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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IRA Question of the Week: How Will Negotiation Affect Reimbursement?
The introduction of the maximum fair price through the Medicare drug price negotiation process is expected to lower provider reimbursement.
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.
Medicare Drug Price Negotiation Guidance: Avalere Experts Respond
Guidance adds clarity on drug selection, maximum fair price application (MFP), evidence submission, and manufacturer engagement, but leaves questions on determining MFP.
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.
iDQI Corporate Roundtable Advances Diabetes Care Quality
On March 2, 2023, the Improving Diabetes Quality Initiative (iDQI) hosted a corporate roundtable to discuss the future of diabetes care and technology.
ESRD Enrollment Shifts in MA Driving Care Management Partnerships
Continued shifts in Medicare Advantage enrollment introduce new value-based care opportunities for patients with ESRD.
Implications of Policy Reforms on Pharmacy DIR in Part D
The use of DIR in Medicare Part D has increased in recent years, and both the IRA and CMS rulemaking are likely to influence DIR dynamics in the future.
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.
RWE Considerations Throughout Product Development Cycle
Drug manufacturers can use real-world evidence (RWE) before and after approval to advance product development and adoption.
Pre-Approval Information Exchange Aids Manufacturer–Payer Engagement
Clarifications in the PIE Act may shift manufacturer-payer engagement strategy and improve coverage and reimbursement of new drugs and devices.
Quality and Value in Telehealth: Progress and Potential
Telehealth solutions aimed at enhancing quality, cost, and equity require greater investment in evidence generation and clinical practice guideline development.
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.
Manufacturers’ Opportunities in Digital Therapeutics
Digital therapeutics is the fastest growing field in digital health, offering promising benefits for patient outcomes and healthcare system efficiencies.
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.
FDA Human Foods Program Redesign Would Centralize Food Safety Efforts
Amid growing safety issues in America’s food supply, the FDA’s proposal for a new Human Foods Program presents opportunities for stakeholders to act.
FDA Diversity Requirement: Impact on Rare Disease Drug Manufacturers
Increasing clinical trial diversity presents unique challenges for rare disease treatments due to population size, disease heterogeneity, and low awareness.
Shortening the Diagnostic Odyssey: Benefits, Barriers, and Solutions
A diagnostic odyssey is defined as the time between when a symptom or feature of a genetic or rare disease is noted to the time when a final diagnosis is made.
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.
CMMI Drug Pricing Model Concepts
CMMI releases long-awaited response to President Biden’s executive order on drug pricing with a directive for the Centers for Medicare & Medicaid Services (CMS) to develop three models.