Gottlieb: COVID-19's Lasting Effects on Healthcare Delivery

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Amazon is gearing up for an era that includes telehealth and home testing, but the former FDA commissioner says the new model is more than a logistics challenge and that healthcare companies will prevail.

The COVID-19 pandemic has forever changed how healthcare is and will be delivered in the future, Scott Gottlieb, M.D., former commissioner of the FDA, said during his keynote address today at the 2021 Pharmacy Benefit Management Institute®Annual National Conference in Orlando, Florida.

The future of healthcare is going to be very different from what it is now, he said, and that doesn’t only mean accelerating the adoption of telehealth. It is broader than that, and bringing diagnostic testing for COVID-19 into the home was just the beginning of this change, opening up a range of possibilities for healthcare delivery.

“COVID has clearly changed the course of world history,” he said. “It’s had geopolitical consequences, and it’s impacted the economy in an irrecoverable way. But it has changed our culture around healthcare and changed our orientation to aspects of healthcare delivery that are fundamental. And it’s not going back.” he said.

Healthcare in the home became the cultural norm during the pandemic, making telehealth, virtual visits, and home testing commonplace. “There was a time when the FDA would not allow people to self-diagnose for infectious disease. There was a perception that people wouldn’t engage in appropriate follow up.”

In a wide-ranging, hourlong talk, Gottlieb sounded an optimistic note about the next six months of the COVID-19 pandemic and wove in some observations about missteps in the federal government’s response. Gottlieb’s book about the pandemic, “Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic” comes out next week.

When discussing the pandemic’s lasting effects on healthcare delivery, Gottlieb pointed to the example of home HIV testing. There was vigorous debate within the regulatory agency two decades ago about home HIV testing and whether patients would seek appropriate care.

“Now there has been a complete change. The FDA has embraced home testing with COVID and not worrying about how it will get reported to a public health authority. This is going to open up a whole new category for home testing.”

Gottlieb said that in the future, routine care will be delivered in a whole new way, with home testing being coupled with virtual visits in a more robust way for many conditions. He pointed to Amazon’s construction of two CLIA labs that are far larger than what is needed for its employees. “Amazon is going to get into this in a more robust way, marrying their pharmacy business with their diagnostics business and build what they see as a missing link.”

But Amazon, Gottlieb said, is approaching this concept of care delivery as a logistic challenge they can solve for. He sees this as a healthcare challenge, not a logistics issue. “The companies that are going to be able to capitalize on this new future and take advantage of this cultural change are healthcare companies that know how to couple diagnostic tests with the delivery of pharmacy in the home, build that relationship with the patient and overlay healthcare services. The healthcare services companies don’t have all the tools to do that.”

PBMs, he said, are uniquely positioned to pull this all together, because their relationship to the patient is through the pharmacy, and they are in are in a position to build out the platforms need for this new care delivery system.

In discussing the short-term outlook on the course of the pandemic, Gottlieb, who is on the board of directors of Pfizer, said the conventional wisdom is that the delta variant of COVID-19 will crowd out other variants such as mu and lambda. He also said the rate of mutation is likely to slow. Citing data from Israel, he said a booster shot would likely increase people’s immunity to getting infected, not just the risk of serious disease, to levels that occurred after two shots of the Pfizer and Moderna vaccines.

Gottlieb also foresaw an emergency use authorization for a vaccine for children ages 5 to 11 by the end of October (Pfizer has said it will submit data to the FDA by the end of this month) and with that OK, some restoration of confidence and normalcy. More childhood vaccines will need to become available, but Gottlieb said he expected the incorporation of COVID vaccination into the CDC’s Advisory Committee on Immunization Practices before the start of the school in 2022. Gottlieb also predicted, though, that COVID-19 would become endemic and that awareness of infectious respiratory illness — flu as well as COVID-19 — will shift workplace and social norms.