How COVID-19 Is Transforming the Regulatory Landscape

September 30, 2020

Amid the onset of the COVID-19 pandemic, policymakers and other healthcare stakeholders made a number of regulatory and programmatic changes to free up healthcare resources and protect the health and safety of the public. Now, with the data to begin to assess the effectiveness of these measures as well as their long-term viability, it is becoming clear that at least some could serve as catalysts for lasting reform.

Eliminating Barriers to Safe, Convenient Access to Healthcare

From January 1 to July 24, 2020, the Federal Government instituted more than 200 legislative and regulatory changes to the Medicare program alone, according to the Commonwealth Fund. Among the most notable changes were those surrounding telehealth, also known as telemedicine. In addition to expanding telehealth coverage for Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) issued several waivers and flexibilities to equip providers to deliver telehealth services and enable beneficiaries to access care safely from home.

Perhaps unsurprisingly, telehealth adoption has soared during the pandemic, with Frost and Sullivan forecasting telehealth demand to increase by 64.3% in 2020. What is somewhat surprising is that it took a global pandemic for telehealth to finally take hold in the U.S. The American Medical Association published the first national estimate of telemedicine use back in 2018, finding that just 15% of U.S. physicians had worked in a practice that interacted with patients using telemedicine.

Today, the Trump administration is working to permanently expand telehealth benefits beyond the COVID-19 emergency period, along with other provisions meant to enhance the sustainability of the Medicare program, according to a press release.

Getting Drugs Safely to Market and Patients Faster

The U.S. Food & Drug Administration (FDA) also relaxed several regulations to ensure continuity of its critical functions and accelerate the development of treatment options for COVID-19, while maintaining compliance with social distancing protocols across its jurisdiction.

Of particular note is the FDA’s Coronavirus Treatment Acceleration Program (CTAP), an emergency program utilizing “every available method to move new treatments to patients as quickly as possible.” Under normal circumstances, the development of a new drug product — from lab to pharmacy shelf — can take upwards of 12 years and $2.6 billion to complete, according to research from Tufts Center for the Study of Drug Development.

We have yet to see the outcome of the FDA’s acceleration program with regard to a coronavirus treatment; however, if current estimates are any indication, we are likely to see a vaccine hit the market in record time, setting a new precedent for future vaccines and therapeutics.

In a June 2020 video message, FDA Commissioner Stephen Hahn, M.D., emphasized the agency’s commitment to ensuring lessons learned during the COVID-19 pandemic will lead to permanent improvements, stating the following:

“To the extent that the innovations and adaptations we implemented during the pandemic crisis worked and would be appropriate to implement outside of a pandemic situation, we will incorporate them into standard FDA procedures. And to the extent that we identified unnecessary barriers, we will remove them.”

“Necessity Is the Mother of Invention”

This unprecedented crisis has and will continue to transform the nation’s health and economic infrastructure. Many changes could in fact be positive for the healthcare system as a whole — i.e., removing needless barriers to care and bringing much-needed therapies to patients faster and at a lower cost. However, a once unfathomable death toll and glaring health disparities surrounding the pandemic make it hard to deny the grave shortcomings this event has thrust into the spotlight.

There are indeed many lessons to be learned from COVID-19; it is critical that we use this crisis and the data that emerges from it as an opportunity to fundamentally improve healthcare in a meaningful and sustainable way.

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