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Washington and Public Policy: The COVID-19 Pandemic

Web Exclusives - COVID-19
Scott Gottlieb, MD
Former FDA Commissioner

Jayson Slotnik, JD, MPH, Managing Partner, Health Policy Strategies

Mr Slotnik opened the session with an inside look at Washington, addressing some of the changes to oncology care policies and operations from the COVID-19 pandemic. He outlined a quick overview of the initiatives from the Centers for Medicare & Medicaid Services (CMS), including new guidelines and the easing of some restrictions on physicians’ options for telemedicine.

“CMS has done a very good job cataloging all their announcements and initiatives for loosening guidelines to allow patients to still access their physicians,” said Mr Slotnik. He noted that stakeholders from across the industry are focusing on helping patients with cancer gain access to their medicines amid a deeply changed healthcare provision environment. To that end, some experts are working with CMS to issue guidelines on home infusion and physician supervision in the outpatient setting.

“Industry and other stakeholders are helping CMS put out guidelines and instructions, billing guides, whatever they can, to help cancer patients get their drugs in the home and create a more robust home infusion opportunity for patients so they don’t miss any of their life-saving treatments,” Mr Slotnik said.

In addition, there are plans to relax the clinical criteria for drugs administered via durable medical equipment, and an expected broadening of the definition of “home-bound.” He is expecting the release of additional guidance on how to set up home infusion, a series of expanded frequently asked questions, and details on how providers should bill for a variety of arrangements that allow patients to continue to receive treatments at home. Mr Slotnik encouraged listeners to reach out to their legislators with ideas on how to broaden access for patients.

Scott Gottlieb, MD, Former FDA Commissioner

Dr Gottlieb provided an assessment of where the pandemic is heading over the next weeks. He started his discussion with an analysis of the epidemic curve in New York City, where the highest number of COVID-19 cases currently are.

Drawing on coronavirus data from Europe and Asia, Dr Gottlieb made an “optimistic” prediction that New York will reach the peak of new diagnoses in 1 or 2 weeks, followed by a week of deceleration and then a leveling off approximately another week later. The New York trajectory is similar to that of Spain and Italy, he said, and will likely follow a similar trend in the time from mitigation implementation to a slowdown in new cases.

Dr Gottlieb cautioned that although the number of new cases of COVID-19 infections will ease in the coming weeks, the number of hospitalizations and deaths will lag diagnoses, sometimes significantly. As data from China show, although the number of new cases peaked 6 weeks after Wuhan implemented its mitigation efforts, the number of new hospitalizations peaked 4 weeks later, and deaths continued to rise. The Chinese data showed an average 9 to 12 days to hospitalization and an average time to death of 3 to 6 weeks.

Although no aggregated data are available for the United States, data from the United Kingdom showed shorter times to hospitalization and death than in China. Dr Gottlieb said he expects US data to follow the UK experience more closely, which means that the disease here may be more aggressive and briefer than in China, but because hospitalizations and deaths lag the peak in the epidemic, the healthcare system will continue to be overburdened, and hospitalizations and ICU admissions will increase for several weeks.

Thus, he said, it is important for policymakers and the public to understand that “just because you see a region declining in the number of new cases, the healthcare system is going to continue to be significantly pressed.”

Turning to what is happening in the rest of the country, Dr Gottlieb called it a “concerning situation.” Although the number of cases in the Pacific Northwest seems to be slowing, in many northern cities, including Philadelphia, Boston, and Detroit, the number of cases is accelerating, with new diagnoses doubling approximately every 3 to 4 days. However, he added, early mitigation efforts were followed more stringently in these regions and travel plummeted. As a result, he expects to see a leveling off of new cases in the coming weeks, even as they continue to rise in the short-term.

The situation is more troubling in areas outside of the Northeast and in some of the western states, because mitigation efforts did not occur, particularly in the Sun Belt states and in the Southeast.

“These regions look really concerning. We’ve been saying for weeks now that New Orleans looks really bad. I would put Florida in that camp as well, perhaps Georgia. And you have to be very concerned about Texas. These are big populated states that were late to mitigation and still haven’t implemented it with vigor…and have potential to have really large outbreaks,” Dr Gottlieb said.

These states are also undertesting, said Dr Gottlieb, with Texas testing only 0.17% of their population, placing it 45th of 50 states for testing per capita. He referred to the grim predictions in the government modeling delivered by Anthony S. Fauci, MD, and Deborah M. Birx, MD. These models forecast possible deaths in excess of 200,000. Although he concedes that such an outcome is possible, the modeling depends on conditions in the South and southeastern states.

Dr Gottlieb believes that Florida and Texas are poised to have very high rates of infection. “It’s going to be a difficult month,” he said.

Dr Gottlieb predicts reaching the peak of infections in early May, with the possibility of lifting some mitigation steps in June. It is possible that the virus will have a seasonal component and will follow the course of the H1N1 epidemic in 2009, he said, where it was quiescent in July and August and re-emerged in September.

The question is, said Dr Gottlieb, “will we have a different enough toolbox…that allows us to go back to some semblance of our normal lives” come September?

Dr Gottlieb is confident that there will be an effective disease surveillance system in place by Fall, but he noted that it will take a drug to effectively change the contours of the risk profile of this pathogen. He added that although we are still learning about the virus, the statistics have been consistent globally. China may have underreported the severity of COVID-19 cases, but “we have a pretty good handle” on the disease morbidity, he said, with approximately 80% of infected patients having moderate disease, 15% needing hospitalization, 3% needing intensive care, and 1% succumbing to the infection.

“This is a virus that wants to infect 40% of the population,” Dr Gottlieb concluded. However, “the notion that there is a vast pool of people who have been exposed and seroconverted is not true. This is a long way of saying, we’re not going to have herd immunity.”

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