POLICY PERSPECTIVE

As the United States and the international community continue to tackle the COVID-19 health crisis, insufficient vaccine supply has made equitable allocation and distribution of the vaccines contentious. State and local governments have been forced to ration this critical public health resource, varying greatly in their decisions on which groups to prioritize and gradually expand the scope of vaccination through several phases. The initial focus was rightly, and rather uniformly, on frontline healthcare personnel and residents of long-term care facilities, such as those living in nursing homes and assisted living facilities who experienced the highest exposure, infection, and mortality rates.

However, in subsequent phases, following the scientific data on risk has given way to cold calculations of reopening the economy, resulting in patients with liver diseases and others at  “high risk for severe COVID-19 due to underlying medical conditions” falling further and further behind other categories of people. Coupled with disparities in digital access, gaps in accessible locations, and few provisions for caregivers and people with disabilities, vaccine distribution policies have created unnecessary stress and harm to patients, most of whom have been in very strict isolation for almost a year, often avoiding necessary screenings, follow up, and treatments.

The Centers for Disease Control and Prevention (CDC) clearly reports that people of any age with certain underlying medical conditions like liver disease, severe obesity (= to or > 40 Body Mass Index, or BMI), cancer, hypertension, chronic kidney disease, immunocompromised state from solid organ transplant, and diabetes are at increased risk of severe illness from COVID-19.

The CDC is following evidence-based research. In the case of liver disease, this research clearly shows that COVID-19 has been found to cause increased levels of liver enzymes and liver damage, which can lead to far worse health outcomes from COVID-19 for people who already have liver fibrosis/cirrhosis. Furthermore, the CDC has also found that obesity, along with a high amount of fat buildup in the liver, posed the highest clinical COVID-19 risks for people with obesity. We have already seen negative outcomes resulting from this connection, and the CDC reports that there are increased mortality rates from COVID-19 among people with chronic liver disease and cirrhosis.

Presently, there are some states who have made revisions to prioritize liver disease patients in their vaccine eligibility qualifications. In February, both New York State and Washington, D.C. updated their lists of underlying conditions and comorbidities used to determine eligibility for the COVID-19 vaccination. As a result of the update, priority is now being given to liver disease patients under the age of 65, as well as to those with other serious health conditions. When we look abroad, we also see prioritization of liver disease in Italy. In the Italian National HC vaccination plan for COVID-19, all liver patients below 70 years of age are now being considered a priority and will have immediate access to vaccinations. Global Liver Institute (GLI) will continue to work to ensure that patients with liver disease receive proper prioritization in every state’s vaccine distribution plan, while working collaboratively with our partners across the chronic disease community.

Protecting patients with liver conditions – rare diseases, hepatitis, NASH, cirrhosis, cancer, pre-and post transplant protects families, communities, and the public and is a statement that the vulnerable are valued.

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 immunosuppressed or immunocompromised due to cancer or transplant. 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.

POLICY DEVELOPMENTS AT GLI

Apollo Endosurgery Receives FDA Breakthrough Device Designation for the Orbera Intragastric Balloon for Treatment of Patients with NASH

On March 1st, Apollo Endosurgery announced that it has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Orbera Intragastric Balloon, specifically for the indication for use in treating patients with BMI between 30-40 kg/m2 with noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. As a patient-driven multi-stakeholder community for whom addressing this disease is a life-and-death issue, we applaud the acknowledgement from the FDA of the urgency for treating this serious disease.

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Over the coming days we look forward to continuing to engage with the FDA to ensure that the patient-with-NASH perspective is represented throughout all future NASH drug and device approval processes.

GLI and A3 Alumni Participate in Multiple Capitol Hill Advocacy Days 

In late February and early March, GLI, along with many A3 alumni, participated in multiple virtual Capitol Hill Advocacy Days. GLI is currently participating in Rare Diseases: Rare Across America and stressing the importance of prioritizing patients with liver disease in vaccine distribution along with the COVID-19 Prevention and Awareness Act, the Medical Nutrition Equity Act, and the need for funding to restart vital liver disease research. GLI will also participate in the Digestive Diseases: Digestive Disease National Coalition 31st Annual Public Policy Forum (March 4-10), and Obesity Care Week advocacy days to build support for the Treat and Reduce Obesity Act (TROA). To close out March, GLI along with many within the liver advocacy community, look forward to advocating for these vital initiatives during the upcoming virtual Liver Capitol Hill Day on March 24.

To stay up to date on vital initiatives like these virtual advocacy days and other opportunities to advocate, join the Liver Action Network.

Advocacy Letters

• GLI signs onto a letter to HHS Secretary designee Xavier Becerra calling on the President to rescind a new CMMI policy proposal that would undermine undermine key patient protections in Medicare’s prescription drug program
• GLI Signs onto Friends of NIDDK letter supporting the research community’s overall funding request for NIH ($46.111 billion) and a proportionate increase for the NIDDK for a total of at least ($2.289 billion)
• GLI signs onto joint letter in support of the dedicated funding for Medicaid Home and Community Based Services (HCBS) in the Budget Reconciliation bill
• GLI signs onto letter with 130 Organizations, Cancer Centers, and Other Institutions Advocating for Patients with Cancer & Survivors of Cancer to be Prioritized to Receive a COVID-19 Vaccine
• GLI joins more than 310 organizations on letter urging Congressional Leadership to support increased, sustained annual funding for state, local, tribal, and territorial public health infrastructure
• GLI signs onto a joint letter to the FDA advocating for a greater prioritization of complex generic drugs to improve access to vital therapies for patients with chronic diseases
• GLI signs onto joint CMMI Part D Payment Modernization Models letter
• GLI joins over 200 organizations in a letter to show support for the Multi-Cancer Early Detection Screening Coverage Act (HR 8845 and S 5051)

OPEN ADVOCACY OPPORTUNITIES

Join the GLI Liver Action Network (LAN)

GLI proudly supports and advances many liver health policy initiatives. If you are interested in taking a more active role with GLI on these critical issues, please join the GLI liver advocacy community and learn about upcoming opportunities to advocate on behalf of all individuals impacted by liver disease.

FOR YOUR CALENDAR

All in-person events and meetings for the month of March have been cancelled or postponed due to the COVID-19 pandemic. Please take the proper precautions, such as social distancing and limiting large gatherings, to remain healthy and safe! See more information on safety precautions from Johns Hopkins Medicine.

With that said, as mentioned earlier, there are a variety of virtual Advocacy days happening in the month of March. Obesity Care Week will include multiple briefings and the Digestive Diseases: Digestive Disease National Coalition 31st Annual Public Policy Forum will occur from March 4-9. Let us know about events we can add to our. Send notices to info@globalliver.org.

GLOBAL NEWS

European Union (EU) Goes Easy on Alcohol in Cancer Plan

The EU released its cancer plan this month, addressing only the harmful level of alcohol consumption, contrary to the topic of tobacco which focuses on any degree of consumption. The Commission is proposing to review the legislation on taxation of alcohol, as well as mandatory labeling of ingredients, nutrient content, and health warnings on alcoholic beverages.

Indian Government to include NAFLD in National Non-Communicable Disease (NCD) Prevention Program

India has decided to include non-alcoholic fatty liver disease (NAFLD) in the National Program for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS). The country hopes to tackle the growing health concern by focusing on strategies to prevent and control NAFLD.

U.S. FEDERAL NEWS

Cosponsors Update on H.R. 173: COVID-19 Prevention and Awareness Act of 2021

Since Rep. Nydia Velazquez (D-NY-07) introduced H.R. 173 into the House in January, the bill has gained 21 Cosponsors, all Democrats, and has been referred to the Committee on Energy and Commerce for further study.

The Congresswoman also recently introduced another vital bill that GLI has endorsed titled, the Building COVID-19 Vaccine Confidence Act of 2021. This bill complements the CPAA and would direct the Centers for Disease Control and Prevention (CDC) to fund grants to state, local, territorial, and tribal health departments to conduct outreach on the vaccine’s safety and efficacy.

H. Res. 93: Calling for the Establishment of the National Institute of Viral Diseases

H. Res. 93 was introduced this month by Rep. Marcy Kaptur (D-OH-09) and the bill is petitioning for a new unit of the National Institutes of Health, called the National Institute of Viral Diseases, aimed at increasing research in the field of viral disease causes, prevention, and treatment.

Reintroduction of the RISE Act in Congress

The Research Investment to Spark the Economy (RISE) Act was reintroduced with backing from Senators Edward J. Markey (D-Mass.), Thom Tillis (R-N.C.), Gary Peters (D-Mich.), and Susan Collins (R-Maine). The act provides nearly $25 billion in funding for research outside the realm of COVID-19, to preserve the current scientific workforce and ensure that the U.S. is prepared to continue its global scientific leadership once the crisis ends.

United Network for Organ Sharing Draws Scrutiny for Underperformance 

The United Network for Organ Sharing is a private nonprofit who was recently subpoenaed by Republican Senator Chuck Grassley (R-IA) and Democratic Senator Ron Wyden (D-OR) for growing concerns about the group’s severe underperformance over decades. The review indicates, “an improper use of Medicare funds, conflicts of interest, and gaps in oversight.”

FDA Released Updated Roster for the Gastrointestinal Drugs Advisory Committee (See Roster Here)

The Biden-Harris administration and CMS have reopened HealthCare.gov for a special enrollment period until May 15, 2021.

U.S. NGO NEWS

Gut Microbiome Study with Possible Links to Predicting Risk of Developing Liver Cancer Linked to NAFLD

Researchers from the University of New South Wales Microbiome Research Center (MRC) have published a recent study which found that the gut microbiome can regulate the immune response in liver cancer patients with NAFLD in a way that promotes the cancer’s survival. While the research is in the early stages, this could be key to predicting someone’s risk of developing liver cancer linked to NAFLD.

NAMES TO KNOW

Chiquita Brooks-LaSure

President Biden has nominated Chiquita Brooks-LaSure to run the Centers for Medicaid and Medicare Services (CMS). Brooks-LaSure has an extensive background in healthcare as a member of the Obama administration where she worked closely on the implementation of the Affordable Care Act.

GRANT OPPORTUNITIES

Mechanisms of Disparities in Chronic Liver Diseases and Cancer (Clinical Trial Not Allowed) Funding available from the NIH. Application Deadline: 04/01/2022

Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (Clinical Trial Not Allowed). Funding available from the NIH. Application deadline: 05/07/2021

Silvio O. Conte Digestive Diseases Research Core Centers (P30 Clinical Trial Optional). Funding available from the NIH. Application Deadline: 07/01/2021

Secondary Analyses in Obesity, Diabetes and Digestive and Kidney Diseases (Clinical Trial Not Allowed). Funding available from the NIH. Application Deadline: 05/07/2021

Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (Clinical Trial Not Allowed). Funding available from the NIH. Application Deadline: 11/12/2021