended to address security vulnerabilities will be considered routine enhancements, which means manufacturers don’t have to alert the FDA every time they issue one. That is, unless someone dies or is seriously harmed because of a bug - then the manufacturer needs to report it. Dangerous bugs identified before they harm or kill anyone won’t have to be reported to the FDA as long as the manufacturer tells customers and device users about the bug within 30 days, fixes it within 60 days, and shares information about the vulnerability with an ISAO.
This attempt to secure medical devices is just the beginning, says Eric Johnson, a cyber security researcher and dean of the Vanderbilt University business school, in an email to The Verge. The FDA’s Schwartz agrees, writing in a blog post: "This is clearly not the end of what FDA will do to address cybersecurity."
...
First issued in draft form last January, this guidance is more than a year in the making. The 30-page document encourages manufacturers to monitor their medical devices and associated software for bugs, and patch any problems that occur. But the recommendations are not legally enforceable - so they’re largely without teeth.
The FDA has been warning the health care industry for years that medical devices are vulnerable to cyberattacks. It’s a legitimate concern: researchers have managed to remotely tamper with devices like defibrillators, pacemakers, and insulin pumps. In 2015, FDA warned hospitals that the Hospira infusion pump, which slowly releases nutrients and medications into a patient’s body, could be accessed and controlled through the hospital’s network. That’s dangerous to patients who could be harmed directly by devices altered to deliver too much or too little medication. It also means poorly secured devices could give hackers access to hospital networks that store patient information - a situation that’s ripe for identity theft.
"In fact, hospital networks experience constant attempts of intrusion and attack, which can pose a threat to patient safety," says Suzanne Schwartz, the FDA’s associate director for science and strategic partnerships, in a blog post about the new guidelines. "And as hackers become more sophisticated, these cybersecurity risks will evolve."
The FDA issued an earlier set of recommendations in October 2014, which recommended ways for manufacturers to build cybersecurity protections into medical devices as they’re being designed and developed. The current guidance focuses on how to maintain medical device cybersecurity after devices have left the factory. The guidelines lay out steps for recognizing and addressing ongoing vulnerabilities. And they recommend that manufacturers join together in an Information Sharing and Analysis Organization (ISAO) to share details about security risks and responses as they occur.
Most patches and updates intended to address security vulnerabilities will be considered routine enhancements, which means manufacturers don’t have to alert the FDA every time they issue one. That is, unless someone dies or is seriously harmed because of a bug - then the manufacturer needs to report it. Dangerous bugs identified before they harm or kill anyone won’t have to be reported to the FDA as long as the manufacturer tells customers and device users about the bug within 30 days, fixes it within 60 days, and shares information about the vulnerability with an ISAO.
This attempt to secure medical devices is just the beginning, says Eric Johnson, a cyber security researcher and dean of the Vanderbilt University business school, in an email to The Verge. The FDA’s Schwartz agrees, writing in a blog post: "This is clearly not the end of what FDA will do to address cybersecurity."
...
A drug distributor owned by Cardinal Health Inc has agreed to pay $10 million to resolve claims it failed to alert the U.S. Drug Enforcement Administration to suspiciously large orders of addictive painkillers by New York-area pharmacies.
The settlement with Kinray LLC, a New York City-based pharmaceutical distributor, disclosed in papers filed late Thursday in federal court in Manhattan, comes amid efforts by U.S. authorities to combat the nation's opioid drug epidemic.
The settlement was secured by the office of Preet Bharara, the U.S. Attorney for the Southern District of New York, who has increasingly turned his sights toward the growing opioid drug epidemic.
The Kinray settlement came after a DEA investigation of pharmacies in New York and elsewhere that had ordered unusually large and frequent shipments of oxycodone or hydrocodone, according to a lawsuit filed earlier this week.
From January 2011 and May 2012, Kinray shipped the drugs to more than 20 New York pharmacy locations in amounts that were many times greater than the distributor's average sales of controlled substances to all of its customers, the lawsuit said.
Kinray ignored numerous "red flags" and did not report any suspicious orders to the DEA despite requirements that it do so for such highly regulated drugs, the lawsuit said.
The latest agreement stemmed from a 2012 settlement with the DEA in which its facility in Lakeland, Florida, was suspended from selling painkillers and other drugs for two years, according to Cardinal.
The 2012 deal only resolved administrative aspects of the case, not potential fines Cardinal Health faced in Florida or elsewhere. The Dublin, Ohio-based company has set aside $44 million to cover those potential liabilities.
Cardinal Health, which announced its $1.3 billion acquisition of Kinray in 2010, said on Friday it continues to work with the U.S. Justice Department to resolve the matter.
As part of the settlement, Kinray admitted and accepted responsibility for failing to report suspicious orders to the DEA, according to court papers.
The case is U.S. v. Kinray LLC, U.S. District Court, Southern District of New York, No. 16-cv-09767 ...
The settlement with Kinray LLC, a New York City-based pharmaceutical distributor, disclosed in papers filed late Thursday in federal court in Manhattan, comes amid efforts by U.S. authorities to combat the nation's opioid drug epidemic.
The settlement was secured by the office of Preet Bharara, the U.S. Attorney for the Southern District of New York, who has increasingly turned his sights toward the growing opioid drug epidemic.
The Kinray settlement came after a DEA investigation of pharmacies in New York and elsewhere that had ordered unusually large and frequent shipments of oxycodone or hydrocodone, according to a lawsuit filed earlier this week.
From January 2011 and May 2012, Kinray shipped the drugs to more than 20 New York pharmacy locations in amounts that were many times greater than the distributor's average sales of controlled substances to all of its customers, the lawsuit said.
Kinray ignored numerous "red flags" and did not report any suspicious orders to the DEA despite requirements that it do so for such highly regulated drugs, the lawsuit said.
The latest agreement stemmed from a 2012 settlement with the DEA in which its facility in Lakeland, Florida, was suspended from selling painkillers and other drugs for two years, according to Cardinal.
The 2012 deal only resolved administrative aspects of the case, not potential fines Cardinal Health faced in Florida or elsewhere. The Dublin, Ohio-based company has set aside $44 million to cover those potential liabilities.
Cardinal Health, which announced its $1.3 billion acquisition of Kinray in 2010, said on Friday it continues to work with the U.S. Justice Department to resolve the matter.
As part of the settlement, Kinray admitted and accepted responsibility for failing to report suspicious orders to the DEA, according to court papers.
The case is U.S. v. Kinray LLC, U.S. District Court, Southern District of New York, No. 16-cv-09767 ...
A new study published in the American Journal of Sports Medicine and summarized in a report by Reuters Health claims that patients receiving a graft of their own knee cartilage cells may be better off returning to full weight bearing after six weeks instead of the standard eight.
Knee surgery patients put on a six-week recovery track were able to get back to work and other activities like sports more quickly, and even reported slightly better results at 24 months than those who had followed an eight-week recovery plan after surgery, researchers report in the American Journal of Sports Medicine.
People with damaged cartilage in their knees can undergo so-called matrix-induced autologous chondrocyte implantation, or MACI, surgery to fix the defects that cause pain and swelling.
In the two-stage MACI surgery, healthy cartilage is collected from unaffected parts of the damaged knee and sent to a lab where it’s used to grow more cartilage on a scaffold-like material. The surgeon then implants this graft into the damaged parts of the knee where it’s expected to integrate with surrounding cartilage.
Standard practice has been to keep weight off the knee for at least eight weeks and up to three months for fear of damaging the delicate new tissue. But there’s evidence that the forces of weight and movement promote growth by the cartilage cells, the authors write, so putting some weight on the implant earlier might help speed recovery of the knee.
"The regimens employed internationally were very conservative in fear of overloading the early repair tissue and jeopardizing the final outcome," lead author Jay Ebert told Reuters Health by email.
Besides the obvious lifestyle benefits of shorter recovery times, there are clinical benefits as well, said Ebert, of the University of Western Australia in Crawley. Returning to walking more quickly may reduce the amount of muscle lost and the level of joint stiffness after surgery, he said.
To explore whether people could heal as well from surgery if they only kept off of their feet for six weeks instead of eight, the study team recruited 37 MACI surgery patients between 2010 and 2014.
The participants were randomly assigned to an eight-week return to weight-bearing group or an accelerated six-week recovery group.
Overall, the results were good for both groups. There were two cases of graft failure, both in the eight-week recovery group.
The two groups had similar results on all tests of knee function, with the accelerated group performing slightly better. For instance their repaired knees, on average, had returned to 94 percent of the peak strength of the undamaged knee, compared to 88 percent in the eight-week recovery group.
The MRI scans showed the patients in the faster recovery group had significantly better healing on two out of eight visible measures, compared with the eight-week group.
Overall, 83 percent of patients in the eight-week group were satisfied with their surgery, while 88 percent of patients in the six-week group reported being satisfied ...
Knee surgery patients put on a six-week recovery track were able to get back to work and other activities like sports more quickly, and even reported slightly better results at 24 months than those who had followed an eight-week recovery plan after surgery, researchers report in the American Journal of Sports Medicine.
People with damaged cartilage in their knees can undergo so-called matrix-induced autologous chondrocyte implantation, or MACI, surgery to fix the defects that cause pain and swelling.
In the two-stage MACI surgery, healthy cartilage is collected from unaffected parts of the damaged knee and sent to a lab where it’s used to grow more cartilage on a scaffold-like material. The surgeon then implants this graft into the damaged parts of the knee where it’s expected to integrate with surrounding cartilage.
Standard practice has been to keep weight off the knee for at least eight weeks and up to three months for fear of damaging the delicate new tissue. But there’s evidence that the forces of weight and movement promote growth by the cartilage cells, the authors write, so putting some weight on the implant earlier might help speed recovery of the knee.
"The regimens employed internationally were very conservative in fear of overloading the early repair tissue and jeopardizing the final outcome," lead author Jay Ebert told Reuters Health by email.
Besides the obvious lifestyle benefits of shorter recovery times, there are clinical benefits as well, said Ebert, of the University of Western Australia in Crawley. Returning to walking more quickly may reduce the amount of muscle lost and the level of joint stiffness after surgery, he said.
To explore whether people could heal as well from surgery if they only kept off of their feet for six weeks instead of eight, the study team recruited 37 MACI surgery patients between 2010 and 2014.
The participants were randomly assigned to an eight-week return to weight-bearing group or an accelerated six-week recovery group.
Overall, the results were good for both groups. There were two cases of graft failure, both in the eight-week recovery group.
The two groups had similar results on all tests of knee function, with the accelerated group performing slightly better. For instance their repaired knees, on average, had returned to 94 percent of the peak strength of the undamaged knee, compared to 88 percent in the eight-week recovery group.
The MRI scans showed the patients in the faster recovery group had significantly better healing on two out of eight visible measures, compared with the eight-week group.
Overall, 83 percent of patients in the eight-week group were satisfied with their surgery, while 88 percent of patients in the six-week group reported being satisfied ...
Allstate went before a judge and jury to put an end to the illegal ownership, kickbacks and fraudulent operation of multiple law offices in the Los Angeles area that were owned, operated and controlled by unlicensed people posing as lawyers.
The verdict in a Los Angeles County Superior Court resulted in a judgment worth more than $11.5 million in favor of Allstate.
"Submitting even one false insurance claim is fraud and insurance fraud is a crime," says Allstate's Senior Field Vice President Phil Telgenhoff. "Fraud drives up the cost we all pay for insurance by stealing millions of dollars from insurers. This cannot and will not be tolerated in California or anywhere."
Allstate alleged Christina Chang, Christine Suh and other unlicensed persons knowingly engaged in a fraud scheme in which they used the identity of practicing lawyers to create eight phony or "sham" law offices to make false, fraudulent or misleading claims against insurance companies so that settlement payments could be converted to their own use.
Evidence presented at trial showed that several California lawyers were paid $3,000 per month for the use of their names and law licenses. None of the licensed lawyers had significant direction or control over the operation of the fake law offices or the making and processing of claims.
Chang and Suh rented office space, hired staff, opened firm bank accounts, obtained clients, made demands to insurance companies for settlement and negotiated settlements, all in the name of licensed California attorneys, falsely making it appear as if a lawyer represented the client and claimant.
The evidence also showed Chang and Suh used remote check-cashing facilities including liquor stores and small local markets to convert the settlement proceeds into untraceable cash from deposits into client-trust accounts.
Allstate contended Chang and Suh knowingly concealed the fact that the law offices were owned, operated and controlled by unlicensed persons, all in violation of California's Insurance Frauds Prevention Act.
"This is one of the first times I've seen this elaborate of an effort with setting up fake law offices and trying to defraud the industry," says Telgenhoff. "We have seen this type of operation before with shady medical clinics across the country, but this takes the scam to a different level. Rest assured, we will fight fraud wherever it lives." ...
The verdict in a Los Angeles County Superior Court resulted in a judgment worth more than $11.5 million in favor of Allstate.
"Submitting even one false insurance claim is fraud and insurance fraud is a crime," says Allstate's Senior Field Vice President Phil Telgenhoff. "Fraud drives up the cost we all pay for insurance by stealing millions of dollars from insurers. This cannot and will not be tolerated in California or anywhere."
Allstate alleged Christina Chang, Christine Suh and other unlicensed persons knowingly engaged in a fraud scheme in which they used the identity of practicing lawyers to create eight phony or "sham" law offices to make false, fraudulent or misleading claims against insurance companies so that settlement payments could be converted to their own use.
Evidence presented at trial showed that several California lawyers were paid $3,000 per month for the use of their names and law licenses. None of the licensed lawyers had significant direction or control over the operation of the fake law offices or the making and processing of claims.
Chang and Suh rented office space, hired staff, opened firm bank accounts, obtained clients, made demands to insurance companies for settlement and negotiated settlements, all in the name of licensed California attorneys, falsely making it appear as if a lawyer represented the client and claimant.
The evidence also showed Chang and Suh used remote check-cashing facilities including liquor stores and small local markets to convert the settlement proceeds into untraceable cash from deposits into client-trust accounts.
Allstate contended Chang and Suh knowingly concealed the fact that the law offices were owned, operated and controlled by unlicensed persons, all in violation of California's Insurance Frauds Prevention Act.
"This is one of the first times I've seen this elaborate of an effort with setting up fake law offices and trying to defraud the industry," says Telgenhoff. "We have seen this type of operation before with shady medical clinics across the country, but this takes the scam to a different level. Rest assured, we will fight fraud wherever it lives." ...
Forest Park Medical Center (FPMC) in Dallas and other Texas cities was touted as a "Luxury" hospital with a "spa-like atmosphere," which did not accept lower-paying Medicare, Medicaid, or "in-network" managed-care insurance rates, but did allow for physician ownership, As such, it rapidly attracted the attention of physician investors and their referrals
The patients were primarily ones with high reimbursing out-of-network private insurance benefits or benefits under certain federally-funded programs. As such, it was free to set its own prices for services and was generally reimbursed at substantially higher rates than in-network providers. FPMC’s strategy was to maximize profit for physician investors by refusing to join the networks of insurance plans for a period of time after its formation, allowing its owners and managers to enrich themselves through out-of-network billing and reimbursement.
But, rather than leave money on the table, FPMC’s owners, managers, and employees also attempted to sell patients with lower reimbursing insurance coverage, namely unwitting Medicare and Medicaid beneficiaries, to other facilities in exchange for cash.
Yet worker's compensation patients were included in the clientele accepted by this "Luxury" facility. According to the indictment, the hospital accepted the referral of patients with high reimbursing, out-of-network private insurance benefits, and benefits under certain non-Medicare and Medicaid federally-funded programs, such as the Federal Federal Employees' Compensation Program also known as federal workers compensation.
Included in the 21 professionals indicted this December were Iris Kathleen Forrest, 56, of Dallas who was a worker’s compensation preauthorization specialist who allegedly received approximately $450,000 in bribe and kickback payments in exchange for referring patients, including those she was preauthorizing, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital. And Royce Vaughn Bicklein, 44, of San Antonio, Texas was a worker’s compensation lawyer who received approximately $100,000 in bribe and kickback payments in exchange for referring patients, including his clients, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital.
Although the typical arrangement in Texas would call for the carve-out of Medicare and Medicaid programs, the intent being to avoid the possibility of running afoul of the Department of Health and Human Services Office of Inspector General, ("HHS OIG"), what many fail to appreciate is the manifold number of federal healthcare programs which could be implicated. Each federal department has its own OIG. Federal worker's compensation and federal employees health insurance benefits are guarded by the United States Department of Labor OIG. Military plans, or TRICARE, is protected by the Department of Defense OIG.
That's what initially triggered federal jurisdiction at Forest Park, according to the indictment. The bribes and kickbacks included more than $10 million to TRICARE, more than $25 million to the Department of Labor FECA healthcare program, and more than $60 million to the federal employees' and retirees' FEHBP healthcare program. As a result of the bribes, kickbacks, and other inducements, from 2009 to 2013, FPMC allegedly billed such patients’ insurance plans and programs well over half of a billion dollars.
What would be illegal, if the prosecutors can make their case, is the alleged $40 million in bribes and kickbacks paid for referring certain patients to FPMC.
But what is interesting in this very ugly fraud case, is the inclusion of federal workers' compensation claimants among those who were to be treated at a luxury hospital with a spa like atmosphere that bills at substantially higher rates than in-network providers. The question to be answered for taxpayers is how did this happen in the first place? ...
The patients were primarily ones with high reimbursing out-of-network private insurance benefits or benefits under certain federally-funded programs. As such, it was free to set its own prices for services and was generally reimbursed at substantially higher rates than in-network providers. FPMC’s strategy was to maximize profit for physician investors by refusing to join the networks of insurance plans for a period of time after its formation, allowing its owners and managers to enrich themselves through out-of-network billing and reimbursement.
But, rather than leave money on the table, FPMC’s owners, managers, and employees also attempted to sell patients with lower reimbursing insurance coverage, namely unwitting Medicare and Medicaid beneficiaries, to other facilities in exchange for cash.
Yet worker's compensation patients were included in the clientele accepted by this "Luxury" facility. According to the indictment, the hospital accepted the referral of patients with high reimbursing, out-of-network private insurance benefits, and benefits under certain non-Medicare and Medicaid federally-funded programs, such as the Federal Federal Employees' Compensation Program also known as federal workers compensation.
Included in the 21 professionals indicted this December were Iris Kathleen Forrest, 56, of Dallas who was a worker’s compensation preauthorization specialist who allegedly received approximately $450,000 in bribe and kickback payments in exchange for referring patients, including those she was preauthorizing, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital. And Royce Vaughn Bicklein, 44, of San Antonio, Texas was a worker’s compensation lawyer who received approximately $100,000 in bribe and kickback payments in exchange for referring patients, including his clients, to FPMC or to surgeons who performed medical procedures, including surgeries, at the hospital.
Although the typical arrangement in Texas would call for the carve-out of Medicare and Medicaid programs, the intent being to avoid the possibility of running afoul of the Department of Health and Human Services Office of Inspector General, ("HHS OIG"), what many fail to appreciate is the manifold number of federal healthcare programs which could be implicated. Each federal department has its own OIG. Federal worker's compensation and federal employees health insurance benefits are guarded by the United States Department of Labor OIG. Military plans, or TRICARE, is protected by the Department of Defense OIG.
That's what initially triggered federal jurisdiction at Forest Park, according to the indictment. The bribes and kickbacks included more than $10 million to TRICARE, more than $25 million to the Department of Labor FECA healthcare program, and more than $60 million to the federal employees' and retirees' FEHBP healthcare program. As a result of the bribes, kickbacks, and other inducements, from 2009 to 2013, FPMC allegedly billed such patients’ insurance plans and programs well over half of a billion dollars.
What would be illegal, if the prosecutors can make their case, is the alleged $40 million in bribes and kickbacks paid for referring certain patients to FPMC.
But what is interesting in this very ugly fraud case, is the inclusion of federal workers' compensation claimants among those who were to be treated at a luxury hospital with a spa like atmosphere that bills at substantially higher rates than in-network providers. The question to be answered for taxpayers is how did this happen in the first place? ...
Several new laws affect workplace safety, including a package of bills that took effect June 9, 2016.
AB 1785 reaffirms the general ban on using wireless electronic devices while driving, but amends existing law to authorize drivers to use their hand to activate or deactivate a feature or function of the device with a single swipe or tap, as long as the device is mounted so as not to hinder the driver’s view of the road.
Despite the steady expansion of legislative prohibitions on the use of wireless telephones and electronic wireless communications devices while driving, and the clear dangers of distracted driving, in 2014, the California Court of Appeals for the 5th District ruled that the existing ban only prohibits a driver from holding a wireless telephone while conversing on it. In making its ruling, the court found that the legislative intent in enacting those prohibitions was merely focused on prohibiting a wireless telephone only while carrying on a conversation, not while using it for any other purpose. For that reason, law enforcement agencies find it difficult, if not practicably impossible to enforce the prohibition, as the scope of a mobile device's functions and its contributions to distracted driving go far beyond simply making and receiving telephone calls.
The new law bans all handheld use of wireless electronic communication devices by the driver of a vehicle during its operation, without reference to the purpose of that use. An exception is provided for windshield-, dashboard-, and center console-mounted devices when the driver can activate or deactivate the feature or function he or she is using with a single swipe or tap and the placement of the mounted device does not hinder the driver's view of the road. As such, drivers can still engage with their phones in the relatively simple ways that are most similar to other sources of distraction that society has long accepted, such as changing the channel on a car radio.
Four bills (SB-5, SB-7 and AB-5, AB-7) were signed earlier this year that extend the ban on workplace smoking. These rules took effect June 9, 2016.
Specifically AB 7 removes many (but not all) exemptions in existing law that allow tobacco smoking in certain indoor workplaces and expands the prohibition on smoking in a place of employment to include owner-operated businesses. It establishes "smoke-free laws," which prohibit the smoking of tobacco products in various places, including, but not limited to, school campuses, public buildings, places of employment, apartment buildings, day care facilities, retail food facilities, health facilities, and vehicles when minors are present.
AB 7 prohibits employers from knowingly or intentionally permitting the smoking of tobacco products in an enclosed space at a place of employment. It defines "enclosed space" as including lobbies, lounges, waiting areas, elevators, stairwells, and restrooms that are a structural part of the building and not specifically exempt. It extends the workplace smoking prohibition to include owner-operated businesses in which the owner-operator is the only worker and there are no employees, independent contractors, or volunteers. There are no exemptions for employers of any size.
SB 1167 requires Cal/OSHA to propose a heat-illness and injury prevention standard for indoor workers by Jan. 1, 2019. SB 1167 does not specify what provisions will be included in the new rule or what types of workplaces will be covered - potentially, the new rule could include all indoor workplaces. The law is a result of litigation on this issue.
A recent Occupational Safety and Health Appeals Board (Appeals Board) decision affirms the responsibility of employers to ensure indoor heat illness is addressed through their IIPP. The case stemmed from a 2012 serious citation issued to Tri-State Staffing and warehouse operator National Distribution Center for the heat illness suffered by an employee who was working inside a metal freight container with a temperature of over 100 degrees. DOSH penalized both companies for failing to implement an effective IIPP and both companies appealed the citation winning their case before an administrative law judge (ALJ).
In March 2015, DOSH appealed that decision to the Appeals Board stating that the employers had failed to effectively correct the indoor hazard and had not trained employees on indoor heat exposure. In November 2015, the ALJ's decision was overturned by the Appeals Board reinforcing the responsibility that employers have to protect the health and safety of their workers, including those working indoors ...
AB 1785 reaffirms the general ban on using wireless electronic devices while driving, but amends existing law to authorize drivers to use their hand to activate or deactivate a feature or function of the device with a single swipe or tap, as long as the device is mounted so as not to hinder the driver’s view of the road.
Despite the steady expansion of legislative prohibitions on the use of wireless telephones and electronic wireless communications devices while driving, and the clear dangers of distracted driving, in 2014, the California Court of Appeals for the 5th District ruled that the existing ban only prohibits a driver from holding a wireless telephone while conversing on it. In making its ruling, the court found that the legislative intent in enacting those prohibitions was merely focused on prohibiting a wireless telephone only while carrying on a conversation, not while using it for any other purpose. For that reason, law enforcement agencies find it difficult, if not practicably impossible to enforce the prohibition, as the scope of a mobile device's functions and its contributions to distracted driving go far beyond simply making and receiving telephone calls.
The new law bans all handheld use of wireless electronic communication devices by the driver of a vehicle during its operation, without reference to the purpose of that use. An exception is provided for windshield-, dashboard-, and center console-mounted devices when the driver can activate or deactivate the feature or function he or she is using with a single swipe or tap and the placement of the mounted device does not hinder the driver's view of the road. As such, drivers can still engage with their phones in the relatively simple ways that are most similar to other sources of distraction that society has long accepted, such as changing the channel on a car radio.
Four bills (SB-5, SB-7 and AB-5, AB-7) were signed earlier this year that extend the ban on workplace smoking. These rules took effect June 9, 2016.
Specifically AB 7 removes many (but not all) exemptions in existing law that allow tobacco smoking in certain indoor workplaces and expands the prohibition on smoking in a place of employment to include owner-operated businesses. It establishes "smoke-free laws," which prohibit the smoking of tobacco products in various places, including, but not limited to, school campuses, public buildings, places of employment, apartment buildings, day care facilities, retail food facilities, health facilities, and vehicles when minors are present.
AB 7 prohibits employers from knowingly or intentionally permitting the smoking of tobacco products in an enclosed space at a place of employment. It defines "enclosed space" as including lobbies, lounges, waiting areas, elevators, stairwells, and restrooms that are a structural part of the building and not specifically exempt. It extends the workplace smoking prohibition to include owner-operated businesses in which the owner-operator is the only worker and there are no employees, independent contractors, or volunteers. There are no exemptions for employers of any size.
SB 1167 requires Cal/OSHA to propose a heat-illness and injury prevention standard for indoor workers by Jan. 1, 2019. SB 1167 does not specify what provisions will be included in the new rule or what types of workplaces will be covered - potentially, the new rule could include all indoor workplaces. The law is a result of litigation on this issue.
A recent Occupational Safety and Health Appeals Board (Appeals Board) decision affirms the responsibility of employers to ensure indoor heat illness is addressed through their IIPP. The case stemmed from a 2012 serious citation issued to Tri-State Staffing and warehouse operator National Distribution Center for the heat illness suffered by an employee who was working inside a metal freight container with a temperature of over 100 degrees. DOSH penalized both companies for failing to implement an effective IIPP and both companies appealed the citation winning their case before an administrative law judge (ALJ).
In March 2015, DOSH appealed that decision to the Appeals Board stating that the employers had failed to effectively correct the indoor hazard and had not trained employees on indoor heat exposure. In November 2015, the ALJ's decision was overturned by the Appeals Board reinforcing the responsibility that employers have to protect the health and safety of their workers, including those working indoors ...
United States Attorney Phillip A. Talbert announced that a federal grand jury returned an 11-count indictment against Anthony Lazzarino, 66, former Chief of Podiatry for the VA’s Northern California Health Care System, and Peter Wong, 58, founder and CEO of Sacramento based Sunrise Shoes and Pedorthic Service, charging them with health care fraud, conspiracy to pay and receive kickbacks on medical referrals, and conspiracy to commit wire fraud.
Lazzarino was a 1982 graduate of Kent State University, College of Podiatric Medicine. Lazzarino began working at the Veterans Health Administration in 2007 with a starting salary of $122,379. California records show his license status as "canceled."
Sunrise Shoes claims on its website to provide services under most insurance plans, including workers' compensation, and specifically the State Compensation Insurance Fund.
According to court documents, between March 2008 and February 2015, Lazzarino and Wong engaged in a scheme to defraud the VA by billing the Veterans Health Administration for custom work and services that were prescribed but not supplied in shoes delivered to veterans.
In addition, Lazzarino referred patients directly to Sunrise in violation of VA policy, and agreed with Wong to offer kickbacks in return for such referrals.
Finally, Lazzarino, Wong, and Jai Aing Chen, who separately pleaded guilty on December 6, 2016, agreed to make materially false statements and omissions to the VA regarding where the shoes were manufactured, in the course of applying for an estimated $59 million contract.
This case is the product of an investigation by the Department of Veterans Affairs, Office of Inspector General, the Department of Veterans Affairs Police Service, and the U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI). Assistant U.S. Attorney Matthew M. Yelovich is prosecuting the case.
If convicted, Lazzarino and Wong face a maximum statutory penalty of 10 years in prison and a $250,000 fine for each health care fraud count, and five years in prison and a $250,000 fine for each of the two conspiracy counts.
...
Lazzarino was a 1982 graduate of Kent State University, College of Podiatric Medicine. Lazzarino began working at the Veterans Health Administration in 2007 with a starting salary of $122,379. California records show his license status as "canceled."
Sunrise Shoes claims on its website to provide services under most insurance plans, including workers' compensation, and specifically the State Compensation Insurance Fund.
According to court documents, between March 2008 and February 2015, Lazzarino and Wong engaged in a scheme to defraud the VA by billing the Veterans Health Administration for custom work and services that were prescribed but not supplied in shoes delivered to veterans.
In addition, Lazzarino referred patients directly to Sunrise in violation of VA policy, and agreed with Wong to offer kickbacks in return for such referrals.
Finally, Lazzarino, Wong, and Jai Aing Chen, who separately pleaded guilty on December 6, 2016, agreed to make materially false statements and omissions to the VA regarding where the shoes were manufactured, in the course of applying for an estimated $59 million contract.
This case is the product of an investigation by the Department of Veterans Affairs, Office of Inspector General, the Department of Veterans Affairs Police Service, and the U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI). Assistant U.S. Attorney Matthew M. Yelovich is prosecuting the case.
If convicted, Lazzarino and Wong face a maximum statutory penalty of 10 years in prison and a $250,000 fine for each health care fraud count, and five years in prison and a $250,000 fine for each of the two conspiracy counts.
...
A new California Workers’ Compensation Institute (CWCI) study takes a detailed look at cumulative trauma (CT) claims in the California workers’ compensation system, identifies characteristics that differentiate CT claims from non-CT claims, and finds a strong association between attorney involvement and regional variation in the Los Angeles Basin and the high cost of CT claims.
Cumulative traumas are physical or mental injuries that arise over time from repetitive stress, motion, or exposures, rather than from a specific event or accident. Earlier this year, the Workers’ Compensation Insurance Rating Bureau reported that CT claims as a percentage of California workers’ compensation lost time cases had more than doubled over the past decade, climbing to about 18 percent of all indemnity cases in 2015. Because CT claims have become a significant cost driver in the system, CWCI initiated a study to gain a better understanding of where these claims come from, identify characteristics and factors contributing to the rapid growth in CT claims, and to compare average medical and indemnity benefits for CT and non-CT claims.
Using data from its Industry Research Information System (IRIS) database on 41,000 CT claims and 608,000 non-CT claims that received California workers’ comp benefits between 2005 and 2013, the Institute compared the claim characteristics of CT claims to those of non-CT claims, including the workers’ average age, gender, earnings, and job tenure; the mix of claims by employer premium, industry and region; the type and nature of injury; notification lag times; level of attorney involvement; presence of indemnity payments; presence of a compensability dispute; and whether or not the injured worker had filed any additional claims.
Among the key results, the study found that CT cases were far more likely to have come from the Los Angeles Basin; were most prevalent in the manufacturing sector; had a higher proportion of claims involving multiple body parts and mental disorders; had twice the attorney involvement rate of non-CT claims and 53 percent higher average claim costs; and workers claiming CT injuries were 10 times more likely to have claimed other injuries against the same employer.
Overall, nearly 56 percent of all CT claims in the study population were filed in the Los Angeles County/Inland Empire/Orange County region compared to 36.5 percent of non-CT claims.
Limiting the analysis to lost-time cases, the study noted that 91 percent of the CT claims involved an attorney, which was twice the attorney involvement rate for non-CT claims; and while CT claims appeared to have higher medical costs than non-CT claims, that difference disappeared when attorney involvement and region were factored into the equation. This result confirms a strong association between the higher costs of CT claims in the study sample and the high levels of attorney involvement and the regional variation in the L.A. Basin.
CWCI’s analysis of cumulative trauma claims has been published in a Research Note which is available from the Institute’s online store and can be downloaded by CWCI members and subscribers who log in to the Research section of the website ...
Cumulative traumas are physical or mental injuries that arise over time from repetitive stress, motion, or exposures, rather than from a specific event or accident. Earlier this year, the Workers’ Compensation Insurance Rating Bureau reported that CT claims as a percentage of California workers’ compensation lost time cases had more than doubled over the past decade, climbing to about 18 percent of all indemnity cases in 2015. Because CT claims have become a significant cost driver in the system, CWCI initiated a study to gain a better understanding of where these claims come from, identify characteristics and factors contributing to the rapid growth in CT claims, and to compare average medical and indemnity benefits for CT and non-CT claims.
Using data from its Industry Research Information System (IRIS) database on 41,000 CT claims and 608,000 non-CT claims that received California workers’ comp benefits between 2005 and 2013, the Institute compared the claim characteristics of CT claims to those of non-CT claims, including the workers’ average age, gender, earnings, and job tenure; the mix of claims by employer premium, industry and region; the type and nature of injury; notification lag times; level of attorney involvement; presence of indemnity payments; presence of a compensability dispute; and whether or not the injured worker had filed any additional claims.
Among the key results, the study found that CT cases were far more likely to have come from the Los Angeles Basin; were most prevalent in the manufacturing sector; had a higher proportion of claims involving multiple body parts and mental disorders; had twice the attorney involvement rate of non-CT claims and 53 percent higher average claim costs; and workers claiming CT injuries were 10 times more likely to have claimed other injuries against the same employer.
Overall, nearly 56 percent of all CT claims in the study population were filed in the Los Angeles County/Inland Empire/Orange County region compared to 36.5 percent of non-CT claims.
Limiting the analysis to lost-time cases, the study noted that 91 percent of the CT claims involved an attorney, which was twice the attorney involvement rate for non-CT claims; and while CT claims appeared to have higher medical costs than non-CT claims, that difference disappeared when attorney involvement and region were factored into the equation. This result confirms a strong association between the higher costs of CT claims in the study sample and the high levels of attorney involvement and the regional variation in the L.A. Basin.
CWCI’s analysis of cumulative trauma claims has been published in a Research Note which is available from the Institute’s online store and can be downloaded by CWCI members and subscribers who log in to the Research section of the website ...
The Food and Drug Administration approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee.
Knee problems are common, and occur in people of all ages. Cartilage defects in the knee can result from an injury, straining the knee beyond its normal motion, or can be caused by overuse, muscle weakness, and general wear and tear.
"Different cartilage defects require different treatments, so therapy must be tailored to the patient," said Celia Witten, Ph.D., M.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. "The introduction of Maci provides surgeons with an additional option for treatment."
Maci is composed of a patient’s own (autologous) cells that are expanded and placed onto a bio-resorbable (can be broken down by the body) porcine-derived collagen membrane that is implanted over the area where the defective or damaged tissue was removed. Administration should be performed by a surgeon specifically trained in the use of Maci.
Each Maci implant consists of a small cellular sheet containing 500,000 to 1,000,000 cells per cm2 (about 0.16 square inches). The amount of Maci administered depends on the size of the cartilage defect, and is trimmed to ensure that the damaged area is completely covered. Multiple implants may be used if there is more than one defect. During a mini-open technique, damaged and / or diseased cartilage tissue is debrided from the defect area and the MACI implant is cut and shaped to fit and adhered in place using an off-the-shelf sealant.
The safety and efficacy of Maci were shown in a two-year clinical trial designed to demonstrate reduced pain and improved function in comparison to microfracture, an alternative surgical procedure for cartilage repair. The trial included 144 patients (72 in each treatment group). A majority of the patients who completed the two-year clinical trial also participated in a three year follow-up study. Overall efficacy data support a long-term clinical benefit from the use of the Maci implant in patients with cartilage defects.
The most common side effect reported by people who received Maci were: joint pain, common cold-like symptoms, headache and back pain.
Maci is manufactured by Vericel Corporation, headquartered in Cambridge, Massachusetts. Vericel focuses on autologous cell therapies, which its website calls "For Me, By Me" treatments. The company is currently developing a heart failure treatment called ixmyelocel-T that involves extracting bone marrow from a patient’s hip, expanding the population of cells and administering them through a catheter. The treatment recently met its primary goal in a Phase 2 study.
Nonetheless, it has been a down year for FDA approvals, with just 20 new drugs approved thus far. That's compared to more than 40 in each of the past two years. Maci is only the fourth biotech treatment to get FDA approval this year developed by a Massachusetts-based company ...
Knee problems are common, and occur in people of all ages. Cartilage defects in the knee can result from an injury, straining the knee beyond its normal motion, or can be caused by overuse, muscle weakness, and general wear and tear.
"Different cartilage defects require different treatments, so therapy must be tailored to the patient," said Celia Witten, Ph.D., M.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. "The introduction of Maci provides surgeons with an additional option for treatment."
Maci is composed of a patient’s own (autologous) cells that are expanded and placed onto a bio-resorbable (can be broken down by the body) porcine-derived collagen membrane that is implanted over the area where the defective or damaged tissue was removed. Administration should be performed by a surgeon specifically trained in the use of Maci.
Each Maci implant consists of a small cellular sheet containing 500,000 to 1,000,000 cells per cm2 (about 0.16 square inches). The amount of Maci administered depends on the size of the cartilage defect, and is trimmed to ensure that the damaged area is completely covered. Multiple implants may be used if there is more than one defect. During a mini-open technique, damaged and / or diseased cartilage tissue is debrided from the defect area and the MACI implant is cut and shaped to fit and adhered in place using an off-the-shelf sealant.
The safety and efficacy of Maci were shown in a two-year clinical trial designed to demonstrate reduced pain and improved function in comparison to microfracture, an alternative surgical procedure for cartilage repair. The trial included 144 patients (72 in each treatment group). A majority of the patients who completed the two-year clinical trial also participated in a three year follow-up study. Overall efficacy data support a long-term clinical benefit from the use of the Maci implant in patients with cartilage defects.
The most common side effect reported by people who received Maci were: joint pain, common cold-like symptoms, headache and back pain.
Maci is manufactured by Vericel Corporation, headquartered in Cambridge, Massachusetts. Vericel focuses on autologous cell therapies, which its website calls "For Me, By Me" treatments. The company is currently developing a heart failure treatment called ixmyelocel-T that involves extracting bone marrow from a patient’s hip, expanding the population of cells and administering them through a catheter. The treatment recently met its primary goal in a Phase 2 study.
Nonetheless, it has been a down year for FDA approvals, with just 20 new drugs approved thus far. That's compared to more than 40 in each of the past two years. Maci is only the fourth biotech treatment to get FDA approval this year developed by a Massachusetts-based company ...
A California-based state court granted the class certification to almost 21,000 Apple employees currently and formerly employed by the Cupertino-based company in July 2014. The lawsuit was first filed in 2011 by four Apple employees in San Diego. They alleged that the company failed to give them meal and rest breaks, and didn't pay them in a timely manner, among other complaints.
In California, the law states that employers are required to provide lunch breaks and rest breaks to employees with the length of each break to be determined according to the employee's number of work hours. It states that for the first five hours at work, an employee should get 30-minute lunch breaks. The next four hours at work should earn him around a 10-minute rest break. For those working on six to ten hour shifts, they should be provided with two rest breaks.
Now Apple has been ordered to cut a $2 million check for denying some of its retail workers meal breaks after the first half of the bifurcated trial.
The class action, officiated by Judge Eddie C. Sturgeon in San Diego Superior Court, is brought by plaintiffs Brandon Felcze, Ryan Goldman, Ramsey Hawkins, and Joseph Lane Carco, all former non-exempt employees of Apple. According to the suit (Fourth Amended Complaint) plaintiffs never waived their right to a meal period and every employee is required to clock-in and clock-out during each meal period - meaning that "Defendents’ meal period violations can be ascertained."
The complaint also alleges that Apple "systematically failed to timely pay its employees upon separation of their employment." One of the four plaintiffs says his employment was terminated January 11, 2011 but did not receive his final paycheck until February 7, 2011. Another plaintiff accuses Apple of paying an "inadequate amount of waiting time penalties."
According to the California labor code, if you are fired, laid off, or otherwise involuntarily separated from your job, you are entitled to your final paycheck that day (i.e., you must be paid immediately on your last day of work.). Your employer must pay you within 72 hours if you quit your job and give less than 72 hours’ notice. If you give your employer at least 72 hours’ notice, you must be paid immediately on your last day of work. And your final paycheck must include all of your accrued, unused vacation time.
Jeffrey Hogue, one of the attorneys who represented the class action, said the $2 million verdict came down last Friday -- but Apple could owe more money.The second half of the case is expected to conclude next week, Hogue told CNNMoney.
It's unclear how much of the $2 million will go to the workers. If divided evenly, it would be just $95 per employee, but it's likely some of the money will go toward attorney fees.
The complaint says Apple's culture of secrecy keeps employees from talking about the company's poor working conditions. "If [employees] so much as discuss the various labor policies, they run the risk of being fired, sued or disciplined," the complaint reads.
Apple wins a few, loses a few...
Apple was sued in a similar lawsuit this year by two former Apple Store employees from New York and Los Angeles. In all suits, plaintiffs claimed they were owed pay for time spent in security checks having their bags searched but US District Judge William Alsup found that Apple only required employees who brought personal bags and devices to the store to undergo a check; employees could avoid the security screening by not bringing their own bags or personal devices. Amanda Frlekin, et al v. Apple, case number 3:2013cv03451.
Apple, along with other tech giants, settled an anti-poaching suit that wound up paying almost 65,000 workers affected by the poaching scheme an average $5,770 each. According to Fortune, the revised arrangement (September 2015) provides "$40,822,311.75 (or 9.8%) in attorney fees plus additional expenses to the law firms in the case." ...
In California, the law states that employers are required to provide lunch breaks and rest breaks to employees with the length of each break to be determined according to the employee's number of work hours. It states that for the first five hours at work, an employee should get 30-minute lunch breaks. The next four hours at work should earn him around a 10-minute rest break. For those working on six to ten hour shifts, they should be provided with two rest breaks.
Now Apple has been ordered to cut a $2 million check for denying some of its retail workers meal breaks after the first half of the bifurcated trial.
The class action, officiated by Judge Eddie C. Sturgeon in San Diego Superior Court, is brought by plaintiffs Brandon Felcze, Ryan Goldman, Ramsey Hawkins, and Joseph Lane Carco, all former non-exempt employees of Apple. According to the suit (Fourth Amended Complaint) plaintiffs never waived their right to a meal period and every employee is required to clock-in and clock-out during each meal period - meaning that "Defendents’ meal period violations can be ascertained."
The complaint also alleges that Apple "systematically failed to timely pay its employees upon separation of their employment." One of the four plaintiffs says his employment was terminated January 11, 2011 but did not receive his final paycheck until February 7, 2011. Another plaintiff accuses Apple of paying an "inadequate amount of waiting time penalties."
According to the California labor code, if you are fired, laid off, or otherwise involuntarily separated from your job, you are entitled to your final paycheck that day (i.e., you must be paid immediately on your last day of work.). Your employer must pay you within 72 hours if you quit your job and give less than 72 hours’ notice. If you give your employer at least 72 hours’ notice, you must be paid immediately on your last day of work. And your final paycheck must include all of your accrued, unused vacation time.
Jeffrey Hogue, one of the attorneys who represented the class action, said the $2 million verdict came down last Friday -- but Apple could owe more money.The second half of the case is expected to conclude next week, Hogue told CNNMoney.
It's unclear how much of the $2 million will go to the workers. If divided evenly, it would be just $95 per employee, but it's likely some of the money will go toward attorney fees.
The complaint says Apple's culture of secrecy keeps employees from talking about the company's poor working conditions. "If [employees] so much as discuss the various labor policies, they run the risk of being fired, sued or disciplined," the complaint reads.
Apple wins a few, loses a few...
Apple was sued in a similar lawsuit this year by two former Apple Store employees from New York and Los Angeles. In all suits, plaintiffs claimed they were owed pay for time spent in security checks having their bags searched but US District Judge William Alsup found that Apple only required employees who brought personal bags and devices to the store to undergo a check; employees could avoid the security screening by not bringing their own bags or personal devices. Amanda Frlekin, et al v. Apple, case number 3:2013cv03451.
Apple, along with other tech giants, settled an anti-poaching suit that wound up paying almost 65,000 workers affected by the poaching scheme an average $5,770 each. According to Fortune, the revised arrangement (September 2015) provides "$40,822,311.75 (or 9.8%) in attorney fees plus additional expenses to the law firms in the case." ...
The Department of Industrial Relations reports that 388 Californians died on the job in 2015.
California experienced 13 multi-fatality incidents in 2015, accounting for a total of 48 workplace deaths. These events include the tragic shootings of public employees attending a holiday event in San Bernardino, four separate farm vehicle collisions, four different helicopter or small airplane crashes (including two separate military helicopter incidents), and 3 multi-victim workplace homicides.
This contrasts with six separate multi-fatality incidents that occurred in 2014 resulting in 17 fatalities.
"Our thoughts are with the families and coworkers of those that died," said Christine Baker, Director of the Department of Industrial Relations (DIR). "In January, Cal/OSHA will convene an advisory committee to address workplace violence."
A review of the past ten years indicates that workplace fatalities remain below the average rate of fatalities prior to 2008, when the last recession began. There were 388 fatal injuries on the job in California in 2015, compared to 344 in 2014, 396 in 2013 and 375 in 2012. Data comes from the Census of Fatal Occupational Injuries (CFOI) which is conducted annually in conjunction with the U.S. Bureau of Labor Statistics (BLS).
Key findings from the latest census in California include:
1) One in five (20%) of all California workplace deaths identified in 2015 were attributed to be due to violence and other injuries by persons or animals. The incidence of workplace homicides in 2015 accounts for 12% of all workplace deaths in the state.
2) Over one third (38%) of all California workplace deaths identified in 2015 occurred in transportation incidents.
3) One in five (19%) of all California workplace deaths identified in 2015 were attributed to trips, slips and falls; with more than two thirds of those deaths involving falls to a lower level.
4) Nearly half of the victims of workplace fatalities (46%) in 2015 were Latinos. This fatality rate has fluctuated over the past ten years between 37% and 49%.
The percentage of Latino deaths in the workplace continues to be an area the department is tracking closely. DIR over the past seven years has increased workplace safety outreach and education to Spanish-speaking workers, with a focus on high-hazard work.
The Census is conducted annually by DIR in conjunction with the U.S. Bureau of Labor Statistics. CFOI produces comprehensive, accurate and timely counts of fatal work injuries. This Federal-State cooperative program was implemented in all 50 states and the District of Columbia in 1992 ...
California experienced 13 multi-fatality incidents in 2015, accounting for a total of 48 workplace deaths. These events include the tragic shootings of public employees attending a holiday event in San Bernardino, four separate farm vehicle collisions, four different helicopter or small airplane crashes (including two separate military helicopter incidents), and 3 multi-victim workplace homicides.
This contrasts with six separate multi-fatality incidents that occurred in 2014 resulting in 17 fatalities.
"Our thoughts are with the families and coworkers of those that died," said Christine Baker, Director of the Department of Industrial Relations (DIR). "In January, Cal/OSHA will convene an advisory committee to address workplace violence."
A review of the past ten years indicates that workplace fatalities remain below the average rate of fatalities prior to 2008, when the last recession began. There were 388 fatal injuries on the job in California in 2015, compared to 344 in 2014, 396 in 2013 and 375 in 2012. Data comes from the Census of Fatal Occupational Injuries (CFOI) which is conducted annually in conjunction with the U.S. Bureau of Labor Statistics (BLS).
Key findings from the latest census in California include:
1) One in five (20%) of all California workplace deaths identified in 2015 were attributed to be due to violence and other injuries by persons or animals. The incidence of workplace homicides in 2015 accounts for 12% of all workplace deaths in the state.
2) Over one third (38%) of all California workplace deaths identified in 2015 occurred in transportation incidents.
3) One in five (19%) of all California workplace deaths identified in 2015 were attributed to trips, slips and falls; with more than two thirds of those deaths involving falls to a lower level.
4) Nearly half of the victims of workplace fatalities (46%) in 2015 were Latinos. This fatality rate has fluctuated over the past ten years between 37% and 49%.
The percentage of Latino deaths in the workplace continues to be an area the department is tracking closely. DIR over the past seven years has increased workplace safety outreach and education to Spanish-speaking workers, with a focus on high-hazard work.
The Census is conducted annually by DIR in conjunction with the U.S. Bureau of Labor Statistics. CFOI produces comprehensive, accurate and timely counts of fatal work injuries. This Federal-State cooperative program was implemented in all 50 states and the District of Columbia in 1992 ...
Twenty states are accusing a group of generic drug makers of conspiring to keep the prices on generic medications artificially high. And the state attorneys general say the lawsuit filed in federal court in Connecticut Thursday may be just the beginning of a much larger legal action.
California is not listed as one of the 20 state plaintiffs.
The lawsuit alleges that the companies, led by New Jersey-based drug maker Heritage Pharmaceuticals, identified competitors and tried to reach agreements on how they could avoid competing for customers on price. The lawsuit was filed under seal in the U.S. District Court for the District of Connecticut. Portions of the complaint are redacted in order to avoid compromising the ongoing investigations.
The back story to this suit claims that prices for a large number of generic pharmaceutical drugs skyrocketed throughout 2013 and 2014. According to one report, "[t]he prices of more than 1,200 generic medications increased an average of 448 percent between July 2013 and July 2014." Currently, the generic pharmaceutical industry accounts for approximately 88 percent of all prescriptions written in the United States.
A January 2014 survey of 1,000 members of the National Community Pharmacists Association ("NCPA") found that more than 75% of the pharmacists surveyed reported higher prices on more than 25 generic drugs, with the prices sometimes spiking by 600% to 2,000% in some cases.
"While the principal architect of the conspiracies addressed in this lawsuit was Heritage Pharmaceuticals, we have evidence of widespread participation in illegal conspiracies across the generic drug industry," Connecticut Attorney General George Jepsen said in a written press release. "We intend to pursue this and other enforcement actions aggressively."
The other companies accused of price-fixing were Aurobindo Pharma USA, Inc., Citron Pharma, LLC, Mayne Pharma (USA), Inc., Mylan Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
The complaint describes in detail Heritage and other drug-company executives meeting at industry conferences and company-sponsored dinners where they would share information about the pricing. It also alleges that, to avoid having to lower prices, the companies would divvy up customers - such as pharmaceutical wholesalers, for example - rather than compete for the business.
The two drugs - a delayed release version of the antibiotic doxycycline hyclate and the diabetes drug glyburide - saw enormous price increases during the time of the alleged conspiracy, the legal complaint says.
The states' lawsuit comes a day after the U.S. Justice Department filed criminal charges against Jeffrey Glazer, Heritage's former CEO and Jason Malek, the company's former president. It accuses the two men of conspiring with companies to manipulate drug prices.
The alleged conspiracy, outlined in court papers filed in Philadelphia, ran from as early as April 2013 to December 2015.
"By entering into unlawful agreements to fix prices and allocate consumers, these two executives sought to enrich themselves at the expense of sick and vulnerable individuals who rely upon access to generic pharmaceuticals as a more affordable alternative to brand-name medicines,'' Deputy Assistant Attorney General Brent Snyder said ...
California is not listed as one of the 20 state plaintiffs.
The lawsuit alleges that the companies, led by New Jersey-based drug maker Heritage Pharmaceuticals, identified competitors and tried to reach agreements on how they could avoid competing for customers on price. The lawsuit was filed under seal in the U.S. District Court for the District of Connecticut. Portions of the complaint are redacted in order to avoid compromising the ongoing investigations.
The back story to this suit claims that prices for a large number of generic pharmaceutical drugs skyrocketed throughout 2013 and 2014. According to one report, "[t]he prices of more than 1,200 generic medications increased an average of 448 percent between July 2013 and July 2014." Currently, the generic pharmaceutical industry accounts for approximately 88 percent of all prescriptions written in the United States.
A January 2014 survey of 1,000 members of the National Community Pharmacists Association ("NCPA") found that more than 75% of the pharmacists surveyed reported higher prices on more than 25 generic drugs, with the prices sometimes spiking by 600% to 2,000% in some cases.
"While the principal architect of the conspiracies addressed in this lawsuit was Heritage Pharmaceuticals, we have evidence of widespread participation in illegal conspiracies across the generic drug industry," Connecticut Attorney General George Jepsen said in a written press release. "We intend to pursue this and other enforcement actions aggressively."
The other companies accused of price-fixing were Aurobindo Pharma USA, Inc., Citron Pharma, LLC, Mayne Pharma (USA), Inc., Mylan Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
The complaint describes in detail Heritage and other drug-company executives meeting at industry conferences and company-sponsored dinners where they would share information about the pricing. It also alleges that, to avoid having to lower prices, the companies would divvy up customers - such as pharmaceutical wholesalers, for example - rather than compete for the business.
The two drugs - a delayed release version of the antibiotic doxycycline hyclate and the diabetes drug glyburide - saw enormous price increases during the time of the alleged conspiracy, the legal complaint says.
The states' lawsuit comes a day after the U.S. Justice Department filed criminal charges against Jeffrey Glazer, Heritage's former CEO and Jason Malek, the company's former president. It accuses the two men of conspiring with companies to manipulate drug prices.
The alleged conspiracy, outlined in court papers filed in Philadelphia, ran from as early as April 2013 to December 2015.
"By entering into unlawful agreements to fix prices and allocate consumers, these two executives sought to enrich themselves at the expense of sick and vulnerable individuals who rely upon access to generic pharmaceuticals as a more affordable alternative to brand-name medicines,'' Deputy Assistant Attorney General Brent Snyder said ...
Pursuant to Labor Code section 5307.1(g)(2), the Administrative Director of the Division of Workers’ Compensation ordered that the Durable Medical Equipment, Prosthetics, Orthotics, Supplies portion of the Official Medical Fee Schedule contained in title 8, California Code of Regulations, section 9789.60, is adjusted to conform to changes to the Medicare payment system that were adopted by the Centers for Medicare & Medicaid Services for calendar year 2017.
The update includes changes identified in Center for Medicare and Medicaid Services Change Request (CR) number 9854.
Effective for services rendered on or after January 1, 2017, the maximum reasonable fees for Durable Medical Equipment, Prosthetics, Orthotics, Supplies shall not exceed 120% of the applicable California fees set forth in the Medicare calendar year 2017 "Durable Medical Equipment, Prosthetics/Orthotics, and Supplies (DMEPOS) Fee Schedule" revised for January 2017, contained in the electronic file "DME17-A (Updated 12/07/16) [ZIP, 2MB]"
For the services on or after January 1, 2017 payment shall not exceed 120% of the fee set forth for the HCPCS code in the CA (NR) column, except the fee shall not exceed 120% of the fee set forth in the CA (R) column if the injured worker’s residence zip code appears on the DMERuralZip_Q12017_V11142017 file. Where column CA (NR) sets forth a fee for a code, but CA (R) for the code is listed as "0.00" the fee shall not exceed 120% of the CA (NR) fee, regardless of whether the injured worker’s address zip code is rural or non-rural.
The order adopting the adjustment can be found on the DWC website ...
The update includes changes identified in Center for Medicare and Medicaid Services Change Request (CR) number 9854.
Effective for services rendered on or after January 1, 2017, the maximum reasonable fees for Durable Medical Equipment, Prosthetics, Orthotics, Supplies shall not exceed 120% of the applicable California fees set forth in the Medicare calendar year 2017 "Durable Medical Equipment, Prosthetics/Orthotics, and Supplies (DMEPOS) Fee Schedule" revised for January 2017, contained in the electronic file "DME17-A (Updated 12/07/16) [ZIP, 2MB]"
For the services on or after January 1, 2017 payment shall not exceed 120% of the fee set forth for the HCPCS code in the CA (NR) column, except the fee shall not exceed 120% of the fee set forth in the CA (R) column if the injured worker’s residence zip code appears on the DMERuralZip_Q12017_V11142017 file. Where column CA (NR) sets forth a fee for a code, but CA (R) for the code is listed as "0.00" the fee shall not exceed 120% of the CA (NR) fee, regardless of whether the injured worker’s address zip code is rural or non-rural.
The order adopting the adjustment can be found on the DWC website ...
An investigation into what is being billed as one of the largest workers’ compensation insurance fraud schemes uncovered in the county’of San Diego's history has swept up medical professionals throughout Southern California and now consequences for Fermin Iglesias, one of the involved cappers.
According to prosecutors, a group of recruiters would entice workers - many of them seasonal workers who lived abroad at times - to file workers’ compensation claims. The alleged recruiters were identified as Fermin Iglesias and Carlos Arguello, who operated Providence Scheduling, Medex Solutions, Prime Holdings International and Meridian Rehab Care, and administrator Miguel Morales.
They would allegedly advertise in the U.S. and Central America via flyers or cards stuck on windshields to contact a call center if a worker has been injured on the job and needs help filing a claim, said Assistant U.S. Attorney Alana Robinson.
The recruiters would then allegedly refer the patients to specific doctors in Southern California, who would in turn prescribe certain medical tests and treatment - such as chiropractic, MRIs, pain management, echo cardiograms and even sleep studies - to companies in return for kickbacks, she said. The bribes were usually $50 to $100 per patient, court records show. The bribes were done without the patients’ knowledge.
The treatment was then billed to various insurance companies, including Liberty Mutual and Hartford.
Chiropractors would be required to fill a monthly quota of referrals or their patient pipeline and bribes would be cut off, authorities said. In one instance, San Diego chiropractor Steven Rigler was warned that he’d fallen $60,000 behind in referrals for procedures and he’d be cut out of the operation unless he wrote the organization a $20,000 to $30,000 check, according to the latest federal indictment.
Rigler has already pleaded guilty, as well as San Diego workers’ compensation attorney Sean O’Keefe.
One of the clinics implicated is Crosby Square Chiropractic, where Rigler worked, which has offices in San Diego, Escondido and Calexico, prosecutors said. Other medical professionals indicted are chiropractors Amir Khan of Orange and David C. Nguyen of Huntington Beach, and pain management Dr. Phong H. Tran of Irvine. Dr. Ronald Grusd of Los Angeles, who was charged federally last year, and was also included in a new state indictment.
And according to the Deferred Prosecution Agreement filed on December 8 in federal court, Fermin Iglesias admitted the allegations of the indictment against him, that he recruited and/or facilitated the recruitment of Workers' Compensation applicants for legal and medical services .He controlled and operated multiple entities, including, Providence Scheduling Inc., Medex Solutions, Inc., Meridian Medical Resources, Inc., d. b. a. Meridian Rehab Care, and Prime Holdings Int. Inc.
Iglesias further admitted that a "purpose of the conspiracy was to fraudulently obtain money from ...insurers by submitting claims for medical goods and services that were secured through an unlawful cross-referral scheme in which defendants supplied patients to doctors and required the doctors to refer those patients to certain providers of ancillary medical goods and services, and the defendants received money from the providers or from health care insurers as part of the scheme, in violation of the doctors' fiduciary duty to their patients, and concealing from insurers and patients the bribes and kickbacks that rendered the claims unpayable under California law."
And Iglesias admitted that "It was a part of the conspiracy that Defendants Iglesias, MedEx, Prime Holdings International, Inc., as well as Carlos Arguello and Miguel Morales, received kickbacks and bribes from providers of diagnostic imaging services, including Dr. Ronald Grusd (charged elsewhere) and others" and that "co-conspirator Dr. Grusd and others, concealed from insurers and patients the material fact that referrals were made because of bribes and kickbacks specifically prohibited by California law".
Iglesias and his coconspirators "further admit that their scheme involved multiple doctors.." and that the "total criminal conduct exceeded $9.5 million in claims to healthcare insurance providers. Iglesias, MedEx, Prime Holdings International, Inc., and Meridian further agree that the gross income derived from this corrupt crossreferral scheme exceeded $5 million."
Charges against Ronald Grusd M.D. are still pending in federal court, case 15-cr-2821-BAS. The trial date was set for January 24, 2017, but was vacated. According to court records, the "discovery produced by the United States to date consists of multiple gigabytes of data, including reports, emails, medical claim files, audio recordings and video recordings." The criminal defendants "retained new counsel, who made his first court appearance on October 11, 2016" and needed more time to prepare.
The California Medical Board reports that the Superior Court has issued an order effective March 14, 2016 that Grusd no longer practice medicine pending the outcome of criminal charges in state court pending against him.
AB 1244 will adversely affect the ability of the medical providers who may have filed liens for the collection of fees from recovering additional funds after January 1 ...
According to prosecutors, a group of recruiters would entice workers - many of them seasonal workers who lived abroad at times - to file workers’ compensation claims. The alleged recruiters were identified as Fermin Iglesias and Carlos Arguello, who operated Providence Scheduling, Medex Solutions, Prime Holdings International and Meridian Rehab Care, and administrator Miguel Morales.
They would allegedly advertise in the U.S. and Central America via flyers or cards stuck on windshields to contact a call center if a worker has been injured on the job and needs help filing a claim, said Assistant U.S. Attorney Alana Robinson.
The recruiters would then allegedly refer the patients to specific doctors in Southern California, who would in turn prescribe certain medical tests and treatment - such as chiropractic, MRIs, pain management, echo cardiograms and even sleep studies - to companies in return for kickbacks, she said. The bribes were usually $50 to $100 per patient, court records show. The bribes were done without the patients’ knowledge.
The treatment was then billed to various insurance companies, including Liberty Mutual and Hartford.
Chiropractors would be required to fill a monthly quota of referrals or their patient pipeline and bribes would be cut off, authorities said. In one instance, San Diego chiropractor Steven Rigler was warned that he’d fallen $60,000 behind in referrals for procedures and he’d be cut out of the operation unless he wrote the organization a $20,000 to $30,000 check, according to the latest federal indictment.
Rigler has already pleaded guilty, as well as San Diego workers’ compensation attorney Sean O’Keefe.
One of the clinics implicated is Crosby Square Chiropractic, where Rigler worked, which has offices in San Diego, Escondido and Calexico, prosecutors said. Other medical professionals indicted are chiropractors Amir Khan of Orange and David C. Nguyen of Huntington Beach, and pain management Dr. Phong H. Tran of Irvine. Dr. Ronald Grusd of Los Angeles, who was charged federally last year, and was also included in a new state indictment.
And according to the Deferred Prosecution Agreement filed on December 8 in federal court, Fermin Iglesias admitted the allegations of the indictment against him, that he recruited and/or facilitated the recruitment of Workers' Compensation applicants for legal and medical services .He controlled and operated multiple entities, including, Providence Scheduling Inc., Medex Solutions, Inc., Meridian Medical Resources, Inc., d. b. a. Meridian Rehab Care, and Prime Holdings Int. Inc.
Iglesias further admitted that a "purpose of the conspiracy was to fraudulently obtain money from ...insurers by submitting claims for medical goods and services that were secured through an unlawful cross-referral scheme in which defendants supplied patients to doctors and required the doctors to refer those patients to certain providers of ancillary medical goods and services, and the defendants received money from the providers or from health care insurers as part of the scheme, in violation of the doctors' fiduciary duty to their patients, and concealing from insurers and patients the bribes and kickbacks that rendered the claims unpayable under California law."
And Iglesias admitted that "It was a part of the conspiracy that Defendants Iglesias, MedEx, Prime Holdings International, Inc., as well as Carlos Arguello and Miguel Morales, received kickbacks and bribes from providers of diagnostic imaging services, including Dr. Ronald Grusd (charged elsewhere) and others" and that "co-conspirator Dr. Grusd and others, concealed from insurers and patients the material fact that referrals were made because of bribes and kickbacks specifically prohibited by California law".
Iglesias and his coconspirators "further admit that their scheme involved multiple doctors.." and that the "total criminal conduct exceeded $9.5 million in claims to healthcare insurance providers. Iglesias, MedEx, Prime Holdings International, Inc., and Meridian further agree that the gross income derived from this corrupt crossreferral scheme exceeded $5 million."
Charges against Ronald Grusd M.D. are still pending in federal court, case 15-cr-2821-BAS. The trial date was set for January 24, 2017, but was vacated. According to court records, the "discovery produced by the United States to date consists of multiple gigabytes of data, including reports, emails, medical claim files, audio recordings and video recordings." The criminal defendants "retained new counsel, who made his first court appearance on October 11, 2016" and needed more time to prepare.
The California Medical Board reports that the Superior Court has issued an order effective March 14, 2016 that Grusd no longer practice medicine pending the outcome of criminal charges in state court pending against him.
AB 1244 will adversely affect the ability of the medical providers who may have filed liens for the collection of fees from recovering additional funds after January 1 ...
The Division of Workers’ Compensation (DWC) announced the decrease of the mileage rate for medical and medical-legal travel expenses by one-half cent to 53.5 cents per mile effective January 1, 2017.
This rate must be paid for travel on or after January 1, 2017 regardless of the date of injury.
Labor Code section 4600, in conjunction with Government Code section 19820 and the Department of Personnel Administration regulations, establishes the rate payable for mileage reimbursement for medical and medical-legal expenses and ties it to the Internal Revenue Service (IRS).
The Internal Revenue Service issued the 2017 optional standard mileage rates used to calculate the deductible costs of operating an automobile for business, charitable, medical or moving purposes. IRS Bulletin Number IR-2016-169 dated December 13, 2016 announced the rate decrease.
The standard mileage rate for business is based on an annual study of the fixed and variable costs of operating an automobile. The rate for medical and moving purposes is based on the variable costs.
There has been a steady decrease in mileage reimbursement rates since the 2015 rates which were 57.5 cents/mile. The decreases are largely the result of lower fuel costs nationwide.
The updated mileage reimbursement form is posted on the DWC website ...
This rate must be paid for travel on or after January 1, 2017 regardless of the date of injury.
Labor Code section 4600, in conjunction with Government Code section 19820 and the Department of Personnel Administration regulations, establishes the rate payable for mileage reimbursement for medical and medical-legal expenses and ties it to the Internal Revenue Service (IRS).
The Internal Revenue Service issued the 2017 optional standard mileage rates used to calculate the deductible costs of operating an automobile for business, charitable, medical or moving purposes. IRS Bulletin Number IR-2016-169 dated December 13, 2016 announced the rate decrease.
The standard mileage rate for business is based on an annual study of the fixed and variable costs of operating an automobile. The rate for medical and moving purposes is based on the variable costs.
There has been a steady decrease in mileage reimbursement rates since the 2015 rates which were 57.5 cents/mile. The decreases are largely the result of lower fuel costs nationwide.
The updated mileage reimbursement form is posted on the DWC website ...
