Liver Community Persists for Patients during Global Crisis
POLICY PERSPECTIVE
Advocates throughout the liver community and healthcare communities have come together quickly and collaboratively to address a myriad of issues related to ensuring the safe delivery of COVID-19 and non-COVID-19 healthcare services for liver patients. The key successes so far have been around securing waivers for provision of telehealth services with reimbursement to providers, having Centers for Medicare and Medicaid Services (CMS) declare that liver transplants are not elective surgeries, and paying for phone visits the same as in-person appointments. Outside of liver community specific successes, we have seen the passage of multiple COVID-19 relief packages, including the largest in history. There are still many issues that must be urgently addressed as we continue to respond to COVID-19, and as we reopen the world, but the silver lining of this global crisis is that we have seen collaboration lead to some rapid positive changes already.
This point is demonstrated in a recent letter from Congresswoman Nydia Velázquez (D-NY), Congressman Brian K. Fitzpatrick (R-PA), and Congresswoman Eleanor Holmes Norton (D-DC) to the leaders of the U.S. House of Representatives Appropriations Committee. These offices collaborated with Global Liver Institute (GLI) to urge their peers to include robust funding to authorize necessary resources for Centers for Disease Control (CDC) to implement targeted prevention, and awareness grants that would positively protect patients and families impacted by liver disease.
In response, just recently Congress passed, and the president signed, the Paycheck Protection Program and Healthcare Enhancement Act, a COVID-19 response package targeted at further emergency supplemental appropriations and economic stimulus. Most importantly, the bill included $1 billion to CDC for surveillance, epidemiology, laboratory capacity expansion, contact tracing, public health data surveillance and analytics infrastructure modernization.
We should now be able to carve out specific funds within the $1 billion to protect liver disease patients. We could not be more appreciative of the actions of Congress, and the leadership specifically of Representatives Velázquez, Fitzpatrick, and Norton, in response to COVID-19. We are also thankful for our fellow GI community leaders who joined GLI on this mission. However, even though funding is secured, our efforts are not done. We must now ensure that the funds are properly directed towards protecting the many liver disease patients who have been neglected for too long. We will continue to work to ensure that people living with liver disease are not disproportionately impacted, and do not experience unnecessary or discriminatory health care or treatment disruptions during this pandemic.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
COVID-19 Response Program for Liver Patients
GLI is researching and updating 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 regular updates and join GLI LIVE weekly on Wednesdays at 12:00 p.m. EDT on GLI’s Facebook page.
POLICY DEVELOPMENTS AT GLI
Removing Barriers to Access during COVID-19
The COVID-19 crisis has turned an already strained prior authorization and step therapy process upside down. As doctors are not in their offices or are deployed to work in the hospital, they are not receiving the prior authorization requests to approve, and have limited ability to approve the requests if they could be received.
As a result, patients are being left without timely access to the medications they need, worsening an already severe health crisis. In many cases, patients’ inability to access their medications can lead to hospitalization, adding additional burden to already strained hospitals, or death. A recent Washington Post article highlighted this harsh reality.
GLI along with the American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), and Salix Pharmaceuticals have asked the Trump Administration to temporarily eliminate prior authorization and step therapy requirements for GI-related treatments. This change will allow patients to receive the care they need now by allowing physicians to focus on providing critical care, as opposed to spending countless hours on the phone with insurance companies in lieu of office staff.
International NASH Day (IND™) June 12, 2020 Transformed into Virtual Multi-platform Experience
The Global Liver Institute feels the privilege and the responsibility to lead the IND™ globally and is committed to its success and the safety and well being of patients and partners during this pandemic. GLI is excited to announce that the International NASH Day has been transformed into a Virtual Multi-platform Experience to increase awareness about nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and the actions people can take to prevent these diseases globally.
For the first time, GLI will host, on June 12, six NASH live Panels with important international kols (from scientific societies, patients organizations, Universities and research centers): NASH as a Global Public Health Challenge; NASH in Children; NASH and Obesity; Beyond the Biopsy: the role of NITs in NASH; NASH as a Metabolic Syndrome; NASH and Liver Cancer.
GLI will co-host with its IND™ partners around the world a global social media campaign, dedicated to NASH and NAFLD launching new IND™ patients materials translated in multiple languages, a radio media tour with the FLF and will support the partners’ virtual events.
For partnering with us and for more information, please visit our IND™ website: https://www.international-nash-day.com/ or contact Livia Alimena at lalimena@globalliver.org
Advocacy Letters
GLI also collaborated with many other like-minded organizations in submitting the following letters highlighting critical policy issues for Members of Congress to keep in mind as they respond to COVID-19.
COVID-19 Letters
White House Coronavirus Task Force Letter Addressing Public Health Best Practices
Global Civil Society Statement on COVID-19 and People who use Drugs
Community Sign-On Letter for Surprise Billing
Sign-On Letter on Paid Leave for High Risk Individuals and Households
Patient Assistance During COVID-19 Sign-On Letter
Letter requesting additional funding for CDC and NIH related to the COVID-19 pandemic
Call on State Officials to support Harm Reduction amid COVID-19
Call to take action for Cancer patients during COVID-19 - Two letters
Letter calling for Expanding Resources for Non-COVID Health Services
Letter about stimulus payment deadline for Social Security beneficiaries with dependent children
COVID-19 Testing & Funding Support Letter
Letter to HHS on State Emergency Triage Guidance
Non-COVID-19 Letters GLI Collaborated On:
Friends of NIDDK Letter requesting additional funding for NIDDK to support research
Support for the Health Equity and Accountability Act of 2020
OPEN ADVOCACY OPPORTUNITIES
Apply for GLI’s Advanced Advocacy Academy (A3) Class of 2020
Applications for GLI’s Advanced Advocacy Academy (A3) Class of 2020 are now open! A3 2020 will take place on September 14-15, 2020 in Washington, DC. On September 16, 2020 GLI will be hosting its second annual A3 Hill Day, open to any and all who attend A3 2020. This year’s program will offer 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. If you or someone you know is interested in attending, visit the A3 website to learn more and apply, or email a3@globalliver.org with any questions.
NIDDK Seeks Feedback on Strategic Plan – July 31
NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) issued a March 16 request for information on the institute’s five-year strategic plan. According to the RFI, “The goal of the process is to develop a broad vision for accelerating research into the causes, prevention, and treatment of diseases and conditions within the Institute’s mission,” and focuses on five broad themes for community input. Comments are due by July 31.
NIH Announces New Grant Opportunity to Design Vaccines Against Hepatitis C Virus
The purpose of this grant is to support novel strategies for the rational design of vaccines against the Hepatitis C virus. The design of the study should focus on assessing the vaccine’s ability to induce protective immune response. Furthermore, the grant is looking to select candidates for preclinical development and clinical testing. The closing date to apply is June 15, 2020.
FOR YOUR CALENDAR
All in person events and meetings for the month of May 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 events we can add to our calendar. Send notices to info@globalliver.org
GLOBAL NEWS
EASL-ESCMID Position Paper: Patients with advanced liver disease and transplant recipients require specific care during COVID-19
The European Association for the Study of the Liver (EASL) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) have issued a Position Paper, providing recommendations for clinicians caring for patients with liver diseases during the current pandemic.
WHO/Europe publishes considerations for gradual easing of COVID-19 measures
WHO/Europe has published key considerations for the gradual easing of the lockdown restrictions introduced by many countries in response to the spread of COVID-19 across the European Region.
ERN - European Reference Network
The European Commission launched the COVID-19 Clinical Management Support System (CMSS). The aim is to support doctors, nurses, and other healthcare professionals in hospitals that are currently dealing with COVID-19 cases all over the EU, UK and the EEA countries.
R-Liver Registry (European Rare liver registry)
As of April 6th, there are 521 patients in the R-LIVER registry with an excellent 90% average completion.
R-LIVER COVID-19 registry
The ERN (European Reference Network) set up a dedicated R-LIVER COVID-19 registry. This new registry will focus on adult and paediatric patients with rare liver disease and patients after liver transplantation with documented COVID-19 infection.
New COVID-19 model for implementation of population wide interventions in Italy
Ending the global SARS-CoV-2 pandemic requires implementation of multiple population-wide strategies, including social distancing, testing and contact tracing. The authors of this paper, published on Nature, propose a new model that predicts the course of the epidemic to help plan an effective control strategy.
U.S. Federal NEWS
$484B COVID-19 relief package to help small businesses and hospitals
Congress passed, and the president signed, the Paycheck Protection Program and Healthcare Enhancement Act, a narrow COVID-19 response package targeted at further emergency supplemental appropriations and economic stimulus. The bill would provide an immediate $321 billion infusion for the Paycheck Protection Program, the small business rescue fund that ran out of money last week. The package would also provide another $60 billion in economic disaster loans for small businesses, $75 billion in emergency relief for hospitals and $25 billion to ramp up coronavirus testing.
Trump Administration Releases Guidelines for Reopening the U.S.
President Donald Trump's new guidelines for reopening parts of the country recommend states and localities confirm a two-week downward trend in coronavirus symptoms and documented cases before starting to ease lockdowns while assuring hospitals have adequate capacity and robust testing in place.
The administration envisions states or localities meeting those criteria each time they progress through three phases. It's not prescribing target dates for meeting each phase, and officials acknowledged restrictions could snap back if there's a resurgence in cases.
U.S. Regulatory News
National Institutes of Health (NIH) panel issues first guidance on coronavirus drugs
Coronavirus treatment guidelines issued by a government panel conclude there is not enough data on some of the most touted drugs — including hydroxychloroquine, which the panel said should not be used outside clinical trials when paired with antibiotics.
NIH Launches Public-Private Partnership to Combat COVID-19
The NIH announced on April 17 that it would be joining with the Foundation for the NIH and 16 industry partners in a public private partnership to “develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.”
CMS Announces Guidelines for providing non-emergent, non-COVID-19 Care
Administrator Seema Verma announced new guidelines on how hospitals can move to "Phase I" of providing non-emergent, non-Covid-19 care in states and regions where coronavirus outbreaks are deemed under control.
National Institute of Allergy and Infectious Diseases announces Covid-19 treatment breakthrough
New results from a clinical trial conducted by the National Institute of Allergy and Infectious Diseases establish Gilead's experimental drug remdesivir as the standard of care for Covid-19.
GRANT OPPORTUNITIES
Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funding available from the NIH. Application Deadlines: April 1, 2022
Notice of Intent to Publish a Funding Opportunity for Early Liver Transplantation Cohort Study. Funding available from the NIH. Application Deadlines: Future study available in summer 2020
Mechanisms of Alcohol Associated Cancers. Funding available from the NIH. Application Deadlines: September 7, 2020