Gilead Sciences, Bristol-Myers Squibb, Janssen Pharmaceuticals and a group of consumers who accused the companies of conspiring to keep certain HIV therapy drugs off the market and at high prices have reached a $10 million class action settlement.
Lead plaintiff Peter Staley filed the class action lawsuit against Gilead in August 2019. He claimed the company’s inflated drug costs priced more than 400,000 people in the US out of their necessary HIV medications.
Gilead allegedly held a monopoly on HIV drug patents, the company has been able to charge high premiums for these medications. The class action also claimed that Gilead has violated state and federal laws by allegedly scheming with other drug manufacturers to prevent them from creating generic versions of these drugs, even after the patents on them expired.
And the federal court approved the $10 million settlement between the companies and end-payor plaintiffs, which claimed the pharmaceutical companies engaged in anti-competitive practices that kept less expensive generic HIV drugs from being available to the class members.
The Gilead HIV Drug Class Action Settlement is Staley, et al. v. Gilead Sciences Inc., et al., Case No. 3:19-cv-02573-EMC, in the US District Court for the Northern District of California.
Of that $10 million, $1.25 million will go to consumer members of the proposed Class of Evotaz purchasers. Plaintiffs will also receive up to $200,000 for providing notice to potential other class members, a sum of which Bristol-Myers has agreed to pay half.
The deal also includes "significant injunctive relief" which will prevent Bristol-Myers from continuing its alleged practice, along with Gilead Sciences, of withholding the generic product Evotaz from the market. Without this injunction, Bristol-Meyers’ agreement with Gilead Sciences would have kept the drug inaccessible until at least September 2029.
The settlement was negotiated in "good faith" and at "arm’s length," as is required, and "secures an excellent result for the Class." However, the document maintains Bristol-Myers’ displeasure with the complaints’ characterizations of Bristol-Myers’ conduct and its collaboration with Gilead Sciences.
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Lead plaintiff Peter Staley filed the class action lawsuit against Gilead in August 2019. He claimed the company’s inflated drug costs priced more than 400,000 people in the US out of their necessary HIV medications.
Gilead allegedly held a monopoly on HIV drug patents, the company has been able to charge high premiums for these medications. The class action also claimed that Gilead has violated state and federal laws by allegedly scheming with other drug manufacturers to prevent them from creating generic versions of these drugs, even after the patents on them expired.
And the federal court approved the $10 million settlement between the companies and end-payor plaintiffs, which claimed the pharmaceutical companies engaged in anti-competitive practices that kept less expensive generic HIV drugs from being available to the class members.
The Gilead HIV Drug Class Action Settlement is Staley, et al. v. Gilead Sciences Inc., et al., Case No. 3:19-cv-02573-EMC, in the US District Court for the Northern District of California.
Of that $10 million, $1.25 million will go to consumer members of the proposed Class of Evotaz purchasers. Plaintiffs will also receive up to $200,000 for providing notice to potential other class members, a sum of which Bristol-Myers has agreed to pay half.
The deal also includes "significant injunctive relief" which will prevent Bristol-Myers from continuing its alleged practice, along with Gilead Sciences, of withholding the generic product Evotaz from the market. Without this injunction, Bristol-Meyers’ agreement with Gilead Sciences would have kept the drug inaccessible until at least September 2029.
The settlement was negotiated in "good faith" and at "arm’s length," as is required, and "secures an excellent result for the Class." However, the document maintains Bristol-Myers’ displeasure with the complaints’ characterizations of Bristol-Myers’ conduct and its collaboration with Gilead Sciences.
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In the midst of the pandemic, the total number of job injury claims reported by California public self-insured employers edged down slightly last year, but a growing number of lost-time claims and rising claim severity (average loss per claim) fueled by higher indemnity costs drove up total workers’ compensation paid and incurred losses for cities, counties and other public agencies in the state according to a California Workers’ Compensation Institute analysis of data from the state’s Office of Self-Insurance Plans (OSIP).
OSIP’s summary of public self-insured data for fiscal year (FY) 2020/21, issued late last week, provides an initial glimpse at the volume of claims, total loss payments and total incurred (paid losses plus reserves) for the 12 months ending June 30, 2021.
The state compiles the data annually from workers’ compensation reports submitted by hundreds of public self-insured entities, including cities and counties, local fire, school, transit, utility and special districts, and joint powers authorities. The latest summary shows that in FY 2020/21 these employers provided workers’ compensation coverage to nearly 2 million California public workers whose wages and salaries totaled more than $139 billion.
CWCI’s review of the data found that the number of employees covered by public self-insured employers last year declined 4.4% from the total noted in the FY 2019/20 initial report, though the total number of reported claims fell less than 1% to 107,161 cases.
Despite having fewer workers and slightly fewer claims, public self-insureds’ total claim payments at the first report increased by more than $30 million to $445 million, 7.3% more than the comparable figure for FY 2019/20, and $130.7 million (41.6%) more than the $314.3 million noted in the first report for FY 2013/14, which was the low point for the past decade and the first year following enactment of SB 863, the 2012 workers’ comp reform bill signed by Governor Brown.
Though overall public self-insured claim volume was down compared to a year earlier, CWCI noted that decline was completely due to a 19.7% drop in medical-only claims, which are relatively inexpensive, while the number of more costly lost-time claims increased by 8,957 claims (15.5%).
The average indemnity paid per FY 2020/21 lost-time claim at the first report was $4,256, so the addition of the 8,967 lost-time cases was the key factor fueling the increase in public self-insured payments last year.
According to CWCI, the recent increase in the number of indemnity claims in the public sector last year is likely due, at least in part, to the addition of COVID-19 claims to the claim mix, as the public self-insured work force includes many essential workers such as police, firefighters, prison guards, and state hospital workers who have a presumption of compensability if they contract the virus, and who were particularly hard hit by COVID last year.
The introduction of COVID claims into workers’ comp also coincided with a spike in public self-insured death claims, which according to the OSIP data more than doubled from 104 claims in FY 2019/20 to 220 claims in FY 2020/21.
The incurred data (paid losses + reserves for future payments) on public self-insured claims tell a similar story ...
OSIP’s summary of public self-insured data for fiscal year (FY) 2020/21, issued late last week, provides an initial glimpse at the volume of claims, total loss payments and total incurred (paid losses plus reserves) for the 12 months ending June 30, 2021.
The state compiles the data annually from workers’ compensation reports submitted by hundreds of public self-insured entities, including cities and counties, local fire, school, transit, utility and special districts, and joint powers authorities. The latest summary shows that in FY 2020/21 these employers provided workers’ compensation coverage to nearly 2 million California public workers whose wages and salaries totaled more than $139 billion.
CWCI’s review of the data found that the number of employees covered by public self-insured employers last year declined 4.4% from the total noted in the FY 2019/20 initial report, though the total number of reported claims fell less than 1% to 107,161 cases.
Despite having fewer workers and slightly fewer claims, public self-insureds’ total claim payments at the first report increased by more than $30 million to $445 million, 7.3% more than the comparable figure for FY 2019/20, and $130.7 million (41.6%) more than the $314.3 million noted in the first report for FY 2013/14, which was the low point for the past decade and the first year following enactment of SB 863, the 2012 workers’ comp reform bill signed by Governor Brown.
Though overall public self-insured claim volume was down compared to a year earlier, CWCI noted that decline was completely due to a 19.7% drop in medical-only claims, which are relatively inexpensive, while the number of more costly lost-time claims increased by 8,957 claims (15.5%).
The average indemnity paid per FY 2020/21 lost-time claim at the first report was $4,256, so the addition of the 8,967 lost-time cases was the key factor fueling the increase in public self-insured payments last year.
According to CWCI, the recent increase in the number of indemnity claims in the public sector last year is likely due, at least in part, to the addition of COVID-19 claims to the claim mix, as the public self-insured work force includes many essential workers such as police, firefighters, prison guards, and state hospital workers who have a presumption of compensability if they contract the virus, and who were particularly hard hit by COVID last year.
The introduction of COVID claims into workers’ comp also coincided with a spike in public self-insured death claims, which according to the OSIP data more than doubled from 104 claims in FY 2019/20 to 220 claims in FY 2020/21.
The incurred data (paid losses + reserves for future payments) on public self-insured claims tell a similar story ...
One of the Capitol’s most enduring conflicts pits personal injury attorneys and their allies in consumer advocacy groups against corporate interests and their insurers. The two factions clash incessantly over what events are deemed wrongful acts (torts), who can sue over those acts and what monetary damages can be awarded.
Dubbed "tort wars," the conflict has raged for decades in the Legislature, in the courts and occasionally via ballot measures, each side depicting itself as the good guys and the other as rapaciously evil. Millions of dollars are spent each year on lobbyists, media strategists, political campaign advisors and other tools of the political trade.
CalMatters Reports that the intensity of the war varies from year to year, and 2022 is shaping up as one its hotter periods as the factions propose dueling ballot measures. One would effectively undo a 1975 law that limits damages for "pain and suffering" in medical malpractice cases, while another would place a new limit on the fees that personal injury attorneys can claim.
The controversial 1975 law, entitled the Medical Injury Compensation Reform Act (MICRA) and signed by Jerry Brown during his first year as governor, limits non-economic damages for medical malpractice to $250,000. Its passage was not only a big win for medical providers and their insurers but the opening salvo of the war.
MIRCA also ended workers' compensation subrogation recoveries in California medical malpractice cases.
The attorneys not only have tried - very unsuccessfully so far - to repeal or modify MICRA while business groups and insurers have not only attempted to blunt the attorneys’ expansive ambition but to carry the MICRA model of damage limits into other potential injury cases.
According to the CalMatters article, in 1987, 12 years after MICRA was enacted, the speaker of the state Assembly, Willie Brown, mediated extensive negotiations between the warring factions on a truce, culminating in the infamous "napkin deal" worked out in Frank Fat’s restaurant near the Capitol with Brown hopping from table to table.
Quickly ratified by the Legislature, it gave lobbyists for every interest involved something to take back to their clients, including a slight modification of MICRA and new protections for the tobacco industry from lawsuits by smokers for cancer and other illnesses.
The napkin deal truce lasted for a few years, but tort wars resumed in the 1990s and have been waged ever since on specific issues, including several unsuccessful efforts to change MICRA. One subset of the conflict, involving roughly the same interests, has been perennial jousting over workers’ compensation, the employer-financed, multi-billion-dollar system that covers job-related injuries and illnesses.
A ballot measure that would indirectly but effectively repeal MICRA is already qualified for the 2022 ballot even though the anti-MICRA coalition has failed repeatedly in the past to undo what the Legislature and Jerry Brown wrought 46 years ago.
Meanwhile, the Civil Justice Association of California, an umbrella organization of business and insurance interests, has unveiled its own initiative measure that would limit lawyers’ contingency fees in personal injury cases to 20% of monetary judgments, sharply lower than the traditional one-third or more. The goal, obviously, is to make attorneys less willing to take on cases ...
Dubbed "tort wars," the conflict has raged for decades in the Legislature, in the courts and occasionally via ballot measures, each side depicting itself as the good guys and the other as rapaciously evil. Millions of dollars are spent each year on lobbyists, media strategists, political campaign advisors and other tools of the political trade.
CalMatters Reports that the intensity of the war varies from year to year, and 2022 is shaping up as one its hotter periods as the factions propose dueling ballot measures. One would effectively undo a 1975 law that limits damages for "pain and suffering" in medical malpractice cases, while another would place a new limit on the fees that personal injury attorneys can claim.
The controversial 1975 law, entitled the Medical Injury Compensation Reform Act (MICRA) and signed by Jerry Brown during his first year as governor, limits non-economic damages for medical malpractice to $250,000. Its passage was not only a big win for medical providers and their insurers but the opening salvo of the war.
MIRCA also ended workers' compensation subrogation recoveries in California medical malpractice cases.
The attorneys not only have tried - very unsuccessfully so far - to repeal or modify MICRA while business groups and insurers have not only attempted to blunt the attorneys’ expansive ambition but to carry the MICRA model of damage limits into other potential injury cases.
According to the CalMatters article, in 1987, 12 years after MICRA was enacted, the speaker of the state Assembly, Willie Brown, mediated extensive negotiations between the warring factions on a truce, culminating in the infamous "napkin deal" worked out in Frank Fat’s restaurant near the Capitol with Brown hopping from table to table.
Quickly ratified by the Legislature, it gave lobbyists for every interest involved something to take back to their clients, including a slight modification of MICRA and new protections for the tobacco industry from lawsuits by smokers for cancer and other illnesses.
The napkin deal truce lasted for a few years, but tort wars resumed in the 1990s and have been waged ever since on specific issues, including several unsuccessful efforts to change MICRA. One subset of the conflict, involving roughly the same interests, has been perennial jousting over workers’ compensation, the employer-financed, multi-billion-dollar system that covers job-related injuries and illnesses.
A ballot measure that would indirectly but effectively repeal MICRA is already qualified for the 2022 ballot even though the anti-MICRA coalition has failed repeatedly in the past to undo what the Legislature and Jerry Brown wrought 46 years ago.
Meanwhile, the Civil Justice Association of California, an umbrella organization of business and insurance interests, has unveiled its own initiative measure that would limit lawyers’ contingency fees in personal injury cases to 20% of monetary judgments, sharply lower than the traditional one-third or more. The goal, obviously, is to make attorneys less willing to take on cases ...
The U.S. Supreme Court on Monday declined to issue an injunction against New York’s COVID-19 vaccine mandate for health care workers, which doesn’t allow them to seek a religious exemption.
New York state imposed the vaccine mandate for doctors and nurses in August, which allows only for medical exemptions, not religious ones. The religious exemption policy expired in November.
The latest decision suggests the high court lacks the appetite to wade into the matter of mandates. The Supreme Court has previously rejected other challenges, including one that focused on Maine’s lack of a religious exemption to vaccine mandates for health care workers.
Petitioners, which included Christian doctors, said New York’s vaccine mandate violates the U.S. Constitution’s First Amendment prohibition on religious discrimination on behalf of the government. They also argued that it violates federal civil rights law that requires businesses to accommodate employees’ religious beliefs.
Justices Clarence Thomas, Samuel Alito, and Neil Gorsuch wrote they would have supported temporarily halting enforcement of New York’s mandate.
"Sometimes dissenting religious beliefs can seem strange and bewildering. In times of crisis, this puzzlement can evolve into fear and anger," Gorsuch wrote in his dissent.
"One can only hope today’s ruling will not be the final chapter in this grim story," Gorsuch continued. "Cases like this one may serve as cautionary tales for those who follow."
In October, when the Supreme Court didn’t take up the Maine vaccine case, Gorsuch wrote that "healthcare workers who have served on the front line of a pandemic for the last 18 months are now being fired and their practices shuttered," adding that they have been terminated "for adhering to their constitutionally protected religious beliefs."
"Their plight is worthy of our attention," he argued.
Other than Maine and New York, Rhode Island is the only other state that doesn’t allow religious exemptions to the vaccine for health care workers ...
New York state imposed the vaccine mandate for doctors and nurses in August, which allows only for medical exemptions, not religious ones. The religious exemption policy expired in November.
The latest decision suggests the high court lacks the appetite to wade into the matter of mandates. The Supreme Court has previously rejected other challenges, including one that focused on Maine’s lack of a religious exemption to vaccine mandates for health care workers.
Petitioners, which included Christian doctors, said New York’s vaccine mandate violates the U.S. Constitution’s First Amendment prohibition on religious discrimination on behalf of the government. They also argued that it violates federal civil rights law that requires businesses to accommodate employees’ religious beliefs.
Justices Clarence Thomas, Samuel Alito, and Neil Gorsuch wrote they would have supported temporarily halting enforcement of New York’s mandate.
"Sometimes dissenting religious beliefs can seem strange and bewildering. In times of crisis, this puzzlement can evolve into fear and anger," Gorsuch wrote in his dissent.
"One can only hope today’s ruling will not be the final chapter in this grim story," Gorsuch continued. "Cases like this one may serve as cautionary tales for those who follow."
In October, when the Supreme Court didn’t take up the Maine vaccine case, Gorsuch wrote that "healthcare workers who have served on the front line of a pandemic for the last 18 months are now being fired and their practices shuttered," adding that they have been terminated "for adhering to their constitutionally protected religious beliefs."
"Their plight is worthy of our attention," he argued.
Other than Maine and New York, Rhode Island is the only other state that doesn’t allow religious exemptions to the vaccine for health care workers ...
62 year old Alfredo Casas, who lives in Stockton, has been arraigned on 15 felony counts of insurance fraud, grand theft and tax evasion.
Casas allegedly underreported payroll for his farm labor contracting business by over $1 million, resulting in a substantial loss to two insurance companies and the State Compensation Insurance Fund (State Fund).
Casas was convicted on similar workers' compensation fraud charges in 2012. As part of that conviction, Casas' business was found uninsurable by State Fund.
However, Casas allegedly renamed and restructured his business using family members to serve as its officers, allowing him to obtain new workers’ compensation insurance policies.
On March 6, 2019, the Department of Insurance received a referral from an insurance company alleging Casas' business, AC Farm Ag Inc., was reporting no payroll in order to receive a reduced rate for workers’ compensation insurance. By reporting no payroll throughout the calendar year, Casas paid a lower premium rate than he was entitled to receive.
A joint investigation and search warrant service conducted by the Department of Insurance and San Joaquin County District Attorney's Office discovered Casas failed to disclose payroll, previous insurance claims, and policy cancellations and failed to provide correct job descriptions for his employees.
Casas also operated for over two years as Casas Farm Services using forged Certificates of Insurance, forged Department of Industrial Relations Farm Labor Contractor permits, forged San Joaquin County Agriculture permits and documents he obtained from the state’s Labor and Workforce Development Agency by fraud.
Under state law, employers must accurately report the number of employees, job classifications, and the amount of payroll expended. One of the common ways in which employers avoid paying insurance premiums is to underreport a business’s payroll by providing false payroll reports to their insurance company.
Casas is scheduled to return to court on February 10, 2022, for further arraignment. This case is being prosecuted by the San Joaquin County District Attorney’s Office ...
Casas allegedly underreported payroll for his farm labor contracting business by over $1 million, resulting in a substantial loss to two insurance companies and the State Compensation Insurance Fund (State Fund).
Casas was convicted on similar workers' compensation fraud charges in 2012. As part of that conviction, Casas' business was found uninsurable by State Fund.
However, Casas allegedly renamed and restructured his business using family members to serve as its officers, allowing him to obtain new workers’ compensation insurance policies.
On March 6, 2019, the Department of Insurance received a referral from an insurance company alleging Casas' business, AC Farm Ag Inc., was reporting no payroll in order to receive a reduced rate for workers’ compensation insurance. By reporting no payroll throughout the calendar year, Casas paid a lower premium rate than he was entitled to receive.
A joint investigation and search warrant service conducted by the Department of Insurance and San Joaquin County District Attorney's Office discovered Casas failed to disclose payroll, previous insurance claims, and policy cancellations and failed to provide correct job descriptions for his employees.
Casas also operated for over two years as Casas Farm Services using forged Certificates of Insurance, forged Department of Industrial Relations Farm Labor Contractor permits, forged San Joaquin County Agriculture permits and documents he obtained from the state’s Labor and Workforce Development Agency by fraud.
Under state law, employers must accurately report the number of employees, job classifications, and the amount of payroll expended. One of the common ways in which employers avoid paying insurance premiums is to underreport a business’s payroll by providing false payroll reports to their insurance company.
Casas is scheduled to return to court on February 10, 2022, for further arraignment. This case is being prosecuted by the San Joaquin County District Attorney’s Office ...
In a move that may concern those responsible for payment of healthcare costs, Pfizer and Arena Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Pfizer will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.
Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per share in an all-cash transaction for a total equity value of approximately $6.7 billion. The boards of directors of both companies have unanimously approved the transaction.
Pfizer expects to finance the transaction with existing cash on hand.
"The proposed acquisition of Arena complements our capabilities and expertise in Inflammation and Immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options," said Mike Gladstone, Global President & General Manager, Pfizer Inflammation and Immunology. "Utilizing Pfizer's leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases."
Arena's portfolio includes diverse and promising development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including gastrointestinal and dermatological diseases.
Arena has built a robust development program for etrasimod, including two Phase 3 studies in ulcerative colitis (UC), a Phase 2/3 program in Crohn's Disease, a planned Phase 3 program in atopic dermatitis, and ongoing Phase 2 studies in eosinophilic esophagitis and alopecia areata.
In addition, Arena's pipeline includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is currently in Phase 2 for the treatment of microvascular obstruction and Raynaud's phenomenon secondary to systemic sclerosis. APD418 is currently in Phase 2 for acute heart failure.
"We're delighted to announce Pfizer's proposed acquisition of Arena, recognizing Arena's potentially best in class S1P molecule and our contribution to addressing unmet needs in immune-mediated inflammatory diseases," said Amit D. Munshi, President and Chief Executive Officer of Arena. "Pfizer's capabilities will accelerate our mission to deliver our important medicines to patients. We believe this transaction represents the best next step for both patients and shareholders."
Under the terms of the merger agreement, Pfizer will acquire all of the outstanding shares of Arena common stock for $100 per share in cash. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by Arena's stockholders.
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Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per share in an all-cash transaction for a total equity value of approximately $6.7 billion. The boards of directors of both companies have unanimously approved the transaction.
Pfizer expects to finance the transaction with existing cash on hand.
"The proposed acquisition of Arena complements our capabilities and expertise in Inflammation and Immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options," said Mike Gladstone, Global President & General Manager, Pfizer Inflammation and Immunology. "Utilizing Pfizer's leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases."
Arena's portfolio includes diverse and promising development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including gastrointestinal and dermatological diseases.
Arena has built a robust development program for etrasimod, including two Phase 3 studies in ulcerative colitis (UC), a Phase 2/3 program in Crohn's Disease, a planned Phase 3 program in atopic dermatitis, and ongoing Phase 2 studies in eosinophilic esophagitis and alopecia areata.
In addition, Arena's pipeline includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is currently in Phase 2 for the treatment of microvascular obstruction and Raynaud's phenomenon secondary to systemic sclerosis. APD418 is currently in Phase 2 for acute heart failure.
"We're delighted to announce Pfizer's proposed acquisition of Arena, recognizing Arena's potentially best in class S1P molecule and our contribution to addressing unmet needs in immune-mediated inflammatory diseases," said Amit D. Munshi, President and Chief Executive Officer of Arena. "Pfizer's capabilities will accelerate our mission to deliver our important medicines to patients. We believe this transaction represents the best next step for both patients and shareholders."
Under the terms of the merger agreement, Pfizer will acquire all of the outstanding shares of Arena common stock for $100 per share in cash. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by Arena's stockholders.
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Claims administrators who are evaluating possible subrogation in cancer cases filed by California farm workers who file claims for having been exposed to the weed killer Roundup, should take note of another Southern California favorable jury verdict by the parent company Bayer AG, the German pharmaceutical conglomerate that owns Monsanto the maker the product.
The jury found that Roundup did not cause a San Bernardino woman’s cancer on Thursday, adding another tally to the winner’s column for Bayer over claims that its signature herbicide is carcinogenic.
The plaintiff, Donnetta Stephens, of Yucaipa, California, was diagnosed with non-Hodgkin’s lymphoma in 2017. She argued that it was caused by 17 years of spraying Roundup twice a week in her yard. She sued Roundup maker Monsanto in 2020 for failing to warn her that glyphosate, the active ingredient in Roundup, could cause cancer.
But a jury decided that Roundup was not a substantial factor in Stephens' diagnosis.
"The jury's verdict in favor of the company brings this trial to a successful conclusion and is consistent with the evidence in this case that Roundup isn't the cause of Ms. Stephens' cancer. While we have great sympathy for Ms. Stephens, we agree with the jury that Roundup isn't the cause of her illness," a Bayer spokesperson said.
Stephens’ attorney, Fletch Trammell, told Reuters that he plans to appeal the judgment.
Wednesday’s verdict marks the second trial victory for Bayer, as a Los Angeles jury found in October that Roundup exposure did not cause 10 year-old Ezra Clark’s Burkitt’s lymphoma, a rare and aggressive form of pediatric cancer.
The first three trials were held in the Bay Area, where juries found in favor of the plaintiffs in every instance and awarded millions in damages.
The company hopes a ruling by the U.S. Supreme Court in a separate case will help put to rest yearslong litigation over the weedkiller. "The company continues to stand behind the safety of Roundup and will confidently defend the safety of our product as well as our good faith actions in any future litigation," Bayer said.
Legal issues surrounding Roundup have prompted the company to set aside billions in provisions to settle cases ...
The jury found that Roundup did not cause a San Bernardino woman’s cancer on Thursday, adding another tally to the winner’s column for Bayer over claims that its signature herbicide is carcinogenic.
The plaintiff, Donnetta Stephens, of Yucaipa, California, was diagnosed with non-Hodgkin’s lymphoma in 2017. She argued that it was caused by 17 years of spraying Roundup twice a week in her yard. She sued Roundup maker Monsanto in 2020 for failing to warn her that glyphosate, the active ingredient in Roundup, could cause cancer.
But a jury decided that Roundup was not a substantial factor in Stephens' diagnosis.
"The jury's verdict in favor of the company brings this trial to a successful conclusion and is consistent with the evidence in this case that Roundup isn't the cause of Ms. Stephens' cancer. While we have great sympathy for Ms. Stephens, we agree with the jury that Roundup isn't the cause of her illness," a Bayer spokesperson said.
Stephens’ attorney, Fletch Trammell, told Reuters that he plans to appeal the judgment.
Wednesday’s verdict marks the second trial victory for Bayer, as a Los Angeles jury found in October that Roundup exposure did not cause 10 year-old Ezra Clark’s Burkitt’s lymphoma, a rare and aggressive form of pediatric cancer.
The first three trials were held in the Bay Area, where juries found in favor of the plaintiffs in every instance and awarded millions in damages.
The company hopes a ruling by the U.S. Supreme Court in a separate case will help put to rest yearslong litigation over the weedkiller. "The company continues to stand behind the safety of Roundup and will confidently defend the safety of our product as well as our good faith actions in any future litigation," Bayer said.
Legal issues surrounding Roundup have prompted the company to set aside billions in provisions to settle cases ...
In a case that is not quite good news for workers' compensation claims administrators hoping to see lower generic drug prices, a federal judge on Thursday suspended California’s first-in-the-nation ban on pharmaceutical industry pay-for-delay deals, ruling the law intended to increase the flow of affordable generic drugs likely violates out-of-state commerce protections.
AB 824, was signed into law by California Governor Gavin Newsom on October 7, 2019. It creates a presumption that "reverse payment" settlement agreements regarding patent infringement claims between brand-name and generic pharmaceutical companies are anti- competitive and unlawful. A violation of the law is punishable by a civil penalty.
According to the State, AB 824 closes this loophole in the federal Hatch-Waxman Act and ensures a brand-name company cannot continue to enforce an otherwise weak patent against generic companies through these reverse payment settlement agreements.
The plaintiff in the case is a nonprofit, voluntary association comprised of the leading manufacturers and distributors of generic and biosimilar medicines, manufacturers and distributors of bulk active pharmaceutical ingredients, and suppliers of other goods and services to the generic and biosimilar pharmaceutical industry that filed suit in an attempt to invalidate AB 824.
Plaintiff argues AB 824: violates the dormant Commerce Clause by directly regulating out-of-state-conduct; is preempted by federal patent law, the delicate balance between the competing interests of patent protections and antitrust law struck by the U.S. Supreme Court in prior decisions.
The State contends that "AB 824 seeks to prevent or reduce anticompetitive pharmaceutical sales in California, and, thus, applies to agreements to engage in that conduct," not "conduct occurring wholly outside California."
U.S. District Judge Troy Nunley in his Opinion, agreed the law enables California to issue multimillion-dollar civil penalties against companies that have no connection to the state, and said it must be temporarily enjoined due to clear constitutional shortcomings.
"As it is written, the civil penalties provision could hypothetically reach a corporate officer of a Delaware company entering into a settlement agreement with another Delaware company regarding pharmaceutical sales in only Delaware," Nunley wrote. "The court cannot reasonably find that Assembly Bill 824 regulates only the California market."
"The court finds the balance of equities and the public interest element tips sharply in plaintiff’s favor such that an injunction would be proper even if there were only serious questions going to the merits," Nunley concluded.
According to Courthouse News, the bill's author said the judge's decision was "beyond frustrating."
"The association’s name and mission would imply that they are somehow on the side of patients when, in fact, they are only on the side of protecting their own profits," said Assemblyman Jim Wood, D-Eureka.
On the other side, Jeff Francer, the association's general counsel, celebrated the decision in an email. "AAM is encouraged that the federal court today recognized the harm caused by California in restricting litigation settlements that typically bring more affordable medicines to patients and taxpayers more quickly." ...
AB 824, was signed into law by California Governor Gavin Newsom on October 7, 2019. It creates a presumption that "reverse payment" settlement agreements regarding patent infringement claims between brand-name and generic pharmaceutical companies are anti- competitive and unlawful. A violation of the law is punishable by a civil penalty.
According to the State, AB 824 closes this loophole in the federal Hatch-Waxman Act and ensures a brand-name company cannot continue to enforce an otherwise weak patent against generic companies through these reverse payment settlement agreements.
The plaintiff in the case is a nonprofit, voluntary association comprised of the leading manufacturers and distributors of generic and biosimilar medicines, manufacturers and distributors of bulk active pharmaceutical ingredients, and suppliers of other goods and services to the generic and biosimilar pharmaceutical industry that filed suit in an attempt to invalidate AB 824.
Plaintiff argues AB 824: violates the dormant Commerce Clause by directly regulating out-of-state-conduct; is preempted by federal patent law, the delicate balance between the competing interests of patent protections and antitrust law struck by the U.S. Supreme Court in prior decisions.
The State contends that "AB 824 seeks to prevent or reduce anticompetitive pharmaceutical sales in California, and, thus, applies to agreements to engage in that conduct," not "conduct occurring wholly outside California."
U.S. District Judge Troy Nunley in his Opinion, agreed the law enables California to issue multimillion-dollar civil penalties against companies that have no connection to the state, and said it must be temporarily enjoined due to clear constitutional shortcomings.
"As it is written, the civil penalties provision could hypothetically reach a corporate officer of a Delaware company entering into a settlement agreement with another Delaware company regarding pharmaceutical sales in only Delaware," Nunley wrote. "The court cannot reasonably find that Assembly Bill 824 regulates only the California market."
"The court finds the balance of equities and the public interest element tips sharply in plaintiff’s favor such that an injunction would be proper even if there were only serious questions going to the merits," Nunley concluded.
According to Courthouse News, the bill's author said the judge's decision was "beyond frustrating."
"The association’s name and mission would imply that they are somehow on the side of patients when, in fact, they are only on the side of protecting their own profits," said Assemblyman Jim Wood, D-Eureka.
On the other side, Jeff Francer, the association's general counsel, celebrated the decision in an email. "AAM is encouraged that the federal court today recognized the harm caused by California in restricting litigation settlements that typically bring more affordable medicines to patients and taxpayers more quickly." ...
A fraud conviction and seven-year prison sentence haven’t spared Martin Shkreli from a federal antitrust lawsuit tied to his former company’s infamous drug pricing scandal. Now, the pharmaceutical company formerly known as Turing has agreed to settle for $40 million.
The California Attorney General announced that Vyera Pharmaceuticals has agreed to pay up to $40 million as disgorgement of Ill-Gotten Gains, to settle charges that it engaged in anticompetitive practices to ward off generics and maintain "monopoly profits" from its more than 4,000% overnight price hike on the toxoplasmosis med Daraprim..
The agreement also bans the former Vyera CEO Kevin Mulleady from almost any role at a pharmaceutical company for seven years. Meanwhile, the litigation against Shkreli, who was the architect of the illegal scheme, will continue, James' office said. His antitrust trial is slated to begin Dec. 14.
In January 2020, New York Attorney General James and the Federal Trade Commission (FTC) filed a lawsuit against Vyera, Shkreli, and Mulleady for antitrust violations that stifled competition and permitted the defendants to protect and maintain their monopoly profits from their more than 4,000 percent overnight increase - to $750 per pill - of the drug Daraprim (pyrimethamine).
Daraprim is the only Food and Drug Administration (FDA)-approved drug for the treatment of toxoplasmosis, a parasitic disease which may pose serious and often life-threating consequences for those with compromised immune systems, including babies born to women infected with the disease and individuals with the Human Immunodeficiency Virus (HIV).
Daraprim was cheap and accessible for decades, then, in August 2015, Vyera purchased the drug, increased the price, altered its distribution, and engaged in other conduct to delay and impede generic competition.
The high price and distribution changes limited access to the drug, forcing many to make difficult and risky decisions for the treatment of a life-threatening disease.
The illegal scheme perpetrated by Vyera, Shkreli, and Mulleady involved restrictive distribution and supply agreements, as well as data secrecy, with the intent and effect of delaying entry by lower cost generic competitors.
In April 2020, the states of California, Illinois, North Carolina, Ohio, Pennsylvania, and Virginia joined Attorney General James’ and the FTC’s lawsuit.
All money deposited in the Settlement Fund shall be used for equitable relief, including consumer redress and other equitable relief that the Plaintiff States determine to be related to the Defendants’ alleged violative practices and injury, any attendant expenses for the administration of such fund, and repayment of out-of-pocket expenses, and to satisfy the amount of any settlement reached in the related case,
Any money remaining in the fund after such distributions shall be deposited by the Plaintiff States as disgorgement to be used consistently with their respective state laws ...
The California Attorney General announced that Vyera Pharmaceuticals has agreed to pay up to $40 million as disgorgement of Ill-Gotten Gains, to settle charges that it engaged in anticompetitive practices to ward off generics and maintain "monopoly profits" from its more than 4,000% overnight price hike on the toxoplasmosis med Daraprim..
The agreement also bans the former Vyera CEO Kevin Mulleady from almost any role at a pharmaceutical company for seven years. Meanwhile, the litigation against Shkreli, who was the architect of the illegal scheme, will continue, James' office said. His antitrust trial is slated to begin Dec. 14.
In January 2020, New York Attorney General James and the Federal Trade Commission (FTC) filed a lawsuit against Vyera, Shkreli, and Mulleady for antitrust violations that stifled competition and permitted the defendants to protect and maintain their monopoly profits from their more than 4,000 percent overnight increase - to $750 per pill - of the drug Daraprim (pyrimethamine).
Daraprim is the only Food and Drug Administration (FDA)-approved drug for the treatment of toxoplasmosis, a parasitic disease which may pose serious and often life-threating consequences for those with compromised immune systems, including babies born to women infected with the disease and individuals with the Human Immunodeficiency Virus (HIV).
Daraprim was cheap and accessible for decades, then, in August 2015, Vyera purchased the drug, increased the price, altered its distribution, and engaged in other conduct to delay and impede generic competition.
The high price and distribution changes limited access to the drug, forcing many to make difficult and risky decisions for the treatment of a life-threatening disease.
The illegal scheme perpetrated by Vyera, Shkreli, and Mulleady involved restrictive distribution and supply agreements, as well as data secrecy, with the intent and effect of delaying entry by lower cost generic competitors.
In April 2020, the states of California, Illinois, North Carolina, Ohio, Pennsylvania, and Virginia joined Attorney General James’ and the FTC’s lawsuit.
All money deposited in the Settlement Fund shall be used for equitable relief, including consumer redress and other equitable relief that the Plaintiff States determine to be related to the Defendants’ alleged violative practices and injury, any attendant expenses for the administration of such fund, and repayment of out-of-pocket expenses, and to satisfy the amount of any settlement reached in the related case,
Any money remaining in the fund after such distributions shall be deposited by the Plaintiff States as disgorgement to be used consistently with their respective state laws ...
Nearly 500 Los Angeles Unified School District employees were fired this week for refusing to comply with a mandate that they get vaccinated against COVID-19, while some 34,000 students have not yet been vaccinated as required.
KTLA News reports that the school board voted 7-0 in separate motions on Tuesday to terminate 496 employees, who make up less than 1% of the district’s approximately 73,000 workers.
Most of those fired had likely been on leave since mid-October when LAUSD staffers were to have received at least their first vaccine dose, the Los Angeles Daily News reported. Employees were required to receive their second dose by Nov. 15.
Of the 496 employee dismissals, 418 were classified employees who are non-credentialed but critical staff that can include positions such as instructional aides, custodians, cafeteria workers and others.
The district initially set an Oct. 15 deadline for its employees to be fully vaccinated against COVID-19 but extended the deadline to Nov. 15. "The effective date of separation for employees without record of any vaccine by October 15, 2021, will not be prior to November 1, 2021," according to the district. "Employees will remain in paid status through October 31, 2021."
The mandate applies to all district students, along with charter school students on co-located district school facilities. Students "with qualified and approved exemptions under LAUSD's existing immunization policies" are exempt.
LAUSD is one of several large districts in California to adopt their own rules requiring students to get the COVID-19 vaccination, ahead of a statewide policy that will take effect after federal officials fully approve the immunizations by age group. The state policy, announced by Gov. Gavin Newsom in October, is not expected to go into place before July, but the precise date is still unknown.
Districts including San Diego Unified, Sacramento City Unified, Oakland and West Contra Costa are among those that have deadlines for student vaccine policies scheduled to take effect in early 2022. The policies vary according to district, with some allowing students to opt for weekly testing and others making the shot a requirement for in-person classes.
In Los Angeles, students who are not fully vaccinated - or exempt - will be forced into the district’s independent study program or will have to leave the Los Angeles public school system.
Shifting 34,000 students into independent study would be challenging because the program faces staffing shortages, according to the Times.
...
KTLA News reports that the school board voted 7-0 in separate motions on Tuesday to terminate 496 employees, who make up less than 1% of the district’s approximately 73,000 workers.
Most of those fired had likely been on leave since mid-October when LAUSD staffers were to have received at least their first vaccine dose, the Los Angeles Daily News reported. Employees were required to receive their second dose by Nov. 15.
Of the 496 employee dismissals, 418 were classified employees who are non-credentialed but critical staff that can include positions such as instructional aides, custodians, cafeteria workers and others.
The district initially set an Oct. 15 deadline for its employees to be fully vaccinated against COVID-19 but extended the deadline to Nov. 15. "The effective date of separation for employees without record of any vaccine by October 15, 2021, will not be prior to November 1, 2021," according to the district. "Employees will remain in paid status through October 31, 2021."
The mandate applies to all district students, along with charter school students on co-located district school facilities. Students "with qualified and approved exemptions under LAUSD's existing immunization policies" are exempt.
LAUSD is one of several large districts in California to adopt their own rules requiring students to get the COVID-19 vaccination, ahead of a statewide policy that will take effect after federal officials fully approve the immunizations by age group. The state policy, announced by Gov. Gavin Newsom in October, is not expected to go into place before July, but the precise date is still unknown.
Districts including San Diego Unified, Sacramento City Unified, Oakland and West Contra Costa are among those that have deadlines for student vaccine policies scheduled to take effect in early 2022. The policies vary according to district, with some allowing students to opt for weekly testing and others making the shot a requirement for in-person classes.
In Los Angeles, students who are not fully vaccinated - or exempt - will be forced into the district’s independent study program or will have to leave the Los Angeles public school system.
Shifting 34,000 students into independent study would be challenging because the program faces staffing shortages, according to the Times.
...
Retired WCJ Raymond F. Correro recently published an excellent article on Exploring the Limitations on the WCAB’s Authority to Develop, Augment, and Reopen the Record, on the LexisNexis website.
As he explains, there is tension between the Workers’ Compensation Appeals Board’s power and authority to develop the evidentiary record pursuant to Labor Code sections and , - and prohibitions on admitting evidence not listed on the pretrial conference statement pursuant to Labor Code section 5502(d)(3) and the closure of discovery at that point of the litigation.
Prior to the late 1990s, the tension was less severe, as the power to reopen a case after submission for decision was somewhat limited. If the applicant failed to carry their burden of proof, they simply did not prevail, and a take nothing award was the result.
Judge Carrero discussed a trifecta of cases that seemed to open the door and exacerbate this tension, by allowing seemingly unfettered power of the trial Judge, or WCAB on reconsideration to further develop the record after submission of the case for decision.
The cases are Tyler v, Workers’ Comp. Appeals Bd. ((1997) 56 Cal.App.4th 389, 62 Cal.Comp.Cases 924, 1967 Cal.App LEXIS 562; McClune v. Workers’ Comp. Appeals Bd. (1998) 62 Cal.App.4th 1117, 63 Cal.Comp.Cases 261, 1998 Cal.App. LEXIS 282; and M/A Com-Phi v. Workers’ Comp. Appeals Bd. (Sevadjian) (1998) 65 Cal.App.4th 1020, 63 Cal.Comp.Cases 821, 1998 Cal.App. LEXIS 670.
Judge Carrero points out that "The WCAB continues to rely on these same three cases from the late 1990’s which has been manifested in numerous cases to become a mantra of sorts frequently expressed or formulated in almost the exact same or similar language with little variation."
However he concludes his article by pointing out that there are limitations to the application of the trifecta of cases, and cites as authority a case that followed approximately three years later, McDuffie v. Los Angeles County Metropolitan Transit Authority (2002) 67 Cal.Comp.Cases 138; 2002 Cal.Wrk.Comp. LEXIS 1218 (en banc).
McDuffie sets fourth a limit. Development of the record is allowed only if neither side has presented substantial evidence on which a decision could be based. But it is not appropriate where a decision could be rendered on the existing record and the party seeking to introduce new evidence has failed to show that such evidence "was not available or could not have been discovered by the exercise of due diligence prior to the [mandatory] settlement conference."
In the case where further development of the record is appropriate, a seven step set of procedures to follow are suggested.
Many thanks to Judge Carrero for his thorough and well reasoned analysis of the limits on developing the record in a submitted case ...
As he explains, there is tension between the Workers’ Compensation Appeals Board’s power and authority to develop the evidentiary record pursuant to Labor Code sections and , - and prohibitions on admitting evidence not listed on the pretrial conference statement pursuant to Labor Code section 5502(d)(3) and the closure of discovery at that point of the litigation.
Prior to the late 1990s, the tension was less severe, as the power to reopen a case after submission for decision was somewhat limited. If the applicant failed to carry their burden of proof, they simply did not prevail, and a take nothing award was the result.
Judge Carrero discussed a trifecta of cases that seemed to open the door and exacerbate this tension, by allowing seemingly unfettered power of the trial Judge, or WCAB on reconsideration to further develop the record after submission of the case for decision.
The cases are Tyler v, Workers’ Comp. Appeals Bd. ((1997) 56 Cal.App.4th 389, 62 Cal.Comp.Cases 924, 1967 Cal.App LEXIS 562; McClune v. Workers’ Comp. Appeals Bd. (1998) 62 Cal.App.4th 1117, 63 Cal.Comp.Cases 261, 1998 Cal.App. LEXIS 282; and M/A Com-Phi v. Workers’ Comp. Appeals Bd. (Sevadjian) (1998) 65 Cal.App.4th 1020, 63 Cal.Comp.Cases 821, 1998 Cal.App. LEXIS 670.
Judge Carrero points out that "The WCAB continues to rely on these same three cases from the late 1990’s which has been manifested in numerous cases to become a mantra of sorts frequently expressed or formulated in almost the exact same or similar language with little variation."
However he concludes his article by pointing out that there are limitations to the application of the trifecta of cases, and cites as authority a case that followed approximately three years later, McDuffie v. Los Angeles County Metropolitan Transit Authority (2002) 67 Cal.Comp.Cases 138; 2002 Cal.Wrk.Comp. LEXIS 1218 (en banc).
McDuffie sets fourth a limit. Development of the record is allowed only if neither side has presented substantial evidence on which a decision could be based. But it is not appropriate where a decision could be rendered on the existing record and the party seeking to introduce new evidence has failed to show that such evidence "was not available or could not have been discovered by the exercise of due diligence prior to the [mandatory] settlement conference."
In the case where further development of the record is appropriate, a seven step set of procedures to follow are suggested.
Many thanks to Judge Carrero for his thorough and well reasoned analysis of the limits on developing the record in a submitted case ...
Ray Meister, MD, MPH, Executive Medical Director Division of Workers' Compensation Department of Industrial Relations, has just announced a new educational offering for Qualified Medical Evaluators.
The Division of Workers' Compensation launched an update to the online physician education course, Evaluating California’s Injured Workers: Qualified Medical Evaluators (QMEs).
The Center for Occupational and Environmental Health designates this enduring material for a maximum of 2 AMA PRA category 1 Credit(s) and the course is approved for 2 hours of QME continuing education credit. Those who took the previous course are eligible to retake the updated course for the additional credit.
This course will cover the following topics:
1) How to prepare for an evaluation and outline the components of a quality report
2) The concept of apportionment and how to apportion to causation of disability
3) What constitutes substantial medical evidence and how it applies to apportionment
4) Potential bias and how to avoid it in your medical-legal reports
5) Administrative regulations to stay in compliance as a QME
The DWC also offers a CME course on the Medical Treatment Utilization Schedule (MTUS). All providers involved in the care of California’s injured workers have no-cost access to the MTUS-ACOEM treatment guidelines.
- - Learn how to use the MTUS, the MTUS-ACOEM treatment guidelines and formulary to increase UR approvals
- - Learn how to use evidence-based treatment guidelines and medical recommendations in caring for your patients.
- - Learn which medications are consistent with the MTUS-ACOEM treatment guidelines and exempt from Prospective Review authorization.
Both courses are offered free of charge.
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the California Medical Association (CMA) through the joint providership of The Center for Occupational and Environmental Health (COEH) and State of California Department of Industrial Relations Division of Workers' Compensation. The Center for Occupational and Environmental Health is accredited by the CMA to provide continuing medical education for physicians.
The Center for Occupational and Environmental Health (COEH) designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity ...
The Division of Workers' Compensation launched an update to the online physician education course, Evaluating California’s Injured Workers: Qualified Medical Evaluators (QMEs).
The Center for Occupational and Environmental Health designates this enduring material for a maximum of 2 AMA PRA category 1 Credit(s) and the course is approved for 2 hours of QME continuing education credit. Those who took the previous course are eligible to retake the updated course for the additional credit.
This course will cover the following topics:
1) How to prepare for an evaluation and outline the components of a quality report
2) The concept of apportionment and how to apportion to causation of disability
3) What constitutes substantial medical evidence and how it applies to apportionment
4) Potential bias and how to avoid it in your medical-legal reports
5) Administrative regulations to stay in compliance as a QME
The DWC also offers a CME course on the Medical Treatment Utilization Schedule (MTUS). All providers involved in the care of California’s injured workers have no-cost access to the MTUS-ACOEM treatment guidelines.
- - Learn how to use the MTUS, the MTUS-ACOEM treatment guidelines and formulary to increase UR approvals
- - Learn how to use evidence-based treatment guidelines and medical recommendations in caring for your patients.
- - Learn which medications are consistent with the MTUS-ACOEM treatment guidelines and exempt from Prospective Review authorization.
Both courses are offered free of charge.
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the California Medical Association (CMA) through the joint providership of The Center for Occupational and Environmental Health (COEH) and State of California Department of Industrial Relations Division of Workers' Compensation. The Center for Occupational and Environmental Health is accredited by the CMA to provide continuing medical education for physicians.
The Center for Occupational and Environmental Health (COEH) designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity ...
The owner of multiple Bay Area Acupuncture clinics admitted to committing medical insurance fraud and violating California’s aggravated white-collar statute.
Dr. Hidenori Anto (aka Dr. Yunyong Lu), age 61, of Saratoga, pleaded no contest to two felony counts of insurance fraud. Dr. Anto’s plea agreement requires that he be placed on five years formal probation, serve one year of county jail, and make complete restitution of $400,000.
During the five-year term of his probation, Dr. Anto cannot bill or assist anyone else in billing insurance companies for acupuncture treatments. He will be sentenced on January 3, 2022 at 9:00 AM in Department 34.
Since 2016, Dr. Anto has operated the following clinics:
- - Anto Acupuncture & Herb Clinic (aka Anto Acupuncture & Chinese Medicine Clinic aka California Holistic Health Center aka Cupertino Holistic Healing Clinic aka Bay Acupuncture Wellness Center) located at 20445 Pacifica Dr #A1 in Cupertino.
- - Vitality Acupuncture Clinic (aka Vitality Health Center aka Mind and Body Wellness Center California Holistic Health Center) located at 2464 W El Camino Real #B in Mountain View.
- - Prospect Acupuncture (aka Cupertino Holistic Healing) located at 18568 Prospect Rd in Saratoga.
- - Green Creek Acupuncture, located at 20735 Stevens Creek Blvd #B in Cupertino.
Between 2016 and 2020, Dr. Anto illegally billed numerous insurance carriers hundreds of thousands of dollars by misclassifying patient treatments, billing for work he was not qualified to complete, overbilling for patient treatments that never occurred, and masking his identity from insurance carriers. In some cases, Dr. Anto billed for medical treatment on patients, but those patients were traveling outside of country at the time.
When insurance carriers attempted to stop the excessive billing by placing Dr. Anto’s clinics on "pre-payment review," Dr. Anto would simply obtain new identifying information and submit new bills, thus avoiding the pre-payment review process.
After a multi-year investigation, his complex scheme was exposed by Santa Clara County District Attorney investigators with the help of investigators from the respective insurance carriers. In interviews, patients shared that they felt "cheated" and referred to Dr. Anto’s conduct as "pure greed."
Deputy District Attorney Mattia Corsiglia said: "Medical providers hold a unique position of trust with their patients. When they use that status to defraud insurance companies and line their own pockets, they increase our insurance rates and harm the public’s confidence in our healthcare system." ...
Dr. Hidenori Anto (aka Dr. Yunyong Lu), age 61, of Saratoga, pleaded no contest to two felony counts of insurance fraud. Dr. Anto’s plea agreement requires that he be placed on five years formal probation, serve one year of county jail, and make complete restitution of $400,000.
During the five-year term of his probation, Dr. Anto cannot bill or assist anyone else in billing insurance companies for acupuncture treatments. He will be sentenced on January 3, 2022 at 9:00 AM in Department 34.
Since 2016, Dr. Anto has operated the following clinics:
- - Anto Acupuncture & Herb Clinic (aka Anto Acupuncture & Chinese Medicine Clinic aka California Holistic Health Center aka Cupertino Holistic Healing Clinic aka Bay Acupuncture Wellness Center) located at 20445 Pacifica Dr #A1 in Cupertino.
- - Vitality Acupuncture Clinic (aka Vitality Health Center aka Mind and Body Wellness Center California Holistic Health Center) located at 2464 W El Camino Real #B in Mountain View.
- - Prospect Acupuncture (aka Cupertino Holistic Healing) located at 18568 Prospect Rd in Saratoga.
- - Green Creek Acupuncture, located at 20735 Stevens Creek Blvd #B in Cupertino.
Between 2016 and 2020, Dr. Anto illegally billed numerous insurance carriers hundreds of thousands of dollars by misclassifying patient treatments, billing for work he was not qualified to complete, overbilling for patient treatments that never occurred, and masking his identity from insurance carriers. In some cases, Dr. Anto billed for medical treatment on patients, but those patients were traveling outside of country at the time.
When insurance carriers attempted to stop the excessive billing by placing Dr. Anto’s clinics on "pre-payment review," Dr. Anto would simply obtain new identifying information and submit new bills, thus avoiding the pre-payment review process.
After a multi-year investigation, his complex scheme was exposed by Santa Clara County District Attorney investigators with the help of investigators from the respective insurance carriers. In interviews, patients shared that they felt "cheated" and referred to Dr. Anto’s conduct as "pure greed."
Deputy District Attorney Mattia Corsiglia said: "Medical providers hold a unique position of trust with their patients. When they use that status to defraud insurance companies and line their own pockets, they increase our insurance rates and harm the public’s confidence in our healthcare system." ...
Mercury News reports that More than 100 Los Angeles city firefighters have been placed off duty without pay for failing to comply with the city’s vaccine mandate.
The City, in August, directed its employees to get vaccinated unless they request a medical or religious exemption. Those who haven’t done either by Dec. 18, including firefighters, eventually will be subject to termination, a LAFD spokeswoman said.
In November, the Los Angeles Fire Department sent out notices to 222 firefighters informing them they would be sent home without pay unless they got the vaccine or requested an exemption, an LAFD spokeswoman said.
As of Monday, 113 firefighters had failed to respond to those notices, she said. They were placed off duty without pay, but will be allowed to use vacation hours or banked overtime to offset their lost wages.
"The number of firefighters placed off duty changes daily due to members updating their (vaccine status)," LAFD officials said in a statement. "That number will fluctuate."
The union representing firefighters, the United Firefighters of Los Angeles City Local 112, requested a preliminary injunction through the court to prevent enforcement of the mandate, saying that it could lead to hundreds of firefighters being put on leave.
But last week that request was denied by a Los Angeles Superior Court judge.
The judge said that even if all of the unvaccinated LAFD employees decided to leave because of the vaccine mandate, the department has sufficient contingency plans. Further, she noted, COVID-19 has disrupted the agency and led to two firefighter deaths.
There are more than 3,340 sworn LAFD firefighters and paramedics. The department recently welcomed 54 new recruits, and another class that began in November should be on duty by March, LAFD officials said.
The union, which did not return several messages for comment, also has an unfair labor practices charge pending before the Los Angeles City Employee Relations Board, according to a union bulletin sent out to members. "While we are disappointed with the outcome, we will continue to fight to protect the rights of all UFLAC members," the bulletin says. The union has not challenged in court the constitutionality of the mandate, but says the city has failed to follow bargaining procedures.
A total of 321 unvaccinated sworn and civilian staff had applied for medical or religious exemptions as of Monday, the LAFD’s spokeswoman said. So far, none have been granted or rejected. Officials were unable to estimate how long it might take to examine the cases, but the process may drag past the Dec. 18 deadline.
...
The City, in August, directed its employees to get vaccinated unless they request a medical or religious exemption. Those who haven’t done either by Dec. 18, including firefighters, eventually will be subject to termination, a LAFD spokeswoman said.
In November, the Los Angeles Fire Department sent out notices to 222 firefighters informing them they would be sent home without pay unless they got the vaccine or requested an exemption, an LAFD spokeswoman said.
As of Monday, 113 firefighters had failed to respond to those notices, she said. They were placed off duty without pay, but will be allowed to use vacation hours or banked overtime to offset their lost wages.
"The number of firefighters placed off duty changes daily due to members updating their (vaccine status)," LAFD officials said in a statement. "That number will fluctuate."
The union representing firefighters, the United Firefighters of Los Angeles City Local 112, requested a preliminary injunction through the court to prevent enforcement of the mandate, saying that it could lead to hundreds of firefighters being put on leave.
But last week that request was denied by a Los Angeles Superior Court judge.
The judge said that even if all of the unvaccinated LAFD employees decided to leave because of the vaccine mandate, the department has sufficient contingency plans. Further, she noted, COVID-19 has disrupted the agency and led to two firefighter deaths.
There are more than 3,340 sworn LAFD firefighters and paramedics. The department recently welcomed 54 new recruits, and another class that began in November should be on duty by March, LAFD officials said.
The union, which did not return several messages for comment, also has an unfair labor practices charge pending before the Los Angeles City Employee Relations Board, according to a union bulletin sent out to members. "While we are disappointed with the outcome, we will continue to fight to protect the rights of all UFLAC members," the bulletin says. The union has not challenged in court the constitutionality of the mandate, but says the city has failed to follow bargaining procedures.
A total of 321 unvaccinated sworn and civilian staff had applied for medical or religious exemptions as of Monday, the LAFD’s spokeswoman said. So far, none have been granted or rejected. Officials were unable to estimate how long it might take to examine the cases, but the process may drag past the Dec. 18 deadline.
...
Access to medical care, including pharmaceuticals is a critical task for workers' compensation claim administrators. It may soon become a problem if supply chain issues interrupt the delivery of prescriptions written by the physicians treating injured workers.
As impossible as it may seem, pharmacies are reportedly running out of important prescription medications, and the U.S. Food and Drug Administration (FDA) shows there are about 111 drugs on backorder - including heart medications, antibiotics and cancer drugs.
The agency said on its website that it "continues to take steps to monitor the supply chain."
"The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak," it wrote.
The FDA highlights that there are a number of reasons why drug shortages can occur, including manufacturing and quality problems, delays and discontinuations.
"Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages," it said, also reporting that about 80% of active pharmaceutical ingredients manufacturers are located outside the U.S.
A November survey released by the National Community Pharmacists Association (NCPA) found that the majority of independent pharmacy owners and managers are struggling to fill staff positions and deal with supply chain disruptions, in addition to market pressures.
Sixty percent of respondents said they are dealing with supply chain disruptions and nearly 70% reported struggling to fill staff positions.
According to the group, 76% reported being concerned about possible tax increases on small businesses and 64% were also worried about inflation.
Only 31% of respondents described the overall financial health of their business as very good or somewhat good, 28% described it as average and 41% described it as somewhat poor or very poor.
"Pharmacists have worked heroically throughout the pandemic so to have insurance middlemen push so many of these small business owners to the edge is troubling," NCPA CEO B. Douglas Hoey said in an accompanying statement. "Policymakers in Congress, the Biden administration and in the states should keep this in mind. There are important policy changes they can make to lower drug prices for seniors and protect small businesses, like eliminating pharmacy DIR fees."
"Between rollouts of COVID-19 vaccines for children, boosters, and seasonal flu shots - on top of their other existing patient care services - pharmacies are stretched very thin, while patients need them more than ever," he said. "Independent pharmacies are the safety nets protecting their communities, and owners are working overtime, docking their own pay and doing everything they can to answer the call. Policymakers must repair the broken prescription drug payment model to better support pharmacy teams; successful pharmacies mean healthier, happier lives for patients."
An American Society of Health-System Pharmacists report warned earlier this year that supply chain disruptions in the midst of the COVID-19 pandemic have the potential to negatively impact patient care.
Tom D’Angelo, chairman of the Pharmacists Society of the State of New York, told Long Island's Newsday that "a lot of stuff is stuck on barges," including generic blood pressure pills and cold and flu medication ...
As impossible as it may seem, pharmacies are reportedly running out of important prescription medications, and the U.S. Food and Drug Administration (FDA) shows there are about 111 drugs on backorder - including heart medications, antibiotics and cancer drugs.
The agency said on its website that it "continues to take steps to monitor the supply chain."
"The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak," it wrote.
The FDA highlights that there are a number of reasons why drug shortages can occur, including manufacturing and quality problems, delays and discontinuations.
"Manufacturers provide FDA most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages," it said, also reporting that about 80% of active pharmaceutical ingredients manufacturers are located outside the U.S.
A November survey released by the National Community Pharmacists Association (NCPA) found that the majority of independent pharmacy owners and managers are struggling to fill staff positions and deal with supply chain disruptions, in addition to market pressures.
Sixty percent of respondents said they are dealing with supply chain disruptions and nearly 70% reported struggling to fill staff positions.
According to the group, 76% reported being concerned about possible tax increases on small businesses and 64% were also worried about inflation.
Only 31% of respondents described the overall financial health of their business as very good or somewhat good, 28% described it as average and 41% described it as somewhat poor or very poor.
"Pharmacists have worked heroically throughout the pandemic so to have insurance middlemen push so many of these small business owners to the edge is troubling," NCPA CEO B. Douglas Hoey said in an accompanying statement. "Policymakers in Congress, the Biden administration and in the states should keep this in mind. There are important policy changes they can make to lower drug prices for seniors and protect small businesses, like eliminating pharmacy DIR fees."
"Between rollouts of COVID-19 vaccines for children, boosters, and seasonal flu shots - on top of their other existing patient care services - pharmacies are stretched very thin, while patients need them more than ever," he said. "Independent pharmacies are the safety nets protecting their communities, and owners are working overtime, docking their own pay and doing everything they can to answer the call. Policymakers must repair the broken prescription drug payment model to better support pharmacy teams; successful pharmacies mean healthier, happier lives for patients."
An American Society of Health-System Pharmacists report warned earlier this year that supply chain disruptions in the midst of the COVID-19 pandemic have the potential to negatively impact patient care.
Tom D’Angelo, chairman of the Pharmacists Society of the State of New York, told Long Island's Newsday that "a lot of stuff is stuck on barges," including generic blood pressure pills and cold and flu medication ...
Last week we reported on the WCIRB release of its Friction in the California Compensation System report, which details the primary drivers of California frictional costs, the impact of high frictional cost claims and recent trends in frictional costs.
In California, it costs $0.48 in frictional costs to deliver $1 of benefits to injured workers. This is almost twice the median workers’ compensation system and significantly above other systems that deliver medical benefits
Perhaps the MEMIC Group has found at least one way to reduce these frictional costs.
The MEMIC Group has selected One Inc's ClaimsPay platform to transform its outbound payments process. The partnership will modernize MEMIC's claim payments infrastructure and deliver a faster and more efficient payments process by expanding outbound payment options.
Portland, Maine-based MEMIC began operations in 1993 to provide insurance solutions to policyholders in a state where rates were twice the national average. MEMIC now is a competitive force within the workers' compensation insurance market from Maine to Florida.
The MEMIC Group includes MEMIC Indemnity Company, MEMIC Casualty Company, and parent company Maine Employers' Mutual Insurance Company; all rated "A" (Excellent) by A.M. Best. The MEMIC Group holds licenses to write workers' compensation across the entire country. The group insures and serves more than 20,000 employers and their estimated 300,000 employees with dedicated safety and injury management service teams from Maine to Florida.
Prior to the One Inc selection, MEMIC distributed its payments to non-medical providers and injured workers by check through an internal system, while sending payments to medical providers by mail. With One Inc, MEMIC will now adopt digital claims workflow instead, moving away from paper-based processes.
"We believe One Inc's exclusive focus on the insurance industry will integrate seamlessly with our existing vendor network, provide extensive payment options, and help us to not only lower costs associated with outbound claim payments, but deliver a consolidated and streamlined process, speeding up our response times," said Matthew Harmon, SVP of Claims at MEMIC. "We are thrilled to have One Inc on board and will look to the ClaimsPay implementation as a key contributor towards greater digitalization throughout our enterprise."
MEMIC joins nearly 200 independent insurance clients for One Inc, including five of the 15 largest insurance companies in the US.
"MEMIC has taken an exciting step towards digitizing its claims payment experience for customers," said Ian Drysdale, Chief Executive Officer at One Inc. "This successful project is proof of our team's industry-leading expertise. It responds to specific insurance use cases like workers' compensation by addressing particular technology challenges only One Inc can solve, so we're thrilled to be a part of MEMIC's digital transformation."
One Inc is modernizing the insurance industry through a unified and frictionless payment network. As one of the fastest growing digital payments platforms in the insurance industry, One Inc manages billions of dollars per year in premiums and claim payments. According to it's website "One Inc offers a single platform to process digital payments for premiums and claims. Designed to integrate with modern and legacy insurance core systems, the One Inc Digital Payments Platform engages policyholders through the channels they use most while securely processing payments through those same channels." ...
In California, it costs $0.48 in frictional costs to deliver $1 of benefits to injured workers. This is almost twice the median workers’ compensation system and significantly above other systems that deliver medical benefits
Perhaps the MEMIC Group has found at least one way to reduce these frictional costs.
The MEMIC Group has selected One Inc's ClaimsPay platform to transform its outbound payments process. The partnership will modernize MEMIC's claim payments infrastructure and deliver a faster and more efficient payments process by expanding outbound payment options.
Portland, Maine-based MEMIC began operations in 1993 to provide insurance solutions to policyholders in a state where rates were twice the national average. MEMIC now is a competitive force within the workers' compensation insurance market from Maine to Florida.
The MEMIC Group includes MEMIC Indemnity Company, MEMIC Casualty Company, and parent company Maine Employers' Mutual Insurance Company; all rated "A" (Excellent) by A.M. Best. The MEMIC Group holds licenses to write workers' compensation across the entire country. The group insures and serves more than 20,000 employers and their estimated 300,000 employees with dedicated safety and injury management service teams from Maine to Florida.
Prior to the One Inc selection, MEMIC distributed its payments to non-medical providers and injured workers by check through an internal system, while sending payments to medical providers by mail. With One Inc, MEMIC will now adopt digital claims workflow instead, moving away from paper-based processes.
"We believe One Inc's exclusive focus on the insurance industry will integrate seamlessly with our existing vendor network, provide extensive payment options, and help us to not only lower costs associated with outbound claim payments, but deliver a consolidated and streamlined process, speeding up our response times," said Matthew Harmon, SVP of Claims at MEMIC. "We are thrilled to have One Inc on board and will look to the ClaimsPay implementation as a key contributor towards greater digitalization throughout our enterprise."
MEMIC joins nearly 200 independent insurance clients for One Inc, including five of the 15 largest insurance companies in the US.
"MEMIC has taken an exciting step towards digitizing its claims payment experience for customers," said Ian Drysdale, Chief Executive Officer at One Inc. "This successful project is proof of our team's industry-leading expertise. It responds to specific insurance use cases like workers' compensation by addressing particular technology challenges only One Inc can solve, so we're thrilled to be a part of MEMIC's digital transformation."
One Inc is modernizing the insurance industry through a unified and frictionless payment network. As one of the fastest growing digital payments platforms in the insurance industry, One Inc manages billions of dollars per year in premiums and claim payments. According to it's website "One Inc offers a single platform to process digital payments for premiums and claims. Designed to integrate with modern and legacy insurance core systems, the One Inc Digital Payments Platform engages policyholders through the channels they use most while securely processing payments through those same channels." ...
Public Health and Medical Professionals for Transparency (PHMPT) is a not-for-profit organization. It's members include over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, UCSF, UCI and Brown.
These academics and scientists represent a cross section of every discipline relevant to the licensure of the Pfizer vaccine and include many of the best our country has to offer when it comes to reviewing and assessing the appropriateness and validity of the FDA’s decision-making in licensing of the Pfizer COVID Vaccine.
In furtherance of its mission, on August 27, 2021, PHMPT submitted the Freedom of Information Act (FOIA) Request to the FDA seeking all data and information pertaining to the application and approval of the Pfizer Vaccine. Federal law (21 C.F.R. § 601.51(e)) provides that: "After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown." PHMPT desires to perform its own independent analysis of the safety and efficacy the the vaccine, especially in light of the vaccine mandates being promulgated at the federal and state levels.
FOIA provides for "expedited processing of request for records" upon a showing of "compelling need." PHMPT requested expedited processing of the FOIA Request, which was rejected by the FDA. Thus, PHMPT filed a lawsuit in federal court, seeking to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine by way of expedited processing. The FDA denied the expedited processing request.
In the Second Joint Status Report following filing this case, the FDA assessed that there are more than 329,000 pages potentially responsive to the PHMPT FOIA request. The FDA asks that the Court limit the FOIA response to no more than 500 pages per month. This would be nearly 55 years or until about 2077.
PHMPT requests that the Court enter an order requiring the FDA to produce all documents on a rolling basis such that all of it shall be produced on or before March 3, 2022. The Court will at some point dictate the schedule.
Meanwhile, in the months following the August FOIA request, the FDA has managed to dribble out five documents by November 17, which are now on the PHMPT website. The most alarming of these is the "Cumulative Analysis Of Post-Authorization Adverse Event Reports Of Pf-07302048 (Bnt162b2) Received Through 28-Feb-2021." This document covers just three months of Adverse Events after commencement of marketing of the Vaccine (December 1, 2020 through February 28, 2021.
In that short time span which was in the first few months of the Vaccine roll out, Table 1 shows that Pfizer became aware of 1,223 deaths reported as a result of the Vaccine administration. Moreover, there were 42,086 Adverse Events as a result of the vaccine in total, with various outcomes between death (1,223), recovered.with sequela (520) and "recovered" (19,582).
In Table 7, there are 69 cases of confirmed (57) or probable (12) cases of acute kidney injury and renal failure. In section 3.1.4 the U.S. topped the charts in medical errors with US (1201), France (171), UK (138), Germany (88), Czech Republic (87), Sweden (49), Israel (45), Italy (42), Canada (35), Romania (33), Finland (21), Portugal (20), Norway (14), Puerto Rico (13), Poland (12), Austria and Spain (10 each) with ten of these "medical errors" reported as fatal.
The next scheduling conference is set for December 14, 2021, and it remains to be seen if the FDA will be compelled to deliver documents in a more expedited manner ...
These academics and scientists represent a cross section of every discipline relevant to the licensure of the Pfizer vaccine and include many of the best our country has to offer when it comes to reviewing and assessing the appropriateness and validity of the FDA’s decision-making in licensing of the Pfizer COVID Vaccine.
In furtherance of its mission, on August 27, 2021, PHMPT submitted the Freedom of Information Act (FOIA) Request to the FDA seeking all data and information pertaining to the application and approval of the Pfizer Vaccine. Federal law (21 C.F.R. § 601.51(e)) provides that: "After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown." PHMPT desires to perform its own independent analysis of the safety and efficacy the the vaccine, especially in light of the vaccine mandates being promulgated at the federal and state levels.
FOIA provides for "expedited processing of request for records" upon a showing of "compelling need." PHMPT requested expedited processing of the FOIA Request, which was rejected by the FDA. Thus, PHMPT filed a lawsuit in federal court, seeking to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine by way of expedited processing. The FDA denied the expedited processing request.
In the Second Joint Status Report following filing this case, the FDA assessed that there are more than 329,000 pages potentially responsive to the PHMPT FOIA request. The FDA asks that the Court limit the FOIA response to no more than 500 pages per month. This would be nearly 55 years or until about 2077.
PHMPT requests that the Court enter an order requiring the FDA to produce all documents on a rolling basis such that all of it shall be produced on or before March 3, 2022. The Court will at some point dictate the schedule.
Meanwhile, in the months following the August FOIA request, the FDA has managed to dribble out five documents by November 17, which are now on the PHMPT website. The most alarming of these is the "Cumulative Analysis Of Post-Authorization Adverse Event Reports Of Pf-07302048 (Bnt162b2) Received Through 28-Feb-2021." This document covers just three months of Adverse Events after commencement of marketing of the Vaccine (December 1, 2020 through February 28, 2021.
In that short time span which was in the first few months of the Vaccine roll out, Table 1 shows that Pfizer became aware of 1,223 deaths reported as a result of the Vaccine administration. Moreover, there were 42,086 Adverse Events as a result of the vaccine in total, with various outcomes between death (1,223), recovered.with sequela (520) and "recovered" (19,582).
In Table 7, there are 69 cases of confirmed (57) or probable (12) cases of acute kidney injury and renal failure. In section 3.1.4 the U.S. topped the charts in medical errors with US (1201), France (171), UK (138), Germany (88), Czech Republic (87), Sweden (49), Israel (45), Italy (42), Canada (35), Romania (33), Finland (21), Portugal (20), Norway (14), Puerto Rico (13), Poland (12), Austria and Spain (10 each) with ten of these "medical errors" reported as fatal.
The next scheduling conference is set for December 14, 2021, and it remains to be seen if the FDA will be compelled to deliver documents in a more expedited manner ...
The PBM Accountability Project, reports it is a coalition made up of stakeholders across healthcare, labor, business, pharmacy and consumer/patient advocacy. It is working to advance solutions to help redirect prescription drug savings from PBMs back to patients, employers, health plans and taxpayers.
It just released a new report that it claims sheds light on how pharmacy benefit managers (PBMs) are finding new and hidden ways to profit off of the role that they play in managing prescription drug benefits for consumers, businesses, unions, government and other payers.
The report, "Understanding the Evolving Business Models and Revenue of Pharmacy Benefit Managers," claims that between 2017 and 2019, PBM gross profit increased by 12%, from $25 billion to $28 billion, but the sources of these profits changed substantially over the same period.
The report also says that, while total PBM gross profit increased over the study period, the sources of PBM gross profit shifted due to changes in contracting practices, competitive pressures and public scrutiny.
- - PBM gross profit from retained administrative fees paid by manufacturers for services provided by PBMs increased 51%, from $3.8 billion to $5.7 billion.
- - Gross profit from PBM-owned mail order and specialty pharmacies increased by more than 13% from $8.9 billion in 2017 to $10.1 billion in 2019.
- - Gross profit from "other sources," including spread pricing, pharmacy fees and clawbacks, fees collected from payers, and other non-administrative fees collected from manufacturers grew by nearly 26%, from $8.5 billion in 2017 to $10.7 billion in 2019. Although these "other sources" constitute nearly 40% of all PBM gross profit, analysis of the publicly available financial data sheds little light on how much gross profit is derived from the specific components.
The report discusses the market dynamics and misaligned incentives that have resulted in system-wide inefficiencies and allowed PBMs to drive up costs for patients, employers and the overall health care system:
- - PBMs benefit directly from prescription medicine list price growth, leading to misaligned incentives in the system. Several sources of PBM revenue for medicines are linked directly to the list price of the medicine. When the list price of a medicine goes up, the PBM often collects more revenue. These misaligned incentives can drive up costs for plans and patients.
- - Excess complexity and information asymmetry in the market prevent payers and patients from properly evaluating PBM decisions or drug costs. Pricing complexity and lack of transparency allows PBMs to buy products or services from one stakeholder in the system and sell the same products or services to other stakeholders at higher prices, without the payer understanding the true cost or inflationary nature of the services purchased.
- - Lack of meaningful PBM industry standards, limited transparency and lack of regulatory oversight enable PBM revenue growth. Many PBM contracting mechanisms and revenue sources lack agreed-upon definitions, providing PBMs with the broad discretion to design the terms of a complex contract in their favor.
It concludes by saying these findings highlight the need for consideration of new approaches to realigning PBM incentive structures as part of prescription drug policy discussions, including delinking PBM compensation from the list price of medicines, requiring rebates and discounts to be shared with plans and patients at the pharmacy counter, ensuring patient choice of pharmacies, limiting spread pricing within Medicaid, and establishing disclosure requirements for employers and commercial health plans ...
It just released a new report that it claims sheds light on how pharmacy benefit managers (PBMs) are finding new and hidden ways to profit off of the role that they play in managing prescription drug benefits for consumers, businesses, unions, government and other payers.
The report, "Understanding the Evolving Business Models and Revenue of Pharmacy Benefit Managers," claims that between 2017 and 2019, PBM gross profit increased by 12%, from $25 billion to $28 billion, but the sources of these profits changed substantially over the same period.
The report also says that, while total PBM gross profit increased over the study period, the sources of PBM gross profit shifted due to changes in contracting practices, competitive pressures and public scrutiny.
- - PBM gross profit from retained administrative fees paid by manufacturers for services provided by PBMs increased 51%, from $3.8 billion to $5.7 billion.
- - Gross profit from PBM-owned mail order and specialty pharmacies increased by more than 13% from $8.9 billion in 2017 to $10.1 billion in 2019.
- - Gross profit from "other sources," including spread pricing, pharmacy fees and clawbacks, fees collected from payers, and other non-administrative fees collected from manufacturers grew by nearly 26%, from $8.5 billion in 2017 to $10.7 billion in 2019. Although these "other sources" constitute nearly 40% of all PBM gross profit, analysis of the publicly available financial data sheds little light on how much gross profit is derived from the specific components.
The report discusses the market dynamics and misaligned incentives that have resulted in system-wide inefficiencies and allowed PBMs to drive up costs for patients, employers and the overall health care system:
- - PBMs benefit directly from prescription medicine list price growth, leading to misaligned incentives in the system. Several sources of PBM revenue for medicines are linked directly to the list price of the medicine. When the list price of a medicine goes up, the PBM often collects more revenue. These misaligned incentives can drive up costs for plans and patients.
- - Excess complexity and information asymmetry in the market prevent payers and patients from properly evaluating PBM decisions or drug costs. Pricing complexity and lack of transparency allows PBMs to buy products or services from one stakeholder in the system and sell the same products or services to other stakeholders at higher prices, without the payer understanding the true cost or inflationary nature of the services purchased.
- - Lack of meaningful PBM industry standards, limited transparency and lack of regulatory oversight enable PBM revenue growth. Many PBM contracting mechanisms and revenue sources lack agreed-upon definitions, providing PBMs with the broad discretion to design the terms of a complex contract in their favor.
It concludes by saying these findings highlight the need for consideration of new approaches to realigning PBM incentive structures as part of prescription drug policy discussions, including delinking PBM compensation from the list price of medicines, requiring rebates and discounts to be shared with plans and patients at the pharmacy counter, ensuring patient choice of pharmacies, limiting spread pricing within Medicaid, and establishing disclosure requirements for employers and commercial health plans ...
In the insurance industry, frictional costs include claim adjustment, and administrative expenses that are not normal business expenses generally contemplated by fixing a premium amount by underwriting, but rather are consequences of extraordinary events that might put a strain on capital and profitability.
The WCIRB has released its Friction in the California Compensation System report, which details the primary drivers of California frictional costs, the impact of high frictional cost claims and recent trends in frictional costs.
Frictional costs in the California workers’ compensation system are much higher than other systems across multiple categories, despite some recent decreases in frictional costs in California. In California, it costs $0.48 in frictional costs to deliver $1 of benefits to injured workers. This is almost twice the median workers’ compensation system and significantly above other systems that deliver medical benefits
Recent favorable trends have moved California somewhat closer to the median state in the last 5 years, but it is still 61% higher than the median state in total defense costs per lost time claim at 36 months. Given the significantly longer claim duration in California, these differences are likely larger at later periods. Since 2015, total frictional costs in the California insured system declined by about $0.3 billion. This decline was largely concentrated in medical-legal costs.
The WCIRB has identified four primary drivers of California frictional costs, labeled the "Frictional Four". They include the higher volume of permanent disability claims, the higher proportion of cumulative trauma injuries, the longer duration that claims remain open, and disproportionate levels of friction regionally within California.
California has by far the highest number of PPD claims filed compared to any other state and more than twice that of the median state. States that use the same version of the American Medical Association (AMA) guides to determine permanent disability as California do not have similar volumes of PPD claims. PPD claims are more complex, remain open longer, and incur more than three times the ALAE than temporary-only claims on average.
While data in other states is not readily available, CT claims are believed to be significantly more prevalent in California. The proportion of CT claims that involve nontrivial ALAE costs is significantly higher compared to that for specific injury claims. Prior WCIRB studies also indicate that the vast majority of CT claims are litigated with many filed later and on a post-termination basis.
Average ALAE costs differ significantly across the state with the highest costs in Southern California around the Los Angeles Basin. The average ALAE cost per indemnity claim in this region is approximately 29% higher than the rest of the state at 10th unit statistical report level.
The longer claim duration is estimated to have the most significant impact on California average ALAE costs, reducing it by over 30% when assuming an average duration similar to the median state ...
The WCIRB has released its Friction in the California Compensation System report, which details the primary drivers of California frictional costs, the impact of high frictional cost claims and recent trends in frictional costs.
Frictional costs in the California workers’ compensation system are much higher than other systems across multiple categories, despite some recent decreases in frictional costs in California. In California, it costs $0.48 in frictional costs to deliver $1 of benefits to injured workers. This is almost twice the median workers’ compensation system and significantly above other systems that deliver medical benefits
Recent favorable trends have moved California somewhat closer to the median state in the last 5 years, but it is still 61% higher than the median state in total defense costs per lost time claim at 36 months. Given the significantly longer claim duration in California, these differences are likely larger at later periods. Since 2015, total frictional costs in the California insured system declined by about $0.3 billion. This decline was largely concentrated in medical-legal costs.
The WCIRB has identified four primary drivers of California frictional costs, labeled the "Frictional Four". They include the higher volume of permanent disability claims, the higher proportion of cumulative trauma injuries, the longer duration that claims remain open, and disproportionate levels of friction regionally within California.
California has by far the highest number of PPD claims filed compared to any other state and more than twice that of the median state. States that use the same version of the American Medical Association (AMA) guides to determine permanent disability as California do not have similar volumes of PPD claims. PPD claims are more complex, remain open longer, and incur more than three times the ALAE than temporary-only claims on average.
While data in other states is not readily available, CT claims are believed to be significantly more prevalent in California. The proportion of CT claims that involve nontrivial ALAE costs is significantly higher compared to that for specific injury claims. Prior WCIRB studies also indicate that the vast majority of CT claims are litigated with many filed later and on a post-termination basis.
Average ALAE costs differ significantly across the state with the highest costs in Southern California around the Los Angeles Basin. The average ALAE cost per indemnity claim in this region is approximately 29% higher than the rest of the state at 10th unit statistical report level.
The longer claim duration is estimated to have the most significant impact on California average ALAE costs, reducing it by over 30% when assuming an average duration similar to the median state ...
SF Gate reports that a San Francisco resident became the first in the United States to have an identified case of the omicron variant of COVID-19, marking a new phase in a pandemic that has persisted for nearly two years, officials said Wednesday.
The individual returned to SF from South Africa on Nov. 22 and symptoms showed up Nov. 25, Gov. Gavin Newsom said at a press conference. Newsom said the person is between the ages of 18 and 49. The person has mild symptoms that are already improving, city officials said.
"The symptoms were very mild," said Dr. Peter Chin-Hong, an infectious disease expert at UCSF, where the genomic sequencing to identify the case was done. "It’s fitting with the other reports we’ve been hearing from around the world that people are getting mild symptoms. It’s probably the first of many many that we’ll be hearing about."
The person had received a full dose of Moderna (two shots) but hadn't received a booster shot, Dr. Grant Colfax, San Francisco's director of public health, said at a Wednesday press conference. The individual is self-quarantining.
"This is not a surprise," Colfax said. "We knew omicron was going to be here. We thought it was already here and we just had not identified it yet. So this is a cause for concern, but it is also certainly not a cause for panic. We are prepared for this in the city."
Colfax added that there are no plans to make changes to the city's health orders at this time.
The Biden administration moved late last month to restrict travel from southern Africa, where the variant was first identified and had been widespread. Clusters of cases have also been identified in about two dozen other nations.
The Centers for Disease Control and Prevention was moving to tighten U.S. testing rules for travelers from overseas, including requiring a test for all travelers within a day of boarding a flight to the U.S. regardless of vaccination status. It was also considering mandating post-arrival testing.
Officials said those measures would only "buy time" for the country to learn more about the new variant and to take appropriate precautions, but that, given its transmissibility, omicron's arrival in the U.S. was inevitable.
At the press conference in San Francisco, Colfax echoed the sentiment from officials and experts across the globe that there's still a lot to learn about the virus.
"We don’t know how infectious it is, although there is strong likelihood that it is more infectious than delta," Colfax said. "We don’t know how sick it will make people, but that is being studied furiously right now across the world. And we don’t know yet how effective the vaccines are protecting against transmission or serious cases and hospitalizations, but most experts I have spoken to believe that the vaccines will still be of critical importance in protecting ourselves, our families and our communities ...
The individual returned to SF from South Africa on Nov. 22 and symptoms showed up Nov. 25, Gov. Gavin Newsom said at a press conference. Newsom said the person is between the ages of 18 and 49. The person has mild symptoms that are already improving, city officials said.
"The symptoms were very mild," said Dr. Peter Chin-Hong, an infectious disease expert at UCSF, where the genomic sequencing to identify the case was done. "It’s fitting with the other reports we’ve been hearing from around the world that people are getting mild symptoms. It’s probably the first of many many that we’ll be hearing about."
The person had received a full dose of Moderna (two shots) but hadn't received a booster shot, Dr. Grant Colfax, San Francisco's director of public health, said at a Wednesday press conference. The individual is self-quarantining.
"This is not a surprise," Colfax said. "We knew omicron was going to be here. We thought it was already here and we just had not identified it yet. So this is a cause for concern, but it is also certainly not a cause for panic. We are prepared for this in the city."
Colfax added that there are no plans to make changes to the city's health orders at this time.
The Biden administration moved late last month to restrict travel from southern Africa, where the variant was first identified and had been widespread. Clusters of cases have also been identified in about two dozen other nations.
The Centers for Disease Control and Prevention was moving to tighten U.S. testing rules for travelers from overseas, including requiring a test for all travelers within a day of boarding a flight to the U.S. regardless of vaccination status. It was also considering mandating post-arrival testing.
Officials said those measures would only "buy time" for the country to learn more about the new variant and to take appropriate precautions, but that, given its transmissibility, omicron's arrival in the U.S. was inevitable.
At the press conference in San Francisco, Colfax echoed the sentiment from officials and experts across the globe that there's still a lot to learn about the virus.
"We don’t know how infectious it is, although there is strong likelihood that it is more infectious than delta," Colfax said. "We don’t know how sick it will make people, but that is being studied furiously right now across the world. And we don’t know yet how effective the vaccines are protecting against transmission or serious cases and hospitalizations, but most experts I have spoken to believe that the vaccines will still be of critical importance in protecting ourselves, our families and our communities ...
