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.

Emergency State Licensing Flexibilities May Improve Provider Access

Recent regulatory changes have eased restrictions for providers delivering care across state lines during the COVID-19 public health emergency. However, state and federal cooperation on extended licensure expansion would help address long-term provider access issues.

What’s Next for Medicaid Drug Pricing?

On February 27, Avalere experts discussed the latest policy, pricing, and reimbursement challenges for prescription drugs in Medicaid in the “What’s Next for Medicaid Drug Pricing?” webinar. They reviewed the ways prescription drugs are managed in Medicaid, what innovative medicines may mean for the program, and potential implications of CMS’ Healthy Adult Opportunity (HAO).

What’s Next for Telehealth? HITECH May Offer Lessons

Major catastrophes, like natural disasters, global pandemics, and sudden economic downturns require rapid interventions to protect the American public from long-term health and financial damage. Because there is significant momentum and political will during and immediately following a catastrophe, promising innovations may be fast-tracked.

John Neal

COVID-19 and Its Impact on the Global Drug Supply Chain

Although COVID-19 is introducing new challenges within the global pharmaceutical supply chain, the current situation also creates opportunities for stakeholders to evaluate drug security and implement risk-mitigation strategies around shortages and required stockpiles.

Reducing Funding to WHO May Impact Existing Vaccines Programs

On April 15, President Trump announced his intention to halt funding to the World Health Organization (WHO), pending an investigation into WHO’s response to the COVID-19 pandemic. WHO first declared the outbreak a Public Health Emergency of International Concern on January 30 and a global pandemic on March 11. A reduction in funding from the US could limit WHO’s COVID-19 response activities as well as its regular vaccine programming, including product prequalification, global surveillance, and ongoing efforts to strengthen health systems.

Impact of the COVID-19 Pandemic on Sickle Cell Disease Management

Sickle cell disease (SCD) is a severe red blood cell disorder that disproportionately affects African-American and Hispanic populations. In the United States, there are approximately 100,000 individuals living with SCD (although there is a lack of accurate reporting and the exact number is unknown).

FDA Guidance on Digital Devices for Mental Health During COVID-19

To protect the public’s health during the COVID-19 pandemic, the Food & Drug Administration (FDA) released guidance expanding the availability of digital health therapeutic devices and applications for psychiatric disorders by clarifying which regulatory requirements it does not plan on enforcing as well as which products do not necessitate FDA oversight. This guidance intends to limit extraneous contact between patients (users) and providers by providing regulatory flexibility for low risk products. The policies will last until the national public health emergency ends.

Provider Impact of COVID-19 Telehealth Policies by Specialty

Approximately ⅓ of physician services payments are eligible for telehealth reimbursement under Medicare (fee-for-service) FFS through existing Center for Medicare and Medicaid Services (CMS) guidance as of January 2020, in addition to temporary coding guidance specific to COVID-19 effective as of March 1, 2020. Avalere’s analysis highlights the immediate potential for specific physician specialties to utilize telehealth based on temporary flexibilities regarding which procedures are eligible for telehealth reimbursement.

COVID-19 Complicates Access to Provider-Administered Autoimmune Treatments

The large-scale disruptions resulting from COVID-19 are significantly reshaping how patients receive care. In particular, patients taking infused and injectable drugs administered by a healthcare professional at a physician office, infusion center, or hospital outpatient department now face greater challenges receiving their medications.

Sign up to receive more insights about Regulatory Strategy and FDA Policy
Please enter your email address to be notified when new Regulatory Strategy and FDA Policy insights are published.

Back To Top