In this episode of the Only Healthcare Podcast, hosts Michael Navin and Dr. Randy Vogenberg welcome back Jayson Slotnick for a fast-moving year-in-review of 2025 and a grounded outlook for 2026. The conversation breaks down what changed through the Inflation Reduction Act implementation, why Most Favored Nation pricing keeps resurfacing, and how these policy forces could ripple across Medicare, Medicaid, and employer-sponsored coverage.

Jayson also explores how direct purchasing, transparent pricing models, and the shifting PBM landscape may affect affordability, access, and benefit design. From Part D redesign and underused smoothing to biosimilars, 340B dynamics, and the role of the FDA in driving competition, this episode connects the policy headlines to what employers, manufacturers, and plans should realistically watch next.

Key Topics
• 2025 recap: IRA implementation and Part D redesign
• Drug negotiation timelines and spillover effects
• Most Favored Nation pricing: what is voluntary vs mandatory
• Patient affordability: premiums, deductibles, out-of-pocket pressure
• Employer direct purchasing, net pricing, and PBM disruption
• Biosimilars, patent cliffs, and what 2027 could change
• 340B, hospital economics, and who really benefits from drug money
• FDA’s role: faster approvals, competition, and innovation
• 2026 watchlist: Part B negotiation list, CMS rules, ACA dynamics, CMMI models

Chapters
00:04 Welcome and intro to Jayson Slotnick
02:04 2025 recap: IRA, CMS, affordability pressures
02:45 Predictable vs unpredictable: Part D redesign, MFN momentum
06:22 IRA vs MFN: separate lanes, real-world collisions
09:12 Voluntary MFN models, IRA is not voluntary
12:24 Employer net pricing and direct purchasing trends
16:30 Affordability, hospital costs, and 340B dynamics
18:57 FDA’s role: competition, generics, biosimilars, faster approvals
23:22 2026 predictions: what we know is coming
29:06 Stay current, stay calm, stay focused
31:51 Commercial market changes and employer leverage
39:33 Wrap and where to follow OHP

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Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.

In this episode of the Only Healthcare Podcast, hosts Michael Navin and Randy Vogenberg welcome back healthcare policy veteran Deborah Williams for a candid conversation on why 2025 became such a difficult year for employers, patients, and policymakers alike.

Coming off the tensions of the government shutdown and escalating healthcare costs, the discussion breaks down what is actually driving premium increases, prescription drug spending, hospital consolidation, and benefit design changes. Deborah draws on decades of Washington experience to explain why many policy ideas keep resurfacing, why they continue to fall short, and what risks lie ahead as the system moves into 2026.

From direct-to-consumer drug pricing and PBM reform to political gridlock and consumer backlash, this episode explores where healthcare policy may realistically land next and why affordability remains the unanswered question.

Key Topics Discussed

• Why employer healthcare costs outpaced exchange inflation in 2025
• Hospital consolidation and cost-shifting pressures
• Prescription drug spending trends and policy spillover effects
• Direct-to-consumer drug pricing and deductible portability
• PBM reform debates and unintended consequences
• Political gridlock, populism, and healthcare affordability
• What employers, plans, and consumers may face in 2026

Chapters with Time Stamps

00:04 Welcome and episode framing
00:44 Deborah Williams' background and policy perspective
01:44 Why 2025 was a brutal year for employers
03:34 Hospital consolidation and cost shifting
04:35 Prescription drug costs and market pressure
07:15 Consumer behavior, adherence, and affordability
09:00 Political realities and exchange subsidies
12:08 Insurers, public sentiment, and misinformation
14:03 Drug pricing models and global comparisons
16:41 Employer leverage and failed market solutions
17:49 Emerging therapies and future cost risk
20:24 What could improve in 2026
24:26 Populism and the next policy inflection point

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Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.

Recorded live at the Nicholas Hall North American Conference, this special episode of the Only Healthcare Podcast dives into the FDA’s new Additional Conditions for Nonprescription Use (ACNU) pathway and what it means for access, compliance, and the future of consumer healthcare.

Host Randy Vogenberg is joined by industry veterans Bob Stirling and Bob Barron, with questions moderated by Mary Alice Lawless. Together, they break down how ACNU differs from telepharmacy and direct to consumer models, why scale matters, and how built-in safeguards could enable safer nonprescription access to certain therapies, including acne treatments.

The conversation explores compliance challenges, payer dynamics, employer sponsored accounts like FSAs and MSAs, and why ACNU represents a fundamentally different approach to access that could benefit consumers, manufacturers, and plans alike. This episode provides essential context for anyone tracking FDA policy, OTC switches, market access strategy, or healthcare affordability.

Key Topics Discussed

• What ACNU is and how it differs from telepharmacy and DTC
• FDA safeguards and consumer level decision support
• Scale, retail access, and why shelf access matters
• Simultaneous Rx and nonprescription marketing considerations
• Compliance challenges in traditional Rx models
• Implications for payers, coverage, and benefit design
• The role of FSAs, HRAs, and MSAs in supporting access
• Why ACNU represents a new paradigm for consumer healthcare

Chapters with Time Stamps

00:04 Episode overview and ACNU context
01:27 ACNU vs telepharmacy and DTC models
02:48 Simultaneous marketing and provider oversight
03:33 Introduction to compliance and consumer engagement
04:18 Why traditional Rx compliance programs fall short
05:46 Payer and manufacturer cost dynamics
07:05 ACNU as a leadership opportunity for consumer health
07:51 Coverage, payers, and outcomes expectations
08:34 FSAs, HRAs, and MSAs in the ACNU ecosystem
09:57 Pricing stability and consumer affordability
10:45 Key takeaways from Nicholas Hall Conference

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Sponsored by:
Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.

In this year-end episode of the Only Healthcare Podcast, hosts Randy Vogenberg and Michael Navin reflect on the defining healthcare shifts of 2025 and share what they are watching as the industry moves into 2026 and beyond.

The conversation looks back at the rise of consumer-driven healthcare, expanding price transparency requirements, and the growing pressure on affordability across both medical and pharmacy benefits. Randy and Michael discuss the continued disruption driven by GLP-1 utilization and pricing, emerging direct-to-consumer strategies from manufacturers, and why real change is finally starting to take hold after years of talk.

They also examine the growing role of litigation around ERISA plans, rebates, and fiduciary responsibility, along with increasing employer concern over employee loyalty, recruitment, and retention tied directly to healthcare benefits. Looking ahead, the episode explores trends toward self-funded plans, greater scrutiny of health plans and hospitals, cash-pay and consumer-controlled models, and long-term challenges facing Medicare as demographics and utilization shift.

The episode closes with a forward-looking perspective on economic uncertainty, workforce changes, and why healthcare transformation is likely to accelerate through 2026 and into 2027.

Key Topics Discussed

• The biggest healthcare shifts and controversies of 2025
• Consumer-driven healthcare and price transparency momentum
• GLP-1 utilization, affordability, and direct-to-patient pricing
• Litigation targeting ERISA plans, rebates, and fiduciary duties
• Employer health benefits, employee loyalty, and workforce pressure
• Growth of self-funded employer plans and ERISA implications
• Cash-pay models, HSAs, and consumer-controlled healthcare decisions
• Medicare strain, demographic shifts, and long-term system risk
• Economic outlook and its impact on healthcare access and coverage

Chapters

00:00 Year-end welcome and gratitude to listeners
01:00 Consumer-driven healthcare and transparency gains in 2025
03:30 GLP-1 pricing, utilization, and manufacturer responses
04:45 Litigation, ERISA plans, and affordability pressure
07:00 Employee loyalty, benefits strategy, and workforce impact
08:30 Shift toward self-funded employer plans
10:30 Looking ahead to 2026: transparency, disruption, and risk
12:30 Medicare strain, economic uncertainty, and future scenarios
14:20 Closing reflections and what’s next for Only Healthcare

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Sponsored by:
Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.

In this episode of the Only Healthcare Podcast, host Randy Vogenberg, PhD, is joined by Carole Tremonti of ConcertAI to recap insights from the Clinical Pathways Congress in Boston and discuss the Predictable Cost of Care initiative. Carole shares how the congress reflected stronger engagement, broader perspectives, and deeper integration across clinical pathways, oncology operations, and the business of cancer care.

The discussion highlights how pathways have evolved over the past five years through improved data capture and workflow automation, enabling population-level learning alongside more personalized treatment decisions. Carole also explains where AI can add near-term value in pathways by incorporating comorbidities, social determinants of health, and real-world evidence to help guide patients toward treatments they can sustain.

The episode concludes with an overview of the Predictable Cost of Care model, an effort to move beyond drug cost alone by estimating predictable treatment-related costs across six-month and one-year timeframes. Carole outlines key challenges, including variability in side effect management and the lack of shared standards, and shares next steps to validate the model with real data. The conversation closes on how this work could support better planning, clearer patient conversations, and reduced prior authorization friction through greater predictability and transparency.

Key Topics Discussed

• Clinical Pathways Congress highlights and cross-functional alignment
• Pathway evolution through improved workflows and data capture
• Where AI adds practical value in oncology pathways
• Why predictable cost matters more than retrospective total cost
• What the Predictable Cost of Care model includes and excludes
• Six-month and one-year cost windows for fair regimen comparison
• Challenges in standardizing side effect management costs
• Who benefits from the model across the healthcare ecosystem
• Next steps and long-term potential for evidence-based decisions

Chapters
00:00 Welcome and guest introduction
03:00 Congress recap and key takeaways
07:00 Pathway evolution: data and workflow
12:00 AI in pathways and real-world decision support
18:00 Why predictable cost of care needed
22:00 Predictable Cost of Care model overview
29:00 Model inputs and time horizons
40:00 Side effect cost challenges
47

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Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.

In this episode of the Only Healthcare Podcast, host Randy Vogenberg, PhD, sits down with consultant and longtime oncology pathways leader Gordon Kuntz to explore the evolution of the Clinical Pathways Congress and a new initiative focused on predictable cost of care in oncology. Gordon reflects on how oncology pathways have matured over the last two decades, why Congress has shifted from a primarily clinical lens to include business and operational strategy, and how artificial intelligence is beginning to move from theory into real-world oncology practice.

The conversation then turns to a multi-year effort to develop a Predictable Cost of Care model for oncology treatment decisions, recently published in the Journal of Clinical Pathways. Gordon explains why traditional pathway cost inputs have focused almost exclusively on drug price, why that approach no longer works, and how this new framework aims to capture a more complete picture of predictable costs, including drug administration, monitoring, side effect management, and patient touchpoints.

The episode concludes with a discussion on governance, measurement, and the broader value of predictable cost modeling for payers, providers, oncology practices, and employer plan sponsors seeking greater certainty and transparency in cancer care.

Key Topics Discussed
• The evolution of the Clinical Pathways Congress and its growing business focus
• How oncology pathways differ from guidelines and why efficacy, safety, and cost sequencing matter
• Why oncology remains a leading-edge specialty for innovation and change
• The real state of AI in oncology and where it is creating value today
• Who attends the Congress and what each stakeholder group is seeking
• Predictable cost of care versus total cost of care in oncology
• Core components of the Predictable Cost of Care model
• New use cases for payers, pathway developers, practices, and employers
• Incorporating patient experience and system touchpoints into cost modeling

Chapters
00:00 Introduction and guest overview
02:10 Clinical Pathways Congress history and milestones
06:30 Oncology pathways and guideline distinctions
11:20 AI in oncology today
17:00 Congress audience and stakeholder mix
22:30 Oncology as a test bed for innovation
27:40 Predictable Cost of Care model origins
33:30 Predictable versus total cost of care
39:00 Model inputs and trial-based data
46:20 Patient touchpoints and experience
52:10 Stakeholder applications
57:00 Governance

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Sponsored by:
Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.

In this episode of the Only Healthcare Podcast, co-host Randy Vogenberg, PhD moves beyond the Nicholas Hall North America Conference to break down the FDA’s new Additional Conditions for Nonprescription. Guests Mary Alice Lawless, Ted Lawless, and Chelsea Ryan explain how ACNU grew from long-standing FDA concern over chronic undertreatment in conditions like hypertension, high cholesterol, asthma, and migraine, leading to the rule’s launch in May 2025.

Mary Alice outlines the public health need behind ACNU, showing how nonadherence drives avoidable hospitalizations, higher costs, and an estimated 125,000 preventable deaths each year. She explains why the FDA sees digitally supported nonprescription access as a safe way to expand treatment. Ted covers the financial implications, from algorithm-based tools that reduce development risk to the long-term value of direct consumer relationships.

Chelsea brings the retail view, describing why brick and mortar remains central even as consumers expect blended digital and in-store steps like ID checks and guided prompts. The conversation also explores equity, the limits of simple questionnaires, and how ACNU programs can use existing health data infrastructure to support lower-literacy and multilingual populations.

Key Topics
• Why ACNU was created to address undertreatment and access barriers.
• The public health toll of nonadherence and preventable hospitalizations.
• How ACNU differs from traditional OTC switches through added safety steps.
• The role of algorithm-driven digital pathways to verify safe use.
• How sponsors can forecast investment, timelines, and long-term value.
• Where ACNU fits in retail and omnichannel journeys.
• Consumer attitudes toward nonprescription access and required steps.
• How equity, literacy, and interoperable data shape ACNU tools.
• A sponsor roadmap covering education, alignment, and retail strategy.

Chapters
00:00 Introduction
02:10 FDA motivations
09:30 Barriers driving nonadherence
14:20 ACNU structure and populations
20:15 Financial implications
27:30 Forecasting and consumer value
33:45 Retail and omnichannel strategy
40:10 Consumer attitudes
46:00 Equity and care design
53:30 Getting started
59:00 Final takeaways

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Sponsored by:
Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.

In this episode of the Only Healthcare Podcast, co-host Randy Vogenberg, PhD, sits down with Winston Wong, Editor-in-Chief of the Journal of Clinical Pathways, to explore the past, present, and future of one of the most influential publications in oncology care.

Winston shares how clinical pathways have evolved over more than two decades—from simple treatment sequencing tools designed to reduce variability, to comprehensive frameworks that now integrate personalized medicine, genomic testing, value-based care, and whole-person support. As the first and only editor-in-chief since the journal’s inception in 2015, Winston offers a unique perspective on how the publication has grown, adapted, and helped shape the national conversation around oncology quality, affordability, and outcomes.

Listeners will also get a behind-the-scenes look at the journal’s mission, how article categories have expanded across clinical, operational, economic, and palliative domains, and why JCP is now pursuing National Library of Medicine indexing to strengthen its credibility and impact for clinicians, employers, and researchers.

The episode concludes with a forward-looking discussion on what the next decade may bring for pathways—and how integrated care, social determinants of health, and evolving value-based care models will define the next frontier of oncology practice.

Key Topics Discussed

• The evolution of clinical pathways: From early-stage treatment sequencing to advanced tools supporting personalized oncology, genomic testing, and multidisciplinary care.

• The growth and mission of the Journal of Clinical Pathways: How JCP expanded from its 2015 launch to a nationally recognized publication advancing value-based oncology care.

• Article categories shaping the future of oncology: Prevention and diagnosis, treatment innovation, outcomes measurement, business infrastructure, predictive cost modeling, palliative care, and prehabilitation.

• The role of employers and managed care stakeholders: Why value-based care and clinical effectiveness require alignment between clinical quality and economic impact.

• The journal’s pursuit of NLM indexing: How indexing will enhance credibility, visibility, and submissions across clinical and health economics fields.

• The next decade of clinical pathways: Integration of whole-person care, personalized medicine, social disparities, and cross-journal collaboration.

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Sponsored by:
Peek: A game-changing prescription shopping solution that allows its members to view all their prescription cost options across cash discount programs and their insurance in one easy-to-use platform. Peek is currently being offered to organizations to help both employees and plan sponsors save money on their prescription spend. https://peekmeds.com/.

Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.