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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Manufacturers Should Assess Wastage to Inform Mitigation Strategy
Manufacturers impacted by the Part B discarded drug refund policy should assess claims billing and adjudication patterns to inform mitigation strategy.
Physician Payment for Some Services Lags Behind Inflation
Physician reimbursement for some services under Medicare FFS has declined, while payment increased for the same services in the hospital outpatient setting.
Will Part D Redesign Lower OOP Costs for HIV Care?
The IRA’s Part D redesign could lower out-of-pocket costs for people with HIV; providers can help make sure their patients are aware of these changes.
What is the Role of 340B Grantees?
Some federal grant recipients use 340B program eligibility to expand their reach and services provided to a wide range of patient populations.
CMS Finalizes Changes to NTAP Payment Designation
The recent FY 2024 IPPS final rule revised NTAP eligibility criteria for certain technologies. Applications for the FY 2025 NTAP cycle are due by October 17, 2023.
CMS Selects First 10 Drugs for Medicare Negotiation
CMS selected 10 Part D drugs for the first year of negotiation. Stakeholders should consider engagement opportunities and evaluate broader therapeutic dynamics.
How May the IRA Shift Part D Market Dynamics?
IRA policies and growing enrollment in Medicare Advantage could begin to destabilize the standalone PDP and LIS benchmark plan market.
Decentralized Clinical Trials for Rare Disease Treatments
Decentralized clinical trials offer the potential to democratize rare disease research, advancing drug development and improving patient experiences.
How Will the IRA Impact the Future of Biosimilars?
Multiple Inflation Reduction Act provisions impact biologics and biosimilars, but the net impact and potential consequences will vary across products.
CAR-T Reimbursement Updated in FY 2024 IPPS Final Rule
Medicare CAR-T payment remains stable, but changes to outlier payments and NTAP eligibility may create challenges.
States Turn to Drug Price Boards to Reduce Spending
State legislatures are increasingly considering prescription drug affordability boards and upper payment limits to lower state expenditures and patient costs.
How a New Technology Add-On Payment (NTAP) Works
Additional Medicare payment in the inpatient setting may be available to certain qualifying new technologies, but requires successful navigation of application processes.
Stakeholders Address Disparities in Breast Cancer Screening
Avalere found disparate breast cancer screening rates by race/ethnicity and insurance type. Stakeholders are seeking to address barriers to patient access.
Therapeutic Vaccines Raise Regulatory, Policy Pathway Questions
In light of the growing therapeutic vaccine pipeline, policymakers are starting to define coverage, access, and reimbursement pathways.
How Did Public Comments Shape Revised Negotiation Guidance?
Comments on initial negotiation guidance significantly shaped the revised guidance, underscoring the importance of stakeholder engagement in IRA implementation.
Proposed Operational Updates to the Discarded Drug Refund Policy
In CY 2024 rulemaking, CMS proposes operational clarification to the discarded drug refund policy finalized last year.
How Do IRA Policies and the Enhancing Oncology Model Interact?
Manufacturers should adjust commercial and evidence generation strategies in response to the shifted incentives under the IRA and Enhancing Oncology Model.
CMS Best Price Discount Stacking Proposal May Trigger AMP Cap
Requiring manufacturers to stack all discounts provided through the supply chain could increase Medicaid rebate liability and complicate rebate dynamics.
Use of Patient-Centered Outcomes in ICER Assessments
Avalere assessed the current use of patient-centered outcomes in ICER evidence reports and determined the patient voice minimally influences modeling results.
CMMI Releases EOM Participation and Lessons Learned from OCM
The CMMI’s EOM began on July 1 with 44 participants. A recent OCM evaluation report described net losses to CMS and lessons that can be applied to EOM.