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.
How Will the IRA Impact Product Launch Prices?
IRA inflation rebates and drug price negotiation will impact drug launch prices in Medicare, with spillover effects in the Medicaid and commercial markets.
Video: IRA Impacts on Patient Access
Ahead of Asembia 2023, Avalere experts discuss how the IRA and other regulatory changes will impact patient access and affordability.
How Should Manufacturers Adjust Their Pipeline Strategies to the IRA?
In response to IRA provisions, life sciences companies should reevaluate their pipeline investment and development strategies.
What Evidence Is Needed for Medicare Drug Price Negotiation?
As CMS clarifies evidence requirements for drug price negotiations, manufacturers should prepare their strategies for asset development and on-market products.
Medicaid Redeterminations Will Increase Use of Patient Support
Medicaid redeterminations will bring changes to individual prescription drug access. Manufacturers should consider the impact on patient support programs.
Biden’s 2024 Budget: New Drug Pricing and Coverage Policies
The Biden administration’s budget outlines a healthcare policy agenda focused on drug pricing, coverage reform, infectious diseases, and biomedical research.
IRA Question of the Week: How Will the Law Impact Plans and PBMs?
Part D redesign and OOP smoothing shift financial liability from beneficiaries to plans, incentivizing utilization and formulary management.
IRA Question of the Week: How Does the Law Impact Patients?
The IRA will reduce out-of-pocket drug costs (especially in Medicare Part D), increase the availability of marketplace plans, and expand access to vaccines.
IRA Question of the Week: When Will the IRA Be Implemented?
The first Insight in this series explores timing for Medicare negotiation, inflation rebates, and Part D benefit redesign changes and details to be defined.
Orphan Drug Development Amid Regulatory Uncertainty
Policies within the IRA and at the FDA in response to recent litigation could influence commercialization decisions for orphan drugs and may need to be clarified by policymakers.
Risk Adjustment Under Part D Benefit Redesign
With higher plan liability under Part D benefit redesign, risk adjustment could play a larger role in how plans set formulary design and contracting strategies.
Video: IRA Policy Changes: Planning for Life Sciences
The Inflation Reduction Act (IRA) brings some of the biggest changes affecting the pharmaceutical industry in the last decade. Avalere expert Megan West discusses how these shifts will impact pharmaceutical organizations and how Avalere can support in developing strategies to mitigate risk and identify opportunities across the product lifecycle.
CMS Engagement Opportunities in Discarded Drug Refund Implementation
Manufacturers should assess liability to drug waste refunds and engage with CMS as it considers an increased applicable percentage for specific product types.
Proposed MA Plan Payment Changes May Impact Premiums and Benefits
Due to changes proposed in the CY 2024 Advance Notice, enrollees in Medicare Advantage could have higher premiums and fewer benefits in 2024 than 2023.
Video: Medicare Advantage and Part D Advance Notice: Proposed Payment Changes
Avalere expert Sean Creighton explains key policy changes proposed in the Advance Notice for Medicare Advantage and Part D Payment for Plan Year 2024.
MA RADV Policy Changes Raise Questions for Plans
Policy changes included in the final MA RADV rule will substantially affect the MA program, plan benefit design, and operations.
2024 Advance Notice Would Substantially Alter Risk Adjustment Model
Proposed technical changes to the MA risk adjustment model would have major implications if finalized.
Video: Plan and Beneficiary Responses to IRA Policies
Avalere expert Rebecca Yip discussed plan and beneficiary responses to IRA policies during our 2023 Outlook webinar.
5 Ways the IRA Will Impact Healthcare Investors in 2023 and Beyond
The IRA’s drug price negotiation policies, extended marketplace subsidies, and Part D redesign will impact investors’ current portfolios and investment strategy in the future.
Some Enrollees May Face Affordability Challenges Under Part D Redesign
An Avalere analysis finds that about 800,000 beneficiaries in 2024 and 200,000 in 2025 will have OOP costs that exceed 10% of their annual income.