POLICY PERSPECTIVE

At the start of 2020 health care was already a prominent element of each candidate’s campaign. Yet, even during the single greatest modern public health emergency, the COVID-19 pandemic, and the U.S. Supreme Court experiencing a major conservative shift that could substantially alter America’s healthcare system for the future, the economy or racial equity were top priorities for voters.

Election Day ended without a definitive outcome. Even if early polling numbers showed Vice President Biden leading almost every pivotal election deciding swing state based on mail in and absentee voting, the pollsters needed to adjust for an in-person election day push by Republicans, and that many of these swing states have just started counting their mail in ballots.

This uncertainty underlines the reality of a U.S. Presidential election in 2020. It is unlike any other in history.

Despite or because the world is still in the middle of a global pandemic, we saw voter turnout as never before. The number of mail in ballots for early voting is unheard of. For example in the state of Texas, more than 9 million Texans cast their ballots early, this represents more votes cast than in the state’s total turnout for the 2016 presidential election. Pairing this with the issues for many Americans to access vote centers, the safety concerns for voters to vote in person, and the continued problems with the U.S. postal service, the coming days will be full of debate between election lawyers about the legality of ballots. This uncertainty has cast a large shadow on the U.S. election process that will need to be reconciled for future elections.

However, even if at this point it is unclear who the next president of the United States is, we can still begin to sketch out each candidate's health policy priorities for 2021 and beyond.

If President Trump wins a Second Term

President Trump has been in a tenuous situation for weeks now. To put it bluntly his messaging has been scattered. He has battled with the nation’s top science agencies, had to explain a recent increase in U.S. COVID-19 cases, and literally had to fight through his own COVID-19 infection. His single underlying goal of “get back to normal” has been severely damaged.

However, we can still piece together his health policy goals for his second term. If President Trump were to win a second term we can expect a continued push to restart the American economy, for kids to go back to school, and for a complete dismantling of the Affordable Care Act (ACA). We will also see more weight put behind “Operation Warp Speed” the initiative focused on providing at least 300 million doses of a safe and effective COVID-19 vaccine by early 2021.

Outside of the current priorities, looking back at the last 4 years can give us some idea of where President Trump will try to go next. The Trump Administration has pushed for many regulatory changes that include an expansion of short-term health plans, overhauling Medicare payments to discourage hospital consolidation, implementing rules forcing hospitals to disclose negotiated insurance rates, requiring drugmakers to include prices in television ads, cutting funds for Planned Parenthood, and more.

Many of these initiatives face numerous challenges whether politically by Democrats or legally by state courts. Also if President Trump is successful in eliminating the ACA, it is still unclear how he plans to protect all the people with preexisting conditions who are currently covered. With that said, it is clear that going forward the President will continue to use all of his executive powers to make more quick regulatory health system changes.

If Vice President Biden Becomes President-Elect Biden

Since early on in this election process Vice President Biden has led in almost every major poll. Based on any other usual Presidential election, what is most likely is that he will continue this trajectory culminating in him being elected President of the United States. Based on President-Elect Biden’s track record in Congress and the White House, we can expect a drastic shift in not only how the U.S. Administration discusses the COVID-19 pandemic, but also how the U.S. responds with relief funds and activities. This includes funds for restarting medical research, public health programs, unemployment assistance, contact tracing, rapid testing, and more. The U.S. would most likely collaborate more with the EU, and WHO on COVID-19 stabilizing strategies, along with plans focused on protecting, recovering and reforming. We can also expect a roll back of many of Trump’s regulatory changes to the health care system.

However, it is hard to deny that there is a large shadow outside of COVID looming over President-Elect Biden’s future policy agenda. A legal challenge of the ACA, the signature piece of legislation from his time as Vice President in the Obama Administration, is heading to the U.S. Supreme Court, and now with a 6-3 conservative majority, the entire law may be in jeopardy putting millions of lives at risk. We can expect a vast majority of President-Elect Biden’s initial health policy agenda to be focused on defending the legality of the law, and improving it to be more stable for the future.

What does this all mean for Global Liver Institute

No matter who is the next President of the United States, Global Liver Institute will remain committed to improving the lives of individuals and families impacted by liver disease by promoting innovation, encouraging collaboration, and scaling optimal approaches to help eradicate liver diseases. As a patient advocacy organization our role is to fight for patient-centric initiatives, and upset the status quo, no matter who is in charge.

If President Trump remains President, we will continue to collaborate on vital policies like the “Advancing American Kidney Health” executive order. With more than 14,000 liver patients currently waiting for transplant, initiatives like this one will save lives, and rightfully call for a complete reform of the organ procurement and management system to significantly increase the supply of transplantable organs. We will continue to stress that it is critical to strengthen public health programs, protect science, support liver disease research, and prevent financial hardships. We will also highlight the need for targeted efforts that improve health disparities. Most importantly we will continue to elevate the patient voice, and ensure equitable access to comprehensive healthcare coverage regardless of health status.

If Vice President Biden becomes President-Elect Biden, we will continue to extend our strongest support for reliance on science and science-based policy. Most importantly we will emphasize that liver health is public health. We will utilize established connections to emphasize that any initiative targeted at improving liver health will have a wide-ranging impact that will almost certainly have secondary impacts of value. We will also stress to the new Administration that patients with liver disease rely on a strong safety net in the best of times to ensure access to affordable and comprehensive care. This crisis has shown the need to reinforce and even build upon that safety net has never been more urgent.

As we have always done, we will remain nonpartisan. We will ensure that patients have a seat at every relevant decision table, and that the patient voice is heard loud and clear. In tandem to this effort we will also continue to fight to elevate liver health policy to its rightful place on the global public health agenda based on prevalence and impact. Whether it is President Trump or Biden, our mission remains the same.

Donna R. Cryer, JD
President & CEO
Global Liver Institute

COVID-19 Response Program for Liver Patients

GLI continues to research and update information about COVID-19 specifically addressing the needs and concerns of liver patients, particularly those who are immuno-suppressed, immuno-compromised, and who have chronic liver conditions. Please check here for all of our COVID-19 Response resources and join GLI LIVE weekly on Wednesdays at 12:00 p.m. EDT on GLI’s Facebook page.

#OctoberIs4Livers: Liver Cancer Won’t Wait

We proudly announce the successful conclusion of our 2020 #OctoberIs4Livers global awareness program in the fight against liver cancer. We will follow up in the near future with a full outreach report, in the meantime please see below for some of the highlights.

There is much more and something for everyone. Together we can end liver cancer.

Liver Health Provision in COVID-19 Response Package (COVID-19 Prevention and Awareness Grants)

GLI continues to work with the liver health community to urge Congress to include robust funding to authorize necessary resources for Centers for Disease Control to implement targeted prevention, and awareness grants that would positively protect patients and families impacted by liver disease.

Congresswoman Nydia Velázquez (D-NY) is leading the charge by ensuring funds are available for grants for people of any age with certain underlying medical conditions, including liver disease, who are at increased risk for severe illness from COVID-19.

GLI’s Advanced Advocacy Academy (A3) Class of 2020

This past month the fourth annual Advanced Advocacy Academy (A3) took place worldwide on October 26-30. It was a week-long virtual event offering liver patients, caregivers, and professionals the opportunity to learn from experts in the fields of drug development, clinical trials, state and federal legislation, media and communications, and liver health and disease. The event included live discussions with faculty members enhanced individual learning, fostered engagement, and promoted important conversations. It also consisted of self-paced lessons that were customized to fit each attendee’s personal learning style and schedule.

Please stay tuned for a full 2020 A3 report for more details on the outcomes of this year’s event.

GLI collaborates with OCAN and the Obesity Advocacy Community on advocating for Treat and Reduce Obesity Act (TROA) inclusion in next COVID response package

COVID-19 is disrupting the normal life of many Americans and others throughout the world, especially individuals with chronic liver disease and obesity, conditions that often put them at higher risk of the virus and its health consequences. The primary sponsors of TROA (Representatives Kind, Guthrie, Ruiz and Reed) sent a May 8th letter and we echo their support that "updating Medicare’s coverage policies to support the treatment and prevention of obesity should be part of a comprehensive response to COVID-19.”

If you would like to join GLI and others in the advocacy community on this important effort please click here to take action to support the Treat and Reduce Obesity Act.

Advocacy Letters

This past month, GLI collaborated with many leaders in the Viral Hepatitis Patient Advocacy Space to submit comments on the draft Viral Hepatitis National Strategic Plan.

GLI also initiated several “calls to action” for GLI’s patient advocacy community, including “Get out to Vote for Liver Health Policy Champions,” and the “Global Liver Cancer Proclamation.”

OPEN ADVOCACY OPPORTUNITIES

Global Liver Cancer Proclamation

Pledge to support your country’s efforts to double the five-year survival rate for liver cancer by 2030 by adding your name to our proclamation supporters.

FOR YOUR CALENDAR

Outside of the U.S. Presidential election, all in person events and meetings for the month of November have been cancelled or postponed due to the COVID-19 pandemic. Please take the proper precautions of social distancing to limit large gatherings and to remain healthy and safe!

Let us know about other events GLI can add to the calendar. Send notices to info@globalliver.org.

Global News

UK Government Introduces New Genomic Strategy

The UK has collectively launched Genome UK, a mission to create an advanced genomic healthcare system within the next 10 years. The overall goal is to deliver the highest quality healthcare at a low cost with a focus on early detection and personalized treatment of diseases via genomics. Since the majority of patients with liver disease are diagnosed at a late stage this initiative could significantly decrease liver disease morbidity and mortality across the four participating nations.

Medicine Nobel Awards Scientists for Discovery on Hepatitis C Virus

The Nobel Prize in Physiology or Medicine was awarded to Harvey Alter of the US National Institutes of Health (NIH), Michael Houghton of the University of Alberta, Edmonton, and Charles Rice of Rockefeller University for their discovery involving the Hep C virus. After over three decades of work the researchers were able to show how the virus is responsible for most of the unexplained cases of Hepatitis in blood transfusions. This discovery makes it possible to screen future blood donations for the virus, an important step in preventing chronic liver inflammation which can lead to cirrhosis or even cancer.

EU Secures Additional COVID-19 Vaccine Doses for Member States

The EU recently signed a deal with Johnson & Johnson to supply up to 400 million doses of its potential COVID-19 vaccine. Previously, the EU had signed advance purchase contracts with AstraZeneca and Sanofi. With the addition of Johnson & Johnson the EU has the potential to get 1.1 billion doses of various vaccines for a population of 450 million.

Oxford Researchers to Speed Up COVID-19 Testing

Researchers at Oxford University have developed a rapid antigen test for COVID-19 that can produce results in under 5 minutes. The test is ideal for situations where time is particularly of the essence, such as mass testing situations in airports or before surgery. Oxford is planning to start product development in early 2021 and is expecting to have an approved device by mid-2021. As the world prepares for a difficult next few months and probable surges in COVID-19 cases, this test could help quickly distinguish if patients are in fact infected with COVID-19 as opposed to other viruses such as influenza.

United Kingdom Presents Possible Cause for Disparities in COVID-19 Mortality

The government’s Race Disparity Unit released a new quarterly report stating that socioeconomic factors, rather than genetics, may be responsible for the disparities in deaths attributed to COVID-19 between ethnic groups. Specifically the report details how factors such as someone’s profession and whether they live in a rural area or city may put them at an increased risk for severe COVID-19 infections. The report does attribute COVID-19-related morbidity and mortality in part to genetics and pre-existing conditions, but states it is secondary to external factors such as socioeconomic status.

U.S. Federal NEWS

US Senate Confirms Amy Coney Barrett to the US Supreme Court

The Senate confirmed Amy Coney Barrett to the highest court in the land by a vote of 52-48 on 10/26, just eight days before the Presidential election. President Trump nominated Barrett in late September following the death of Justice Ruth Bader Ginsburg. Barrett, an established conservative and constitutional originalist, is expected to shift the court significantly to the right in future holdings. Since Barrett is only 48 years old her confirmation will affect the future of the country for decades to come.

FDA Launches Digital Health Center

The FDA released its Digital Health Innovation Action Plan in 2017, outlining plans for a digital health precertification program pilot which would allow device makers to apply for broad clearance instead of being reviewed after each update to a device’s software. The project has come to fruition in the form of a Digital Health Center which will focus on research into digital health regulatory science to help advance oversight of devices. There is one more virtual listening session, on November 12th, to gather input on the Digital Health Center. They are both open to the general public.

CDC broadens definition of who's at risk of getting coronavirus

The CDC has ramped up its criteria for who's at risk of contracting the coronavirus, and implemented a stricter contract tracing guidance. This new guidance is an expansion of the original COVID-19 and chronic liver disease webpage on the CDC’s website.

U.S. NGO News

U.S. Surpasses 9 Million COVID-19 Cases

The U.S. coronavirus case count passed 9 million on October 30th with the disease surging across the northern tier of the country and public health officials urging tough new steps to promote use of masks and social distancing. The milestone, based on a tracker maintained by Johns Hopkins University, is the latest in a pandemic that's claimed more than 228,000 lives in the U.S. and comes only two weeks after the country recorded 8 million cases.

American Society for the Study of Liver Diseases Publishes Report Detailing COVID-19’s Effect on the Organ Transplantation Process

AASLD recently published a study in their Hepatology Communications journal outlining the effect of COVID-19 on organ donation, procurement, and liver transplantation in the United States. Major issues that the authors identified were inadequate donor evaluation and consent due to the widespread implementation of telemedicine, increased risk for complications while inpatient after transplantation, and lack of donor hospital resources in general.

Delays in U.S. COVID-19 Vaccine

In late October, Pfizer announced that it still doesn’t know whether its coronavirus vaccine will work. Despite the government and drug companies pumping billions of dollars into the vaccine race, getting shots into trials faster than ever before, and enrolling tens of thousands of volunteers in studies, a Covid-19 vaccine could still be months away. Four shots are now in late-stage U.S. trials. Johnson & Johnson and AstraZeneca were forced to pause their trials over safety concerns, but got the all-clear last week from the FDA to resume the studies.

Commonwealth Fund Details Effect of COVID-19 on Outpatient Care Visits

In addition to impacting how emergency services are operating, COVID-19 has greatly affected outpatient care in the United States. In the beginning of the pandemic visits to outpatient care centers decreased by almost 60%. By mid-May these numbers began to increase, only to decrease again substantially in August in COVID-19 “hotspots.” As of October 10th outpatient care visits have increased back to pre-pandemic levels, but not for all populations and specialties. For up to date data comparing pre-pandemic and current visits based on several variables such as age, medical specialty, and insurance type visit the Commonwealth Fund.

GRANT OPPORTUNITIES

Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funding available from the NIH. Application Deadlines: April 1, 2022

The U.S. Presidential Election and the Impact on Health Policy