A new chapter begins
Top 10 health, fringe and leave benefit compliance and policy issues in 2026
Topics covered include the following:
-
The July enactment of much of Republicans’ policy agenda in the OBBBA, continuing partisan strife over the government shutdown and the looming year-end expiration of the expanded and enhanced ACA marketplace subsidies are contributing to the unpredictability of the moment.
-
A flurry of executive orders (EOs) and policy directives and an emphasis on deregulation mark a significant reshaping — and reversal, in some cases — of federal healthcare policy.
-
Active litigation continues on several key health policy issues, including challenges to Trump administration actions, surprise billing and the ACA preventive services mandate.
-
All but four state legislatures will be in session next year. Employers should be mindful of the increasing number of state laws affecting benefit design, especially those limiting prescription drug programs and PBM activities and imposing paid leave requirements.
-
This list highlights 10 top compliance-related priorities for planning 2026 health, leave and fringe benefits and recommends general actions for each item.
Congressional outlook
Expiring ACA subsidies loom large
Republican interest earlier this year in moving a second party-line reconciliation measure, which would likely be even more difficult, has waned. But advancing legislation under “normal order” that requires 60 votes and thus some support from Senate Democrats is proving to be a major challenge, as evidenced by the government shutdown driven mainly by the partisan standoff over whether/how to extend the enhanced ACA subsidies that expire at year end. Although key lawmakers in both parties would like to pass a bipartisan healthcare package this year that may include employer-backed bipartisan policies contained in a failed December 2024 government spending bill, the fraught political environment makes the outlook uncertain.
Democrats, already feeling burned by the partisan reconciliation OBBBA process that included deep cuts to Medicaid spending and some ACA reforms expected to increase the number of uninsured, have demanded that Republicans negotiate on extending the enhanced subsidies as a condition for ending the shutdown. While some Republicans support an extension of current subsidies, and some conservative members staunchly oppose any extension, still others are open to extending them if major changes are made. Ideas under discussion include reinstating an income cap above which individuals could not receive subsidies, requiring some level of cost-sharing for all enrollees and further tightening sign-up procedures.
Since the expanded/enhanced ACA marketplace subsidies were put in place during the coronavirus pandemic, enrollment in marketplace plans has more than doubled from about 11 to over 24 million people, with the vast majority receiving the expanded/enhanced subsidies, according to the health policy research group KFF.
Projections by the non-partisan Congressional Budget Office expect more than four million individuals to lose marketplace coverage over the next 10 years if the expanded/ enhanced ACA subsidies expire. Provisions in the OBBBA that will shorten ACA marketplace enrollment periods in 2027, eliminate auto-reenrollment for certain individuals receiving subsidies and end the monthly low-income special enrollment periods are likewise expected to dampen enrollment.
If Congress allows the expanded/enhanced ACA subsidies to expire or substantially pares them back for 2026, there could be ramifications for employer health plan sponsors. Employer plans may become more affordable and valuable in the eyes of current and potential employees and providers may attempt to make up lost revenue by charging higher rates to employer-sponsored plans.
PBM, transparency, provider billing reforms may be in play
As the government shutdown continues as of this writing, any congressional vote on extending the ACA subsidies in some form is not likely to happen until late this year, possibly as part of an end-of-year government funding measure. While the legislative path forward is unclear, a year-end bill could also be a vehicle for bipartisan priorities that raise offsetting revenue — like PBM reforms, site-neutral provider payment requirements, healthcare price transparency and curbs on anti-competitive provider contracts.
Bipartisan bills addressing these and other issues have passed committees in the House and Senate in recent years but have not cleared the finish line, partly due to external factors. A PBM overhaul that would have required regular PBM reports to employers detailing their direct and indirect compensation and providing extensive data on employers’ prescription drug spending was part of a bipartisan spending bill that nearly passed in December 2024, but that was derailed by then President-elect Trump and his allies over broader concerns about the cost of the overall package.
Additional PBM reforms that could be in the mix for employer plans and/or public programs would delink list drug prices and PBM compensation; ban PBMs from engaging in “spread pricing” (i.e., charging a plan sponsor or insurer more than the amount reimbursed to the pharmacy dispensing the drug); and require PBMs to pass through all rebates, fees and discounts received from drug manufacturers directly to health plans.
Speeding generics to market and capping out-of-pocket costs for insulin in employer plans (similar to what has already been done for Medicare) are other bipartisan priorities that could make the cut.
Other potential add-ons include legislation to codify and strengthen current price transparency rules for health plans and hospitals and require new price transparency for services like diagnostic lab tests, imaging and ambulatory surgical centers owned by hospitals.
Democrats and Republicans have also eyed aligning Medicare payments for outpatient services across care settings (e.g., a hospital outpatient department or a freestanding physician office), to control costs and raise revenue. Plan sponsor groups hope lawmakers will extend the policy to the commercial market. Legislation under discussion would, for example, require each off-campus hospital outpatient department to include a unique provider identifier on payment claims to help Medicare and employers determine whether charges are appropriate.
Another possible bipartisan proposal would strengthen the No Surprises Act’s (Pub. L. No. 116-260) gag clause prohibition to ensure that employer plan sponsors are not contractually restricted from obtaining their plans’ cost or quality-of-care data from service providers. Other proposals would expand transparency and encourage more provider competition by barring anticompetitive contract provisions that prevent plans from directing employees to higher-value, lower-cost providers.
Negotiations on any year-end healthcare package would likely see Republicans also push for new HSA enhancements and codification of first-term Trump era rules that created individual-coverage health reimbursement arrangements (ICHRAs) and expanded association health plans (since rolled back by courts and the Biden administration).
After years of work on these bipartisan proposals, key lawmakers will be looking for opportunities to move them forward this year, but the outlook is uncertain in a legislative environment where mutual trust between Republicans and Democrats is at low ebb. Their fate this year may be determined by how Congress addresses the expiring ACA subsidies, as a compromise on that issue could pave the way for some of these longtime agenda items.
Provisions in a year-end healthcare package would likely defer many effective dates to 2027 or later, though some requirements could take effect next year.
Healthcare legislation that does not cross the finish line in 2025 will roll forward into the second session of the 119th Congress next year without having to be reintroduced. Although all eyes next year will be on November’s midterm elections and mean a smaller legislative calendar, lawmakers may be motivated to showcase legislative accomplishments to their constituents and push for passage of bills that address pocketbook issues like healthcare.
Control of both chambers will be in play in the 2026 midterms, and the results could dramatically reshape congressional healthcare priorities after 2026.
Regulatory outlook
Since taking office in January, President Trump has moved quickly to outline his healthcare agenda, largely through numerous EOs, policy directives, deregulatory actions and a sweeping reorganization of federal health agencies. While there have been high-level expressions of policy priorities, specific regulatory actions are still taking shape with several political appointees just now being confirmed by the Senate. Staff reductions and budget cuts across many agencies may slow the pace of new rules, however.
The administration characterizes its agenda as focused on lowering drug prices; expanding healthcare price transparency; targeting “waste, fraud and abuse” in federal health programs; addressing chronic disease and prevention through the new “Make America Healthy Again” (MAHA) Commission; and reducing regulation and broadening consumer choice.
EOs and policy directives to date have laid out broad strategies aimed at, among other things:
- Lowering prescription drug prices, speeding regulatory approval of generic drugs and biosimilars and increasing PBM transparency, including disclosures of direct and indirect compensation to health plan fiduciaries
- Improving (and potentially expanding) existing hospital and health plan price transparency requirements
- Expanding access to fertility treatment, including in-vitro fertilization
- Prohibiting gender-affirming care for children aged 18 or younger
- Banning use of federal funds for elective abortions
Agencies are working on advancing related rulemaking on these issues, with more expected. Whether they can meet the deadlines for new rules specified in many of these EOs and policy directives is uncertain, as is what rules might ultimately take effect.
Regulators are also working on guidance to implement the OBBBA’s health and fringe benefit provisions effective in 2026. These include the interplay of HSAs and direct primary care service arrangements (DPCSAs), the retroactive reinstatement and permanence of HSA-qualifying high-deductible health plans’ (HDHPs’) ability to cover (and otherwise HSA-eligible individuals to receive) telehealth and other remote care services on a pre- or no-deductible basis. The law also sets up new tax-preferred “Trump accounts” for children. It is unclear whether we will see guidance on the expansion of employer paid family and medical leave tax credits under § 45S of the Internal Revenue Code.
Other regulatory projects identified in the Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions may bring new proposed and/or final rules in these areas:
- Default electronic delivery of health and welfare plan disclosures under ERISA
- PBM fee disclosures
- Healthcare and health plan transparency (e.g., air ambulance services reporting, agent/broker disclosures, provider enforcement, advanced explanations of benefits and amendment of 2020 Transparency in Coverage rules, etc.)
- No Surprises Act’s independent dispute resolution process
- HIPAA Security rule, particularly cybersecurity
- Minimum essential coverage (MEC) reporting and employer shared-responsibility (ESR)
- Application of ESR and self-funded health plan nondiscrimination rules to individual-coverage health reimbursement arrangements
- Gender identity and dysphoria nondiscrimination under section 1557
- Tax treatment of funded welfare benefit plans under IRC §4976
The Trump administration did not include in its regulatory agenda published in September a Biden administration rule that would have addressed whether drug manufacturer cost assistance (e.g., coupons) must count towards (or can be excluded from) a plan member’s annual cost-sharing limits. It still may be addressed, possibly in the next iteration of the Notice of Benefit and Payment Parameters, which should be issued later this year.
The administration is also rolling back several Biden-era initiatives, including expanded special enrollment periods, funding for ACA marketplace plans and restrictions on the duration of short-term limited duration insurance. It has also announced a nonenforcement policy for the 2024 final mental health parity regulations pending the outcome of a legal challenge to the rules.
So far, we do not have details on the regulatory priorities of the Equal Employment Opportunity Commission (EEOC). However, with the EEOC now having a quorum following the recent confirmation of a second Republican commissioner, it is expected to advance Trump administration priorities, including challenging employers’ diversity, equity and inclusion programs and scaling back protections for LGBTQ+ individuals.
Employers also need to monitor administration actions regarding tariffs. While key elements of the president’s proposals are the subject of litigation, experts warn that tariffs on healthcare industry products and prescription drugs could increase costs, disrupt the medical supply chain, hamper pharmaceutical innovation and exacerbate ongoing shortages of certain medical equipment and products.
Litigation outlook
A monumental tariff case is pending before the US Supreme Court. Oral argument is slated for Nov. 5. The decision will have major implications for pharmaceuticals and other aspects of the healthcare ecosystem. Another case seeks US Supreme Court review of the parameters of ERISA fiduciary liability.
We are likely to see a sharp decline in the use of nationwide injunctions, as a result of the decision in Trump v. CASA. The degree of fiduciary responsibility will continue to warrant close attention, particularly related to three large employers facing legal challenges from participants in federal district court.
Behavioral health litigation should remain in the spotlight as participants continue to contest actions by insurers and third-party administrators on mental health parity grounds.
Several lower court cases will likely progress, testing the limits of state PBM laws in light of ERISA preemption.
Applicable large employers (ALEs) should also keep an eye on the Faulk Company v. Kennedy case, currently on appeal to the 5th Circuit. The District Court rejected the IRS Letter 226-J process used to assess tax penalties against ALEs for ESR violations.
Finally, litigation on the validity of certain ACA-mandated preventive services (Kennedy v. Braidwood Management) continues at the lower courts, even after the US Supreme Court upheld the US Preventive Services Task Force recommendations as being constitutional.
State outlook
Top 10 2026 health and leave benefit planning
-
Prescription drugs (Rx)Watch for potential PBM legislation, regulations, legal actions and other guidance in the coming months as state and federal lawmakers and agencies continue to consider PBM restrictions and prohibitions as a way to curb Rx costs. Address how any enacted Rx laws and regulations affect plan design with PBMs, actuaries and other vendors. Note Congressional hearings on PBM activities. Stay alert to substantive federal agency actions involving, in particular, EOs, vaccine access, the unified regulatory agenda and MAHA activity. Pay attention to tariffs. Follow state legislative activity and related litigation affecting plan design and costs for fully insured and self-funded ERISA plans. Track state bills restricting or eliminating customary PBM activities and assess efforts, which may result in erosion of ERISA preemption doctrine. Review PBM contracts and processes. Monitor ongoing Federal Trade Commission activities focused on PBMs, particularly the complaint about insulin pricing. Scrutinize PBM and Rx consultant compensation, given greater ERISA fiduciary sensitivity. Keep a constant eye on GLP-1 developments. Don’t forget about the possibility of further triagency guidance on drug manufacturers’ financial assistance and plan cost sharing. Look for federal guidance on — and state laws banning — copay accumulators and the possible expansion of federal policy on copay maximizers. Update RxDC processes as needed. Keep up on Medicare Rx price negotiations with manufacturers and any downstream financial impact on group health plan coverage.
-
ERISA fiduciary issuesAssess with legal counsel fiduciary roles, responsibilities, delegations and processes for ERISA benefit plans. Prudently select and regularly monitor service providers, ensuring they mitigate cybersecurity risks, don’t have contractual gag clauses and make plan data available upon request when required, among other responsibilities. Regularly review compensation arrangements and service agreements with brokers, consultants and service providers. Use transparency data, claims data and quality metrics to analyze plan costs and consider effects on participants. Monitor litigation against group health plans and their service providers, including cases alleging failure to properly describe plan options, prescription drug prices, pharmaceutical rebates and service provider fees (including “shared savings”). Ensure claims and appeals processes are compliant, focusing on the use of AI and other automated processes at the center of some fiduciary litigations. Update plan documents and communications as needed. Comply in a timely manner with reporting and disclosure requirements and develop a response plan for document requests. Review other applicable fiduciary matters, such as those related to plan assets and bonding. Confirm that fiduciary insurance coverage is appropriate. Watch for Department of Labor (DOL) enforcement priorities under the Trump administration as they begin to take shape.
-
Group health plan transparencyConsider that group health plan transparency has bipartisan support and holds great promise for both consumers and group health plan sponsors in better understanding healthcare pricing and fees, but that comes with many compliance requirements that remain challenging, with new requirements in the pipeline. Continue complying with the final Transparency in Coverage rule (including posting machine-readable files (MRFs) for in-network and out-of-network allowed amounts and providing a self-service transparency tool for all covered items and services), and watch for related new guidance (for example, implementing the MRF requirement for prescription drugs). Confirm that vendors’ data is accurate, complete and updated as required and that the MRFs and tools meet other requirements, including compliance with Schema 2.0 for MRFs by Feb. 2, 2026. Ensure plan-related contracts have no gag clauses on price or quality information and submit the gag-clause attestation by Dec. 31. Ensure timely submission of the required prescription drug data collection (RxDC) reports. Continue to comply with additional transparency requirements in the Consolidated Appropriations Act of 2021 (2021 CAA) and look for more guidance on several 2021 CAA transparency topics in 2026. Review proposed ERISA §408(b)(2) rules when issued. Review group health plan and hospital transparency data as well as third-party analyses of previously unavailable pricing information and consider how to use such information. Work with vendors on compliance with transparency requirements and make sure that they will provide the necessary assistance to employers to help them comply with those requirements. Watch for new transparency legislation.
-
Data privacy and securityRegularly review compliance with HIPAA security requirements and DOL cybersecurity measures for ERISA plans. Use compliance tools from regulators to identify and address security vulnerabilities. Evaluate vendors, new technologies and apps to determine whether HIPAA or other data protection and privacy laws apply and assess compliance. Pay special attention to mobile technologies and tracking technologies across all platforms. Assess how federal policy facilitating the exchange of health data may affect data privacy and security priorities of group health plans. Review HIPAA privacy policies and procedures for any revisions needed following the vacatur of the 2024 HIPAA privacy rule.
-
Artificial intelligence (AI) in benefitsBecome familiar with — if not already — the use of AI in healthcare and employee benefits. Monitor the federal policy shift regarding the use of AI in healthcare and employment. Consider implications for design and administration of employee benefits, including group health plans and the effects on plan participants and beneficiaries. Consider setting guardrails encouraging the responsible use of AI internally and by employee benefit plan vendors, given the risks and opportunities of this fast-evolving technology. Remember that ERISA plan fiduciaries must act prudently in selecting and monitoring service providers, including with respect to their use of AI. Watch for federal legislation, state regulation and litigation to unfold, and apply any new requirements or best practices to plans.
-
Health savings account (HSA), health reimbursement arrangement (HRA) and health and dependent care flexible spending arrangement (FSA) developmentsConsider adopting provisions to reinstate and/or permanently allow HSA-qualifying HDHPs to cover telehealth and other remote care services on a pre- or no-deductible basis. Study whether to add HSA-compatible direct primary care service arrangements (DPCSAs) into a benefit design strategy and monitor IRS guidance for clarification on various unresolved issues related to DPCSAs. Update HSA-qualifying HDHPs, HSAs, excepted-benefit HRAs (EBHRAs) and health FSAs for 2026 indexed dollar limits. Identify pre- or no-deductible health benefits, programs or point solutions that could jeopardize an individual’s eligibility to make or receive HSA contributions and confirm strategy. Review IRS guidance that expands the list of preventive care benefits that HSA-qualifying HDHPs may cover on a pre- or no-deductible basis. Evaluate whether to offer fertility benefits through an HRA — either an integrated HRA or an EBHRA (limited to $2,200 for 2026). Determine whether to raise the annual income exclusion for dependent care assistance programs (DCAPs), such as dependent care FSAs (DCFSAs), and monitor impact on nondiscrimination testing. Monitor legislation that would provide safeguards for pre-deductible coverage for chronic disease treatments under HSA-qualifying HDHPs. Follow pending proposed IRS regulations on individual-coverage HRAs that could influence benefit strategy and compliance efforts. Review future IRS guidance on the definition of a tax dependent for any impact on account-based health plans.
-
ACA preventive servicesUpdate a nongrandfathered group health plan’s preventive services covered without cost sharing for the latest ACA guidance and any new or revised recommendations from the US Preventive Services Task Force, the Health Resources & Services Administration and the Advisory Committee on Immunization Practices. Review guidance addressing coverage of pre-exposure prophylaxis HIV medications and confirm that your third-party administrator and/or PBMs have updated their claims processing systems to comply. Monitor ongoing litigation and administrative/regulatory actions that might modify or rescind some of the ACA-mandated preventive services and consider whether the group health plan might continue no-cost coverage of particular preventive services if current recommendations change. Update official plan documents, summary plan descriptions, summaries of benefits and coverage and other materials as needed.
-
Other ongoing ACA concernsReview planned 2026 benefits against employer shared-responsibility (ESR) standards, including minimum essential coverage (MEC) for ACA full-time employees and the affordability and minimum value of health coverage. Ensure the adequacy of ESR and MEC recordkeeping and reporting and consider revisions to take advantage of reporting relief legislation. Review plan design for compliance with ACA benefit mandates and market reforms. Consider whether to modify or implement benefits or update communications based on recent developments related to noncoordinated excepted benefits. Continue to monitor the impact of ACA Section 1557’s prohibition on discrimination on the basis of race, color, national origin, sex, age or disability. Continue to calculate and pay the Patient-Centered Outcomes Research Institute fee for self-funded group health plans, including certain health reimbursement arrangements and retiree-only plans. Prepare for continued medical loss ratio rebates if sponsoring a fully insured group health plan. Continue to provide SBCs and ACA claims and appeals notices in a culturally and linguistically appropriate manner, consistent with updated guidance. Monitor legislation and regulations expected to reduce ACA marketplace and Medicaid enrollment and consider potential impact on employer-sponsored group health plans.
-
Mental health parityContinue to comply with the Mental Health Parity and Addiction Equity Act (MHPAEA) by ensuring that no financial or treatment limits on mental health/substance use disorder (MH/SUD) benefits apply only to MH/SUD benefits or are more restrictive than those applied to medical/surgical (M/S) benefits. Maintain a written analysis of all nonquantitative treatment limits that is ready to disclose upon request to federal regulators, states or plan enrollees. Watch for developments related to the Trump administration’s nonenforcement of new requirements in the 2024 final rule. Require that vendors provide adequate assistance with MHPAEA compliance. Consider parity requirements when improving a plan’s M/S benefits. Monitor parity and behavioral health coverage litigation. Watch for changes to MHPAEA enforcement, as well as additional guidance or legislation.
-
State-mandated paid leave and other state law trendsLook for bills affecting paid leave, PBMs, fully insured plan coverage mandates and telehealth access as 46 states (except Montana, Nevada, North Dakota and Texas) convene their regular sessions in 2026. Do not overlook ongoing regulatory activity, particularly in the three states where paid family and medical leave (PFML) programs will be in full effect in 2026: Delaware, Maine and Minnesota. Examine how state PFML, paid sick and safe leave (PSSL) and other paid and unpaid leave mandates fit with existing employer programs, and assemble the puzzle pieces into a rational leave mosaic. Keep an eye out for renewed debate on a federal PFML program, given heightened interest and several pending bills. Review changes to the § 45S employer tax credit for PFML benefits as a result of OBBBA. Monitor telehealth developments, particularly related to behavioral health. Discuss with insurers how new state coverage mandates affect fully insured plans and consider whether to mirror those mandates for self-funded coverage. Be aware of access issues related to abortion and gender-affirming care. Continue health-coverage reporting where required. Maintain compliance with state laws related to group health plan assessments (and related reporting). Pay attention to PBM developments and ERISA preemption issues in the courts and state legislatures.