Menu Close

Author: WorkCompAcademy

Hospitals Failing to Comply with Price Transparency Law

The California Attorney General issued a consumer alert reminding Californians of their right to access hospital price information online pursuant to federal regulations that went into effect on January 1, 2021.

According to the Attorney General announcement, “a significant number of hospitals, including those in California, have refused to comply. In fact, the regulations were amended in 2022 to increase penalties for noncompliance in response. Recent reports have indicated that many hospitals are still not in compliance. With today’s alert, DOJ strongly urges hospitals to comply with these laws and encourages consumers to assist DOJ’s efforts in tracking noncompliance by filing a complaint with the department here.”

The federal government has strong laws in place to provide healthcare transparency, which includes requiring hospitals to publish online annually the price of all their items and services, such as supplies and procedures, room and board, facility fees, physician professional charges, and shoppable services, such as imaging and laboratory services, medical and surgical procedures, and outpatient clinic visits. In today’s alert, Attorney General Bonta urges Californians seeking medical attention to do their research to learn more about the price transparency information available to them, including:

– – A Description of Each Item, Service, or Shoppable Service: This may include any code used by the hospital for accounting or billing purposes.
– – Gross Charge: The charge that applies absent any discounts.
– – Payer-Specific Negotiated Charge: The discounted rate the hospital has negotiated with a third-party payer, such as your medical insurer.Each charge must be clearly associated with the name of the third-party payer and plan.
– – De-Identified Minimum Negotiated Charge: The lowest charge the hospital has negotiated with a third-party payer, including with your medical insurer.
– – De-Identified Maximum Negotiated Charge: The highest charge the hospital has negotiated with a third-party payer, including with your medical insurer.
– – Discounted Cash Price: The price for those who pay cash. Hospitals that do not provide a cash discount for a shoppable service must provide the gross charge for the service.

If a hospital is not complying with these requirements, a complaint can be filed with the Centers for Medicare & Medicaid Services (CMS) here. You may also file a consumer complaint with the California DOJ here.

More hospital price transparency information through CMS.

QME With 3,005 WCAB Liens worth $29.4 M Faces 40 Fraud Charges

Dr. Gary Martinovsky graduated from the University of California, Berkeley, as a bachelor of science and from Stanford University as a medical doctor. He completed a residency in anesthesiology and acute care at Stanford School of Medicine, and a postgraduate fellowship in Pain Medicine at the University of California, Davis. He holds board certification in Pain Medicine from the American Board of Anesthesiology.

NBC Bay Area reports that Dr. Gary Martinovsky was first arrested on Thursday, March 20, 2014 and charged with insurance fraud and unlawful dispensing of medicine. About half of his patients at the time were injured workers, and investigators claimed he was bilking the California workers’ compensation system.

Inspectors for the Alameda County District Attorney’s Office, the agency behind an undercover investigation into Martinovsky, accused him of running a medical mill and using injured workers for his own financial gain. They would claim in court documents that his office billed an insurance company for services he never performed and that Martinovsky had a “cavalier attitude” toward dispensing drugs.

But the case against Martinovsky was dismissed in Alameda because it had been filed in the wrong county.

Prosecutors then filed a a single felony count for violating Cal. Penal Code § 550(a)(7) (knowingly submitting a claim for a health care benefit not used by, or on behalf of, the claimant) was filed in Contra Costa County Superior Court. During the preliminary hearing, which was not completed, the charge was reduced to a misdemeanor. That case was dismissed after Martinovsky completed a one-year diversion program. He never entered a guilty plea or admitted guilt of any kind.

In 2016 Dr. Martinovsky filed a civil rights lawsuit in federal court against the Alameda County District Attorney’s Office and an investigators for the Department of Insurance. He alleged that because “of the search of the clinic, and the defamatory statements made by Defendants, word spread quickly through the regional medical community, legal professionals and insurance industry that Dr. Martinovsky had been arrested and charged with felony drug and insurance fraud charges. The effect was immediate and devastating for Plaintiffs’ otherwise spotless reputation and growing medical practice, and caused severe emotional distress”.

The federal civil rights case was resolved and dismissed with prejudice based upon a stipulation and a settlement between the parties in May 2018 for undisclosed terms.

Now, on December 7, 2023, the San Francisco District Attorney Brooke Jenkins announced that a 51 year old Doctor Gary Martinovsky, who lives in San Francisco; and his 68 year old office assistant and mother-in-law, Raisa Rikoshinsky, who lives in San Bruno; and one of the businesses he owns, Integrated Pain Care (IPC), have been criminally charged with 40 violations of insurance fraud under (PC 550(a)(5), PC 550(a)(7), and PC 550(a)(8)), for fraudulent billing, double billing, and billing for services not rendered.

Gary Martinovsky MD is listed as a QME in Anesthesiology, and also in Pain Managment. DWC Medical Unit records reflect 10 Northern California Offices for each specialty, or a total of 20 addresses. According to the California Department of Industrial Relations, Dr. Martinovksy has 3,005 liens worth $29,443,467 outstanding as of October 2023.

As alleged in court documents in this newest case, Dr. Martinovsky, IPC, and Raisa Rikoshinsky allegedly filed liens with the State of California Division of Workers Compensation asking for payment of bills which had already been paid in full or in part.

California’s Workers Compensation law allows a doctor to file a lien against an insurance provider for payment for services rendered to an injured worker, where the bill has not been paid.

In support of the filed liens, prosecutors allege the defendants submitted fraudulent documents and/or failed to disclose that they had already received payments for the billed services. In addition, Dr. Martinovsky and IPC billed three insurers for services not rendered, by claiming $625 numerous times for services not provided to injured workers.

In terms of number of liens filed from 2022 to the present,  prosecutors claim Integrated Pain Care was second in the State of California only to the Employment Development Department, the state agency that administers California’s Unemployment Insurance, Disability Insurance, and Paid Family Leave programs and maintains records for more than 19 million workers.

Dr. Martinovsky and Ms. Rikoshinksy are scheduled to be arraigned on January 12, 2024, at 9A in Department 10 at the Hall of Justice. If convicted of all charges, Dr. Martinovsky and Ms. Rikoshinsky each face over five years in State Prison.

This case was developed through an investigation conducted by the San Francisco District Attorney’s Office Economic Crimes Unit, with the California Department of Insurance assisting in the arrests.

Although charges have been filed, this remains an active investigation. Anyone with information is asked to call the San Francisco District Attorney’s Investigations Tip Line at 1-628-652-4362. You may remain anonymous.

Google to Pay Workers $27M – the Largest PAGA-Only Settlement to Date

Google has reached a $27 million settlement with its California employees who accused the tech giant of unfair labor practices, setting a record for the largest agreement of its kind, according to California state court documents. The settlement covers individuals who worked at Google and Alphabet from Oct. 16, 2015, to Sept. 15, 2023, excluding temporary employees, vendors, or contractors and those of senior vice president positions or higher.

In the December 4 settlement approval order, the trial court granted attorneys’ fees of $9 million to plaintiffs’ counsel Outten & Golden LLP and Baker Curtiz & Schwartz PC. Named plaintiffs John Doe and DeWayne Cassel each will receive $20,000 in incentive awards with $10,000 each to Paola Correa and David Gudeman.

The net $17.66 million settlement will be split with 75% going to the California Labor and Workforce Development Agency and 25% to the class. Each of the 96,939 aggrieved employees receives a fixed payment of $20 and a max payment of $79 depending on pay periods, the plaintiffs said in a supplemental filing. The settlement is effective Feb. 3.

Plaintiffs in this case alleged that Google, Inc. and Alphabet, Inc., and Adecco USA, Inc. require their employees to comply with various confidentiality policies. John Doe, David Gudeman, and Paola Correa, who were current and former Google and Adecco employees, sued Google and Adecco under the Labor Code Private Attorneys General Act of 2004 (PAGA) (Lab. Code, § 2698 et seq.), alleging the employers’ confidentiality policies restricted their employees’ speech in violation of California law.

The trial court sustained defendants’ demurrers without leave to amend, concluding plaintiffs’ claims were preempted by the National Labor Relations Act (NLRA or Act) (29 U.S.C. § 151 et seq.) under San Diego Bldg. Trades Council v. Garmon (1959) 359 U.S. 236, 244-245 (Garmon). In September 2020, the California Court of Appeal reversed the trial court in the published case of Doe v. Google, Inc., 54 Cal. App. 5th 948.  It held that the claims fall within the local interest exception to Garmon preemption and may therefore go forward.

Plaintiffs’ third amended complaint alleged 17 causes of action under PAGA based on defendants’ confidentiality policies. Plaintiffs’ confidentiality claims fall into three subcategories; restraints of competition, whistleblowing, and freedom of speech.

In their competition causes of action plaintiffs alleged that Google’s confidentiality rules violated state statutes by preventing employees from using or disclosing the skills, knowledge, and experience they obtained at Google for purposes of competing with Google. For example, the policies prevented Googlers from disclosing their wages in negotiating a new job with a prospective employer, and from disclosing who else works at Google and under what circumstances such that they might be receptive to an offer from a rival employer.

Plaintiffs’ whistleblowing causes of action alleged that Google’s confidentiality rules prevent employees from disclosing violations of state and federal law, either within Google to their managers or outside Google to private attorneys or government officials. (See Bus. & Prof. Code, §§ 17200 et seq.; Lab. Code, § 1102.5.) They also allege the policies unlawfully prevent employees from disclosing information about unsafe or discriminatory working conditions, or about wage and hour violations.

In their freedom of speech claims, plaintiffs alleged that defendants’ confidentiality rules prevent employees from engaging in lawful conduct during non-work hours and violate state statutes entitling employees to disclose wages, working conditions, and illegal conduct.

The 2016 lawsuit was among the first glimpses of employee activism that swept through the tech industry over the past seven years. It stemmed from the termination of a worker at Google-owned Nest, who was fired for posting complaints about the company’s management on Facebook.

In the years that followed, Google, Facebook, Netflix and others faced employee walkouts, whistleblowers, and public letters, which led to firings, town halls, and revamped policies as tech companies grappled with how to contend with increasingly vocal staff.

The California Labor and Workforce Development Agency submitted comments regarding the proposed settlement agreement in this action in response to the Court’s invitation. The Agency told the court the $27 million settlement in this action “is the largest PAGA-only settlement, and second largest civil penalty recovery, in a PAGA action to date.”

And the agency went on to say “to our knowledge this is the first PAGA case which has obtained remedies of this nature, which clearly further labor law enforcement. And undoubtedly, as Plaintiffs state, ‘knowledge of this $27,000,000 PAGA settlement against Google should serve to deter Alleged Speech Restrictions by other employers.’ “

Woman to Serve 15 Years for $24M DME Sales & Repair Fraud

A South Bay woman has been sentenced to 180 months in federal prison for billing Medicare more than $24 million by submitting fraudulent claims for medically unnecessary durable medical equipment – mostly power wheelchairs (PWC) – and PWC repairs, many of which were never performed, the Justice Department announced today.

Tamara Yvonne Motley, 55, a.k.a. “Tamara Ogembe,” of Redondo Beach, was sentenced Tuesday by United States District Judge Stanley Blumenfeld Jr., who also ordered her to pay $13,107,422 in restitution as well as an additional $2,300 in special assessments.

At the conclusion of a five-day trial, a jury on June 27 found Motley guilty of 20 counts of health care fraud, two counts of aggravated identity theft, and one count of conspiracy to commit money laundering. Judge Blumenfeld ordered her remanded into federal custody that same day after the verdict was read.

From July 2006 to August 2014, Motley was the de facto owner of the Hawthorne-based Action Medical Equipment and Supplies. From January 2013 to November 2016, Motley was the de facto owner of the Ventura-based Kaja Medical Equipment & Supply. Both companies were enrolled with Medicare in the names of Motley’s out-of-state relatives.

Motley orchestrated a scheme in which she paid marketers for patient referrals and then directed them to take patients to corrupt physicians, who prescribed medically unnecessary durable medical equipment, such as PWCs, that Motley’s companies used to submit fraudulent bills to Medicare.

In January 2011, when Medicare changed the reimbursement rules for PWCs to make the upfront payments less lucrative to suppliers, Action switched to billing Medicare for PWC repairs, and continued that scheme at Kaja once Action was shut down. These repairs were not medically necessary not only because the patients did not need the PWCs to begin with, but also because those repairs were not needed to make the PWCs serviceable in any event and often were never performed. These repairs were expensive – often billed for $3,000 to $4,000 each – and accounted for nearly half of Action’s billings and almost all of Kaja’s.

Over an eight-year period, Action billed Medicare more than $18.2 million for DME – most for PWCs, but also for PWC accessories, knee braces and back braces – and the repair or replacement of PWCs. Medicare paid Action nearly $10.3 million.

Between July 2013 and November 2016, Kaja billed Medicare $6.3 million, primarily for PWC repairs. Medicare paid Kaja approximately $2.8 million for those claims.

“[Motley] manipulated those around her to serve her criminal ends,” prosecutors argued in a sentencing memorandum. “She used relatives and employees to conceal her role in the scheme, and even used her infant’s caretaker to carry out the illegal activities of her scheme. She took advantage of vulnerable Medicare beneficiaries in far-flung places like Calexico who were elderly and often non-English speaking. She deceived inspectors to preserve her companies’ accreditation with Medicare.”

Two other defendants were convicted in this case:

– – Cynthia Karina Marquez, 48, of Paramount, who worked as an office manager at both Action nd Kaja, pleaded guilty in December 2019 to two counts of making false statements affecting a health care program. She received a time-served sentence, was placed on supervised release for three years, and was ordered to pay $9,886,646 in restitution.
– – Juan Roberto Murillo, 47, of Montebello, who worked at both medical supply companies as a repair technician, pleaded guilty in November 2019 to one count of conspiracy to commit money laundering. He was sentenced to three years’ probation and was ordered to pay $2,504,119 in restitution.

The United States Department of Health and Human Services, Office of Inspector General; the FBI; and the California Department of Justice investigated this matter.Assistant United States Attorneys Kristen A. Williams of the Major Frauds Section and David H. Chao of the General Crimes Section prosecuted this case.

DWC Announces Move of Stockton Office to Lodi

The Division of Workers’ Compensation (DWC) announced its Stockton office will move to Lodi on December 12, 2023.

The new office will be known as the Lodi district office, and will be located at:

3021 Reynolds Ranch Parkway, Suite 130
Lodi, CA 95240

The main office phone number, (209) 948-7759 will remain the same.

To accommodate the move, the Stockton district office will operate on a virtual basis on Thursday, December 7, Friday, December 8, and Monday, December 11, 2023. All in-person trials and expedited trials have been rescheduled. All conferences will proceed as scheduled on the AT&T Teleconference lines.

Parties may reach the Stockton district office on December 7, December 8 and December 11 by calling the main office phone number, (209) 948-7759.

All parties are encouraged to file documents electronically. Parties may also file documents through the US Mail. If parties need to file a document in person on December 7, December 8, or December 11, they may do so at the Sacramento district office, located at 160 Promenade Circle, Suite 300, Sacramento, CA 95834-2962; phone number (916) 928-3101.

The Lodi district office will commence in-person operations on Tuesday, December 12, 2023.

Employers Sexual Harassment Defense Verdict Reversed

Eunices Argueta began working at Menzies Aviation, a freight operations company in El Segundo, California, in 2008 when she was 18 years old. From about 2008 to 2014, Argueta and Dzung Nguyen worked for Menzies at a location near Los Angeles International Airport.

In October 2014, Worldwide acquired Menzies; Argueta and Nguyen continued to work for Worldwide. Argueta was a lead agent in the import department; her supervisor was Sonia Flores. Nguyen worked as their manager. When Flores was not present, Argueta worked as the acting supervisor and oversaw the work of other agents.

In November 2016, Worldwide hired Maria Diaz as its Director of Human Resources for its western region. Before Diaz, there was no human resources director at Worldwide’s Los Angeles Airport location.

In November 2016 and January 2017, several employees whom Argueta supervised submitted written complaints to Worldwide about Argueta, accusing her of bullying, harassment, retaliation, yelling, making threats and other bad behavior, including discriminating against a pregnant subordinate. Although Argueta moved in limine to preclude admission of the substance of the complaints, the trial court not only allowed their admission but ruled that the entire text of the complaints could be admitted. So Argueta’s attorneys preemptively asked Worldwide’s Diaz to read the written complaints aloud to the jury.

In January 2017, Diaz met with Argueta to discuss these complaints. Diaz testified she told Argueta that if her behavior did not improve, she would be terminated. Argueta gave a different account of the meeting, testifying she was not expressly threatened with termination.

In early May 2017, Urania Chavarria, one of the authors of a complaint that has been admitted into evidence, became upset because she believed that Argueta picked up and ate almost all of the chocolate bar Chavarria had left on her desk, leaving only a tiny piece. Argueta claimed she broke off only a small piece. When her supervisor Flores questioned her about the chocolate, Argueta said she only took a little piece. Flores reviewed a surveillance video and accused Argueta of lying.

In her complaint, Argueta alleged Nguyen began sexually harassing her in 2016. On May 11, 2017, Nguyen placed Argueta “out of service” while the matter was investigated; this essentially meant she was placed on paid leave. Argueta subsequently claimed many more acts of harassment. Worldwide conducted an investigation of Argueta’s complaint, although Argueta contends it was not thorough.

Diaz, facility assistant general manager Javier Trujillo, and facility general manager John Oh then met with Nguyen. Nguyen admitted some but not all the acts Argueta alleged.As a result of the investigation, Worldwide issued a “Letter of Concern” to Nguyen stating that Nguyen had admitted to some actions “that can easily be construed as sexual harassment” and “[t]his is a violation of our policy.” Worldwide imposed a number of conditions on Nguyen’s continued employment: undergo additional sexual harassment training; cease sending emojis to subordinates; use “appropriate language”; keep a minimum of three feet from employees; and not make any physical contact with an employee without their express permission.

When Argueta returned from leave in June 2017, she was transferred to a different floor and assigned to a different client; she worked for the client’s manager and was supervised only by Trujillo. Her pay remained the same. In February 2018, Argueta resigned from Worldwide. She stated she resigned because her new schedule was not compatible with her family responsibilities and her new position offered diminished potential to advance.

In 2019, three female Worldwide employees made written complaints that Nguyen was sexually harassing them. Some of the actions occurred as far back as 2017. Worldwide’s (new) local human resources manager for the Los Angeles Airport facility investigated the complaints and found Nguyen had violated Worldwide’s sexual harassment policy and the conditions in the Letter of Concern. Worldwide terminated Nguyen in March 2019.

Argueta filed this action against Worldwide, alleging sexual harassment and retaliation in violation of the Fair Employment and Housing Act (FEHA), and failure to prevent both. After the jury returned a defense verdict she filed a motion for a new trial and a motion for judgment notwithstanding the verdict. The trial court denied both motions. Argueta appealed, contending the trial court’s admission of evidence of the substance of other employees’ complaints about her to Worldwide was erroneous and warrants a new trial. The Court of Appeal agreed in the published case of Argueta v. Worldwide Flight Services, Inc -B306910 (November 2023). It agreed that admission of the substance of the complaints against Argueta was prejudicial error and reverse the trial court’s denial of her motion for a new trial. The judgment was reversed and the matter is remanded for a new trial.

A party is entitled to a new trial when an irregularity in the proceedings, or any order of the court or abuse of discretion, “materially affect[s] the substantial rights of such party” and prevents them from having a fair trial. (Code Civ. Proc., § 657(1).)

As a general matter, the denial of a motion for new trial is reviewed for abuse of discretion, with the appellate court making an independent determination as to whether any error was prejudicial. The most fundamental rule of appellate review is that the judgment or order challenged on appeal is presumed to be correct, and it is the appellant’s burden to affirmatively demonstrate error.

Here, the employee complaints about appellant fit the quintessential definition of prejudice. The trial court failed to recognize that the evidence had a high potential for undue prejudice. It is, as Argueta contends, character evidence. The complaints show her as mean, rude, lazy, and dishonest. “

“The trial court gave a limiting instruction on this evidence, and such instructions can ameliorate section 352 prejudice. Indeed, they are generally considered effective. Limiting instructions are less effective, however, when there is little or no probative value to the evidence and it has a high potential for prejudice.” … “It simply and vaguely told the jury that “the complaints of other employees about Ms. Argueta are not being received for the truth of those complaints; rather, they are being received for the effect on Ms. Argueta when she was told about those complaints.”

We find her arguments on appeal sufficient. We agree with Argueta that the high potential for undue prejudice from admission of the substance of the complaints far outweighed the very minimal probative value of that evidence, and a limiting instruction would not be effective under the circumstances of this case.”

Felon on Probation is Not Employee of Rehabilitation Center

Jose Velasquez pleaded guilty in Santa Barbara County Superior Court to a felony count of forgery. (Pen. Code, § 476.) The court suspended pronouncement of judgment, placed Velasquez on supervised probation for three years with terms, including that he “[e]nter and complete a residential treatment program as directed by Probation.”

Velasquez entered The Salvation Army’s residential adult rehabilitation center in Santa Monica for substance abuse treatment. The Salvation Army is a private, nonprofit organization. Its residential treatment program is a six-month program provided at no cost to the beneficiaries. The program includes 12 hours per week of counseling, attendance at weekly religious services, meditation, and a work therapy component during which participants work in The Salvation Army’s warehouse. The work therapy component is designed to help individuals become productive members of society.

Velasquez was injured while moving furniture at The Salvation Army’s warehouse and sought workers’ compensation for his injuries. Both The Salvation Army and the County denied his claim for benefits.

At the administrative hearing, the workers’ compensation judge (WCJ) identified the issue as: “Employment and whether the applicant was an employee of Defendant The Salvation Army when he was the beneficiary of a Court-mandated drug diversion program per Labor Code Section 3352. [¶] The parties further raise the applicability of Labor Code Section[s] 3351 and 3301.”

During the program, Velasquez had no contact with the County. But The Salvation Army contacted his probation officer and reported everything he was doing and how he behaved. Velasquez was required to show his probation officer his program graduation certificate.

The WCJ concluded Velasquez was not an employee of either The Salvation Army or the County, and ordered he “take nothing” against either. The WCJ acknowledged that Velasquez’s work “conferred a benefit upon the Salvation Army.” But he reasoned The Salvation Army was not an employer because it was “sponsoring” Velasquez pursuant to section 3301, subdivision (b), “as a condition of his probation to get him clean and sober.” The WCJ concluded: “Based upon this statutory scheme and the societal interest in having private, non-profit organizations working with County and State prosecutors and government in terms of probation and drug and alcohol intervention, that societal interest outweighs the workers’ compensation general interest of finding persons to be employees whenever possible.”

On May 31, 2022, the Board issued its opinion and decision after reconsideration, affirming the WCJ’s order. The Board concluded The Salvation Army was exempt from providing workers’ compensation as a nonprofit sponsor (§ 3301, subd. (b)), and the County did not employ Velasquez because it did not exercise control over his working conditions. (Velasquez v. Salvation Army (May 31, 2022, ADJ 11436476) 2022 Cal.Wrk.Comp. P.D. LEXIS 162.)

In briefing filed in the Court of Appeal in this case, the Board requested “the Decision be annulled and this matter remanded to the Appeals Board for further consideration” whether Velasquez was an employee of the County, and whether The Salvation Army was his employer. Velasquez and the County oppose the request.  

Employee excludes “a person performing services in return for aid or sustenance only, received from any religious, charitable, or relief organization.” (§ 3352, subd. (a)(2) (former subd. (b).) “Employee” also excludes “[a] person performing voluntary service for a public agency or a private, nonprofit organization who does not receive remuneration for the services, other than meals, transportation, lodging, or reimbursement for incidental expenses.” (§ 3352, subd. (a)(9) (former subd. (i).)

Velasquez also contends he was an employee of the County. He relies on the probation department’s role in his enrollment in The Salvation Army program. The County denies it had an employment relationship with Velasquez.

The Board concedes its decision on reconsideration relied upon erroneous legal analysis and that there has been no evidentiary review or factual findings in this case with respect to whether the County was Velasquez’s employer.

Section 5908.5 mandates that “[a]ny decision of the appeals board granting or denying a petition for reconsideration or affirming, rescinding, altering, or amending the original findings, order, decision, or award following reconsideration . . . shall state the evidence relied upon and specify in detail the reasons for the decision.” “This procedural demand aims at revealing the basis of the Board’s action, at avoidance of careless or arbitrary action, and at assisting meaningful judicial review.” (Patterson v. Workers’ Comp. Appeals Bd. (1975) 53 Cal.App.3d 916, 924.)

“As the Board concedes, the record contains insufficient factual findings and legal analysis from the Board so this court can conduct a meaningful judicial review of the question whether Velasquez was an employee of the County. The Board’s failure to comply with section 5908.5 constitutes a sufficient basis to annul the Board’s decision and remand for further proceedings.”

The Court of Appeal concluded: 1) The Salvation Army is statutorily excluded from being an employer for workers’ compensation purposes under section 3301; and 2) the record was inadequately developed during the administrative proceedings to determine whether the County was Velasquez’s employer. The latter issue must be remanded to the Board for further consideration. Accordingly, it affirmed in part, annulled in part, and remanded the matter for further proceedings in the published case of Velasquez v WCAB -B321638 (December 2023).

Feds Voice Concern About Quality of Foreign Manufactured Generics

Last July, according to a report by HealthAffairs.org. the Chair of the House Energy and Commerce Committee, Cathy McMorris Rodgers (R-WA) and two colleagues on the Health and Oversight Subcommittee sent a forceful letter to Food and Drug Administration (FDA) Commissioner Robert Califf regarding FDA’s inadequate inspections of drug manufacturing plants in India and China: “The FDA’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China makes having effective foreign inspection programs in those countries critical … we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.”

Bloomberg News reports that the Department of Defense recently announced that it will begin independently testing the quality and safety of imported generic drugs. Defense officials are in talks with Valisure, an independent lab, to test the quality and safety of generic drugs it purchases for millions of military members and their families, according to several people familiar with the matter who asked not to be named as the details aren’t public..

Generic drugs account for 90 percent of prescriptions dispensed in the United States. They also represent a sizeable share of the drugs used by hospitals to treat patients in ICUs, oncology units, transplant centers and emergency departments.

Because generic drugs sold in the U.S. must be FDA-approved, health care providers and patients assume that they are safe and effective. There is growing evidence that this confidence may be misplaced. In fact, quality issues are the precipitating factor in more than 60 percent of generic drug shortages.

The Hatch-Waxman Act of 1984 created a streamlined pathway for generic drugs. All a manufacturer must do is demonstrate that the generic version it proposes to sell is “bioequivalent” – meaning it delivers roughly the same amount of active pharmaceutical ingredient (API) into a person’s bloodstream, at roughly the same rate and duration, as the brand-name drug on which it is based. To demonstrate bioequivalence, a manufacturer typically hires a contract research organization (CRO) to perform the necessary testing with 24 to 36 healthy volunteers.

Once a drug is approved for sale in the U.S., FDA relies on periodic inspections of pharmaceutical plants and record reviews to ensure that a company complies with “Good Manufacturing Practices,” (GMP). FDA does not routinely test the medicines themselves. Instead, it asserts that manufacturers are responsible for the quality and safety of their products. In the early years of Hatch-Waxman, this honor system worked reasonably well. It does not today. Recent FDA actions and published research indicate that generic medicines are not always bioequivalent or safe. For example:

– – In 2009, researchers published a study in Neurology titled “The risks and costs of multiple-generic substitution of topiramate,” a drug that treats epilepsy. They found that switching generics was associated with significantly higher rates of hospitalizations, head injury or fracture and longer hospital stays.
– – In 2012, an FDA-sponsored a study of Budeprion XL, an extended-release antidepressant, revealed that a manufacturer’s generic did not perform as well as the brand-name drug. Years after hundreds of consumers first raised concerns, the product was withdrawn from the market.
– – Although generic manufacturers may contain different “inactive” ingredients, such as fillers and binders, than the brand-name drug, few of these ingredients have been tested to determine if they can affect bioequivalence. In 2015, FDA reported that in some instances, they do.
– – In 2017, Circulation published a study titled “Impact of the Commercialization of Three Generic Angiotensin II Receptor Blockers on Adverse Events in Quebec, Canada.” The researchers found that shortly after the generic versions came on the market, reports of adverse events significantly increased.
– – In 2018, after being alerted by independent industry testing, FDA determined that some generic ARB medicines, including versions of valsartan, losartan, and irbesartan, contained nitrosamines – a probable carcinogen.
– – In 2020, an independent laboratory found “unacceptable levels” of NDMA, a known carcinogen, in samples of metformin, a diabetes medication taken by 20 million The finding was reported to FDA and led to broad recalls.
– – In 2021, a study of generic versions of tacrolimus, an immunosuppressant, found that some dissolve too rapidly. This might affect therapeutic duration and increase the risk of organ rejection.
– – Also in 2021, FDA raised integrity concerns with the bioequivalence studies of approximately 100 drugs conducted by two Indian CROs. The agency rejected the studies and required manufacturers to repeat them. Unlike its European counterpart, which suspended marketing of the products, the FDA allowed the drugs to continue to be sold with a special code to alert pharmacists that they should not be considered “automatically substitutable” for their brand-name counterparts.

Because FDA approval is considered the benchmark for drug quality, the US companies that supply most generic drugs to America’s pharmacies, clinics, and hospitals search the globe for the least expensive generic versions of brand-name drugs. The “race to the bottom” this engendered drove most generic drug production offshore. As a result, America is highly reliant on other countries for its generic drugs and the ingredients and raw materials required to make them.

CVS Plans Overhaul of Pharmacy Reimbursement Model

CVS Pharmacy announced CVS CostVantage, a new approach that evolves the traditional pharmacy reimbursement model and brings greater transparency and simplicity to the system. CVS CostVantage will define the drug cost and related reimbursement with contracted pharmacy benefit managers (PBMs) and payors, using a transparent formula built on the cost of the drug, a set markup, and a fee that reflects the care and value of pharmacy services. These changes will also help ensure that CVS Pharmacy locations will continue to be a critical touchpoint for consumers to access affordable health care in their communities.

CVS Pharmacy plans to launch CVS CostVantage with PBMs for their commercial payors in 2025, working together to ensure a smooth transition.

Following on from the launch of its Choice Formulary program earlier this year, CVS Caremark also introduced TrueCost, a model innovation that offers client pricing reflecting the true net cost of prescription drugs, with visibility into administrative fees. Simplified pricing will help consumers be confident that their pharmacy benefit is providing the best possible price and will allow members to have stable access to our national pharmacy network.

Through this approach, the company said that clients will have the flexibility to choose a pharmacy benefit model that works best for the unique needs of their members and plan, and CVS Caremark TrueCost provides another valuable option for them. CVS Caremark plans to launch CVS Caremark TrueCost in 2025.

CVS is shifting course amid a changing commercial and regulatory landscape for drug pricing. Blue Shield of California announced in August it would revamp how it pays for medicine by enlisting five companies to handle the chain of getting drugs from manufacturer to consumer – instead of a single entity known as a pharmacy-benefit manager.

“The current pharmacy system is extremely expensive, enormously complex, completely opaque, and designed to maximize the profit of participants instead of the quality, convenience and cost-effectiveness for consumers,” Paul Markovich, chief executive of Blue Shield of California, said at the time.

To help demonstrate the connection and convenience CVS Health uniquely delivers, CVS Healthspire will be the new branded name for the company’s Health Services segment, including Caremark, Cordavis TM, Oak Street Health®, Signify Health®, and MinuteClinic®. The groups within CVS Healthspire will continue to focus on integration across the company’s assets to deliver connected patient care, pharmacy benefits, and innovative provider support solutions in communities across the country, making expert care simple, more accessible, and more affordable.  

The CVS Healthspire brand will begin to roll out publicly this month and advance throughout 2024. Consumers will initially see “Part of CVS Healthspire” appear on select CVS Health care delivery offerings across digital and physical assets as the company continues to create an integrated ecosystem for patients.

While CVS Health’s business segments continue to be successful and profitable on their own, there is a sizable opportunity to continue strengthening these connections and create incremental value for the overall company.

A notable example was the recent improvement of Aetna’s Medicare Advantage Star Ratings. In just a year, by leveraging the power of the company’s cross-enterprise assets and executional excellence, Aetna was able to achieve 87% of their members in four star plans or better for the 2025 plan year, a recovery from 21% in the previous year.

“This achievement was due to the work across our Aetna, CVS Pharmacy, and CVS Caremark colleagues. Even more important than our ratings, these teams worked together to help members improve medication adherence and overcome barriers such as costs and transportation,” said Lynch. “Our strong performance in this area shows how we can quickly unite our businesses to achieve important common goals.”

McDonalds Prevails in PAGA Claim Over Providing Employees Seats

Roosevelt Luckett worked for a McDonald’s restaurant located on Venice Boulevard in Los Angeles.From time to time, Luckett worked in the drive-thru cash booth. Luckett asked whether he could use a seat in the drive-thru cash booth, and McDonald’s denied his request. His employer operated approximately 78 corporate McDonald’s restaurants in California with drive-thru cash booths.

Luckett sued his former employer, McDonald’s Restaurants of California, Inc. under the Private Attorneys General Act of 2004 (PAGA; Lab. Code, § 2698 et seq.). Luckett alleged McDonald’s violated Industrial Welfare Commission Wage Order No. 5-2001, section 14(A), which requires employers to provide suitable seats to their employees “when the nature of the work reasonably permits the use of seats,” and section 14(B), which requires an employer to provide suitable seats in reasonable proximity of the work area for employees to use during lulls in operation. (Cal. Code Regs., tit. 8, § 11050, subd. 14(A) &(B) [Wage Order No. 5-2001];

McDonald’s moved for summary judgment. McDonald’s argued (among other issues) that there was no factual dispute that the nature of the work did not reasonably permit the use of a seat at its drive-thru cash booths. It argued the booths were a tight workspace, designed for standing, and the fluidity of movement required to service customers (including frequent foot movements, reaching, bending, shifting, and twisting) could not be reasonably performed from a seated position. Additionally, placing a seat in the booth would create a tripping hazard. McDonald’s also argued that Luckett failed to exhaust administrative remedies as required under PAGA with respect to his section 14(B) claim and thus, the claim was procedurally barred.

Defendant’s evidentiary submission in support of its motion included among other things the declaration of its operations manager in California since January 2013, Saad Sabbagh, the declaration of McDonald’s then-director of customer experience, Michael Cramer, and the report of a retained ergonomics expert, Jeffrey Fernandez, PhD.

The trial court granted the motion, finding there was no factual dispute that the nature of the work did not reasonably permit use of a seat in McDonald’s California drive-thru booths. The Court of Appeal affirmed the summary judgment In the unpublished case of Luckett v. McDonald’s Restaurants of California -B317481 (November 2023).

In Kilby v. CVS Pharmacy, Inc. (2016) 63 Cal.4th 1,the California Supreme Court explained, “Whether an employee is entitled to a seat under section 14(A) depends on the totality of the circumstances. Analysis begins with an examination of the relevant tasks, grouped by location, and whether the tasks can be performed while seated or require standing. This task-based assessment is also balanced against considerations of feasibility. Feasibility may include, for example, an assessment of whether providing a seat would unduly interfere with other standing tasks, whether the frequency of transition from sitting to standing may interfere with the work, or whether seated work would impact the quality and effectiveness of overall job performance. This inquiry is not a rigid quantitative analysis based merely upon the counting of tasks or amount of time spent performing them. Instead, it involves a qualitative assessment of all relevant factors.” (Id. at pp. 19-20.).)

Drive-thru cash booth employees have primary and secondary duties. Their primary duties include taking orders and completing payment transactions for drive-thru customers, and providing “excellent customer service” while doing so. For example, Sabbagh observed, “It is McDonald’s expectation that employees in the cash booth reach out to customers who are sitting in their vehicles, rather than make our guests take off their seat belts, stretch, or open their vehicle doors to reach in toward the employee during a payment transaction.” Sabbagh also declared that McDonald’s places great emphasis on the guest experience and speed of service. Therefore, McDonald’s tracks the speed of service for each restaurant and provides training regarding how to diagnose and fix slowdowns.”

“There is seating in the crew break room to ensure that employees are able to sit and rest during their formal breaks. However, generally speaking, outside of these breaks, it is not acceptable to McDonald’s for an employee to be sitting down and doing nothing while on duty – except, perhaps, as an accommodation for a medical issue.” Thus, to provide the requisite level of service, McDonald’s expects its employees to remain busy between customer transactions by performing secondary duties.

Because the work in the cash booth is most appropriately done from a standing position, McDonald’s generally only allows employees to sit as an accommodation for medical reasons.

In assessing feasibility, the employer’s business judgment and the physical layout of the workspace may be relevant considerations. (Kilby, supra, 63 Cal.4th at pp. 21-22.) However, physical differences among employees are not relevant to the section 14(A) inquiry. “That provision requires a seat when the nature of the work reasonably permits it, not when the nature of the worker does.” (Kilby, supra, at p. 23.)

The Court of Appeal Concluded by noting “Luckett has not demonstrated a genuine issue of material fact as to whether it is feasible to place a seat in the drive-thru cash booths.”