In today’s fast-paced world, the conversation around mental health has taken center stage in workplace wellness initiatives. As employers strive to create a more supportive and resilient workforce, integrating mental health resources into employee benefits and absence strategies has never been more critical.

According to the National Institute of Mental Health, nearly 1 in 5 U.S. adults live with a mental illness1. That number rises significantly among working-age adults, especially in high-stress professions or environments lacking psychological safety and support. This increased prevalence of mental illness leads to more time away from work, reduced ability to perform while present, and an increase disability claims incidence rates.

The Insurance Impact: Disability & Mental Health Claims

From a disability insurance standpoint, behavioral health-related disability claims are a major concern for Benefits and HR teams across the country. Mental health conditions like anxiety, depression, PTSD, and burnout are now among the leading causes of short term and long term disabilities.

A significant area of concern and recent discussion pertains to the common inclusion of a 24-month lifetime limitation for mental health-related claims in long term disability (LTD) policies. The consequence of this provision is that an employee whose disability stems from a mental health condition becomes ineligible for continued LTD benefits after a lifetime combined 24 months, even if they continue to meet the plan’s definition of disability. These limitations stand in contrast to individuals experiencing other types of disability, who are not subjected to an equivalent restriction. While the rationale for such limitations includes mitigating plan risk exposure by capping the duration and encouraging a return to work before prolonged disengagement, these provisions undeniably create a disparity in the treatment of individuals with different types of disabilities. Furthermore, they are frequently perceived as being at odds with the array of mental health initiatives that employers are increasingly implementing to address the escalating incidence of mental health issues within their workforce.

Tools to Help: Leveraging Absence and Benefits Strategy

Employers have the opportunity and, some would argue, the responsibility to take a proactive role in supporting mental health. Integrating meaningful mental health resources into leave and benefits programs is no longer optional. It is a critical business imperative. Leading organizations are stepping up to close the gap in several ways.

1. Employee Assistance Programs (EAPs) and Virtual Behavioral Health Programs

EAPs are often an underutilized resource, despite their potential to have a real, immediate impact. EAPs are employer-sponsored programs that are designed to help support employees’ health habits and well-being. Some common examples include counseling, substance abuse support, financial guidance, and legal advice. By actively promoting EAPs and embedding access points and reminders to employees throughout the leave process, employers can help support an employee’s mental health challenges.

To further assist employees with mental health concerns, employers can offer virtual Behavioral Health programs. These programs can significantly enhance employee mental health by expanding access to care and offering convenient and confidential support from anywhere. This accessibility helps overcome traditional barriers like stigma, travel, and scheduling conflicts, enabling earlier intervention and consistent engagement with mental health services. Ultimately, these programs empower employees to manage their well-being proactively, leading to improved overall health and productivity.

2. Financial Wellness Resources

Financial stress significantly impacts mental health. When employees grapple with issues like debt, budgeting difficulties, or unexpected expenses, they often experience heightened anxiety, reduced focus, and even physical symptoms2. This direct link underscores the importance of addressing financial well-being as a component of overall mental health support.

Employers can play a crucial role by offering financial counseling, whether through specialized vendors or as part of a broader EAP. This type of support helps employees navigate their financial challenges, which in turn can alleviate the associated mental burden. When an employee takes leave for mental health reasons, integrating recovery resources with financial guidance can create a more holistic approach, promoting greater well-being and facilitating a smoother return to work.

3. Integrated Absence Management Programs

Forward-looking integrated absence management programs take a holistic view of why an employee may be absent from work, coordinating federal protections such as the Family Medical Leave Act (FMLA) and the Americans with Disabilities Act (ADA), state leave programs, and employer-specific offerings. Taking an integrated approach not only streamlines compliance, but also allows for early intervention and triage, ensuring that mental health needs are identified and addressed as part of the overall leave experience.

The Bigger Picture: Prevention and Culture

Prevention remains the most cost-effective approach. Employers can have an impact by building a workplace culture where mental health is normalized and where resources are visible and accessible. Communication is also key. In addition to formal programs and benefits, employers can provide employees with education and resources such as Alera Group’s Mental Health Awareness Toolkit, which provides employers with email templates, campaigns, and more to help support employee wellbeing and keep their colleagues informed about what resources they have.

Employers that prioritize mental well-being as part of their overall strategy are seeing positive results across the board. These include shorter claim durations, higher employee engagement, and reduced turnover. Mental health challenges are not going away, and the workplace plays a key role in both creating and addressing these issues. By utilizing tools like EAPs, virtual Behavioral Health programs, financial counseling, and integrated absence programs, employers can reduce the long-term costs and disruptions of behavioral health-related absence, while helping their employees lead healthier lives.

1National Institute of Mental Health (NIMH), “Mental Illness,” 2023. https://www.nimh.nih.gov/health/statistics/mental-illness
2Debrosky, “Why Are Mental Health Disability Claims Denied More Often? Insights from Mark DeBofsky on Main & Wall” 2024. https://www.debofsky.com/articles/denied-mental-health-disability-claims/#:~:text=Most%20long%2Dterm%20disability%20policies,which%20creates%20an%20unfair%20distinction.
3American Psychological Association (APA), “Stress in America: The State of Our Nation,” 2023. https://www.apa.org/news/press/releases/stress

Substance use disorder (SUD) is often discussed in relation to student health and wellness across colleges and universities. Just as important, but sometimes overlooked, are faculty, administrators, and staff who may be silently struggling with substance use or supporting loved ones who are.

When schedules are demanding and support systems may be limited, institutions can better support their workforce by offering comprehensive and stigma-free solutions related to SUD and recovery.

Understanding Substance Use Disorder

Substance use disorder is a chronic condition affecting millions of Americans.  It’s often characterized by the compulsive use of substances such as alcohol, prescription medication, or illicit drugs despite harmful consequences, with impacts felt across all socioeconomic, professional, and educational backgrounds.

According to the National Survey on Drug Use and Health, about one in eleven full-time workers struggles with SUD, and nearly 12 percent of U.S. adults live with someone in recovery. ¹

Why It Matters

Workplace cultures that reward overworking, multitasking, and perfectionism may add to the pressure.  In education specifically, faculty and staff may silently manage stress or avoid disclosing personal struggles out of fear for their careers or a desire to prioritize student health. Since academic institutions influence the broader community, unaddressed employee struggles can impact student experience, productivity, and retention.

Supporting recovery is more than a wellness initiative, it is a cultural responsibility and a strategic investment in employee wellbeing.

What Recovery-Supportive Workplaces Can Offer

Limitless options exist in supporting employees with substance use disorders or those who are caregivers for family and friends with similar challenges.  The most common is to provide programs that focus on this area, but perhaps even more important is to foster a culture that allows employees to take advantage of these programs and feel supported. 

Programs that should be considered include, but not be limited to, the following:

Employee Assistance Programs (EAPs)

EAPs can provide free counseling, treatment referrals, and crisis support. Promoting awareness and confidentiality is essential to building trust in these services.

Recovery-Focused Benefits Platforms

Some employers partner with vendors to provide treatment matching, sobriety coaching, medication-assisted treatment, and caregiver resources.

Flexible Leave Policies

Non-punitive leave for treatment and recovery can make it easier for employees to seek help. Review existing policies to ensure they support behavioral health needs.

Caregiver Support

Employees supporting a loved one through addiction need resources, too. Solutions that offer navigation support, stress management, and mental health care can ease the burden.

Training for Managers and HR

Educating leadership on how to recognize signs of SUD and refer employees to resources ensures the first response is supportive, not disciplinary.

Campus Recovery Communities

Some colleges have launched employee recovery groups or partnered with local organizations like AA or NA to provide safe, supportive spaces.

Breaking the Stigma

Regardless of the programs implemented, the culture within your organization can directly impact success.  Stigma remains one of the greatest barriers to seeking help. Misconceptions that SUD is a moral failing rather than a health condition prevent many from accessing support. This is especially true in academia, where self-sufficiency and achievement are often prioritized.

Using person-first language—such as “person with a substance use disorder” instead of “addict”—can help humanize and normalize these experiences. Institutions that model this language in policy and communication help shift the culture.

If this bias exists, it likely extends beyond SUD to all mental health or substance use concerns. Therefore, adopting a culture that actively works to break the stigma will help all employees.

1Substance Abuse and Mental Health Services Administration. 2022 National Survey on Drug Use and Health (NSDUH).
2SAMHSA National Helpline: https://www.samhsa.gov/find-help/national-helpline
3Shatterproof Treatment Atlas: https://treatmentatlas.org

Rapidly emerging technologies are now guiding patients through the complexities of the healthcare system and helping them receive care that best fits their individual needs. Artificial intelligence (AI) is being used to bridge gaps in healthcare access by supporting patient navigation, ensuring patients understand their options and are directed to the most appropriate providers, care settings, and treatment paths. Although many tools are working behind the scenes, the benefits to patients and providers are vast, but must be carefully monitored to avoid inadvertent consequences. 

Patient Data Management

Electronic health records (EHRs) store vast amounts of information, much of which is unstructured. Natural language processing (NLP), a subset of AI, can interpret and extract meaningful insights from these notes, making them useful for predicting diagnoses and delivering individualized care recommendations. This significantly improves data accessibility, especially when extracting information from scanned documents, which have long posed challenges. It also contributes to cost reduction and enhanced care quality. The ability to mine patient data will allow providers to more quickly assess care and make recommendations, sometimes based on systematic analysis.

Automated Communication

AI-powered chatbots and virtual health assistants are transforming communication in healthcare, enabling instantaneous, 24/7 interactions that improve patient engagement. These tools can respond to routine inquiries, offer care options, provide health advice, and remind patients about appointments or medications. This kind of around-the-clock support enhances convenience and personalization, making healthcare navigation more user-friendly and patient-centric.

Provider Matching and Scheduling

AI-driven scheduling platforms and algorithms help patients identify and access the most appropriate healthcare services while also improving operational efficiency for providers. These tools match patients with in-network providers based on personalized criteria such as location, insurance, and specialty. AI and machine learning applications can find appointment slots that meet patient needs, factoring in provider availability and urgency of care. One powerful feature is real-time adaptability, which enables appointment reallocation to accommodate urgent cases with minimal disruption. The result is reduced wait times, better resource allocation, greater transparency, and improved patient satisfaction.

AI Detection

AI is highly effective in identifying patterns and correlations to aid in the prediction and diagnosis of diseases. Several case studies highlight AI’s growing role in early detection and risk prediction for conditions such as cancer, diabetes, and heart disease, as well as other chronic illnesses. As machine learning and NLP algorithms are exposed to more data, their accuracy and reliability continue to improve. Early identification helps shape the course of treatment and enables timely intervention. Another cutting-edge advancement is symptom analysis and virtual triage, where patients can conduct self-assessments and receive guidance on when and where to seek care. This empowers patients with accessible information and helps reduce unnecessary visits to the emergency room.

The Future of AI-Powered Care Navigation

The use of AI in healthcare navigation will continue evolving and further revolutionize the patient experience. One major trend is the movement toward highly personalized care, with AI tailoring guidance to each patient’s unique needs. Future developments may include enhanced AI features in medical imaging for diagnostics and greater integration with wearable health monitoring technologies. While AI-powered navigation tools have already made significant progress, there remains vast potential to further streamline the patient journey and break down access barriers. This will ensure timely, effective, and patient-centered care.

Source: Maleki Varnosfaderani, S., & Forouzanfar, M. (2024). The Role of AI in Hospitals and Clinics: Transforming Healthcare in the 21st Century. Bioengineering (Basel, Switzerland), 11(4), 337. https://doi.org/10.3390/bioengineering11040337

CAs focus continues to grow on mental wellbeing and diversity, the concept of neurodiversity has garnered increasing attention. Neurodiversity refers to the range and variation in how human brains function, and includes conditions such as autism, ADHD, Tourette’s, dyslexia, dyspraxia, social anxiety disorders, and more. Recognizing and supporting these differences can foster inclusivity, innovation, and personal wellbeing. Cognitive wellness tools are playing a crucial role for employers looking to help all employees thrive.

Neurodiversity challenges the idea of a single “normal” brain type. It highlights that neurological differences are not deficits, but rather variations in processing, communication, and learning. While the potential benefits of hiring a diverse workforce are high, reports estimate that the unemployment rate in the U.S. for neurodivergent individuals is between 30% and 40%.[1] Embracing neurodiversity promotes equity in education, work, and healthcare by acknowledging the unique strengths and needs of each person. In addition, neurodivergent individuals may be highly skilled, more productive, and exhibit different strengths than neurotypical individuals, such as attention to detail or direct communication skills.

To address this gap, various tools—often referred to as cognitive wellness tools—have emerged. Cognitive wellness focuses on supporting brain health and functionality through personalized strategies. For neurodivergent individuals, this may include tools that assist with executive function, focus, emotional regulation, and sensory processing. Investing in cognitive wellness has been shown to reduce burnout and improve productivity—not just for neurodivergent individuals, but for all employees.

There are a variety of tools available:

  1. Digital Apps: Tools like MindMeister, Todoist, and Calm help with organization, mindfulness, and task management.
  2. Assistive Technology: Speech-to-text software, noise-canceling headphones, and screen readers enhance accessibility.
  3. Therapeutic Supports: Cognitive Behavioral Therapy (CBT) adapted for neurodivergence, occupational therapy, and coaching foster self-understanding and practical skills.
  4. Workplace & Educational Tools: Flexible work arrangements, sensory-friendly environments, and universal design principles empower success in diverse settings.

In addition, employers must comply with laws such as the Americans with Disabilities Act (ADA), which may extend to certain neurodivergent conditions, including autism or ADHD. This means that employers may be required to engage in the interactive process to ensure employees and prospective employees are provided with fair opportunities to succeed. Possible accommodations include:

Supporting neurodiversity through cognitive wellness tools is more than just a trend—it’s a necessary evolution. By integrating technology, therapy, and systemic accommodations, we can empower neurodivergent individuals to thrive and contribute their full potential in the workplace.

1 https://imagine.jhu.edu/blog/2022/10/05/neurodivergence-at-a-glance/

Medical stop-loss coverage protects organizations that self-insure their health plans from catastrophic medical and prescription drug claims. It has long been a valuable tool for small- and medium-sized employers seeking to limit their financial exposure to unexpected, high-cost claims. However, as healthcare and insurance dynamics shift, even large employers are increasingly turning to stop-loss coverage, particularly through captive insurance models.

1. Hardening Markets and Rising Premiums

Insurance markets have been hardening, with factors such as the lingering effects of the COVID-19 pandemic, economic uncertainty, and climate-related disasters (e.g., California wildfires, Hurricane Milton, etc) driving up premiums. Providers face higher operational costs due to regulatory changes and rising healthcare utilization, pushing insurers to reassess risks and raise prices. For self-insured employers, these market shifts result in increased reinsurance costs and reduced flexibility.

Captive medical stop-loss programs offer protection from these rising premiums by allowing employers to control claims funding and reserves. Captives offer a more customized solution compared to traditional insurers, enabling companies to mitigate costs while maintaining financial stability.

2. Volatile Claims and High Costs

Healthcare claims have become more unpredictable, especially with the rise of costly specialty treatments such as gene therapies and cancer drugs. This unpredictability can make it difficult for employers to forecast healthcare costs. A well-structured medical stop-loss program smooths out this volatility, helping employers manage cash flow by transferring risk to a captive. This approach allows for more predictable healthcare spending, similar to a fixed-premium model, despite the fluctuating nature of claims.

3. Rising Healthcare Costs

Healthcare costs continue to rise sharply, projected to increase by 8% annually due to higher care utilization and rising specialty medication costs. Traditional cost-shifting methods like high-deductible plans are no longer sufficient. Medical stop-loss coverage through captives offers a long-term solution by allowing employers to establish formal reserves and fund future high-cost years. This enables them to take a proactive approach to managing healthcare costs while improving benefits offerings.

4. Enhanced Control and Transparency

Captive stop-loss programs give employers more control over plan design and claims management. With greater access to data, employers can make informed decisions about cost drivers and health management initiatives. They can also secure better rebates on pharmacy benefits, reducing overall spending. Employers using captives as a purchasing platform to carve out pharmacy benefits, see overall Rx spend decrease, often saving 15-30% on net pharmacy claims. Captives provide the flexibility to tailor coverage to an employer’s unique needs, aligning with broader financial and risk management strategies.

A Multi-Layered Protection Strategy

In a volatile healthcare environment, captive medical stop-loss coverage offers employers a customizable, multi-layered approach to risk management. It enables organizations to not only manage current challenges but also shape a sustainable future for their healthcare benefits.

History of MHPAEA

Mental Health Parity is designed to ensure individuals receive equal access to Mental Health and Substance Use Disorder (MH/SUD) benefits as they do for Medical and Surgical (MED/SURG) benefits. This quest for parity began legislatively in 1996 with the Mental Health Parity Act (MHPA), prohibiting insurance companies from imposing more restrictive annual or lifetime dollar limits on mental health benefits than MED/SURG. Since then, many regulations have been passed to help achieve this goal.

Despite previous efforts and regulations, disparities between MH/SUD and MED/SURG benefits have continued to grow over the last 15 years. In 2022, according to the Substance Abuse and Mental Health Services Administration’s (SAMHSA) National Survey on Drug Use and Health (NSDUH), almost 54.6 million people aged 12 and older were diagnosed for needing treatment for substance abuse, and only 24% of that population were able to receive treatment.1 Additionally, a study by RTI International showed that in 2021, out-of-network behavioral health clinician office visits were reported to be 3.5 times higher than all MED/SURG out-of-network office visits.2  

Final Rules to the MHPAEA were released by the Departments of Labor, Health and Human Services, and the Treasury on September 9th, 2024, with the intent to rapidly address these barriers. These rules take effect on January 1, 2025, with some requirements having a delayed application until January 1, 2026. The Final Rules expand on previous requirements, provide clarification for group health plans and health insurance issuers to stay compliant with MHPAEA, and aim to eliminate any restrictions on MH/SUD treatments or resources, ensuring the same level of coverage as MED/SURG benefits. 

The final regulations are complex and will be cumbersome for all employers, especially those with self-insured plans.  At the core of the regulation are two requirements: a Benefit Coverage Requirement and an NQTL Comparative Analysis Requirement.

Benefit Coverage Requirement

This review must ensure that financial requirements and quantitative treatment limitations (QTL) are not more restrictive when comparing MH/SUD and MED/SURG benefits. The final rules remove away from the tests mentioned in 2013 and emphasized that plans cannot impose an NQTL that is more restrictive on MH/SUD benefits compared to MED/SURG benefits. To determine whether the NQTL meets the requirement to be no more restrictive, the plan must satisfy both a Design and Application Requirement as well as a Relative Data Evaluation Requirement. 

Design and Application Requirement: Plans must show that the processes, strategies, evidentiary standards, and other factors used when both designing and applying the NQTL are comparable, rather than the previously only evaluating the application itself. Additionally, a key provision prohibits using discriminatory factors or evidentiary standards when designing the NQTL.

When evaluating the plans, the regulation is clear that health plans must provide “meaningful benefits,” which entail covering at least one core treatment in each category for MH/SUD benefits, as they do for MED/SURG. The six recognized categories are emergency services, in-network inpatient, out-of-network inpatient, in-network outpatient, out-of-network outpatient, and prescription drugs. For example, if a health plan covers a hospital surgery in the inpatient category, it must also provide access to mental health treatment, such as inpatient psychiatric care, in the same category. If they provide antibiotics in the prescription drugs category, they must also provide antidepressants.

Data Evaluation Requirement: Plans must collect and evaluate data to assess the relevant outcomes of applying the NQTL. Plans and issuers must identify material differences in access to services and take reasonable action to address them. Although the Departments will not provide a set list of required data, they expect plans to collect data relevant to most NQTLs, allowing flexibility based on the NQTL in question. If data is lacking, plans must state why it is missing, how they will collect it in the future, or provide a reasoned justification concluding no data exists.

If the Departments determine that the NQTL is more restrictive and that the above requirements are not met, they can enforce plans to stop imposing the NQTL on their MH/SUD benefit offering.

NQTL Comparative Analysis Requirement

The Final Rules reiterate the need for an NQTL comparative analysis, which has been a requirement since the CAA (2021). The analysis requirements are robust, requiring the Plan to explain how and why the Benefit Coverage Requirements are satisfied within their NQTL Comparative Analysis.  This narrative must be detailed and include the following Content Elements:

This analysis must consider all facets of the plan, including core treatment, standards of care, utilization, access, networks, prior authorizations, etc. The plan must assess any material differences and what meaningful actions are being taken to ensure compliance. 

For ERISA-covered plans, the named plan fiduciary must verify an appropriate analysis was conducted with a prudent process.  Fiduciaries are also responsible for continually monitoring the plan and compliance with the NQTL analysis. 

The comparative analysis must be readily available upon request and provided within the specific timeframe: 10 business days for the relevant Secretary, and 30 days for participants or beneficiaries. If an insufficient analysis is determined, plans must submit additional information within 10 business days. If there is an initial determination of noncompliance, they have 45 calendar days to make corrections. If there is a final determination of noncompliance, the plan must inform all enrolled participants and beneficiaries within 7 days and provide the Secretary with a copy of this notice, along with the names of everyone involved in the process.

Action Plan

The Departments recognize that employers with self-insured health plans rely on TPAs and service providers for plan administration and understand the challenges in obtaining the necessary comparative analyses or required data. However, plans and issuers are ultimately responsible for compliance with MHPAEA. If you don’t already have a comparative analysis on hand, it should become a top priority due to the quick turnaround response times outlined. It is recommended to consult with a legal partner for an in-depth analysis. Additionally, the MHPAEA Final Self-Compliance Tool, finalized in 2020, serves as a valuable resource, guiding plans and issuers to meet compliance with MHPAEA’S parity requirements. This tool has not been updated, but that is expected. 

The Final Rules generally apply starting January 1, 2025, though provisions like meaningful benefits and certain comparative analysis requirements are delayed until January 1, 2026, to give employers more time to comply.

Although we recommend that employers carefully examine their plans and work toward immediate compliance, a lawsuit has been filed and more are anticipated.  The lawsuit from ERIC (The ERISA Industry Committee) indicates that the new regulations are fundamentally flawed, exceed the statutory authority that Congress provided to the agencies and threaten the ability to offer quality and affordable benefits in compliance with applicable laws. 

1 SAMHSA (2023), Key substance use and mental health indicators in the United States: Results from the 2022 National Survey on Drug Use and Health (HHS Publication No. PEP23-07-01-006, NSDUH Series H-58), https://www.samhsa.gov/​data/​report/​2022-nsduh-annual-national-report.
2 Mark, T.L., Parish, W. (2024), Behavioral health parity—Pervasive disparities in access to in-network care continue, RTI International, https://dpjh8al9zd3a4.cloudfront.net/​publication/​behavioral-health-parity-pervasive-disparities-access-network-care-continue/​fulltext.pdf.

As healthcare costs continue to rise, employers are exploring innovative strategies to manage expenses while maintaining quality coverage. One increasingly popular option is joining an insurance consortium or coalition—a group of organizations that collaborate to provide insurance coverage. For employers considering self-insuring medical costs, consortiums offer several compelling advantages:

Alternative Funding Opportunities

Coalitions enable organizations to explore cost-effective funding models, such as self-insurance or utilizing a captive. By pooling resources, members share costs and risks across a larger base, reducing financial volatility while creating potential savings.

Group Purchasing Power

Collaborating within a consortium enhances buying power. Members can secure volume discounts and negotiate better contract terms with key vendors, including medical third-party administrators (TPAs), pharmacy benefit managers (PBMs), stop-loss carriers, and more. Additionally, consortiums often extend group benefits to services like point solutions, data warehousing, and wellness programs, maximizing value for all participants.

Claims Savings

Self-funding claims through a TPA allows employers to avoid high insurer premiums and directly manage healthcare costs. This approach can lead to significant savings, particularly when combined with a coalition’s shared resources.

Data

Consortium structures typically provide regular access to claims data, offering employers greater transparency and control. With actionable insights into trends and spending, organizations can make informed decisions and proactively address cost drivers throughout the year.

Engage with Like-Minded Organizations

While a variety of collaboratives exist, many are designed to bring together organizations of a similar nature, whether based on the type of organization, geography, size, or the nature of the business. These organizations not only pool risk but also collaborate, enabling members to exchange ideas, benchmark performance, establish common plan designs, and access shared administrative services. These collective efforts create a stronger foundation for sustainable healthcare strategies. One successful example is our client edRISK, which includes edHEALTH. We’ve worked with edHEALTH since the beginning and today it’s an 11-year-old member-owned group of educational institutions that are saving money on their employee health insurance costs and uncovering new opportunities to improve health and value for their faculty and staff.

Is a Collaborative Right for Your Organization?

While joining a consortium may seem like a significant step, the potential benefits often outweigh the effort required. From cost savings and risk mitigation to enhanced data transparency and collaboration, collaboratives are a powerful tool for employers seeking sustainable healthcare solutions. To learn more about how consortiums can benefit your organization, please reach out to us.

Cell and Gene Therapy (CGT) represents a revolutionary approach to the treatment of rare and complex diseases. Cell therapy is the transfer of live cells, into a patient to lessen or cure a disease using cells from the patient or a donor. Cell therapy can be used to treat a variety of conditions, including cancer, autoimmune diseases, and neurological disorders1,4,5.

Gene therapy alters faulty genes or replaces them with healthy ones to correct genetic disorders at the molecular level. Unlike traditional treatments that often focus on managing symptoms, gene therapy targets the underlying cause of a disorder, offering a potential one-time curative intervention that could radically improve the quality of life for patients. With nearly all gene therapies designed to provide durable effects from a single administration, these cutting-edge therapies are considered transformative, particularly for rare and genetic diseases that have long lacked effective treatment options.

Currently, there are over 30 FDA-approved cell and gene therapy treatments5 in the United States, with more than 4,000 therapies at various stages of development. While prevalence and incidence rates are low today, experts predict the treatable population will increase 11.5 times over the next five years, reaching nearly 50,000 patients in the US alone1,5. This growth is driven not only by the increased pace of FDA approvals for more prevalent diseases but also by greater access to qualified providers and facilities.

Cell and gene therapies are closely related and often overlap. In some cases, both are used together to treat diseases. For example, cell-based gene therapy involves removing cells from a patient, modifying them using gene therapy, and then reintroducing the modified cells into the patient’s body. Treatments for Duchenne Muscular Dystrophy (DMD), certain cancers, and spinal fusion are just a few examples3,4.

How Cell and Gene Therapy Will Transform Healthcare in the Next Decade

Cell and gene therapy are poised to radically transform healthcare over the next decade by offering potential cures for currently untreatable diseases, such as genetic disorders, certain cancers, and neurological conditions. These therapies allow for more targeted and potentially life-changing treatments. The ability to address the root cause of diseases, rather than simply managing symptoms, could lead to a paradigm shift in medical treatment. Conditions like sickle cell anemia, cystic fibrosis, Parkinson’s disease, and even HIV may benefit from these breakthroughs. This shift could foster a focus on preventative and curative approaches, moving away from the current treatment protocols that primarily manage symptoms.

These therapies have already caused significant disruptions in the pharmaceutical industry, pushing beyond traditional methods of disease management to fundamentally curative approaches. In the short term, more than a dozen new therapies could gain approval in 2024, including treatments for multiple myeloma and leukemia. In 2025, new treatments for hemophilia A and cutaneous melanoma could be approved. By 2026, there is potential for gene therapies targeting wet age-related macular degeneration and knee osteoarthritis, a condition affecting millions1.

The Future of Treating Chronic Conditions

In the next decade, cell and gene therapies may expand beyond rare genetic conditions and cancers to include areas like cardiology and neurology, including high-profile diseases such as ALS and coronary artery disease. The prospect of next-generation viral-vector therapies for neurodegenerative conditions like Parkinson’s disease suggests the possibility of curing these lifelong diseases rather than simply managing them. Gene therapy could also disrupt transplantation by reducing, or even eliminating, the need for donor organs. Therapies could enable patients’ own cells to regenerate damaged tissues, bypassing immunosuppression or the need for transplantation entirely offering a groundbreaking alternative to transplants and potentially alleviating the donor shortage crisis.

Targeted Cell and Gene Therapy: In Vivo and Ex Vivo Approaches

Both in vivo and ex vivo therapies will play crucial roles in the future of cell and gene therapy. In vivo therapies involve directly administering a therapeutic agent into the patient, allowing for gene modification within the body to treat diseases affecting complex tissues and organs. This approach holds promise for treating conditions like heart disease and central nervous system disorders. In contrast, ex vivo therapies involve removing cells from a patient or donor, editing those cells in a controlled environment, and reintroducing them into the patient. This method has been particularly effective in CAR-T cell therapy for certain cancers, offering precise gene editing in a controlled setting.

As these techniques mature, they will expand into areas beyond oncology and hematology. For instance, 51% of current cell therapy pipelines are focused on CAR-T therapies, while other areas, such as RNA therapies and non-genetically modified cell therapies, are rapidly growing to address conditions ranging from pancreatic cancer to Duchenne Muscular Dystrophy1.

Systemic and Economic Challenges of Scaling Cell and Gene Therapy

Cell and gene therapies are inherently complex, and large-scale adoption requires healthcare systems to navigate both logistical and economic challenges. With over 4,000 therapies currently in development, 650 of which are in Phase II or beyond1, the healthcare ecosystem must adapt quickly to accommodate a surge of new treatments. Key factors include:

  1. Regulatory Adaptation and Oversight4: As therapies approach the market, regulatory bodies like the FDA’s Office of Tissues and Advanced Therapies (OTAT) will need to streamline and update guidelines to ensure safety and effectiveness. With over 100 therapies in Phase III trials, regulatory adaptations may be necessary to expedite approvals while balancing innovation with patient protection.
  2. Cost and Accessibility4: Cell and gene therapies are costly, with many treatments exceeding $1 million per patient. To manage the financial burden, outcome-based payment models, such as value-based pricing, subscription models, and risk-pooling arrangements, are being explored to make life-changing therapies accessible without straining employers and insurers financially. Employers may need to re-evaluate benefit plans to address these high-cost treatments.
  3. Healthcare Delivery Infrastructure2,4: Widespread adoption of cell and gene therapy will require specialized treatment centers and care delivery protocols. Advanced digital infrastructure will also be needed to support long-term patient monitoring, given the durability of gene therapies and the need for consistent data on success. Healthcare providers will need to educate and train professionals across specialties to provide appropriate follow-up and supportive care.

What’s Next for Cell and Gene Therapy?

The cell and gene therapy pipeline is robust, with 348 therapies expected to come to market within the next 3-5 years1. This includes new therapies for neurology and cardiology, areas where gene therapy has historically been less prevalent. As gene and cell therapies diversify into new specialties, they offer new avenues for treating complex diseases that have previously had limited therapeutic options. For example, in oncology, therapies are being developed for hard-to-treat cancers such as pancreatic, liver, and head and neck cancer. In neurology, therapies for conditions like ALS and Huntington’s disease are progressing through clinical trials and could open the door to targeted, long-term treatments for these debilitating diseases.

Moving from Treatment to Cure

Over the next decade, as gene therapies evolve from symptomatic treatments to curative solutions, the approach to chronic and genetic diseases may be forever altered. From reducing the need for transplantation to curing neurodegenerative diseases with a single treatment, cell and gene therapy has the potential to fundamentally redefine healthcare and patient outcomes. By addressing diseases at their genetic roots, gene therapy may offer patients a future free from the limitations of chronic illness, providing transformative solutions, health, and hope for those affected by genetic and complex diseases. Additionally, while the upfront costs of gene therapy can be high, these treatments could ultimately reduce long-term healthcare expenses by minimizing the need for ongoing care and costly treatments for chronic conditions.

As this field advances, cell and gene therapy’s impact on healthcare will be profound, laying the groundwork for a future in which medicine is curative, not just therapeutic. The next 10 years hold the promise of remarkable change, and as cell and gene therapies move from research labs to patient bedsides, the healthcare industry and society at large will need to prepare for a world where “treatment” is redefined by the power of genetic science.

1 https://www.asgct.org/publications/landscape-report
2 https://icer.org/news-insights/press-releases/icer-publishes-final-evidence-report-on-gene-therapies-for-sickle-cell-disease/
3 https://www.mckinsey.com/industries/life-sciences/our-insights/how-could-gene-therapy-change-healthcare-in-the-next-ten-years
4 https://www.milliman.com/-/media/milliman/pdfs/articles/managing_risks_related_to_gene_and_cell_therapies_for_self-insured_employers_with_stop-loss-coverage.ashx
5 https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products

As we slowly approach the end of 2024, we had the pleasure of sponsoring and attending The Northeast HR Association (NEHRA)’s Annual Conference in the scenic Newport, RI. NEHRA brings together HR experts across the region to discuss current trends and developments impacting the HR and benefits industry. Some of the topics I found most noteworthy include:

Championing Diversity, Equity and Inclusion (DEI)

Championing DEI was a focal point at NEHRA’s Annual Conference this year, underscoring its significance in today’s workforce. By actively promoting diverse perspectives, organizations can enhance creativity and problem-solving capabilities, driving better business outcomes and creating equitable workplaces. Here are some related sessions I found impactful:

Fostering a Supportive (& Efficient) Work Culture

Creating a supportive yet efficient work culture remains a challenge for HR teams nationwide. Speakers shared best practices for prioritizing collaboration and open communication while emphasizing efficiency. This focus on supportive environments that boost employee morale and productivity was a hot-button topic this year.

– HR leaders explored unique “Situational Awareness & De-Escalation [tactics] in the Workplace” and tips for addressing high-tension workplace situations.

– As the war for talent continues, two talent acquisition professionals discussed the importance of “Strategic Flexibility: [and] Navigating Talent Shortages with Flexible Hiring Practices.”

-Berklee College of Music’s Associate Director of Talent Acquisition discussed the importance of “Stay Interviews” and how simple check-ins can remind employees of their importance to organizational success.

Supporting Mental Health

Mental health continues to be a top priority for  HR and benefits professionals across the region. Workshops and panels highlighted the need for initiatives that reduce stigma and promote work-life balance. By prioritizing mental health, HR professionals can create happier, healthier workplaces that enhance company culture and drive long-term growth. Below are some valuable sessions I’d like to spotlight.

– This year, attendees were able to enjoy a Sunrise Wellness Walk each morning of the conference. It provided a great opportunity to destress and explore the beautiful Newport neighborhood.

– As isolation and loneliness continue to impact many Americans, the session “Isolation, Inclusion and Workplace Collective Care: Strengthening Staff Mental Health” showcased tactics  for fostering a supportive environment.

– A clinical psychologist addressed “Getting Intentional About Managing Stress and Burnout: From Personal Practice to Organizational Impact,” providing guidance on navigating personal stress and building confidence.

In summary, the NEHRA’s Annual Conference created a vibrant atmosphere for networking and meaningful discussions on pressing trends shaping the HR landscape. We thoroughly enjoyed reconnecting with industry leaders, meeting emerging talent, and participating in insightful sessions. We look forward to seeing how these discussions evolve at next year’s conference.