PBM Reform, Drug Pricing Policy, and Regulatory Uncertainty
Key Takeaways
- Drug pricing policy remains a central focus across stakeholders, with continued activity expected at both federal and state levels.
- PBM reform is accelerating, with new requirements related to transparency, rebate structures, and compensation models.
- Regulatory complexity is increasing, as federal and state actions evolve in parallel.
- Medicare Advantage and IRA implementation continue to shift, creating operational and financial considerations for payers.
- Employer-sponsored coverage strategies are evolving, including growing interest in alternative benefit designs such as ICHRAs.
- New distribution and care delivery models—including direct-to-consumer and retail-based approaches—are gaining traction.
- Policy considerations are increasingly influencing market strategy, requiring closer alignment between regulatory and business planning.
At Asembia 2026, Avalere Health experts outlined how accelerating pharmacy benefit manager (PBM) reform, evolving drug pricing policy, and ongoing regulatory activity are converging to reshape the payer landscape in a session titled "Healthcare and Drug Pricing at a Crossroads: Policy Directions Ahead of the Midterms."
The session—featuring Mina Allo, PharmD, Managing Director of Market Access and Commercialization; Mike Ciarametaro, Managing Director of Policy Practice; and Lisa Joldersma, JD, Senior Advisor in Policy Practice—focused on what health plans, employers, and other payer stakeholders should expect across federal and state policy in the coming years.
Drug Pricing Policy Remains a Key Area of Activity
Audience polling during the session identified drug pricing policy as the most impactful issue shaping the healthcare landscape, followed by PBM regulation and state-level initiatives.
Speakers noted that multiple policy approaches to drug pricing are under consideration, including international reference pricing models, continued implementation of the Inflation Reduction Act (IRA), and potential future modifications to existing frameworks.
Areas of ongoing discussion include eligibility thresholds for drug price negotiations, timelines for inclusion, and how pricing benchmarks may be incorporated into broader policy structures.
PBM Reform Gains Momentum Across Federal and State Levels
PBM reform has entered a more active phase, with several recent developments at the federal level.
Joldersma highlighted key areas of focus:
- Federal Trade Commission (FTC) activity, including settlements related to PBM business practices
- Department of Labor (DOL) proposed rules aimed at increasing transparency for ERISA plan sponsors
- Recent Medicare Part D changes, including limits on certain types of PBM compensation and rebate-related requirements
A notable trend is the movement toward “delinking” PBM compensation from drug prices, shifting toward fee-based models. Additional policy efforts include addressing spread pricing and expanding data reporting to plan sponsors.
At the same time, speakers noted that flexibility remains within the system, particularly for employer-sponsored plans, though increased transparency may lead to greater scrutiny of benefit design decisions.
State-level PBM reform activity is also expanding, contributing to a more varied regulatory environment across markets.
Medicare Advantage and IRA Implementation Add Complexity
Speakers also highlighted ongoing changes in Medicare Advantage (MA) and IRA implementation as important considerations for payers.
Recent MA updates have focused on payment adjustments, cost containment, and refinements to the STAR ratings program. In parallel, IRA-related drug price negotiations are expanding to include additional therapies, including those covered under Part B.
Uncertainty remains around how certain provisions will be implemented, including criteria used to determine drug eligibility, particularly in areas where biosimilars or generics may influence market dynamics.
Employer Market and Benefit Design Continue to Evolve
Employers are exploring new strategies to manage healthcare costs, including increased interest in individual coverage health reimbursement arrangements (ICHRAs) and similar models.
These approaches may allow employers to better manage financial exposure while shifting plan design decisions. At the same time, increased transparency requirements tied to PBM reform may influence how employers evaluate pharmacy benefit arrangements.
Distribution Channels Shift as Consumer-Focused Models Expand
Policy and market forces are also driving changes in pharmacy and care delivery channels.
Allo noted that reforms targeting spread pricing are primarily focused on retail and independent pharmacies, while the impact on specialty pharmacy remains less defined.
Meanwhile, direct-to-consumer, direct-to-employer, and retail-based models are expanding, particularly in high-demand therapeutic areas. These developments reflect broader trends toward healthcare consumerization and may influence how patients access medications and services.
Policy-Driven Environment Requires Strategic Adaptation
A consistent theme throughout the session was the growing influence of policy on healthcare decision-making.
This environment underscores the need to:
- Monitor evolving federal and state policy developments
- Adapt contracting and reimbursement strategies
- Evaluate emerging distribution and care delivery models
- Incorporate regulatory considerations into long-term planning
As Ciarametaro emphasized, the increasing pace of policy change is making it essential for stakeholders to align business strategy with the evolving regulatory landscape.
Reference
Allo M, Ciarametaro M, Joldersma L. Healthcare and drug pricing at a crossroads: policy directions ahead of the midterms. Asembia. 2026. Las Vegas, NV.
