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Tag: 2023 News

Chamber of Commerce & Others Sue Government Over Drug Pricing Plan

The U.S. Chamber of Commerce filed a lawsuit this month in U.S. District Court in Dayton, Ohio, arguing that the price-negotiation program created under last year’s Inflation Reduction Act. is unconstitutional, violating due proces and other protections.

The Chamber lawsuit was filed just days after pharmaceutical giant Merck & Co. filed a similar federal lawsuit in the U.S. District Court the District of Columbia in early June. Merck alleges the negotiation setup is a violation of the Fifth Amendment, which requires the government to fairly compensate companies or individuals for property that is used for the public good among other theories.

Then last Friday, Bristol Myers Squibb filed a similar lawsuit in the U.S. District Court for the District of New Jersey.

As part of the Inflation Reduction Act (IRA) passed last summer, Congress established something called the “Drug Price Negotiation Program” for Medicare.

The Program’s name suggests a framework under which federal officials sit down with prescription drug manufacturers and negotiate voluntary price agreements that will save money for American taxpayers while ensuring that the companies remain able to continue investing billions of dollars into research and development of new life-saving medicines. Under the Inflation Reduction Act, Medicare will begin negotiating prices for the drugs that it spends the most on beginning in 2026.

This provision amends Medicare’s noninterference clause – which prevents the secretary of the U.S. Department of Health & Human Services (HHS) from interfering with negotiations between drug manufacturers, pharmacies and Medicare prescription drug plans – and establishes a new Drug Price Negotiation Program.

Days after the IRA was passed, the biopharma industry blasted the policy.

According to an analysis by PhRMAThese polices are expected to have a negative impact on access to medicines covered by Medicare Part B and Part D, in addition to discouraging continued drug development.”

“Biopharmaceutical research companies are having to rethink how and where they invest in medical R&D, with the government essentially picking winners and losers by discouraging the development of some types of medicines and treatments for certain patient populations.”

According to a white paper published by the University of Southern California Schaeffer Center for Health Policy and Economics last April, the Centers for Medicare and Medicaid Services (CMS) released additional information for the Medicare Drug Price Negotiation program in March 2023, “but how CMS will implement a key feature – the ‘maximum fair price’ – remains unclear.

It suggests that “the calculation of a ‘maximum fair price’ for drugs should be transparent and focus on measured social value rather than price minimization.”

6th Consensus Statement on Concussion in Sport Rejects CTE Causation

About a decade ago, a great number of former NFL players filed civil and industrial injury claims in California alleging that sport related head trauma and concussions while engaged in professional football resulted in the development of a Alzheimer’s like dementia decades later. At the time, this medical condition became known as CTE or Chronic Traumatic Encephalopathy.

Their claims were based, in part, on the work of Anne McKee M.D. who is a neuropathologist and expert in neurodegenerative disease at the New England Veterans Affairs Medical Centers and is professor of neurology and pathology at Boston University School of Medicine and director of Boston University CTE Center, which was established in 1996 and funded by the National Institutes of Health to advance research on Alzheimer’s disease and related dementias.

In her early work published in 2009, she reviewed 48 cases of neuropathologically verified CTE recorded in the literature and document the detailed findings of CTE in 3 professional athletes, 1 football player and 2 boxers, and theorized that “Chronic traumatic encephalopathy is a neuropathologically distinct slowly progressive tauopathy with a clear environmental etiology.”

Het hypothesis received widespread media attention with the arrival of the movie “Concussion” a 2015 American biographical sports drama film. Will Smith starred as Dr. Bennet Omalu, a forensic pathologist who fights against the National Football League trying to suppress his research on chronic traumatic encephalopathy (CTE).

Over the years, much scientific debate ensued over her theory, and the relationship between a head trauma and the development of CTE many years later. And for over two decades, the Concussion in Sport Group (CISG) has held meetings and developed five international statements on concussion in sport.  CISG is an international multidisciplinary group of experts who work to improve the understanding and management of concussion in sport. It was founded in 2001 and has met every four years since then to produce consensus statements on the latest evidence about concussion in sport.

The CISG is made up of experts from a variety of disciplines, including neurology, neurosurgery, sports medicine, neuropsychology, and epidemiology. The group’s work is supported by the International Olympic Committee (IOC) and the World Health Organization (WHO).

The 4th Consensus Statement on Concussion in Sport published in the British Journal of Sports Medicine in 2013, reviewed the medical literature at the time and rejected the blanket conclusion that there is a definitive cause and effect connection between repetitive head trauma and CTE. It concluded that ‘the speculation that repeated concussion or subconcussive impacts cause CTE remains unproven,

The sixth International Consensus Conference on Concussion in Sport was delayed because of the pandemic, and was rescheduled to meet in Amsterdam on 27 October 2022 through 29 October 2022. As a result of this newest Conference, the Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport – Amsterdam, October 2022 was published in the British Journal of Sports Medicine on June 14, 2023. It was compiled by 114 co-authors.

It first noted that “To avoid conceptual confusion between the pathology and a possible clinical condition, the postmortem neuropathology is referred to as CTE neuropathologic change (CTE-NC).” However “CTE-NC is not a clinical diagnosis. The first consensus criteria for traumatic encephalopathy syndrome (TES), a new clinical diagnosis, were published in 2021.

Using these new terms, CISG then wrote “These diagnostic criteria can be used to determine the extent to which CTE-NC identified after death was associated with this new clinical diagnosis during life. The prevalence of CTE-NC (a neuropathological entity) and TES (a clinical diagnosis) in former athletes, military veterans and people from the general population is not known. It is also not known whether (1) CTE-NC causes specific neurological or psychiatric problems, (2) the extent to which CTE-NC can be clearly identified within the presence of Alzheimer’s disease neuropathology or (3) whether CTE-NC is inevitably progressive.”

Critiques of the latest Consensus Conference were immediate. According to an article in Nature, “Their refusal to acknowledge a causal relationship between contact-sports participation and CTE [chronic traumatic encephalopathy] is a danger to the public,” said Chris Nowinski, a neuroscientist and chief executive of the Concussion Legacy Foundation in Middletown, Delaware, which supports athletes and veterans affected by concussions and CTE.

Yet Robert Cantu M.D. one of the co-authors of the consensus report and colleague of Ann McGee M.D. at the Boston University School of Medicine in Massachusetts said  “The CTE literature is almost exclusively case series studies” and he went on to say “And that literature did not meet the inclusion criteria for the systematic review.”

NLRB Reverses It’s 2019 Trump Era Independent Contractor Standard

In a highly-anticipated decision issued this week in The Atlanta Opera, Inc.  In this case the National Labor Relations Board returned to the 2014 FedEx Home Delivery (FedEx II) standard for determining independent contractor status under the National Labor Relations Act, and overruled it’s Trump era standard in SuperShuttle (2019).

In applying the FedEx II standard, the Board found that the makeup artists, wig artists, and hairstylists who work at the Atlanta Opera – and who had filed an election petition with the Board seeking union representation – are not independent contractors, excluded from the Act, but rather are covered employees.

In its decision, the Board said it reaffirmed longstanding principles – consistent with the instructions of the Supreme Court – and explained that its independent-contractor analysis will be guided by a list of common-law factors.

The Board expressly rejected the holding of the SuperShuttle Board that entrepreneurial opportunity for gain or loss should be the “animating principle” of the independent-contractor test.

Super Shuttle, a 2019 case involving the company that transports its passengers primarily to airports, set the primary definition of an Independent Contractor as one who in his or her work for a company can benefit from “entrepreneurial opportunity” and enhance his or her financial gain. The Super Shuttle decision said control and “entrepreneurial opportunity are two sides of the same coin: the more of one, the less of the other.”

The Board further explained, in Atlanta Opera, that entrepreneurial opportunity would be taken into account, along with the traditional common-law factors, by asking whether the evidence tends to show that a supposed independent contractor is, in fact, rendering services as part of an independent business.

In reviewing the facts of this case and applying the FedEx II standard in Atlanta Opera, the Board determined that the majority of the traditional common-law factors point toward employee status. The Board also determined that the evidence did not show that the stylists rendered services as part of their own independent businesses.

In today’s decision, the Board returns to the independent contractor test articulated in FedEx II, and reaffirms the Board’s commitment to the core common-law principles that the Supreme Court has determined should guide the Board’s consideration of questions involving employee status,” said Chairman Lauren McFerran. “Applying this clear standard will ensure that workers who seek to organize or exercise their rights under the National Labor Relations Act are not improperly excluded from its protections.”

Members Wilcox and Prouty joined Chairman McFerran in issuing the decision. Member Kaplan dissented from the overruling of SuperShuttle, but concurred in finding that the stylists were employees, not independent contractors.

Teamsters General President Sean M. O’Brien said thatthe Teamsters Union is pleased that the NLRB has taken a critical step in putting power back into the hands of workers and reversing an egregious rule that made it easier for corporations to misclassify hardworking men and women.

Reuters reports that Kristin Sharp, CEO of gig economy trade association Flex, said Tuesday’s ruling was out of step with an increasingly tech-driven economy defined by worker flexibility. America’s leading app-based platforms, representing more than 52 million workers, joined together in 2022 to form Flex , a new industry association to serve as the voice of the app-based economy. Founding member companies include DoorDash, Gopuff, Grubhub, HopSkipDrive, Instacart, Lyft, Shipt, and Uber.

The U.S. Department of Labor is expected to soon finalize a proposed rule opposed by business groups that would narrow the circumstances in which workers qualify as independent contractors under federal wage laws.

Comp Case Manager Prevails Against Liberty Mutual on Discrimination Appeal

Liberty Mutual Insurance Company employed Joy Slagel from 1985 to June 30, 2016, most recently as Senior Case Manager in its Glendale claims department. For 30 years, she received consistently positive reviews from supervisors, colleagues and clients. A review of allegations and documentation in the litigation file between them revealed the following allegations.

In February 2015, Slagel went on disability leave due to stress and anxiety.

After returning in March 2015, Ariam Alemseghed, Regional Claims Manager, overseeing Liberty’s Glendale claims department, instructed Craig Ballard, Slagel’s immediate supervisor, to rate Slagel as “needs improvement” on her performance assessment. When Slagel asked Ballard why she received this rating, he told her he had not wanted to give it but Alemseghed instructed him to do so. When Slagel complained to Alemseghed about the rating, Alemseghed stated that because of her “tenure,” Slagel would be held to “higher expectations.”

On March 4, 2015, Slagel wrote to Glenn Shapiro, Liberty’s Vice President/Chief Claim Officer, complaining that Alemseghed mistreated her and several other long-term employees “in a manner that lacked dignity and respect,” and she feared retaliation because Alemseghed had a close relationship with Virginia Bennett, Liberty’s Human Resources Generalist. Slagel received no response.

In June 2015, Slagel told Human Resources (HR) Manager Michael Polk that 15 people had left in the last 12 months, and Alemseghed wanted long-term employees to leave so she could hire recent college graduates. Nothing was done.

In November 2015, Slagel received a Customer Service Award for her handling of claims for one of Liberty’s accounts. Alemseghed told her, “You just got lucky, it will never happen again.”

In January 2016, Leann Lo became Slagel’s Claims Manager. Shortly thereafter, Lo accused Slagel of speaking negatively about Liberty, and said, “I am warning you!” Lo and Alemseghed allegedly thereafter inundated Slagel with work and shunned and ostracized her.

A protracted dispute between Joy and her managers over the documentation of a social media check made during a claim review with an employer. Slagel complained to Bennett and Lo that she was being targeted because she was a 30-year employee whom Alemseghed wanted to replace.

On April 19, 2016, Slagel sought medical care for hypertension, coronary artery disease, hyperlipidemia, and panic attacks related to work-related stress and depression, and subsequently applied for short-term disability leave.

While Slagel was on leave, Bennett analyzed her failure to obtain a social media report for the employer in question, and noted that Slagel thought she was being set up because she was a 30-year employee. Bennett resolved Slagel’s complaint with no investigation because he believed she was a “negative influence in the Glendale office.”

After receiving authorization from attorney Gabriel Williams, Liberty’s Employee Relations Consultant, who could authorize terminating an employee, Lo terminated Slagel on June 30, 2016, the day she returned from leave. Slagel filed a complaint against Liberty, Alemseghed, and Lo, alleging 12 causes of action.

During discovery, Slagel attempted to depose Williams concerning his decision to approve Slagel’s termination. During the deposition Williams, an attorney, was unable to understand several basic questions, and according to the review by the Court of Appeal “Williams avoided the entire line of questioning pertaining to Slagel’s termination.” Other disputes between arose during plaintiffs discovery process concerning Polk’s depostion.

Defendants filed motions for summary judgment, arguing no triable existed as to whether they harbored a discriminatory motive for Slagel’s discharge. Slagel sought to continue the summary judgment hearing to complete discovery regarding Polk’s interviews, including the notes and an interview chart he had not produced, and also requested time to depose Latecia Flemming about her discussions with Polk. Slagel further requested time to depose Dan Karnovsky, who controlled some the investigatory reports and notes. The court denied these requests

The trial court found that Slagel submitted evidence of a discriminatory motive on the part of Alemseghed, but no triable issue existed as to whether Liberty’s reason for terminating Slagel was pretextual. The court found, Slagel “simply has not submitted evidence to show how Alemseghed’s age bias caused her termination when Alemseghed was not responsible for her termination, and when the proffered reason for Plaintiff’s termination, i.e., the social media report incident, actually did occur.” Accordingly, the court granted summary judgment in defendants’ favor and entered judgment. It awarded Liberty and Alemseghed jointly $26,917.61 in costs as prevailing parties, allocated to Slagel’s non-FEHA claims. The court awarded Lo $70,058.15 in attorney’s fees and $15,418.96 in costs as a result of Lo’s subsequent sanctions request.

The Court of Appeal reversed in the unpublished case of Slagel v. Liberty Mutual Insurance Company -B310132 (June 2023).

The Court of Appeal noted that “Here, triable issues exist as to whether Williams’s decision to approve Slagel’s termination was tainted by Alemseghed’s bias. Alemseghed influenced Bennett’s and Williams’s deliberations by portraying Slagel’s performance in the worst possible light. This influence may well have been decisive. Williams’s deliberations were brief, perhaps perfunctory, taking only about half an hour.”

Williams testified in deposition that he could not remember having considered the issue. Having no personal knowledge of the facts, Williams, who was not conversant with the possible age animus that may have motivated Alemseghed’s recommendations (as filtered through Bennett), was apt to defer to Bennett’s and Alemseghed’s judgment. If Williams acted as the conduit of Alemseghed’s bias, his innocence would not spare Liberty from liability for Alemseghed’s procuring Slagel’s discharge because of her age.”

On summary judgment, inferences must be drawn in favor of the opposing party. Here, the trial court should have but failed to draw several inferences in Slagel’s favor. Therefore, summary judgment was improper.

The Court of Appeal also concluded that the court arguably found only that Slagel’s claims against Lo lacked evidentiary support, not that they would have been legally insufficient even if supported by evidence. “Because the trial court found only that a subset of Slagel’s allegations lacked legal and evidentiary support, and because some of her allegations against Lo actually did have evidentiary support, sanctions were improper.

The judgment was reversed as to Slagel’s first through fifth and tenth and twelfth cause of action. The costs and sanctions awards were vacated. The judgment was otherwise affirmed.

California Proposed Change to TD Cap Will Have Nominal Impact

According to a California Workers’ Compensation Institute study, AB 1213 is a pending legislative proposal to alter the California 104-week cap on temporary disability (TD) benefits, by excluding TD paid or due during the resolution of medical disputes if a utilization review (UR) treatment denial is overturned by independent medical review (IMR) or the Appeals Board, would drive up IT and administrative expenses for claims administrators – but provide only a nominal increase in total TD to less than 0.3% of all claims.

To estimate the impact of the proposal included in AB 1213, now being debated by state lawmakers, CWCI compiled special datasets that allowed it to merge insured claims data from its Industry Research Information System (IRIS) database with IMR decision data from Maximus Federal Services, which manages the IMR process for the state.

Nearly a third (31.7%) of the 178,956 IRIS claims had paid TD days, which represents the proportion of all claims for which claims administrators would need to develop new tracking systems and protocols to identify and monitor claims that could be covered by AB 1213.

Within the subset of TD claims, however, only those that had a UR treatment denial submitted to IMR would be eligible for the proposed tolling of the TD cap, so CWCI matched the IRIS claims data to the IMR data from Maximus and found that 11.7% of all TD claims had a treatment denial that resulted in an IMR determination.

A review of the IMR outcomes further narrowed the population of claims that could be affected by AB 1213 down to just 3.2% of the TD claims that had a UR denial overturned by IMR.

AB 1213 would only apply to claims that reach the 104-week TD cap, so the final step in estimating the impact of the proposed change was to determine how many of the TD claims in the study sample that had an overturned UR denial were approaching the 104-week TD cap.Those claims represented less than 0.3% of the 178,956 medical-only and indemnity claims that were included in the original IRIS study sample, underscoring the very small proportion of the total injured worker population that would likely receive a nominal increase in their total TD benefits under AB 1213.

Meanwhile, the analysis notes that AB 1213’s current language would create costly new requirements for oversight and compliance for claims administrators. Chief among these would be the automation and programming costs required to update claims systems and the ongoing administrative costs for manual processes to identify and track claims with TD payments and UR and IMR activity.

These requirements would apply to every workers’ compensation claims administrator in the state, further increasing California’s average loss adjustment expense, which has historically been the most expensive in the country, and as of 2022, exceeded the average amount paid by the median state by 73%.

As state lawmakers debate the relative merits of AB 1213, the findings from this study raise the question of whether the minor impact of the proposal merits the substantial cost.

Congress and FTC Deepen Inquiry into PBM Business Tactics

The current congressional inquiry into pharmacy benefit managers (PBMs) is being led by the House Committee on Oversight and Accountability, chaired by James Comer (R-KY). The inquiry is focused on the role of PBMs in rising health care costs and their impact on patient care.

Comer issued a report in 2021 outlining how pharmacy benefit managers’ (PBMs) practices increase prescription drug prices, impact patient health, hurt competition, and distort the marketplace. The report, entitled “A View from Congress: The Role of Pharmacy Benefit Managers in Pharmaceutical Markets,” details findings from a forum held by Comer examining how PBM tactics contribute to the rising cost of prescription drugs for Americans. The report emphasizes the need for greater transparency to determine the extent of the damage PBM practices are having on patients and the marketplace and calls for further congressional review of legislative solutions to provide meaningful reform.

Key views from his report include:

– – PBMs use their market leverage to increase their profits, not reduce costs for consumers. PBMs control which medications are included on a given health plan’s formulary, or the list of drugs that plan agrees to cover. Drug manufacturers agree to discounts, or pay rebates, in order to get their products placed more favorably on formularies. But the savings from the discounts and rebates do not make their way down to the consumer; they go to the PBMs’ bottom line.
– – Drug manufacturers actually raise their prices due to PBMs. As PBMs demand larger and larger rebates or discounts, manufacturers offset these reductions by raising the “list” prices for their drugs. PBMs encourage this practice because they pocket the higher rebates received from higher priced drugs.
– – PBMs own their own pharmacies, which creates conflicts of interest, hurts competition, and distorts the market. Another key function of PBMs is to establish a network of pharmacies from which plan beneficiaries can get their prescriptions filled. However, the three largest PBMs – CVS Caremark, Express Scripts, and Optum Rx – own their own pharmacies. They also control 80 percent of the market. But they are not the only ones – smaller PBMs own their own pharmacies too.
– – PBMs “steer” patients to the pharmacies they control, making it difficult for independent pharmacies to survive. PBMs also reimburse unaffiliated pharmacies at low rates and charge a number of fees to independent pharmacies. These retroactive fees can be for just participating in the network, or they can be tied to performance metrics, such as pharmacy refill rates, error rates, or audit rates, which the PBM establishes. These retroactive fees add up – sometimes it costs a pharmacy more to fill a prescription than it is reimbursed. For specialty pharmacies, they accrue fees based on irrelevant metrics.
– – Rebates are not the only way PBMs drive up costs. A list price is like the sticker price on a car: few people actually pay that amount. Higher list prices still drive-up costs, even if that’s not the actual cost patients are paying. Insurance premiums and copayments are based on list prices. PBMs engage in a number of questionable practices, one of which is “spread pricing,” in which PBMs pay a pharmacy a lower amount than they report to a health plan sponsor. The PBM pockets the difference. Sometimes they get caught – PBMs have overcharged state Medicaid programs in Ohio, Kentucky, Illinois, and Arkansas more than $415 million once spread pricing schemes were discovered.

More recently, in March 2023, Chairman Comer sent letters to senior officials at the Office of Personnel Management (OPM), Centers for Medicare and Medicaid Services (CMS), and the Defense Health Agency (DHA) requesting documents and communications related to PBMs. The letters stated that the Committee is “examining the extent to which PBMs’ tactics impact healthcare programs administered by the federal government.”

And on May 23, 2023, the Committee held a hearing on the role of PBMs in rising health care costs. The hearing featured testimony from representatives from PBMs, insurers, pharmacies, and patient advocacy groups.

The Committee is continuing its investigation into PBMs. It is unclear when the Committee will release its findings or make recommendations for reform.

In addition to the congressional inquiry, the Federal Trade Commission (FTC) is also investigating pharmacy benefit managers (PBMs). The FTC’s inquiry is focused on whether PBMs are engaging in anti-competitive practices that are driving up the cost of prescription drugs.

The FTC issued compulsory orders to six of the largest PBMs in the United States: CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics, and MedImpact Healthcare Systems. The compulsory orders require these companies to provide the FTC with information and documents about their business practices, including their contracts with drug manufacturers, pharmacies, and health plans.

And last month issued two additional orders to Zinc Health Services, LLC, and Ascent Health Services, LLC. Zinc and Ascent refer to themselves as group purchasing organizations or GPOs, sometimes also called rebate aggregators, which negotiate rebates with drug manufacturers on behalf of the PBMs and hold the contracts that govern those rebates.

Zinc was founded in 2020 and operates as the GPO for CVS Caremark. Ascent was founded in 2019 and operates as a GPO for Express Scripts, Prime Therapeutics, Envolve Pharmacy Solutions, and Humana Pharmacy Solutions.

The FTC is issuing the orders under Section 6(b) of the FTC Act, which authorizes the Commission to conduct studies without a specific law enforcement purpose. The companies will have 90 days from the date they receive the order to respond.

The FTC’s inquiry is a significant development in the effort to address the high cost of prescription drugs. The FTC has the power to take enforcement action against companies that engage in anti-competitive practices. If the FTC finds that PBMs are engaging in anti-competitive practices, it could take steps to lower the cost of prescription drugs for patients and health plans.

Studies and Surveys Show VA Hospitals Outperform Private Hospitals

Maybe it is now time for private health care facilities to step up their game!

A nationwide Medicare survey released this month found that veterans rated Veterans Affairs hospitals higher than private health care facilities in all 10 categories of patient satisfaction. The VA takes care of about 9 million veterans at 1,255 facilities – the nation’s largest integrated health care system.

This most recent survey, known as HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems), showed that the VA beat out private facilities in all the categories surveyed, such as patient satisfaction, hospital cleanliness and communication with nurses and doctors.

As a part of the survey, Medicare awards star ratings from one star to five stars, with “more stars representing better quality care.” Based on patient surveys between July 2021 and June 2022, 72% of VA hospitals received four or five stars for Overall hospital rating compared to 48% of reporting non-VA hospitals.

Additionally, VA hospitals received a higher percentage of four or five star ratings than non-VA hospitals for Communication with doctors (87% vs. 48%), Communication with nurses (59% vs. 35%), Responsiveness of hospital staff (63% vs. 34%), Communication about medicines (80% vs. 38%), Cleanliness of the hospital environment (69% vs. 52%), Quietness of the hospital environment (49% vs. 38%), Discharge information (65% vs. 55%), Care transition (76% vs. 35%), and Willingness to recommend the hospital (76% vs. 52%). The results are drawn from Medicare’s Care Compare website.

“This offers among the first opportunities to directly compare us with our private sector counterparts, and we’re really happy with the results but we won’t be content until 100% of hospitals are pinging in the right ratings,” Dr. Shereef Elnahal, VA undersecretary for health. told NPR. who reported on this new survey.

VA also surveys Veterans in order to understand and improve the Veteran experience with VA. The VA Trust Report for the second quarter of fiscal year 2023 shows that nearly 90% of Veterans who get their care from VA trust VA for their care (based on 560,000 surveys). Additionally, more than 79% of Veterans trust VA overall, reflecting a 1.9% increase from the last quarter and a 24% increase since 2016.

And, despite many widely publicized scandals, VA health care has been consistently rated as competitive with private care in dozens of peer-reviewed articles.

The Journal of General Internal Medicine and the Journal of the American College of Surgeons published articles based on a systematic review of studies about VA health care, concluding VA health care is consistently as good as – or better than – non-VA health care.

The findings come from a national review of peer-reviewed studies that evaluated VA on quality, safety, access, patient experience, and comparative cost/efficiency. Of the 26 studies that looked at non-surgical care, 15 reported VA care was better than non-VA care and seven reported equal or mixed clinical quality outcomes. Of the 13 studies that looked at quality and safety in surgical care, 11 reported VA surgical care is comparable or better than non-VA care.

This year’s systematic review included studies published between 2015 and 2021. This is the third systematic review of studies comparing VA care to non-VA care, the most recent of which was published in 2017. Each of these systematic reviews has come to the same overarching conclusion: on average, VA care is better than or comparable to non-VA care in the domains of clinical quality and safety.

9th Circuit Finds Co-Worker Sexist/Racist Music-Blasting Actionable

Stephanie Sharp and seven other plaintiffs in this action are former employees of apparel manufacturer S&S Activewear. Seven are women and one is a man.

Sharp alleges that S&S permitted its managers and employees to routinely play “sexually graphic, violently misogynistic” music throughout its 700,000-square-foot warehouse in Reno, Nevada. According to Sharp, the songs’ content denigrated women and used offensive terms “very offensive” lyrics that “glorifie[d] prostitution” extreme violence against women.

Blasted from commercial-strength speakers placed throughout the warehouse, the music overpowered operational background noise and was nearly impossible to escape. Sometimes employees placed the speakers on forklifts and drove around the warehouse, making it more difficult to predict – let alone evade – the music’s reach.

In turn, the music allegedly served as a catalyst for abusive conduct by male employees, who frequently pantomimed sexually graphic gestures, yelled obscenities, made sexually explicit remarks, and openly shared pornographic videos. Although the music was particularly demeaning toward women, who comprised roughly half of the warehouse’s workforce, some male employees also took offense.

Despite “almost daily” complaints, S&S management defended the music as motivational and stood by its playing for nearly two years, until litigation was filed.

Sharp eventually filed suit, alleging that the music and related conduct created a hostile work environment in violation of Title VII. The district court granted S&S’s motion to dismiss and denied leave to amend the music claim, reasoning that the music’s offensiveness to both men and women and audibility throughout the warehouse nullified any discriminatory potential. The court countenanced S&S’s argument that the fact that “both men and women were offended by the work environment” doomed Sharp’s Title VII claim.

The 9th Circuit (with presides over California and other western states) reversed in the published case Sharp et al. v. S&S Activewear, L.L.C., – No. 21-17138 (Jun. 7, 2023).

The trial court held that Sharp failed to state an actionable Title VII claim because there was no allegation “that any employee or group of employees were targeted, or that one individual or group was subjected to treatment that another group was not.” Because the music offended men and women alike, the district court reasoned, it could not be the basis of a sexual harassment claim.

However, the 9th Circuit noted that the offensive conduct must be “sufficiently severe or pervasive to alter the conditions of employment.” Christian v. Umpqua Bank, 984 F.3d 801, 809 (9th Cir. 2020). Notably, individual targeting is not required to establish a Title VII violation. See Reynaga v. Roseburg Forest Prods., 847 F.3d 678, 687 (9th Cir. 2017). “It is enough,” it has held, “if such hostile conduct pollutes the victim’s workplace, making it more difficult for her to do her job, to take pride in her work, and to desire to stay on in her position.” Steiner v. Showboat Operating Co., 25 F.3d 1459, 1463 (9th Cir. 1994).

And context matters. “Workplace conduct is to be viewed cumulatively and contextually, rather than in isolation.” This approach makes common sense in order to screen out one-off, isolated events and yet benchmark conduct in the context of a specific workplace. Objectionable conduct is not “automatically discrimination because of sex merely because the words used have sexual content or connotations.”

Applying these core principles, we conclude that the district court erred in rejecting Sharp’s hostile work environment claim as incurable and legally deficient. More than offhand foul comments, the music at S&S allegedly infused the workplace with sexually demeaning and violent language, which may support a Title VII claim even if it offended men as well as women.”

“Although we have not before addressed the specific issue of music-as-harassment, this court and our sister circuits have recognized Title VII redress for other auditory offenses in the workplace and for derogatory conduct to which all employees are exposed. The EEOC, which filed an amicus curiae brief on behalf of Sharp, endorses this position. Emphasizing this appeal’s impact on the future ‘ability of the EEOC and private parties to enforce Title VII,’ the agency agrees that ‘exposing employees to misogynistic and sexually graphic music can be discrimination because of sex, even where the employer exposes both women and men to the material and even though both women and men find the material offensive.’ ”

U.S. Opioid Settlements Now total Over $50 Billion

More than $50 billion in settlement funds is being delivered to thousands of state and local governments from companies accused of flooding their communities with opioid painkillers that have left millions addicted or dead. The settlement money comes from a number of legal battles around the nation and the world.

Christine Minhee, attorney by training and founder of OpioidSettlementTracker.com, has compiled data on the settlements tracking the amount of money allocated and where states have decided to spend it. According to her data, which is used by state governments and the Centers for Disease Control and Prevention, the total pot of funds available from the settlements has reached around $54 billion dollars, with nearly half of the money coming from a $26 billion dollar 2022 settlement with drug manufacturers and distributors, and more funds expected from ongoing legal battles.

However, her website says that “of this sum, about 75% – a whopping $39.8 billion – remains unattached to explicit requirements to publicly report opioid remediation expenditures. Thus they have created a state-by-state “Opiod Settlement Transparency Map” to help answer the question “Will opioid settlements be spent in ways that bolster the public health response to drug addiction?

The California Attorney General confirms that Opioid manufacturers Allergan and Teva have committed to move forward with settlements for up to $2.37 billion and $4.25 billion, respectively, to resolve allegations that, among other things, the companies deceptively marketed opioids by downplaying the risks of addiction and overstating their benefits.

If the settlements are approved by the court, California may receive up to approximately $375 million from the Teva settlement and up to approximately $205 million from the Allergan settlement. The settlements with the opioid manufacturers also include strong injunctive relief that prohibits opioid-related marketing by Teva while Allergan is prohibited from selling opioids for the next 10 years.

Chain pharmacies CVS and Walgreens also committed to moving forward with national settlements worth up to $5 billion and $5.7 billion, respectively, to resolve claims that the companies ignored signs of prescription abuse and failed to prevent drug diversion.

If approved by the court, California may receive up to approximately $470 million from the CVS settlement and up to $510 million from the Walgreens settlement. CVS and Walgreens have also agreed to injunctive relief that requires the pharmacies to monitor, report, and share data about suspicious activity related to opioid prescriptions. A final agreement with Walmart, worth up to $3.1 billion, is not being announced today; however, that settlement is expected to move forward in the coming weeks.

In addition to these new announcement, in March of 2022, the California Attorney General announced a $6 billion conditional settlement with Purdue Pharma and the Sackler family over their alleged deceptive and illegal marketing and sales practices, in an agreement that would also allow the family’s name to be removed from buildings, scholarships, and fellowships.

In February 2022, a bankruptcy court confirmed a plan that would allow an agreement between certain states, including California, and Mallinckrodt, the largest generic opioid manufacturer in the United States, to move forward. That settlement includes an expected $1.6 billion payment by the company to a trust that would benefit public and private opioid-related claimants.

In July 2021, the California Attorney General announced a $26 billion settlement, which was finalized in Spring 2022, with Johnson & Johnson, which manufactured and marketed opioids, and Cardinal Health, McKesson, and AmerisourceBergen, the nation’s three major pharmaceutical distributors. It was the second largest multistate agreement in U.S. history, and its terms bar Johnson & Johnson from being involved in selling or promoting opioids for a decade and require the distributors to monitor, report, and share data about suspicious activity related to opioid sales.

In February of 2021, the California Attorney General announced a $573 million settlement with one of the world’s largest consulting firms, McKinsey & Company. The settlement resolves California’s investigation into the company’s role in advising opioid companies (including OxyContin maker Purdue Pharma) in the promotion and sale of their drugs.

New Book Says EDD Failures Emblematic of Antiquated Governmental Tech

A former federal technology official enlisted by Gov. Gavin Newsom to triage California’s pandemic unemployment response, explains in her new book, how technical and political failures are costly to citizens at all levels of government.

According to a report by CalMatters, Jennifer Pahlka, founder of Code For America and former U.S. deputy chief technology officer, writes in her new book, that the turmoil at California’s Employment Development Department is a prime example of failures that have also plagued other major civic tech efforts, such as the post-Obamacare implosion of healthcare.gov or archaic IT systems at the U.S. Department of Veteran Affairs.

Pahlka founded Code for America, a San Francisco-based non-profit organization that aims to make government for all people. According to the Washington Post itis the technology world’s equivalent of the Peace Corps or Teach for America” [offering] an alternative to the old, broken path of government IT.” In her 2012 TED Talk, Pahlka noted that we will not be able to reinvent government unless we also reinvent citizenship, and asked “Are we just going to be a crowd of voices, or are we going to be a crowd of hands?

In her TED Talk she said “We had a team that worked on a project in Boston last year that took three people about two and a half months. It was a way that parents could figure out which were the right public schools for their kids. We were told afterward that if that had gone through normal channels, it would have taken at least two years and it would have cost about two million dollars. And that’s nothing. There is one project in the California court system right now that so far cost taxpayers two billion dollars, and it doesn’t work. And there are projects like this at every level of government.”

Of all the tech disasters I’ve witnessed and tried to help untangle, the one I’ve come to see as most emblematic of these forces – and the ways we consistently misunderstand them – is the story of California’s unemployment insurance in the first year of the pandemic,’ Pahlka writes in the book “Recoding America: Why Government is Failing In the Digital Age and How We Can Do Better.

Three chapters of the book chronicle Pahlka’s time co-leading a “Strike Team” deployed by Newsom in mid-2020, as long benefit delays and outlandish stories of fraud began to dominate headlines. In the months to follow, state officials would find that payments were delayed to some 5 million workers and may have been improperly denied for another 1 million, all while the state lost as much as $32 billion to fraud, according to varied state and industry estimates.

Among the problems and potential solutions detailed in the new book: Why it was easier for scammers to file successful unemployment applications than it was for some workers, how a $100 million-plus tech modernization project by state contractor Deloitte buckled during the pandemic, and why the furor about outdated online systems has more to do with flawed state and federal policy than old software.

Modernizing technology without rationalizing and simplifying the policy and process it must support seldom works,” Pahlka wrote. “Mostly, it results in much the same mess you had before, only now in the cloud.”

An EDD spokesperson declined to comment.

The new details come amid a national reckoning over pandemic unemployment failures, including millions in federal funding recently made available for new tech modernization efforts. More than 150,000 workers in the state are still facing long appeals backlogs as they fight for delayed or denied unemployment benefits.

Meanwhile, congressional factions have also dragged jobless benefits back into bitter political fights. Last week, questions about responsibility for EDD woes resurfaced during a contentious U.S. House committee hearing led by Republican lawmakers opposed to President Biden’s nomination of ex-California labor chief Julie Su to be the U.S. Labor Secretary.

What exactly derailed the EDD’s computer system – or “grab bag of somewhat connected, somewhat separate systems,” as Pahlka wrote in the new book – is far more complicated than popular notions that “EDD staff was just incompetent at technology.” Even understanding the agency’s layers of antiquated technology, which she likens to an archeological dig, doesn’t get to the heart of the issue.

Rather, Pahlka explains, the dysfunction stems from the policy environment at the EDD and the bodies that oversee it. The California Legislature, federal labor regulators and flawed oversight mechanisms have all contributed, she wrote, to ever-growing and often-incompatible regulations, plus a political system that rewards compliance over public access.

“The bureaucratic confusion,” Pahlka wrote, “ultimately lands on the people.”

Some of the problems cited by Pahlka and state watchdogs have since been addressed, at least in part. The federal Pandemic Unemployment Program that was the biggest target for fraud has since ended. The EDD also went on a tech buying spree during the pandemic for services including call center support from longtime contractor Deloitte and an online identity verification system recommended by Pahlka’s Strike Team (which, in turn, spurred different complaints about long waits for some workers). The agency is now working on another nascent tech modernization project called EDDNext.

Still, Pahlka warns, the biggest underlying issues remain harder to address.

What we need has less to do with updating rigid 1950s code than with updating rigid 1950s thinking,” Pahlka wrote. “We need a fundamentally different way of delivering on the promise of policy.”