Federal and State Policy
As the largest US healthcare payer, the federal government plays a dominant role in shaping the healthcare marketplace, while states take center stage when it comes to developing novel policy approaches. Our experts track, interpret, and model policies that affect insurance coverage, access, and consumer choice so you can see around the bend.
Implications of PBM-Pharmacy Co-ownership Legislation
Avalere Health examines how new federal and state efforts to oversee PBM-pharmacy ownership may affect stakeholders systemwide.
State Oversight of AI in Healthcare: Status and Impacts
State oversight of AI in healthcare has primarily focused on prior authorization, disclosure and operations requirements, and scope of practice.
Clinicians and Several Lawmakers Unify in Support of USPSTF
Policymakers, professional societies, and advocates support the preservation of USPSTF’s evidence-based recommendations and independence amid reported plans for a sweeping overhaul.
CMS Rulemaking Can Have Immediate Impact on Site-of-Care Trends
A case study of musculoskeletal surgery site-of-care regulations indicates that proposed changes to the Medicare OPPS could trigger immediate site-of-care shifts.
CMS Modifies Part D Premium Stabilization Demonstration
Continued NAMBA increases and changes to the Part D Premium Stabilization Demonstration may signal further destabilization of the standalone PDP market.
OBBBA and Medicare Negotiation Eligibility: Considerations for Manufacturers
For IPAY 2028 and beyond, the OBBBA expands the exclusion for orphan drugs subject to Medicare negotiation, with implications for negotiation selection timing.
OBBBA Provider Tax Provisions Impact on Medicaid Stakeholders
The changes to provider tax provisions included in the One Big Beautiful Bill Act will impact state Medicaid funding, and its effects will be felt by plans and providers.
2025 Update: Biosimilar Substitution State Statute Report
The 2025 edition of the annual report provides insights into state statutes on point-of-service substitution of biosimilar products and is available
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.
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.
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.
Video: Inside the Latest RADV Regulatory Developments
Avalere Health Advisory experts break down major updates to the CMS Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) audit process, including enhanced technology, workforce expansion, and increased audit volume, and how health plans can prepare.
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: 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.
Stakeholder Considerations for MFP Effectuation in Part B
Several pathways exist to effectuate the MFP for Part B negotiation with benefits and drawbacks for stakeholders across the drug supply chain.
Early Enrollment Data Indicates More Beneficiaries Could Benefit from MPPP
Avalere Health’s analysis of early MPPP enrollment shows that only a small portion of beneficiaries who are likely to benefit from the program have enrolled.
Revisiting Medicaid Work Requirements
Federal policymakers are considering Medicaid work requirements as a mechanism to reduce spending; recent state experiences offer important considerations.