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.
Who Will Approve a COVID Vaccine in the US?
As life sciences companies sprint toward COVID-19 vaccines and therapies, the discussion below considers who has the authority to make the call on their availability at the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS).
COVID-19 Therapies Could Benefit from NTAP Reimbursement Opportunity
Therapies currently being developed to treat COVID-19 in the inpatient setting have opportunity for additional Medicare reimbursement.
New ESRD Analytics Featured in Kidney 360
On August 25, “Calcimimetic Use in Dialysis-Dependent Medicare Fee-for-Service Beneficiaries and Implications for Bundled Payment” was published in Kidney 360. The article featured research and analytics conducted by Avalere experts.
5 Activities to Make the Most of the HEDIS® Off-Season
While the HEDIS® collection season lasts for a limited time, the focus on initiatives that impact HEDIS results is a year-round priority. The period between submission and HEDIS season ramp-up, known as the “off-season,” offers an opportunity for health plans to elevate the member experience, amplify quality improvement activities, and improve HEDIS submission effectiveness.
COVID-19 Guide for Patients and Providers
As our healthcare industry rapidly evolves to address the COVID-19 pandemic, keep track of new resources and policies affecting patients and providers with the COVID-19 guide below.
CMS Proposal Would Increase Provider Payment for Vaccine Administration
The proposed CY 2020 MPFS rule includes provisions that, if finalized, would increase provider reimbursement for vaccine administration. However, the proposed crosswalk of the codes to a separate, nonvaccine related code could subject the code to future unrelated payment fluctuations.
MedPAC Proposes Replacement for MA Star Ratings Program
Under the Medicare Advantage (MA) Star Ratings Program, plans with 4-stars or more receive the greatest benefit from the Quality Bonus Program (QBP) in the form of higher benchmarks and bonus payments.
Charitable Assistance Covers a Small Share of Part D Non-LIS OOP Costs
As policymakers discuss ways to curb program expenditures and improve patient affordability in Medicare Part D, the role of charitable assistance in helping beneficiaries with out-of-pocket (OOP) costs has garnered interest. To understand the relationship between charitable assistance and various Part D metrics, Avalere examined Part D prescription drug claims for beneficiaries without the Low Income Subsidy (LIS) for 2014 and 2018.
Overview: Balance Billing or Surprise Medical Bill Reform
Surprise and balance billing reform efforts have been a subject of ongoing debate at the federal level.
EO on Rebate Reform Raises Key Considerations for Pharmacies
As currently written, a proposed rule on rebate reform from January 2019 may impose financial and operational challenges for pharmacies related to cash flow and new technology requirements.
Bringing COVID-19 Vaccines and Therapeutics to Market
On July 22, Avalere experts discussed the marketplace for COVID-19 vaccines and therapeutics in the “Cutting Through the Noise: Market Evolution and Pathways to Access for COVID-19 Vaccines and Therapeutics” webinar. They examined FDA regulatory considerations, coverage and access challenges, and key pricing and distribution scenarios for optimal US market access.
EOs Direct Drug Pricing Action, Raise Additional Questions
The administration’s 4 drug pricing EOs direct agency action across a host of policy areas, including Part D rebates, Part B reimbursement and pricing, 340B drug discounts, and drug importation. Next steps and a timeline for agency action will vary by EO dependent on the specific policies to be advanced or finalized. In the interim, stakeholders should explore outstanding questions and contemplate near- and longer-term policy scenarios.
Research Agenda for Health Equity Released in Collaboration with RWJF
Avalere is releasing a new research agenda to guide evidence generation for health system models of care that advance the intersection of social and clinical needs of Medicaid-eligible individuals.
Avalere Vaccines: 2020 Mid-Year Outlook
Vaccine development is at the forefront of global efforts to address the COVID-19 pandemic, with a rapidly growing pipeline of candidates that will expand the existing vaccine landscape.
Avalere Statement on Prescription Drug Pricing Executive Orders
On July 24, the administration released 3 executive orders (EO) and announced the planned publication of a fourth EO, all focused on prescription drug pricing. The EOs reflect a combination of familiar policy goals (e.g., rebate reform, importation, international pricing) and a new 340B initiative, and in combination could have substantial implications for healthcare stakeholders and pharmaceutical markets if implemented.
8 Return-to-Work Considerations for Employers Amid COVID-19
As businesses across the country begin to reopen, navigating the COVID-19 pandemic will continually require employers to be resilient, flexible, innovative, and forward looking when it comes to returning employees safely to work sites. Among the myriad of concerns and considerations, organizational leadership will need tools that assist decision making and ensure compliance with Centers for Disease Control and Prevention (CDC) guidance.
Access to Medicare Part B Drugs Remains Challenging During COVID-19
Avalere continues to find a significant drop in utilization of key physician-administered therapies in 2020 relative to 2019.
Expanding LIS Subsidies Could Save Part D Beneficiaries Money
Avalere assessed the impacts of select policies to expand low-income subsidy (LIS) eligibility under Medicare Part D
Majority of API in US-Consumed Medicines is Produced in the US
New analysis of trade data finds that 54% of API, in dollars, used in domestically consumed medicines came from the US in 2019.
Proposed Medicaid Line Extension Definition Alters Rebate Calculation
The CMS proposes to define line extension under the MDRP to broadly include any product that has at least one ingredient in common with the original drug, even if it is a different dosage form. If finalized, this change would have significant implications on classification and rebate liability for a wide set of current and future products.

