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Costco, Ryder Last Mile, Mega Nice Trucking Cited for Misclassification

The California Labor Commissioner’s Office cited Costco Wholesale Corporation, Ryder Last Mile Inc., and Mega Nice Trucking LLC for misclassification and labor law violations affecting 58 delivery drivers.

Mega Nice Trucking, based in Chula Vista, served as a subcontractor for third-party logistics companies, including Ryder Last Mile, which contracted with drivers to deliver large items from big box retailers across the San Diego region.

An investigation by the LCO’s Bureau of Field Enforcement (BOFE) determined that drivers working under Mega Nice Trucking were systematically misclassified as independent contractors, depriving them of basic workplace protections such as minimum wage, overtime pay, and legally mandated meal and rest breaks.

Although the drivers were reclassified as employees in 2023, the violations persisted. Workers continued to receive a flat daily rate without proper compensation for overtime hours or missed meal breaks. Investigators also uncovered falsified payroll records, suggesting deliberate efforts to conceal these ongoing labor law violations.

The LCO also found that Costco and Ryder Last Mile exercised both direct and indirect control over the delivery drivers. They scheduled deliveries, mandated uniforms, enforced specific protocols, and closely monitored driver performance. These actions establish a joint employer relationship with Mega Nice Trucking and make Costco and Ryder Last Mile equally liable for the misclassification and resulting wage theft.

The investigation began in July 2024 after two former Mega Nice Trucking employees filed complaints alleging wage theft and misclassification. During the investigation, Mega Nice Trucking admitted to misclassifying its drivers. Investigators also discovered that the company had previously been penalized by the California Employment Development Department for similar violations, indicating a repeated pattern of noncompliance.

Costco, Ryder Last Mile, and Mega Nice Trucking have been jointly cited by the LCO for a total of $868,128, of which $662,978 is payable to the affected workers. All three employers have appealed the citations.

The Bureau of Field Enforcement (BOFE) is a unit within the LCO enforcing key labor laws through on-site investigations and strategic enforcement actions.

BOFE targets industries with high rates of labor violations, conducting workplace inspections to uncover wage theft, child labor violations, failure to carry workers’ compensation insurance, and other unlawful employment practices. Its work helps ensure fair treatment for workers while promoting a level playing field for responsible employers.

BOFE has issued more than 2,200 citations against employers for labor law violations between January 2022 and October 2025, recovering over $48.4 million in stolen wages, damages, and interest on behalf of workers.

This comes on top of multiple announcements this year highlighting a range of violations, including a settlement of $431,601 to return unpaid wages and damages to 86 carpenters, $1.1 Million in penalties issued to a Buena Park restaurant over wage and sick leave violations, and a citation of over $2 million for another case of misclassifying workers.

BOFE has also issued more than 3,100 notices to discontinue labor law violations in the past year, and corrected violations that collectively impacted more than 40,000 California workers.

NCCI Publishes 3rd Quarter Medical Inflation Insights Report

The NCCI Medical Inflation Insights report provides a quarterly overview of the latest insights and analysis into what is driving changes in claim costs, and how these changes may or may not impact workers compensation. NCCI released its latest quarterly edition on October 30, 2025.

The Workers Compensation Weighted Medical Price Index (WCWMI) is a composition of medical cost components from the Producer Price Index and the Consumer Price Index, reweighted using our Medical Call data to better match the mix of spend in workers compensation.

In the third quarter of 2025, the average medical cost for a lost-time workers-compensation claim climbed 3.8 % compared with the same quarter a year earlier – noticeably above the 2.4 % rise in the Consumer Price Index for Medical Care yet only half the 7–8 % jumps seen in group-health plans.

Physician services, which make up four out of every ten medical dollars, rose 4.2 %, pushed higher by more office visits and pricier evaluation-and-management codes. Hospital outpatient payments jumped 5.1 % as facilities layered on extra facility fees and shifted routine injections into hospital-owned clinics. Inpatient hospital costs stayed nearly flat, gaining just 0.8 %, thanks to fixed per-diem schedules in many states. Prescription-drug spend held steady at 0.0 % change, the eighth straight quarter of no inflation, as generics now fill 93 % of scripts and opioid volume has fallen 45 % in five years.

Zoom out and the picture softens: the one-year rolling average sits at +3.5 %, the three-year average at +2.9 %, and the five-year average at +2.4 % – all comfortably below the 4–6 % medical inflation that carriers baked into 2025 rate filings.

However, based on historical trends and the broader economic backdrop, NCCI believe this softening is more likely to be temporary than a new emerging trend. Should hospital services price growth rise back into the 4% to 5% range next year and other categories remain constant, overall price growth would be closer to 3% rather than the current 2.5%

Looking ahead, early 2026 claim data show physician and outpatient prices still accelerating, but a wave of new generic launches and tighter hospital networks should keep the full-year increase under 4 %. For the first time in three years, workers-comp medical trend is once again tracking below both Medicare and group-health benchmarks, giving underwriting teams breathing room on loss costs and reserves.

Trader Joe’s Successfully Defends Worker’s Retaliatory Termination Case

On September 25, 2019, at a Trader Joe’s store where Ortiz and her brother, Noe Ortiz, were employed, Noe was knocked to the ground when another employee, Alex Salas, slammed a U-boat cart loaded with produce into Noe’s flatbed cart.

Noe appeared visibly injured and upset, though he stated he was okay. Ortiz expressed concern about the incident to a supervisor, who allegedly disciplined her verbally and told her to mind her own business. Ortiz was terminated a few days later for purportedly unprofessional conduct, which she claimed was pretextual retaliation for reporting unsafe workplace conditions.

Ortiz filed a lawsuit alleging breach of contract, tortious breach of the implied covenant of good faith and fair dealing, retaliation under Labor Code section 6310 (prohibiting discharge for reporting work-related injuries or unsafe conditions), and wrongful termination in violation of public policy based on Labor Code § 6310 and 132a (barring retaliation for workers’ compensation claims).

Trader Joe’s demurred to the contract and implied covenant claims and the trial court sustained the demurrer without leave to amend as to the implied covenant claim but overruled it as to the breach of contract claim. Ortiz did not appear at the demurrer hearing, and the record on appeal lacked a transcript or the court’s written ruling on this matter.

Trader Joe’s subsequently moved for summary judgment on the remaining claims, arguing that Ortiz could not establish protected activity under Labor Code § 6310, as there was no evidence of a work-related injury to Noe (e.g., no broken bones, medical treatment, or workers’ compensation claim) or an unsafe working condition (the incident was described as an isolated accident without malice or prior similar occurrences).

Trader Joe’s also presented evidence that Ortiz was terminated for repeated violations of its Crew Member Conduct Policy, including prior performance reviews documenting unprofessional behavior and a statement from Salas describing Ortiz’s combative response to him. Additionally, Trader Joe’s contended that Ortiz was an at-will employee, defeating her breach of contract claim, and that there was no link between her 2012 workers’ compensation application and her 2019 termination, undermining her Labor Code § 132a-based claim.

Ortiz opposed the motion focusing on her retaliation claim and submitting a declaration asserting that Noe appeared hurt, that she reported the incident because he was injured, and that it involved unsafe work practices. Following a hearing, the trial court granted summary judgment finding no triable issues: no evidence of injury or unsafe conditions under Labor Code § 6310, at-will employment status barring the contract claim, and no retaliation linked to section 132a.

On appeal, Ortiz challenged the demurrer ruling on her implied covenant claim and the summary judgment grant. The judgment was affirmed by the Court of Appeal in the unpublished case of Ortiz v. Trader Joe’s Co., -B329657.PDF (October 2025).The opinion emphasized that isolated accidents without harm or systemic risks do not constitute protected reports under Labor Code § 6310.

The appellate court held that Ortiz forfeited her demurrer challenge due to an inadequate record (lacking the trial court’s ruling or hearing transcript) and insufficient briefing, which failed to articulate the claim’s elements or explain why the allegations sufficed, violating California Rules of Court and established precedents emphasizing the appellant’s burden to provide reasoned argument and authority.

“[I]t is a fundamental principle of appellate procedure that a trial court judgment is ordinarily presumed to be correct and the burden is on an appellant to demonstrate, on the basis of the record presented to the appellate court, that the trial court committed an error that justifies reversal of the judgment.” (Jameson v. Desta (2018) 5 Cal.5th 594, 608–609 (Jameson).) “ ‘ “A necessary corollary to this rule is that if the record is inadequate for meaningful review, the appellant defaults and the decision of the trial court should be affirmed.” ’ ” [Citation.] ‘Consequently, [the appellant] has the burden of providing an adequate record.’ ” (Id. at p. 609.)

Regarding summary judgment, reviewed de novo, the court applied the McDonnell Douglas burden-shifting framework to Ortiz’s Labor Code § 6310 retaliation claim, requiring a prima facie showing of protected activity, adverse action, and causation.

Trader Joe’s met its initial burden by citing Ortiz’s deposition testimony confirming no injury (e.g., no medical treatment or lost time) and describing the incident as an isolated accident. The burden then shifted to Ortiz, who failed to raise a triable issue. Her declaration was deemed speculative, conclusory, and self-serving, contradicted by her own testimony and other evidence (e.g., Noe’s statement that he was “good,” and no corroboration of injury).

The court interpreted “work-related injury” under Labor Code § 6310 by analogy to reportable occupational injuries under section Labor Code § 6409.1, requiring lost time or medical treatment beyond first-aid criteria unmet here.

Similarly, no evidence supported a reasonable belief in an unsafe working condition or practice. As Ortiz’s wrongful termination claim depended on violations of Labor Code § 6310 or 132a, it failed accordingly.

CDC Adopts Individual-Based Decision-Making for COVID-19 Shots

The Centers for Disease Control and Prevention (CDC) updated its adult and child immunization schedules to apply individual-based decision-making to COVID-19 vaccination and recommend that toddlers receive protection from varicella (chickenpox) as a standalone immunization rather than in combination with measles, mumps, and rubella vaccination.

The immunization schedules adopt recent recommendations by the CDC Advisory Committee on Immunization Practices (ACIP), which were approved recently by Acting Director of the CDC and Deputy Secretary of Health and Human Services Jim O’Neill.

“Informed consent is back,” said Deputy Secretary O’Neill. “CDC’s 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today.

“I commend the doctors and public health experts of ACIP for educating Americans about important vaccine safety signals. I also thank President Trump for his leadership in making sure we protect children from unintended side effects during routine immunization.”

Unlike the COVID-19 primary series vaccination pioneered by Operation Warp Speed (OWS) that reached a estimated nearly 85% of the U.S. adult population, just 23% of adults followed the CDC’s most recent seasonal booster recommendation according to its National Immunization Survey. The booster shots prompted widespread risk-benefit concerns about their safety and efficacy as the COVID-19 virus became endemic following population-wide immunity acquired during the pandemic and OWS.

ACIP’s recommendation emphasized that the risk-benefit of vaccination in individuals under age 65 is most favorable for those who are at an increased risk for severe COVID-19 and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors. The U.S. Food and Drug Administration has approved marketing authorization for COVID-19 vaccines for individuals who have one or more of these risk factors, as well as for individuals age 65 and older.

Individual-based decision-making is referred to on the CDC’s immunization schedules as vaccination based on shared clinical decision-making, which references providers including physicians, nurses, and pharmacists. It means that the clinical decision to vaccinate should be based on patient characteristics that unlike age are difficult to incorporate in recommendations, including risk factors for the underlying disease as well as the characteristics of the vaccine itself and the best available evidence of who may benefit from vaccination.

Like routine recommendations, individual-based-decision-making allows for immunization coverage through all payment mechanisms including entitlement programs such as the Medicare, Medicaid, Children’s Health Insurance Program, and the Vaccines for Children Program, as well as insurance plans regulated by the Affordable Care Act.

The CDC child and adolescent immunization schedule’s new recommendation of standalone chickenpox vaccination for toddlers through age three follows evidence presented to ACIP by the CDC Immunization Safety Office’s that healthy 12–23 months old toddlers have increased risk of febrile seizure seven to 10 days after vaccination for the combined measles, mumps, rubella, and varicella vaccine compared to those given immunization for chickenpox separately. The combination vaccine doubles the risk of febrile seizures without conferring additional protection from varicella compared to standalone vaccination.

DOI Seeks Public Input on Proposed Long-Term Solvency Regulation

The California Department of Insurance will conduct a prenotice public discussion regarding contemplated adoption of California Code of Regulations, Title 10, Chapter 5, Subchapter 3, Article 4.7 (commencing with section 2319.7). The proposed regulations aim to clarify the information related to emerging risks faced by insurance companies that the Department will consider during future financial examinations.

Participation in this prenotice public discussion will be in addition to, and not in substitution for, any participation in any formal rulemaking process that may follow. This invitation to the prenotice public discussion does not constitute a Notice of Proposed Action. Consequently, comments (oral or written) received in connection with these prenotice public discussions will not be included in any record of rulemaking that may follow. Similarly, the Department is not required to respond to comments received in connection with the prenotice public discussion. For this reason, if you wish to have comments included in any rulemaking file that may follow, or if you wish for the Department to respond to your comments as part of the process by which it adopts this regulation, you must present your comments during the public comment period according to the procedures outlined in any Notice of Proposed Action.

To increase public participation and improve the quality of regulations, interested parties are invited to attend the virtual meeting and offer comment, if they so choose. In connection with this prenotice public discussion, the Department hereby seeks public input regarding alternatives to the contemplated regulations.

This meeting is scheduled for November 14, 2025 at 10:30 a.m. The virtual workshop shall continue until all in attendance wishing to provide comments have commented, or 12:00 p.m., whichever is earlier. The link to register for the Web-based Virtual Format is https://us06web.zoom.us/webinar/register/WN_8L5R7ixrQK-e5QiKOTReig. Other methods of submitting comments are contained in the Prenotice Public Discussion Invitation.

The Long-Term Solvency Regulation aligns with the Commissioner’s work as a member of the International Association of Insurance Supervisors (IAIS), where he contributed to the development of guidance for insurance supervisors on climate risks, as well as various reports and standards. The regulation focuses on solvency strategies and leverages the growing implementation of standardized climate risk disclosures by regulators worldwide, alongside UN-led efforts to establish the Principles for Sustainable Insurance and the Sustainable Development Goals.

Topics of Interest Include:

– – Using global tools to safeguard Californians: Financial regulators from the Banque de France, the Bank of England, the Bank of the Netherlands, Canada’s chief insurance regulator, and the Monetary Authority of Singapore have participated in scenario analysis exercises. This presents an opportunity for enhanced collaboration among regulators to promote sustainability in insurance markets and to develop frameworks for addressing emerging risks. As the largest sub-national insurance market in the world, California’s regulator must actively engage and secure a seat at the table in global discussions on long-term risk analysis and solvency.

– – Robust financial oversight is essential for the security of Californians: The Department of Insurance supervises California-based insurance companies to ensure their stability and capacity to meet future obligations. According to the draft regulatory text released today, these companies must provide information to the Department to strengthen consumer protection against unforeseen challenges. Over the past three years, The Commissioner has contributed to the technical guidance of the IAIS climate risk framework, which has informed this proposed regulation as well as existing regulations in Europe for the banking industry.

– – New information on impact of climate and technology: Insurance companies are significant institutional investors in the U.S., with approximately $8.2 trillion in assets reported in 2022. Their investment performance directly influences their capacity to underwrite new policies. The Long-Term Solvency Regulation requires documentation of risks and opportunities projected for 2030, 2040, and 2050, which could impact underwriting, investments, or operations.

– – Addressing cybersecurity and artificial intelligence: The regulation will also address the evolving landscape of cybersecurity, focusing on data quality, the use of large datasets, and artificial intelligence.

– – Mitigating catastrophic risk: Companies will be required to share information on strategies to mitigate climate-related risks, such as extreme weather patterns and gradual market shifts expected to become pronounced by 2050. These risks include sea-level rise, changes in land use, and variations in water availability and agricultural productivity.

– – Enhancing stability amid transitions: The regulation will require information on transition risks associated with new technologies, particularly regarding the reduction of reliance on greenhouse gas-emitting technologies. Central to this effort are “stress tests” of climate risk scenarios for 2030, 2040, and 2050.

Scenario analysis is a critical risk management tool for navigating uncertainty,” said Dr. Sean Carmody, Executive Director, Policy and Advice Division of the Australian Prudential Regulation Authority, the country’s insurance regulator. “It helps institutions anticipate and prepare for emerging risks—such as the impact of a changing climate and rapid technological innovation—by exploring a range of plausible futures and identifying areas of vulnerability and strategies that can strengthen resilience in the financial system.”

DWC Posts Draft Regulations Updating EAMS Rules

The Division of Workers’ Compensation (DWC) has posted proposed changes to its Electronic Adjudication Management System (EAMS) Rules to its online forum where members of the public may review and comment on the proposals. The forum will be closed after November 12, 2025.

The EAMS Rules have not been updated since 2012. The proposed updates allow for submission of documents with electronic signatures, consistent with Government Code and Secretary of State Regulations authorizing digital signatures on communications with public entities. The proposed updates also allow for electronic filing and service of all WCAB case related documents in EAMS rather than requiring service by mail.

The proposed changes will update the California Code of Regulations, Title 8, Chapter 4.5, Division of Workers’ Compensation, Subchapter 1.8.5, Electronic Adjudication Management System Rules, Sections 10205.3, 10205.4, 10205.5, 10205.6, 10205.7, 10205.8, 10205.9, 10205.10, 10205.11, 10205.12, 10206.1 and 10206.2.

These proposed changes will increase the efficiency of EAMS for stakeholders and reduce costs to DWC, parties and members of the public by decreasing expenditures on paper and postage.

The forum can be found online on the DWC forums web page under “current forums.” Comments will be accepted on the forum until 5 p.m. on November 12, 2025.

October 20, 2025 – News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: WCAB En Banc Coldiron Decisions Not Superseded by New Regs. Hospital Association Files Lawsuit Against California Spending Caps. New Laws Get Tough on Illegally Uninsured Contractors. New Automated Employment Decision Systems (AEDS) Regulations. Oracle AI Database Increases Children’s Hospital L.A. Efficiency 98%. Pharmacist Job Postings Increased 38% Nationwide in 2025. Health Net Settles Inaccurate Provider Directories Case for $40M. Remote Workers Will Take 25% Pay Cut, But Actually Get 1% More.

Visiting Store Just to Build a Lawsuit No Defense to Unruh Damages

Darren Gilbert, who had lost part of his left leg and some toes on his right foot, relied on a prosthetic leg and wheelchair to get around. In August 2021, he pulled his wheelchair-accessible van into a 7-Eleven in Rio Linda, California.

The van-accessible parking spot was taken, so he parked in a regular space, climbed out on his prosthetic, and made his way across the lot. The curb ramp to the sidewalk was steep and uneven; he struggled to keep his balance and felt exhausted by the effort just to reach the door. Inside, he bought a few items and left.

Two months later, Gilbert sued 7-Eleven under the Americans with Disabilities Act (ADA) and California’s Unruh Civil Rights Act. He claimed the store’s parking lot and entryway violated federal accessibility standards and denied him equal access because of his disability. He wanted the barriers fixed and statutory damages under state law.

While the case was pending, 7-Eleven quietly remodeled the parking lot and entrance. By the time the case went to trial, the store had a fully compliant van-accessible stall, access aisle, curb ramp, and walkway.

The district judge ruled that the ADA claim for an injunction was now moot – there was nothing left to fix. But the violations had existed when Gilbert visited, and because any ADA violation automatically triggers liability under the Unruh Act, the judge awarded Gilbert $4,000 in statutory damages.

7-Eleven appealed, making three main arguments.First, it said Gilbert hadn’t proven that removing the barriers was “readily achievable” under the ADA – after all, he hadn’t submitted cost estimates or design plans. The Ninth Circuit disagreed. Yes, plaintiffs typically have to propose a plausible fix whose benefits seem to outweigh the costs. But 7-Eleven had already fixed everything voluntarily, without claiming it was burdensome. That alone proved removal was feasible. The company could not meet its own burden to show otherwise.

Secondly, 7-Eleven argued that Gilbert needed to prove his experience was worse than an able-bodied person’s – that the barriers affected him specifically because of his disability. The court rejected that argument also. If a physical barrier violates the ADA’s technical standards and relates to the plaintiff’s type of disability (here, mobility impairment), and the plaintiff personally encounters it, that’s discrimination. No side-by-side comparison is required.

Finally, 7-Eleven attacked Gilbert’s standing under the Unruh Act. The district judge had found that Gilbert’s real reason for visiting was to build a lawsuit – he’d filed about 70 similar cases – and that his purchase was just a pretext. 7-Eleven insisted that without a “bona fide” intent to be a genuine customer, he could not recover.

The Ninth Circuit Court of Appeals affirmed the district court’s award of statutory damages for Gilbert’s claim that 7-Eleven violated § 51(f) of the Unruh Act in the published case of Gilbert v. 7-Eleven, Inc. 23-4045 (October 2025).

California law is clear: if you walk (or roll) into a store, encounter discrimination, and transact business, you have been injured under the Unruh Act. Motivation to sue is irrelevant. The California Supreme Court had already said so in earlier cases: even “professional plaintiffs” who pay a discriminatory fee or face a real barrier have standing. And for construction-related accessibility claims like this one, state law spells out exactly what’s needed: personal encounter plus some difficulty, discomfort, or embarrassment. Intent to return or shop again is not on the list.

The court distinguished a recent California Supreme Court case involving online terms of service in White v. Square, Inc., 7 Cal.5th 1019 (2019) 250 Cal.Rptr.3d 770 446 P.3d 276, where intent did matter – because the plaintiff never transacted at all. Here, Gilbert bought something from the store at the time of his visit. That was enough.

Darren Gilbert passed away in July 2024, before the appeal was decided. His successors stepped in. The Ninth Circuit affirmed the $4,000 award in full and sent the case back only to sort out the substitution formalities.

In the end, a voluntary fix helped prove the violation, a completed purchase established standing, and a litigation motive changed nothing. The barriers were real, the injury was personal, and California law demanded accountability.

DWC Opens Registration for 33rd Annual Educational Conference

The California Division of Workers’ Compensation (DWC) announced that registration for its 33rd annual Educational Conference is now open. The conference will take place in person on March 5-6, 2026 at the Oakland Marriott City Center Hotel and on March 19-20, 2026 at the Los Angeles Airport Marriott.

This annual event is the largest workers’ compensation training in the state and allows claims administrators, medical providers, attorneys, rehabilitation counselors, employers, human resources professionals and others to learn firsthand about the most recent developments in the system.

Attendees will have the opportunity for face-to-face networking with colleagues and will learn about current topics from a variety of workers’ compensation experts from DWC, other state and public agencies, as well as the private sector.

DWC has applied for continuing educational credits from attorney, rehabilitation counselor, case manager, disability management, human resource and qualified medical examiner certifying organizations, among others.

Organizations who would like to become sponsors of the DWC conference can do so by going to the International Workers’ Compensation Federation (IWCF) website.

Attendee, exhibitor, and sponsor registration may be found at the DWC Educational Conference webpage.

Tentative Topics Include:

• DWC Update
• AI with a Claims Focus
• Medical and Legal Ethics
• Women in Law and Business
• Cumulative Trauma
• Apportionment
• Chronic Pain Treatment
• Case Law Update
• Top Litigation Tips
• Med/Legal Report Writing
• Alternative Dispute Resolution

New Drug Launch Price Increases Exceed Inflation Benchmarks

The Institute for Clinical and Economic Review (ICER) is an independent, non-profit research institute that conducts evidence-based reviews of health care interventions, including prescription drugs, other treatments, and diagnostic tests. In collaboration with patients, clinical experts, and other key stakeholders, ICER analyzes the available evidence on the benefits and risks of these interventions to measure their value and suggest fair prices. ICER also regularly reports on the barriers to care for patients and recommends solutions to ensure fair access to prescription drugs.

ICER just released its new 118 page “Launch Price and Access Report,” finding that drug launch prices continue to rise at a rate that exceeds inflation, gross domestic product (GDP) growth, and overall healthcare costs.

ICER’s analysis focused on “net price,” or the actual price paid after rebates and discounts, offering crucial information to policymakers, given that most previous analyses of drug pricing trends focus on the publicly available “list price,” which does not always reflect the actual price paid.

The report, using net prices, found that the inflation-adjusted median annual launch price of drugs increased by 51% from 2022 to 2024, while the annual list price increased 24% during the same period. Even after accounting for the differences in the mix of drugs approved each year (by holding certain characteristics constant, like the number of gene therapies approved), the annual net launch price increased by 33% per year.

ICER also conducted an in-depth review of the 23 drugs in scope that had been previously reviewed by ICER. The analysis indicated that aligning the prices of these therapies with ICER’s Health Benefit Price Benchmark (HBPB) could have saved approximately $1.3 to $1.5 billion in the first year post-approval alone – savings that could have been redirected to higher-value drugs and services.

To evaluate the patient access barriers to newly launched drugs, ICER focused on the novel drugs approved in 2024. For the majority of these drugs, insurance coverage policies were not publicly available, even up to one year after approval, and the majority of commercial first-time prescriptions for newly approved drugs were rejected. Non-coverage of the drug was the most common reason for rejection.

The results of ICER’s independent analysis on trends in launch pricing and patient access highlight the critical moment facing the U.S. health care system,” stated ICER’s President and CEO Sarah K. Emond, MPP. “Launch prices are going up, patient access is going down, and in many cases, we are overpaying for treatments. As Americans confront rising health insurance premiums and risk losing health insurance altogether, it has never been more critical to move towards a system that pays for value. When we price treatments based on the benefits they deliver to patients, we ensure Americans have access to affordable, high-quality treatments, all while continuing to reward the hallmark innovation of the U.S. pharmaceutical industry.”