Insights & Analysis
There’s one constant in healthcare: change. Count on us to break down the trends so you can stay up to date. Follow our take on each piece of this deep, intertwined, and often perplexing industry to find opportunities and practical approaches to move healthcare forward.
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FDA Restrictions on PD-L1-Negative Gastric Cancer Treatments
The FDA has limited Keytruda and Opdivo use to PD-L1–positive gastric cancer, raising questions about off-label access and payer coverage.
FY 2026 ICD-10-CM Codes Released
In June, CMS and the CDC announced over 400 new FY 2026 ICD-10-CM codes for patient encounters and discharges. These will address emerging health concerns, enhance clinical specificity, support accurate reporting, and reflect advances in medical knowledge and terminology.
IRA, MFN, and Ongoing Fiduciary Pressures Creates Ripple Effect Across the Healthcare Ecosystem
IRA Medicare provisions, increased focus on price regulations including Most-Favored Nation pricing, and broad fiduciary pressures have ripple effects across the healthcare ecosystem.
A Turning Point for US Vaccine Policy? Signals from the June ACIP Meeting
The ACIP’s first meeting with newly appointed members indicated the committee’s new direction, with potential impacts across US vaccine policy and access.
Supreme Court Upholds Zero-Cost Preventive-Care Rule
In Kennedy v. Braidwood, the Supreme Court affirmed HHS’s USPSTF appointment power, keeping the ACA’s no-cost preventive-service mandate fully in force.
President Trump’s Proposed AHRQ Cuts Would Impact Preventive Care Access
If finalized, the President’s FY 2026 proposed budget cuts and restructuring of AHRQ is anticipated to impede key USPSTF activities.
Quality is Critical to Manufacturers’ Commercialization Strategies
Quality is the bedrock of high-value care and should be a critical focus for manufacturers seeking to ensure access, coverage, and widespread adoption of therapies in clinical practice.
Variability of Comparator Drugs in Ex-US HTAs Offers Lessons for the IRA
Ex-US HTAs often select different therapeutic alternatives when assessing the effectiveness of the same therapies, highlighting the complex factors that influence such decisions.
Chronic Care Management in Medicare: Optimizing Utilization
CCM services remain underutilized, but a subset of claims lacking supporting diagnoses suggests opportunities to improve utilization via coding accuracy.
White Paper: Health System Consolidation and Employer-Payer Considerations
This paper details the financial impact to employers on health system consolidation, using the Chicago healthcare market as a case study.
What the Latest Federal Shifts Mean for Mental and Behavioral Health
The Trump administration is shifting behavioral health priorities, moving away from integration and parity, towards cost containment and structural reform.
Stakeholder Considerations for IPAY 2028 Guidance
Draft guidance for IPAY 2028 Medicare drug price negotiation includes the first-time inclusion of Part B drugs, refinement to MFP effectuation, and considerations around what qualifies as a single-source drug.
White Paper: Policy Considerations for Refining MA Star Ratings
This paper presents several proposed changes to the MA Stars Rating program and offers insight into how each proposal would impact federal entities, payers, and members.
ACNU Provides a New FDA Approval Pathway for Prescription-to-OTC Drugs
The ACNU final rule provides a new approval pathway for prescription drugs to also gain nonprescription marketing status.
White Paper: The Role of PBMs in the US Healthcare System
A new white paper describes the role of PBMs in the US healthcare system using evidence published in the literature to inform future discussions.
MFN EO Raises A Range of Potential Options for DTC Implementation
A DTC purchasing program could take various forms to enable patients to access MFN pricing.
White Paper: Provider Survey on Part B Step Therapy in Medicare Advantage
Step therapy is a form of utilization management increasingly used by health plans, including Medicare Advantage plans, with the stated intent to guide prescribing decisions toward cost-effective, evidence-based therapies.
Part D Cost Pressures May Shape Future Alzheimer’s Drug Management
As new Alzheimer’s drugs are developed, increased plan liability pressures may shape future Part D plan management strategies
Avalere Health Experts React to the Most-Favored Nation Executive Order
A new EO revives international reference pricing as a core Trump administration priority, with a focus on Most-Favored Nation pricing through direct-to-consumer models, regulatory action, and broader enforcement measures.
White Paper: The Cost of Opioid Use Disorder
Avalere Health finds opioid use disorder costs businesses, governments, and households almost $1 trillion per year, but treatment with medications can lower costs.