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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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.
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.
Standards of Care Begin to Reflect Advances in Diabetes Technology
Changes to standards related to diabetes technology indicate a corresponding opportunity to evolve quality measurements.
Characteristics of Hospitals Undergoing Mergers and Acquisitions
Avalere found that from 2016 to 2022, hospitals undergoing mergers and acquisitions were more likely to have 500+ beds and to be a 340B covered entity.
Improving Health Equity in Medicaid-Eligible Populations
The Health Systems Transformation Research Coordinating Center aims to change how research is generated, funded, and used to transform health systems in promotion of broader health equity for Medicaid-eligible individuals.
Medication Adherence Among Medicare Patients with Kidney Cancer
Among LIS Medicare patients using oral/IV therapy for kidney cancer, social risk factors may impact adherence, even when the OOP burden is reduced.
What is the CMS Innovation Center?
The CMS Innovation Center offers policymakers a nimble, non-legislative pathway to experiment with new methods of care delivery, payment, and reimbursement in Medicare and Medicaid.