J Clin Pathways. 2025;11(6):38-42.  INTRODUCTION In the health plan year 2025, health care stakeholders faced the lingering effects of the COVID-19 pandemic, a change in presidential and congressional party leadership, and artificial intelli­gence (AI)’s growing integration in health care. In addition, the rapid growth of the GLP-1 drug category overshadowed the im­pact of biologic-based products, especially cancer therapeutics. These market factors focused the attention of business leadership, human resource departments (HR), and company boardrooms beyond health care costs. Such dynamic changes in this marketplace—shifts in regulation or law and economic ramifications—require a more robust understanding of roles, responsibilities, and available time for all business sector leaders to sustain their business through 2025 into 2026. This column will review health care stakeholders’ final pri­orities for 2025 and the transition to a more complex business­-driven shift in risk mitigation for 2026 health care coverage. YEAR-END 2025 PRIORITIES In August, Law firm Fisher Phillips posted a to-do list for em­ployers regarding workplace law developments and upcoming compliance dates for the remainder of 2025.1 The listed items affect multiple C suite areas and business boards, including HR committees and operating executives. The firm notes that in general, all companies need to watch for major changes from the National Labor Relations Board. Key to-do items that all employers should be aware of according to the firm include: In a similar vein, Foley & Lardner LLP published “2025 Health Care & Life Sciences Top Trends,” highlighting the fol­lowing developments: With this list, the firm’s aim is to help businesses capitalize on opportunities and navigate potential pitfalls in an uncertain regulatory and litigation landscape.2 These risk management efforts can support a welcoming and thriving workplace that leads to a successful company. HEALTH CARE LANDSCAPE TRANSITIONS: ALTERNATIVE COVERAGE AND HR PRACTICES Employer of Record and Global Professional Employer Organizations In the current economic climate, companies have been increas­ingly tasked with reassessing their approach to business success. Despite global economic uncertainty, most business leaders pri­oritized growth and increasing their financial commitment to­ward hiring throughout 2024.3,4 However, this priority shifted in 2025 to leverage cost efficiency. More business leaders are adopting a “global growth mind­set.” Small- and medium-sized businesses alike are taking advantage of global expansion to navigate common challenges such as talent shortages.5 In addition, many companies are seek­ing an alternative to streamline HR functions such as hiring, recruiting, and compliance.6 Companies looking to quickly expand their workforce can try to partner with an employer of record (EOR) or a global professional employer organization (PEO) to effi­ciently manage HR needs while saving time and money.7 A PEO is a company that co-employs individuals with another company that already has its own registered entity. There are currently over 500 PEOs in the US alone.8 While a PEO only assists with employer responsibilities and certain HR tasks, an EOR handles all HR-related tasks to streamline day-to-­day operations.  Individual Coverage Health Reimbursement Arrangements and Alternative Funding Programs Employers are also looking at alternative coverage options to adapt to market changes. One option is Health Reimbursement Arrangements, which are “skinny plans” that offer mostly cata­strophic coverage. Individual Coverage Health Reimburse­ment Arrangements have also received much attention from pharmaceutical companies, their advisors, and vendors; how­ever, they lack an understanding of the employer marketplace perspective. The concept sounds great to those who don’t un­derstand insurance risk markets, but it represents a minority of businesses, mostly smaller employers. Alternative funding programs (AFPs) are increasingly be­ing discussed as another solution, particularly for higher cost biologic therapies, managing the costs of specialty medications, and for those without standard commercial insurance cover­age.9 However, AFPs, along with other emerging risk-based so­lutions or so-called direct to consumer web platforms, tend to be short-term band aids for pharma/biotech firms rather than solutions to root cause problems. In addition, premium costs and out-of-pocket (OOP) costs will likely go up for members (patients) as part of these programs. AFPs are often used by self-funded employer plans and involve a third party to manage high-cost specialty drugs.9 They may exclude these drugs from the plan and help employees ob­tain them through other means, like patient assistance pro­grams. However, there are concerns that AFPs can create barriers to accessing medications, increase patient costs, and di­vert funds. It is important to research any program thoroughly, understanding potential impacts on costs and access to neces­sary medications.10 Common types of AFPs include the following: IMPORTANT CONSIDERATIONS FOR 2026 Overall, the trends emerging for 2026 include market segment splitting, reducing or limiting access to care via commercial insurance, and minimizing plan risk (cost) to balance anticipated double-digit premium increases on employers. Government programs have also seen large increases in similar annual costs post-pandemic. Advocates, advocacy groups, and some individual employers have the following recommendations for navigating these trends: COMMERCIAL EMPLOYER PLANS FOR 2026 Public Sector Preliminary data shows double-digit increases in health plan renewals are impacting employers across the country. Public sector plans are getting hit especially hard. In New Jersey, for example, state and local government workers have faced rate hikes of more than 20% year over year—115% in the last five years alone—with little relief in sight.11,12 Massachusetts has also seen proposed rate hikes averaging greater than 13% for businesses with fewer than 50 employees. That renewal rate increase is double the 3.6% benchmark for health care costs set by the Massachusetts Health Policy Commission.13 For ACA marketplace plans, analyses of initial rate filings for 2026 indicate a median proposed premium increase of 18%, according to a report by Peterson-KFF Health System Tracker.14 Another analysis of preliminary filings from July 18 found a median premium increase of 15%.15 This means that many individuals and families who obtain health insurance through the ACA marketplace will likely experience double-digit premium increases for 2026 coverage. This would be the largest increase since 2018.  Private Sector In today’s challenging economic environment, private sector employers are facing double-digit percentage increases in their commercial health care insurance premiums upon renewal. This trend—as seen with ACA plans—is driven by several interconnected factors, creating a complex and ever-changing landscape for both employers and employees. These factors include the following: 

F. Randy Vogenberg, PhD, FASHP J Clin Pathways. 2025;11(5):55-56. There is a path forward for employer plans and manufactur­ers despite the health care sector surging with costs from unprecedented medical and technological breakthroughs. From artificial intelligence (AI)-assisted diagnostics and real-time clinical data platforms to the emergence of cell and gene thera­pies (CGTs), biologics, and targeted medicines, we are on the cusp of an overdue medical transformation. Pathways, clinical guidelines, and other management tools can barely keep cur­rent. Yet, despite this acceleration, many patients—particularly those insured through employer-sponsored plans—still struggle to access these advancements due to outdated care or reimburse­ment models, payer silos, and rising treatment costs of care. It’s no longer just a health care issue. It’s a workforce issue. And it’s one employers and biopharmaceutical or device manu­facturers must solve together. The Real Problem: Innovation Without Access Innovation without access is a failure for manufacturers and employers. Clinical pathways, for example, are just one tool with multiple users, purposes, and developers. Simply focusing on clinical or cost control has not worked for members. For innovation to be sustainable, there must be a dynamic balance to member access. The following issues prevent members from receiving optimal care: According to McKinsey & Company, US employers are ex­pected to spend over $1.5 trillion on health care by 2030, with­out a guarantee of improved outcomes.1 American society in general now seeks a health care reboot through White House initiatives such as Make America Health Again, upending a long-time status quo ecosystem.2 Interestingly, commentary in and about that Report indicates the desire for commercial insurance to drive innovation at a faster pace than the government could achieve. Such a strategy would leverage faster continuous qual­ity improvement cycles of innovation that are more routinely utilized in the private sector. What Employers Can Do Differently and Why Manufacturers Should Join Them Challenged employers are stepping up—not just as plan spon­sors, but as architects of access to care using their own pathway sources. With more freedom or flexibility in being Employee Retirement Income Security Act (ERISA) plan sponsors, com­mercial-insured entities have a long history of unique offerings but minimal-to-no scaling. Building on the past successes, there is a renewed seeking of scaling solutions through collabora­tion with manufacturers and facilitative organizations such as Only Healthcare Consultants (OHC). They are supporting new models that prioritize member education, transparency, and actionable data that both employers and manufacturers have sought independently for decades. Different from prior direct contract efforts, Employer Em­powerment Models (EEM) reimagine health care engagement at the grassroots level, empowering employers to take the fol­lowing actions: This model isn’t just a theory. Like continuous quality im­provement models, EEMs have evolved toward a scalable ap­proach and are being validated by real-world employer-manufac­turer pilots with long-term potential for market transformation. Why This Moment Matters AI is holding health care accountable at a rapid pace, just as technologies continue to accelerate devices, drugs, and vaccines through the FDA approval pipeline. Employee expectations around benefits have also changed since the pandemic. And the next wave of therapies—from mRNA-based cancer vaccines to gene editing solutions for rare diseases—won’t succeed without broader consumer buy-in. Manufacturers can no longer rely solely on historically based top-down awareness or traditional television campaigns. Existing third-party intermediaries are not trusted. The path to sustainable member utilization runs through trust, and trust is built at the community level in workplaces, families, and households. The call to action today runs through a new kind of part­nership. An EEM that seeks to enable manufacturers to meet plan members where they are remains elusive. Collaborating purposely inside employer ecosystems, through data-driven strategy and culturally relevant engagement, is a strategic path forward. Such a strategy can enhance the effective utilization of clinical guidelines, pathways, or other care management tools that can be beneficial to all concerned. Much can be achieved together to ensure that innovation reaches the people who need it, when they need it. Because what good is technology or benefit innovation if no one member trusts it enough to use it, let alone fails in efforts to access it? Originally published in the Journal of Clinical Pathways.

F. Randy Vogenberg, PhD, FASHP J Clin Pathways. 2025;11(5):52-54. Stakeholder Positioning Across the Commercial and Government Health Insurance Landscape During the annual budget debate, Congress and state legislatures continued their advocacy and lobbying efforts to advance health care reform. Employers, manufacturers, providers, and consum­er advocates descended upon statehouses and Congress to draw attention to problems in US health care economics. In response to such advocacy and proposed governmental program inter­ventions emanating from new budgets, commercially insured populations have discussed potential strategies with government officials to address these issues. Despite these efforts, reform outcomes have been uneven, and common issues remain, including the following: employ­ers do not have complete access to claims data from their plan; pricing and claim cost transparency remain mired in supply chain opacity behind multiple contracted entities; and manu­facturers are not collaborating or partnering with employers on insurance solutions for novel therapies. All parties need to get involved with health care reform, as the government has become engaged in market change. Gov­ernment actions and related market-based cost shifting have created barriers or operational issues for other commercial plan stakeholders. For example, the Health Insurance Portability and Accountability Act (HIPAA) has member data sharing bar­riers to hide the value of medication therapies. In addition, the Affordable Care Act created a fiscal problem for commercial employer plans by removing lifetime health care benefits. Oth­er legislation of government programs impacting health care include Medicaid best price regulation, 340B pricing discounts, prior approvals (PAs) for coverage or formulary procedures, and state regulations that limit individual utilization data and create barriers for member patients to access drugs. Manufacturers and employers express a desire to learn from each other, yet both fail to understand the other’s operation­al position in the market. For example, personal bankruptcy trends show how employers are confronting medical plan-re­lated or business bankruptcies. The commercial trend of not covering drug therapies is likely to continue, as most employers wait until they are hit with a catastrophic claim to come up with a solution—akin to a deer in headlights. Commercial employer insurance plans will require a lot of education. Established business groups have been active in education with their members, but that is a small percentage of plans. In January, the National Pharmaceutical Council pro­duced the open-source publication Patient & Caregiver Odys­sey1 to illustrate challenges patients face in therapeutic care for cell and gene therapy (CAGT). Care guidelines and pathways, while informative clinically, can go awry with the presence of multiple financial adaptations in the market. These adaptations, used by both government and commercial plan administrators, often conflict, ultimately preventing optimal care for a patient. The Evolution of Commercial Health Insurance As novel therapies and CAGTs grow in number in the market, there are key issues to address for multistakeholders. These in­clude plan and patient affordability; the role of drug therapy re­bates vs no-rebates models; the strategic use of PAs vs current PA practices that yield few denials; and patient assistance programs (PAPs) funded by manufacturers. To date, manufacturers have shown an inability to work toward change in a market landscape without rebates. In addition, hospitals and large specialty medi­cal groups tend to be combative, rather than collaborative, re­garding 340B program changes during federal or state legislative sessions. Lost in many public conversations among health care stake­holders is the total cost of care and what that means for the employer-sponsored plan or patient. The original purpose of commercial health insurance was primarily to provide a safety net for workers by protecting against income loss due to ill­ness, particularly hospital-based care.2 While its initial focus was not on making health care cheaper, as the US business landscape changed, insurance gradually evolved to encompass medical and pharmacy expense coverage, along with cost-con­tainment processes. These included recruiting new employees, retaining existing employees, and being seen as an employee-friendly workplace. At its core, commercial insurance is a form of private health insurance coverage that pays for individual patients’ medical and surgical expenses. Unlike government-sponsored insur­ance, commercial insurance is often offered through an em­ployer’s benefit package.3 It provides employees the option of obtaining coverage at a potentially lower cost than purchasing it independently. In addition, out-of-pocket employee costs may be lower or waived, depending on benefit coverage or spe­cific plan details provided by the employer. In 2024, the year-over-year (YoY) cost of plans increased and is projected to continue rising at double-digit rates into 2025, with the same expected for 2026.4,5 Health insurance costs today are increasing rapidly due to several factors. These include the rising cost of medical services, an aging workforce, medical inflation, insurance market consolidation, coverage strategies by employers, and residual effects of the COVID-19 pandemic. Additional factors that employers face in the con­tinuing cost trend dilemma include the overall economy, tar­iffs, government spending reductions through the Centers for Medicare & Medicaid Services (CMS), and cost-shifting to the employer market. Ellen Kelsay, president and CEO of Business Group on Health (BGH), said that broad-based and sustained cost reduc­tion “must fundamentally come from the delivery system itself and is not isolated only to the commercial/employer market.”6 To do so will require changes and approaches that would em­power commercial employer plans over a sustainable, long-term period. The following are some current approaches to curb costs: Where Do Pathways and Algorithms Fit Pathways and algorithms are integral to the evolving land­scape of health care delivery, serving as valuable tools to en­hance efficiency, accuracy, and patient outcomes. Pathways for clinical care stemming from physicians, surgeons, and ad­vanced practice providers help create and manage a patient’s treatment plan. Such tools or platforms aim to standardize care processes by translating clinical practice guideline recommendations into actionable steps for delivering patient care. Ultimately, these efforts can assist in maximizing patient safety and clinical ef­ficiency to achieve optimal patient outcomes. Studies suggest that using clinical pathways can lead to improved clinical and economic outcomes, such as decreased length of hospital stay, fewer in-hospital complications, and improved professional services documentation.7 In the context of health care delivery, algorithms are com­putational processes designed to analyze data and support