Agenda for Day 2 - Tuesday October 6, 2026Tuesday, 6 October 2026

• Prepare for 2026 state price caps like PDAB UPLs while protecting trade secrets, including R&D and manufacturing costs

• Use confidentiality protocols, such as "confidentiality tagging," to shield proprietary pricing and rebate data from FOIA requests

• Align teams to meet NASHP Model reporting standards with consistent net price calculations across states

• Create standardized narratives to justify pricing while limiting disclosure of sensitive strategies

• Implement early warning systems for audits, using case law to define disclosure boundaries

• Adjust specialty distribution models as "Any Willing Provider" laws in 17+ states force PBMs to include independent pharmacies in exclusive networks

• Prepare for 2026 bans in Arkansas and Arizona that prohibit PBMs from owning or licensing mail-order and specialty pharmacies, disrupting preferred channels

• Ensure compliance with Indiana’s July 1, 2026, mandate restricting compounding of GLP-1s and biologics to protect brand integrity from medical spa alternatives

• Implement Massachusetts’ 2026 Shield Law 2.0 to meet privacy-focused pharmacy labeling requirements for sensitive therapies

• Adapt to California’s January 1, 2026, ban on PBM spread pricing by transitioning to pass-through models and increasing fee transparency

Government Pricing audits continue to uncover many of the same compliance gaps across manufacturers of every size. The difference today is that organizations no longer need to rely solely on manual reviews, spreadsheets, and resource-intensive assessments. AI and intelligent automation are fundamentally changing how compliance teams identify risk, validate data, and prepare for audits. With more than 20 years of Government Pricing audit and assessment experience, we have seen the common types of gaps and issues across all sizes and type of manufactures, as well as where we can apply innovative technology, such as automating Class of Trade Review instead of time intensive and inefficient manual reviews. Not only is this more efficient and accurate, it provides greater transparency, traceability, and audit-ready documentation.

• Creating an AI-enabled GP Documentation Library to organize and align policies, procedures, reasonable assumptions, methodologies, and supporting evidence into a searchable, continuously maintained knowledge base

• Using AI to evaluate methodology integrity, including validation of domain table mappings, smoothing algorithms, and calculation logic to identify inconsistencies and misalignment to Policy and Procedure documentation before they become audit findings

• Automating Customer Master and Class of Trade analysis Evaluating COT assignment in the Customer Master data, identifying assignment exceptions, and improving the accuracy of 340B eligibility validation

• Building an intelligent Contract Master Reconciling contract data with Government Pricing systems and Accounts Payable while documenting Bona Fide Service Fee determinations and supporting rationale

• Applying AI to data collection, reconciliation, and validation across disparate source systems to improve data quality, reduce manual effort, and accelerate monthly and quarterly reporting cycles

• Leveraging AI for parallel pricing calculations and predictive testing to validate results, identify anomalies, evaluate smoothing methodologies, and strengthen audit readiness before submissions are made

• Assess the 2026 impact of uncapped inflation rebates, identifying legacy SKUs with rebate obligations exceeding 100% of AMP

• Leverage WAC reductions to mitigate inflationary rebates and stabilize gross-to-net (GTN) for at-risk mature portfolios

• Examine MDRP withdrawals and product discontinuations for negative-margin assets, evaluating legal implications for remaining commercial availability

• Consider the GENEROUS model to align Medicaid net prices with international benchmarks, replacing uncapped rebates with negotiated agreements

• Implement cross-functional protocols to manage Medicaid price resets' impact on 340B ceiling prices and commercial rebate guarantees, avoiding revenue erosion

Understand how proposed PBM reforms, FTC transparency initiatives, and evolving market dynamics may reshape manufacturer access, contracting, commercialization, and operational investments

• Understand how PBM reform is disrupting the traditional rebate-driven access model

• Assess why and how PBM incentives may change and our perspective on future influence

• Anticipate the shift from financial controls to clinical and patient access controls

• Prepare for expanding transparency, reporting, and audit requirements

• Discuss considerations manufacturer strategies and operational capabilities needed in the new rebate/fee environment

• Use live polling to uncover how and why peers are adopting AI for pricing, contracting, and compliance

• Benchmark trends on GTN accuracy, 340B disputes, and WAC reset modeling for 2027

• See AI in action with a live demo on prompt engineering for PBM contracts, PDAB summaries, and IRA negotiations

• Share success stories and challenges in AI adoption through interactive discussions

• Explore the future of pricing teams, focusing on AI-augmented strategy and essential skills for compliance

• Benchmark pricing and GTN performance against 2025-2026 industry standards using actionable data insights

• Analyze pre/post deal variance across channels, scenario modeling frequency, and common data challenges to assess organizational positioning

• Evaluate accrual accuracy for the new Part D Manufacturer Discount Program and the effectiveness of automated 340B duplicate discount scrubbing in the redesigned environment

• Identify operational strengths and opportunities by comparing practices to industry benchmarks

• Discover strategies to manage pricing complexity, improve cross-functional collaboration, and implement sustainable processes that drive compliance and commercial success

• Expand CAR-T therapies into autoimmune conditions by addressing access challenges in community and specialty settings

• Highlight CGT’s curative value with outcome data, cost comparisons, and hospitalization avoidance metrics

• Tackle hospital margin pressures and DRG-based reimbursement gaps in Medicare Part A, while navigating the 2026 legal landscape of 340B eligibility for specialized biologics

• Operationalize Outcomes-Based Agreements (OBAs) and 'subscription' models aligned with the CMS Cell and Gene Therapy Access Model launching in late 2026

• Optimize manufacturing with automation, scale economies, and logistics tailored to patient-specific products

• Ensure quality and efficiency through robust supply chain and inventory management frameworks