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Tag: 2024 News

Supreme Court to Resolve Conflicting Decisions on ER Fees Class Actions

Taylor Capito received treatment in the emergency room of San Jose Healthcare System LP dba Regional Medical Center San Jose on two occasions. Regional is a major hospital in San Jose with an emergency room.

Regional initially billed Capito $41,016 for her two visits, including two “`Level 4′ Evaluation and Management Services Fee” charges of $3,780. Regional thereafter reduced Capito’s total bill to $8,855.38, after deducting adjustments and discounts.

Capito alleges she did not receive advance notice that Regional would charge the EMS fee in addition to each item of service and treatment provided by the hospital. Capito claims that had she been informed that she would be charged the EMS fee before incurring treatment, she would have left Regional and sought less expensive treatment elsewhere.
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Capito filed a complaint against  on behalf of herself and all others similarly situated in June 2020, under the Consumer Legal Remedies Act (CLRA), which she amended shortly thereafter, challenging Regional’s “unfair, deceptive, and unlawful practice of charging [an EMS fee] without any notification of its intention to charge a prospective emergency room patient such a Fee for the patient’s emergency room visit.”

Capito claimed that Regional charged the EMS fee simply for seeking care in the emergency room – describing it as designed to cover overhead’ type expenses of operating an emergency room without correlating the fee to the individual items of treatment and service that a patient received, and that the EMS fee “invariably comes as a complete surprise to unsuspecting emergency room patients.”

Regional demurred and moved to strike the class allegations. In doing so, it briefed the legislative history behind the Payers’ Bill of Rights (Health & Saf. Code, § 1339.50 et seq.) and other federal and state regulations governing its pricing disclosures.The trial court sustained the demurrer and dismissed the case. And the Court of Appeal affirmed the dismissal in the unpublished case of Capito v. San Jose Healthcare System, LP – H049022, – H049646 (April 2023).

In another case, Joshua Naranjo filed a class action lawsuit against the Doctors Medical Center of Modesto Inc., seeking declaratory and injunctive relief, and alleging violations of the unfair competition law (UCL) and the Consumer Legal Remedies Act (CLRA) in connection with Medical Center’s emergency room billing practices. The Medical Center charged Naranjo a total of $12,889.93 before any discounts or adjustments were applied. The gross charge included a “Level 4” EMS Fee in the amount of $8,833.35. The trial court dismissed his case, however the Court of Appeal reversed and reinstated his class action against the Medical Center.

On July 26, the California Supreme Court granted review in the two different cases in which appellate courts had addressed the same issue and come to different conclusions. The first is Naranjo v. Doctors Medical Center of Modesto (2023) 90 Cal.App.5th 1193, a published decision of the Fifth Appellate District in which the court had ruled that the hospital was required to further disclose the EMS fee prior to treating ER patients. The second case is Capito v. San Jose Healthcare System, an unpublished decision of the Sixth Appellate District holding that no additional disclosure was required.

This month the California Attorney General filed an Amicus Brief in Capito urging the California Supreme Court to reverse the Court of Appeal. He urges the Supreme Court to “ensure that lower courts have clear guidance in deciding cases alleging fraudulent practices, and to adopt a standard definition of unfairness under the Unfair Competition Law, as the current lack of clarity inhibits effective enforcement and creates confusion.”

The California Hospital Association points out that for “over a decade, at least 15 different class action lawsuits have been filed against California hospitals for failing to disclose their facility fees before patients were treated.”

These lawsuits were brought even though each hospital had fully complied with both state and federal pricing transparency laws by disclosing the EMS fee in their chargemaster. While some of these lawsuits were settled or dismissed by the plaintiff after losing important rulings, other cases are on appeal or proceeding to trial.”  

The California Hosptial Association has filed as amicus in both Captio and Narango.

Bipartisan Coalition of 39 States in Support of Pending PBM Legislation

The California Attorney General joined a bipartisan coalition of 39 attorneys general urging Congress to pass legislation that will hold Pharmacy Benefits Managers (PBMs) accountable for what they say are unfair and deceptive practices that drive up the costs of prescription drugs.

PBMs act as middlemen between pharmacies, drug manufacturers, health insurance plans, and consumers. Their position gives them an enormous impact on consumers’ access to prescription drugs.

In the letter, the coalition asks House Speaker Mike Johnson, Senate Majority Leader Chuck Schumer, House Minority Leader Hakeem Jeffries, and Senate Minority Leader Mitch McConnell to urge Congress to implement reform and regulate PBM business practices. Importantly, the attorneys general note three pieces of pending federal legislation that include proposals that would convey important steps to reform the industry and combat high healthcare costs: DRUG Act (S1542/HR6283), Protecting Patients Against PBM Abuses Act (HR2880), and Lower Costs, More Transparency Act (HR5378).The following are some of the key provisions of these three proposed federal laws.

The DRUG Act:

– – Eliminates rebates at the point of sale: This practice allows PBMs to receive rebates from drug manufacturers based on the amount of a drug they manage, incentivizing them to select higher-cost drugs even if cheaper alternatives exist.
– – Bans spread pricing: This involves charging pharmacies more for a drug than they can bill the patient, creating a profit margin for the PBM.
– – Restricts fees on generic drugs: The bill limits the fees PBMs can charge pharmacies for generic drugs, aiming to increase access and affordability.

Protecting Patients Against PBM Abuses Act:

– – Limits PBM income: Restricts PBMs to receiving flat service fees, prohibiting income based on drug prices, discounts, or rebates, which critics argue incentivizes them to choose pricier drugs.
– – Transparency in fees: Requires PBMs to disclose fees to plan sponsors, fostering clearer understanding of pricing structures.
– – Fair reimbursement for pharmacies: Prohibits PBMs from reimbursing network pharmacies less than PBM-affiliated pharmacies, aiming to level the playing field and enhance competition.
– – No hidden costs: Bans charging plan sponsors for ingredient costs or dispensing fees different from what’s reimbursed to pharmacies, addressing potential cost markups.

Lower Costs, More Transparency Act (HR5378):

– – Hospitals: Requires hospitals to publicly disclose charges for standard procedures and services, including the discounted cash price and negotiated rates with insurers.
– – Clinical labs and imaging facilities: Similar transparency requirements for clinical diagnostic labs and imaging facilities.
– – Pharmacy Benefit Managers (PBMs): Increased reporting requirements for PBMs to health plan sponsors, revealing details on spending, rebates, and fees associated with covered drugs.
– – Employer-sponsored plans: Enhanced access for employers to claims and cost information, allowing them to make more informed choices about health insurance plans.

The California Attorney General joins the attorneys general of Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Illinois, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virgin Islands, Virginia, Wisconsin, and Wyoming.

Court has Jurisdiction Over Employer’s Assets in Premium Fraud Case

Detectives with the California Department of Insurance arrested Gina Marie Gregori of Lafayette, for allegedly underreporting payroll and ripping off insurers to the tune of $32 million. Gregori was charged with multiple counts of worker’s compensation insurance fraud and associated thefts. The complaint alleged the white-collar criminal enhancement pursuant to Penal Code section 186.11 and named as criminal defendants several of Gregori’s companies, including Apex Janitorial Solutions.

The department’s investigation revealed Gregori was keeping two sets of books, using a payroll processing service to report to Employment Development Department and pay her employees, and keeping a fraudulent set of books that she provided to insurers and insurance auditors, which showed a significantly lower payroll amount.

The People moved for appointment of a receiver to manage and preserve Gregori’s assets pursuant to Penal Code section 186.11. The court granted the motion and issued an order appointing the Receiver, identifying the assets subject to the receivership, and specifying the Receiver’s powers.

Among other things, the Receiver was authorized to take possession of, collect income from, and otherwise operate, manage, preserve, and control Gregori’s properties. The order also authorized the Receiver to request court approval and confirmation of all fees and expenses incurred by the receivership in executing its duties. The court “reserve[d] jurisdiction to allocate the receivership costs of administration as between the parties.”

One of the real properties in the receivership estate was located on Dolores Street in San Francisco and owned by Gregori’s former romantic partner, Richard Bertero,with whom Gregori had commingled funds. Bertero used the Dolores Street property as collateral for a loan from Avalon Funding Corporation.

Later, Bertero filed for Chapter 11 bankruptcy; the Dolores Street property became part of the bankruptcy estate. The bankruptcy court released the Dolores Street property from the automatic bankruptcy stay to allow foreclosing lenders to sell it. When both Avalon and the Receiver made claims to the surplus proceeds from that sale, the trial court ordered the surplus turned over to it to resolve the priority of their claims. Relying on section 186.11, the court ordered that the bulk of the surplus be used to pay the Receiver’s fees and expenses incurred in administering the receivership estate which was roughly $148,000.

The Court of Appeal Affirmed in the unpublished case of People v. Gregori -A164081 (February 2024)

On appeal, Avalon argues that the Receiver had no valid claim to the surplus; that the court erred by applying section 186.11 rather than the nonjudicial foreclosure statute, Civil Code section 2924k; that the court lacked jurisdiction over the surplus; and that the court misapplied section 186.11. The Receiver argues that the trial court had jurisdiction over the surplus as part of the receivership estate and that the court properly exercised its discretion by finding that section 186.11 authorized it to pay the Receiver before paying Avalon.

Penal Code section 186.11, the “Freeze and Seize’ statute, authorizes a trial court to appoint a receiver to preserve the assets of a criminal defendant subject to an “aggravated white collar crime enhancement’ because the defendant was “charged with having committed two or more related felonies involving fraud . . ., a pattern of related felony conduct, and the taking of more than $100,000.”

The court’s goal in the pendent receivership proceedings is to prevent defendants from “dissipat[ing] or secreting [their] assets or property” while the criminal proceedings are pending, and then to use “those assets to pay restitution to victims if the People secure a conviction.”

Subdivision (b) of Civil Code section 2924j specifies that “[n]othing in this section shall preclude any person from pursuing other remedies or claims as to surplus proceeds.” Thus the trial court did not abuse its discretion in declining to adhere to the claim priorities in Civil Code section 2924k.

The trial court’s interpretation of section 186.11 to permit compensation to the Receiver was not an abuse of discretion or contrary to law. The court reviewed the plain language of section 186.11, harmonized the language of the statute to give force and effect to its distinct provisions, and interpreted it to further the policy interests embodied therein.

California Invests $18 Million in Grants to Prosecute Wage Theft

The California Department of Industrial Relations (DIR) and the Labor Commissioner’s Office have launched an $18 million Workers’ Rights Enforcement Grant Program creating opportunities for local prosecutors to obtain funding for wage theft prosecutions. In 2024-2025 (Year 1) and 2025-2026 (Year 2), there will be two annual grant award cycles amounting to a total of $8,550,000 each.

The funding for this program was provided in Assembly Bill No. 102 amendment to the Budget Act of 2023

The Workers’ Rights Enforcement Grant is a new funding source to protect workers from wage theft and other exploitative practices in the workplace. Grants will be competitively awarded to California “public prosecutors” to develop and implement a wage theft enforcement program. A “public prosecutor” is a district attorney, city attorney, county council or any other city or county prosecutor who has established a workers’ rights enforcement program.

This funding will enhance the capacity of public prosecutors to take action against wage theft – ensuring that labor laws are enforced, violators are prosecuted, and employers are deterred from engaging in practices such as unpaid overtime and minimum wage violations. This investment sends a strong message to employers about the State of California’s commitment to ensuring every Californian is fairly compensated for their labor.

Grant funds can only be used for staff salaries and benefits. No other items will be funded, other than the noted annual audit costs. The year 1 Grant Application Timeframe is August 1, 2024 to July 31, 2025, and the year 2 Grant Application Timeframe is August 1, 2025 to July 31, 2026.

Application, Eligibility, and Funding Essential Details

– – Grant Uses: Staff Salaries/Benefits and Annual Audit Costs
– – $750,000: Maximum per applicant per year
– – Eligible Recipients: Public Prosecutors

Register Today: Wage Theft Grant Informational Webinar scheduled for February 22, 2024 @ 11 am PST

Cal/OSHA Toughens Rules On Workplace Lead Exposure

The nation’s toughest rules for on-the-job lead exposure has just been passed by California workplace safety regulators.The Cal/OSHA Standards Board passed the sweeping update to California’s lead regulation despite heavy concerns of feasibility and inaccurate cost estimates from the construction and battery industries.

In a 5-2 vote, the Standards Board expressed concerns over the timeline for implementation, despite supporting the regulation’s substantive goals and ultimately approving the regulation.

In addition to training and blood lead monitoring of exposed employees, California’s present regulation regarding workplace lead exposure (Title 8, Section 5198) requires employers to ensure that no employees have lead exposure over a Permissible Exposure Limit (PEL) of 50 micrograms in a cubic meter of air.

The California Chamber of Commerce reports that this new update would, among other changes, drastically lower the threshold for testing (from 30 micrograms of exposure to 2 micrograms) and the PEL (from 50 micrograms to 10 micrograms).  Importantly, the new update covers both construction and non-construction worksites.

Because of the extreme lowering of the relevant thresholds, even industries that do not consider themselves to be lead-based should be aware of this regulation. For example, any workplaces working with brass (of which lead is a component) or containing brass fixtures may want to examine whether their activities (such as polishing brass) would now be covered by the regulation.

Although no opposition groups debated the hazards of lead, extensive testimony from opposition groups criticized the cost estimates in the Standardized Regulatory Impact Assessment (SRIA) as grossly inaccurate. In addition, strong opposition from battery manufacturers focused on the unrealistic nature of Cal/OSHA’s implementation timeline, noting that their facilities would need years to come into compliance given the time required to obtain permits and complete construction.

Notably, the Standards Board and staff did acknowledge these implementation timing concerns, and the rulemaking took the rare step of asking the Office of Administrative Law to delay its approval by six months, which will functionally delay enforcement until January 2025.

The Board adopted amendments to title 8, California Code of Regulations (CCR), section 1532.1 of the Construction Safety Orders (CSO) and sections 5155 and 5198 of the General Industry Safety Orders (GISO).

Solana Beach Pharmaceutical Company Resolves Kickback Case for $750K

A California pharmaceutical company has agreed to pay $750,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims for certain opioids in violation of the federal Anti-Kickback Statute.

From Dec. 1, 2015, through Aug. 31, 2016, Sentynl Therapeutics Inc., of Solana Beach, California, a specialty pharmaceutical company, marketed and sold prescription opioids Abstral and Levorphanol Tartrate (Levorphanol).

The settlement resolves allegations that, during the relevant time period, Sentynl knowingly caused the submission of claims for Abstral and Levorphanol medications to Medicare in violation of the federal Anti-Kickback Statute.

These allegedly false claims resulted from Sentynl’s alleged indirect payment of kickbacks to a physician. Specifically, the United States contends that Sentynl hired the girlfriend of a physician who was a top prescriber of Transmucosal Immediate Release Fentanyl (TIRF) medications to act as a sales representative in South Florida – the same region in which the physician practiced.

Sentynl hired, employed, and made salary and bonus payments to the physician’s girlfriend to induce the physician to prescribe its Abstral and Levorphanol medications.

“Pharmaceutical companies that sold opioids are being held accountable for improper inducements offered to prescribers,” FBI – Newark Special Agent in Charge James E. Dennehy said. The Newark FBI and our law enforcement partners will continue our pursuit of those who continue to believe the rules don’t apply to them.”

“Pharmaceutical companies are not exempt from their responsibilities to operate within the confines of the law,” Special Agent in Charge Cheryl Ortiz of the Drug Enforcement Administration’s New Jersey Field Division said. “We are glad our diversion investigators were able to assist efforts to bring this matter to a resolution.”

“Some violations of the Anti-Kickback Statute, like those alleged here, can induce physicians’ imprudent prescribing of controlled substances,” stated Special Agent in Charge Naomi Gruchacz with the U.S. Department of Health and Human Services Office of Inspector General. “Individuals and entities that participate in the federal health care system are required to obey the laws meant to preserve the integrity of program funds and the provision of appropriate, quality services to patients.”

U.S. Attorney Sellinger credited special agents of the FBI, under the direction of Special Agent in Charge James E. Dennehy in Newark; investigators of the U.S. Drug Enforcement Administration (DEA), under the direction of Special Agent in Charge Cheryl Ortiz; special agents of the U.S. Department of Health and Human Services Office of Inspector General, under the direction of Special Agent in Charge Naomi Gruchacz, with the investigation leading to the settlement.

The government is represented by Assistant U.S. Attorney Susan J. Pappy of the U.S. Attorney’s Office, District of New Jersey’s Health Care Fraud Unit and Robert L. Toll of the Office’s Opioid Abuse Prevention and Enforcement Unit, and Trial Attorney Douglas J. Rosenthal of the Department of Justice’s Civil Division, Commercial Litigation Branch (Fraud Section).

The government’s pursuit of this matter illustrates its efforts to combat healthcare fraud. One of the strongest tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the Department of Health and Human Services, at 800-HHS-TIPS (800-447-8477).

The claims resolved by the settlement are allegations only and there has been no determination of liability.

Quest Diagnostics Pays $5M for Illegal Hazardous Waste Disposal

Quest Diagnostics is an American clinical laboratory and Fortune 500 company. It operates in the United States, Puerto Rico, Mexico, and Brazil.Quest also maintains collaborative agreements with various hospitals and clinics across the globe. As of 2020 the company had approximately 48,000 employees, and it generated more than $7.7 billion in revenue in 2019.

The California Attorney General announced a settlement with Quest Diagnostics, Inc., resolving allegations that the diagnostic laboratory company unlawfully disposed of hazardous waste, medical waste, and protected health information at its facilities statewide.

As part of the settlement, Quest Diagnostics will be required to pay nearly $5 million for penalties, costs, and supplemental environmental projects and make significant changes to its operations and practices at its California facilities. The Attorney General was joined by the district attorneys of Alameda, Los Angeles, Monterey, Orange, Sacramento, San Bernardino, San Joaquin, San Mateo, Ventura, and Yolo Counties in the settlement.

The settlement is the result of over 30 inspections conducted by the district attorneys’ offices at Quest Diagnostics laboratories and Patient Service Centers (PSCs) statewide. During those inspections, the district attorneys’ offices reviewed the contents of Quest Diagnostics’ compactors and dumpsters and found hundreds of containers of chemicals, as well as bleach, reagents, batteries, and electronic waste; unredacted medical information; medical waste such as used specimen containers for blood and urine; and hazardous waste such as used batteries, solvents, and flammable liquids. The unlawful disposals are alleged to violate the Hazardous Waste Control Law, Medical Waste Management Act, Unfair Competition Law, and civil laws prohibiting the unauthorized disclosure of personal health information.

After being notified of the investigations, Quest Diagnostics implemented numerous changes to bring its facilities into compliance with California law, including hiring an independent environmental auditor to review the disposal of waste at its facilities and modifying its operating and training procedures to improve its handling, storage, and disposal of hazardous waste, medical waste, and personal health information at all four laboratories and over 600 PSCs in California.

The settlement resolves the allegations above and requires Quest Diagnostics to pay $3,999,500 in civil penalties, $700,000 in costs, and $300,000 for a Supplemental Environmental Project to support environmental training and enforcement in California. The settlement also imposes injunctive terms, including requirements that Quest Diagnostics maintain an environmental compliance program, including hiring a third-party waste auditor, and report annually on its progress.

Quest Diagnostics set a record in April 2009 when it paid $302 million to the government to settle a Medicare fraud case alleging the company sold faulty medical testing kits. It was the largest qui tam (whistleblower) settlement paid by a medical lab for manufacturing and distributing a faulty product.

In May 2011, Quest paid $241 million to the state of California to settle a False Claims Act case that alleged the company had overcharged Medi-Cal, the state’s Medicaid program, and provided illegal kickbacks as incentives for healthcare providers to use Quest labs.

It is also worthy of note that in 2017 Quest Diagnostics Inc. agreed to pay $6 million to resolve a lawsuit by the United States alleging that Berkeley HeartLab Inc., of Alameda, California, violated the False Claims Act by paying kickbacks to physicians and patients to induce the use of Berkeley for blood testing services and by charging for medically unnecessary tests. Quest, which is headquartered in Madison, New Jersey, acquired Berkeley in 2011, and ended the conduct that gave rise to the settlement.

And in 2019 Quest Diagnostics confirmed a third-party billing company has been hit by a data breach affecting 11.9 million patients. The laboratory testing company revealed the data breach in a filing with the Securities and Exchange Commission.

FTC and HHS Probe the Role of Pharmaceutical Middlemen

The Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services (HHS) jointly issued a Request for Information to understand how the practices of two types of pharmaceutical drug middlemen groups – group purchasing organizations (GPOs) and drug wholesalers – may be contributing to generic drug shortages.

In the Request for Information (RFI), the FTC and HHS are seeking public comment regarding market concentration among large health care GPOs and drug wholesalers, as well as information detailing their contracting practices. The joint RFI seeks to understand how both GPOs and drug wholesalers impact the overall generic pharmaceutical market, including how both entities may influence the pricing and availability of pharmaceutical drugs. The joint RFI is asking these questions to help uncover the root causes and potential solutions to drug shortages.

“For years Americans have faced acute shortages of critical drugs, from chemotherapy to antibiotics, endangering patients,” said FTC Chair Lina M. Khan. “Our inquiry requests information on the factors driving these shortages and scrutinizes the practices of opaque drug middlemen. We look forward to public input as we assess how enforcers and policymakers can best address chronic drug shortages and promote a resilient drug supply chain.”

GPOs serve as intermediaries in the pharmaceutical industry by negotiating deals for generic drugs and other medical supplies between health care providers – including hospitals, physicians, nursing homes, and home health agencies – and manufacturers, distributors, and others who sell to health care providers. Drug wholesalers are another type of intermediary group which purchase drugs directly from manufacturers and deliver them to health care providers.

The joint RFI is the latest effort by the FTC and HHS to promote competition in pharmaceutical markets to ensure that every consumer has access to high-quality, affordable care. As announced in December 2023, the FTC, HHS and the Department of Justice are partnering on new initiatives which will include a forthcoming joint RFI to seek input on how private-equity and other corporations’ control of health care is impacting Americans.

The joint FTC and HHS RFI is requesting public input via comments, documents, and data regarding several topics with respect to generic drug markets and the potential causes of generic drug shortages, including:

– –    Whether and to what extent manufacturers, GPOs, and drug wholesalers are complying with their legal obligations under Section 3 of the Clayton Act and the Robinson-Patman Act.
– –    Whether and to what extent do the available protections for GPOs under the Federal Anti-Kickback Statute affect market concentration and contracting practices by GPOs, as well as drug shortages.
– –    Whether and to what extent market concentration among GPOs and drug wholesalers has impacted smaller health care providers and rural hospitals.
– –    Whether and to what extent concentration among GPOs and drug wholesalers has disincentivized suppliers from competing in generic drug markets.
– –   The impact of the prevailing GPO compensation model, which may rely on rebates, chargebacks, and administrative fees from manufacturers and suppliers in exchange for favorable treatment, on generic manufacturers and other suppliers.

The public will have 60 days to submit comments at Regulations.gov. Once submitted, comments will be posted to Regulations.gov.

Whistleblower Cases Accuse Kaiser of Massive Billing Fraud

Jeffrey Mazik is the former “Senior Practice Leader for Kaiser’s National Compliance Office” and has over 25 years of experience in fraud control, auditing, and compliance. He was “employed by Kaiser” from 2008 to 2017, joining as an “Information Technology Audit Specialist” in May 2008 and transitioning to the role of “Senior Practice Leader in the Fraud Control Program” in March 2012.

His duties included working with regional compliance leadership to implement compliance and fraud control initiatives, using data analytics to improve compliance and fraud-mitigation initiatives, investigating potential fraud, and developing corrective action plans to address fraud risks.

He has filed federal lawsuit in the United States District Court tor the Eastern District of California against Kaiser Foundation Health Plan, Inc. (“KFHP”), Kaiser Foundation Hospitals (“KF Hospitals”), The Permanente Medical Group, Inc., Southern California Permanente Medical Group, and Colorado Permanente Medical Group, P.C. (“the PMG defendants”). The PMG defendants are groups of physicians that “contract with the other Kaiser entities” to provide medical services Each PMG defendant operates within its individual territory and is funded primarily by reimbursements from its respective regional Kaiser Foundation Health Plan entity.

Defendant KF Hospitals is a nonprofit corporation headquartered in California that operates hospitals and provides facilities for the benefit of the PMG defendants. (Id.) It also receives its funding from defendant KFHP. (Id.) Defendant KFHP is a nonprofit corporation headquartered in California that enrolls members in health plans and provides medical services for its members through contracts with defendant KF Hospitals and the PMG defendants.

On April 2, 2021 Mazik filed his operative first amended complaint under seal on behalf of the United States of America and the states of California, Colorado, Georgia, Hawaiʻi, Maryland, Virginia,, and Washington pursuant to the federal False Claims Act,

He alleges defendants have schemed to defraud the federal government by allowing external, i.e., “non-Kaiser,” healthcare providers to submit false diagnosis codes, which defendants in turn submit to CMS in order to inflate their capitation rates. In particular, defendants intentionally fail to properly use fraud-detection tools to monitor claims errors. Defendants contract with data analytics vendors to review their external provider claims for each region. The vendors provide software applications that perform various types of reviews. For instance, some programs”detect claims that are incorrectly billed . . . [while] other programs identify intentionally manipulated claims that technically fall within plan rules . . . .”

However, he alleges defendants intentionally misused these programs and used them at minimum capacity, such as by disabling key features, in order to reduce the chances of detecting claims errors. In this way, defendants were actively working to avoid detecting and correcting fraudulent claims.

In late 2015, Mazik was tasked with comparing the functionalities offered by two claims analytics vendors, McKesson and Verisk, with which defendants routinely contracted. McKesson offers auditing software called ClaimsXten that detects fraudulent billing practices using “a robust set of rules.” However, defendants chose to deactivate 25 of the 54 rules used by ClaimsXten – “the principal software program that they were supposedly relying on [to] detect such billing fraud.” When a group of employees including Mazik used a Verisk program to double-check data from “the Georgia region” produced by ClaimsXten, the group found $5.3 million in overpayments stemming from defendants’ decision to deactivate nearly half the rules in ClaimsXten. Defendants neither reactivated the disabled rules nor rectified the $5.3 million in overpayments.

When Mizak audited regional office claims from August 2010 through July 2016, he discovered that inflated diagnosis codes caused $209 million in Medicare Advantage overpayments, $181 million in Medi-Cal overpayments and $181 million in other Medicaid programs.Additional allegations similar to the above were made in the lawsuit, and Mazik claims that ultimately he was “stripped of his duties and responsibilities” On January 5, 2017, Mazik was fired.

On July 13, 2022, defendants filed their motion to dismiss Mazik’s First Amended Complaint. In their pending motion, defendants argued that Mazik’s federal FCA claim is barred by the first-to-file rule and the first amended complaint filed by the relator, Dr. James Taylor, in United States ex rel. Taylor v. Kaiser Permanente, No. 21-cv-03894-EMC (N.D. Cal.) (“the Taylor Complaint”). The Court compared the allegations in both cases and concluded that Mazik’s FCA claim was barred by the first-to-file rule except to the extent relator alleges that defendants deliberately tampered with compliance software to ensure that it did not identify erroneous diagnosis codes.

And on February 13, 2024 the Court issued its ruling granting in part and denying in part the Motion to Dismiss. Thus parts of the Mazik case will proceed, and there is additionally the Taylor case proceeding in another California Federal District Court based upon similar allegations.  

FDA Grants Priority Review of Psychedelic Drug for PTSD

San Jose based Lykos Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) has accepted its new drug application (“NDA”) for midomafetamine capsules (“MDMA”) used in combination with psychological intervention, which includes psychotherapy (talk therapy) and other supportive services provided by a qualified healthcare provider for individuals with post-traumatic stress disorder (“PTSD”).

MDMA is commonly known as ecstasy (tablet form), and molly or mandy (crystal form). MDMA was first synthesized in 1912 by Merck. It was used to enhance psychotherapy beginning in the 1970s and became popular as a street drug in the 1980s. [

The FDA has granted the application priority review and has assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of August 11, 2024. If approved, this would be the first MDMA-assisted therapy and psychedelic-assisted therapy.

The NDA submission included results from numerous studies including two randomized, double-blind, placebo-controlled Phase 3 studies (MAPP1 and MAPP2) evaluating the efficacy and safety of MDMA used in combination with psychological intervention versus placebo with therapy in participants diagnosed with severe or moderate to severe PTSD, respectively.

Both MAPP1 and MAPP2 studies met their primary and secondary endpoints and were published in Nature Medicine.The primary endpoint for both studies was to assess changes in PTSD symptom severity as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (“CAPS-5”). The key secondary endpoint of both studies was to assess improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (“SDS”). No serious adverse events were reported in the MDMA group in either study.

The FDA grants priority review for drugs that, if approved, would represent significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy has not been established for the treatment of PTSD. Investigational MDMA-assisted therapy is also being studied in other indications.

PTSD is a serious mental health condition that can develop when a person experiences or witnesses a traumatic event. PTSD affects approximately 13 million Americans each year with women and disadvantaged or marginalized groups more likely to be affected.

Military personnel also have a greater prevalence of PTSD than the general population however, it may not be as widely known that that the largest cause of PTSD is non-combat-related trauma (e.g., sexual violence, unexpected death of a loved one, life-threatening traumatic event or interpersonal violence). In addition to the significant personal impact, PTSD has an enormous economic impact resulting in an annual cost of over $232 billion in the United States.

Trauma-focused talk therapy, which concentrates on memories of the traumatic event or thoughts and feelings associated with the traumatic event is first-line treatment for PTSD , which can be used alone or in combination with medication. There are two SSRIs approved for the treatment of PTSD (sertraline and paroxetine). Studies have shown talk therapy lessens the severity of PTSD symptoms, however improvements in functioning and quality of life have been modest. Trauma-focused talk therapy is associated with a high risk of dropout and lingering symptoms which occur in as many as two-thirds of people who complete treatment.  

Current treatments for PTSD are “reasonably efficacious” however many people don’t respond to treatment or stop treatment early, underscoring the urgent need for new evidence-based therapies and approaches to address this important public health issue. While there have been advancements in the management of PTSD, there have been no new drug treatments approved by the FDA in over twenty years.

In the 1970’s and early 1980’s MDMA was used in conjunction with talk therapy by mental health providers to enhance patients’ access, processing, and communication of difficult emotions and experiences. However, in 1985, the U.S. Drug Enforcement Administration (“DEA”) made MDMA a Schedule I drug under the Controlled Substances Act preventing it from being used for recreational or medical use.

Since then, research has shown the unique properties of MDMA allow it to act as a powerful catalyst to support psychotherapy by helping diminish the brain’s fear response allowing people to access and process painful memories without being overwhelmed. However, additional clinical trials would be needed to secure regulatory review and potential approval.

Lykos pioneered the first randomized, double-blind, placebo controlled clinical trials evaluating the efficacy and safety of MDMA-assisted therapy as an investigational modality using midomafetamine (MDMA) in combination with psychological intervention to treat PTSD.