The Need for an Immediate Response to Our “New Normal”
POLICY PERSPECTIVE
It's been nearly six months since the WHO announced COVID-19 as a pandemic, and countries are moving out of initial stabilizing strategies, and into plans focused more on protecting, recovering and reforming. In the United States, Operation Warp Speed, a promise to provide at least 300 million doses of a safe and effective COVID-19 vaccine by January 2021, is well underway. The U.S. Congress is also supposedly still working on another necessary COVID-19 stimulus package, although with the August recess and the gap between party goals, there is little hope for anything to be passed before Labor Day.
On top of these issues a new concern has reared its head. In mid-August, the USPS came under attack due to implementing "reductions" and "routine maintenance," such as removing mail sorting machines and public mailboxes.
This threat to the USPS is timely as the 2020 Presidential Election is looming. Since there is no end in sight for the pandemic, an increasingly large amount of voters are considering voting via absentee ballots. For immunocompromised individuals or those at higher risk for COVID-19, like patients with chronic liver disease, this right needs to be protected. Even more concerning and outside of voting specifically, many patients with liver disease also rely on the mail to deliver vital prescriptions.
In late August, the House came back from their recess to vote on an emergency spending bill, which passed and allocated $25B to USPS. The bill also requires USPS to cease its "routine maintenance" until after the election. Although this is a significant first step, it's unlikely the bill will pass the Senate, and the White House has already commented that they plan to veto if it does.
For patients with liver disease, this "new world normal" is increasingly difficult; the amount of funding and awareness allocated to potential drug therapies and treatment has all vastly decreased. There continues to be a lack of funding for liver disease and COVID-19 prevention initiatives. Access barriers like Prior Authorizations and Step Therapy continue to exist, and now coupled with the USPS operations' uncertainty, lives are even more at risk. It is critical for the U.S. Congress to rapidly reach a decision on the next COVID-19 stimulus package. The threat to USPS is only the most recent issue that urgently needs a solution. The longer Congress waits to respond more issues will surface, and more lives will be threatened.
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.
POLICY DEVELOPMENTS AT GLI
Hepatic Fibrosis coding revisions to ICD-10-CM have been accepted for FY 2021!
GLI applauds the actions of CMS and CDC to modernize the ICD-10-CM codes for FY 2021 by specifically adding K74.01 (early fibrosis/F1 or F2), and K74.02 (advanced fibrosis/F3).
In March of 2019 GLI went to CMS and proposed an ICD-10-CM coding update. Specifically, GLI asked for the creation of specific codes for early and advanced hepatic fibrosis, along with a note for these to be coded with NASH. GLI would like to thank the other members of the NASH community who submitted comments of support to CMS and CDC about this change. This important update would not have been possible without the NASH community unifying behind a single goal. These revisions will enable liver fibrosis to be classified more accurately and more consistently with current clinical perspectives and documentation. They will also allow for enhanced tracking and research into the progression of disease and the impact of treatment. These 2021 ICD-10-CM codes are to be used for discharges and patient encounters from October 1, 2020 through September 30, 2021.
GLI and Patient Advocates Urge Members of Congress to Sign Bi- Partisan Letter Requesting HHS Secretary Azar Finalize OPO Rules
HHS has proposed OPO reforms that would increase organizational accountability and help thousands more patients access organ transplants. Several misleading claims have been made by the Association of Organ Procurement Organizations (AOPO) denouncing the reforms, and GLI is working to ensure patients have the facts and are able to encourage their legislators to act.
GLI Urges CDC to Update Recently Released Diabetes Educational Resources to include Fatty Liver Disease
This past month GLI urged the Centers for Disease Control and Prevention Division of Diabetes Translation to update their recently released Diabetes patient education materials, and mention the intrinsic link between diabetes and fatty liver disease. The CDC acknowledged the GLI request, and finalized an update to their resources on September 1st 2020.
GLI Collaborates with Liver Patients International and European Union Patients' Association to Advocate for Increased Transparency and Patient Inclusion Throughout NASH Regulatory Process
GLI collaborated with LPI and ELPA on a joint letter to the European Medicines Agency (EMA) and the Food and Drug Association (FDA). In summary, the goals of both the EMA, and the FDA to foster scientific excellence and protect the public health by assuring the safety, efficacy, and security of medical therapies are ones that we share. We understand that both the FDA and the EMA hope to establish shared expectations, trust, and reliability between themselves and the patient community. This is why it is critical for all regulatory agencies to acknowledge the patient voice, maintain transparency in their decisions, and appreciate the real-world urgency and benefit of a therapy to an impacted patient population.
GLI Submits Comments on Dietary Guidelines Advisory Committee’s 2020 Scientific Report
GLI submitted comments on the 2020 Dietary Guidelines Advisory Committee (DGAC) final report to the USDA and HHS on dietary recommendations for Americans. GLI highlighted the need for a greater priority to be put on NASH, interagency collaboration to promote consistent liver health information, and patient-first/centric language.
GLI Participates in EASL’s Digital International Liver Conference 2020
EASL, The European Association for the Study of the Liver, is a medical association dedicated to pursuing excellence in liver research, clinical practice of liver disorders, and in providing education to all those interested in hepatology. GLI is the first patient led organization to join the community with headquarters both in the U.S. and in the E.U. GLI’s President and CEO, Donna Cryer, was featured in the NASH series podcast Surfing the NASH Tsunami presented during the conference.
#OctoberIs4Livers
Mark your calendars for #OctoberIs4Livers, GLI's informative and exciting awareness campaign to elevate the global dialogue about liver cancer. You can find additional information and opportunities to become involved here.
Liver Health Provision in COVID-19 Response Package
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 (CDC) to implement targeted prevention, and awareness grants that would positively protect patients and families impacted by liver disease.
Congresswoman Nydia Velázquez (D-NY), Congressman Brian K. Fitzpatrick (R-PA), Congresswoman Eleanor Holmes Norton (D-DC), and Senator Tammy Duckworth (D-IL), have collaborated with GLI along with other organizations within the liver health community on this mission.
Removing Barriers to Access during COVID-19
GLI, along with other leaders in the GI Community, have asked the Trump Administration and the leaders of Congress 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 permitting physicians to focus on providing vital care, as opposed to spending countless hours on the phone with insurance companies.
GLI collaborates with OCAN and the Obesity Advocacy Community on advocating for Treat and Reduce Obesity Act (TROA) inclusion in next COVID response package
TROA aims to effectively treat and reduce a key comorbidity of chronic liver disease, obesity, in older Americans by enhancing Medicare beneficiaries’ access to healthcare providers that are best suited to provide intensive behavioral therapy (IBT) and by allowing Medicare Part D to cover FDA-approved obesity drugs.
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 organizations in submitting the following letters to key government agencies, and U.S. Members of Congress.
GLI joined this Key Up the Rates Campaign
ACS CAN Joint Letter with Cancer Organizations on 4th COVID Response Package
Letter to Congressional leadership, asking that they include the Medicaid Reentry Act in the next legislative COVID-19 package
GLI signed onto an AARDA Letter to HHS OIG in Support of Copay Coupon Assistance for Medicare Part D Beneficiaries
Medical Nutrition Act Letter of Support to U.S. Senate Finance
Organizational sign-on letter to Vice President Pence, head of the White House Coronavirus Task Force, urging a reversal of the recent revisions in CDC guidelines around COVID testing.
OPEN ADVOCACY OPPORTUNITIES
Going Virtual: 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 virtually on October 26-30, 2020. That means that the entire program will be presented through interactive, online discussions. An Advokit will be mailed to each participant in advance. 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. The virtual experience will provide a thrilling journey through self-guided didactic learning and engaging live discussions with peers and faculty. 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.
FOR YOUR CALENDAR
Most in-person events and meetings 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.
Virtual Conference on Liver Disease in Africa (COLDA), September 10-12
COLDA, organized by Virology Education, will feature professionals from the African region and abroad to discuss the latest clinical developments and treatment for liver disease. Dr. Lewis Roberts, one of GLI’s board members, will be speaking during the conference about Hepatocellular carcinoma (HCC). Additional information can be found here.
International PBC Day, September 13
GLI has partnered with the PBC Foundation on this vital campaign. To learn more and register please click here.
GLOBAL NEWS
High mortality rates for SARS-CoV-2 infection in patients with pre-existing chronic liver disease and cirrhosis: Preliminary results from an international registry
A recent report from the September 2020 Journal of Hepatology found that in 152 consecutive submissions of clinician-reported cases of laboratory-confirmed COVID-19 in patients with Chronic liver disease (CLD) to two international reporting registries (COVID-Hep.net and COVIDCirrhosis.org) between the March 25 and April 20 2020, mortality far exceeded that reported in unselected populations, hospitalised patients with cirrhosis in the era preceding COVID-19, and in patients with cirrhosis admitted with influenza. Outcomes for patients with cirrhosis included admission to intensive care unit (ICU) in 23.3%, invasive ventilation in 17.5%, non-invasive ventilatory support in 18.6%, renal replacement therapy in 4.9% and death in 39.8%. These findings have important implications for clinicians regarding risk stratification and prognostication for patients with cirrhosis and COVID-19 and suggest the need to maintain a low threshold for SARS-CoV-2 testing in the presence of new hepatic decompensation.
EU Commission Approves First Drug Treatment for Hepatitis D
Heidelberg University Hospital and the Medical Faculty of Heidelberg have developed a new drug, Hepcludex, to combat Hep D. The drug prevents Hep D and B cells from entering the liver via a lock-and-key mechanism, blocking the bile acid transporter NTCP from entering liver cells. Since Hep D/B viruses need to continually infect new liver cells, as infected cells die or are targeted by the immune system, the drug is also effective once an infection has occurred.
NIS4™ NASH Diagnostic included in The Lancet Gastroenterology and Hepatology
NIS4™ is GENFIT’s novel non-invasive, blood-based diagnostic technology, developed to identify patients with non-alcoholic steatohepatitis (NASH) and significant to advanced fibrosis (F>2), also referred to as at-risk NASH in the published study. The study found that NIS4 is a novel blood-based diagnostic that provides an effective way to non-invasively rule in or rule out at-risk NASH in patients with metabolic risk factors and suspected disease. It also suggested that NIS4 in clinical trials or in the clinic has the potential to greatly reduce unnecessary liver biopsies in patients with lower risk of disease progression.
Netherlands Study Suggests Use of MELD-Na Score Could Reduce 90-day Liver Transplant Waiting List Mortality
Researchers from Leiden University Medical Center have determined that the currently used Model for End-stage Liver Disease (MELD), which predicts mortality risk for patients with end-stage liver disease, may be outdated. 5,000 patients from the Eurotransplant waiting list were evaluated and researchers report that more than 25% who died within 3 months of being listed may have received a transplant if the MELD-Na score was used. The MELD-Na score incorporates serum sodium in the risk calculation score, which is often an important predictor of mortality for patients with chronic liver disease. The MELD-Na has been widely used in the United States since 2016.
UK Announces New Obesity Strategy to Protect Citizens Against COVID-19
The NHS has revamped their fight against obesity, citing that two-thirds of adults in England are overweight or living with obesity which puts them at greater risk for serious disease or death related to COVID-19. The strategy includes measures such as banning unhealthy food advertisements, mandatory calorie labeling, and expansion of the NHS. Public Health England (PHE) is also launching a parallel ‘Better Health’ initiative urging people to adopt an overall healthier lifestyle.
U.S. Federal NEWS
Presidential Hopeful Joe Biden Announces California Senator Kamala Harris as Running Mate
After months of campaigning solo Biden made a much-anticipated announcement on August 11- his pick for Vice President, Kamala Harris. Harris has been in the public eye for over a decade, she served as California’s attorney general from 2011-2017 and has since been representing the state in the Senate. In the coming months, we’ll see how Harris aligns her ideals on healthcare with Biden’s platform, which calls to protect and build upon the ACA. Find additional information on the duo’s official healthcare platform here.
U.S. Defense Secretary Mark Esper Puts Military Healthcare on the Line
Esper has recently proposed cutting military healthcare by $2.2B over the next five years. Over 9.5 million Americans rely on military healthcare, which includes TRICARE, the program allowing the military to access out-of-network civilian care. Critics believe this will decrease the ability of the U.S. military to provide necessary healthcare to those abroad, which is paramount due to the ongoing pandemic.
U.S. Government Working to Ensure Operation Warp Speed is a Success
There have been six deals signed with vaccine-producing companies in hopes of creating and mass producing a safe and efficient COVID-19 vaccine, but so far, the process has been anything but easy. Due to the use of experimental technologies with no precedent in place, a shortage of sand for glass vial production, and a limited supply of adjuvants to increase the vaccine’s strength, companies are reexamining if meeting the goal of distributing 300 million doses by January 2021 is attainable. Once a vaccine is created, another host of issues will arise such as shipping and storage.
Senator Elizabeth Warren Proposes New Resolution for PCOS Awareness
S.Res.670, a resolution recognizing the seriousness of polycystic ovary syndrome (PCOS) and expressing support for the designation of September 2020 as "PCOS Awareness Month” was recently proposed to the Senate. The resolution states between 5 and 10 million women are affected by the PCOS in the US, a staggering statistic considering an estimated 50% of women with the disease are undiagnosed. Adolescents with PCOS are at a higher risk for fatty liver disease due to the metabolic dysfunction associated with the disease. Increasing awareness and education, as well as spreading information on the diagnosis, treatment, and management for PCOS and it’s comorbidities such as fatty liver disease is central to the resolution.
HHS’s ODPHP Releases Healthy People 2030
The Office of Disease Prevention and Health Promotion released Healthy People 2030 in mid-August, the fifth iteration of the Healthy People initiative covering 355 national health objectives for the next decade. Goals pertaining to liver disease include reducing the rate of cirrhosis and hepatitis A/B/C, increasing the proportion of people who know they have chronic hep B/C, and reducing the number of deaths attributed to cirrhosis and hep B/C. Unfortunately there is no mention of NASH, NAFLD, or liver cancer, further emphasizing the need for increased education and awareness for liver disease. Additional information on the 2030 objectives can be found here.
U.S. NGO News
UCLA Researchers Receive Grant to Develop Test for Early Detection of Liver Cancer
Earlier this month, the National Cancer Institute awarded researchers at UCLA’s Jonsson Cancer Center a grant worth $3M to research liver cancer. The overall goal is to detect cancer at a stage where treatment and a cure are possible. Early detection of liver cancer can be the difference between life or death; The five-year survival rate decreases from 33% with early detection to 11% once the disease has spread to surrounding tissue.
GRANT OPPORTUNITIES
Mechanisms of Disparities in Chronic Liver Diseases and Cancer. Funding available from the NIH. Application Deadlines: April 1, 2022
Mechanisms of Alcohol Associated Cancers. Funding available from the NIH. Application Deadlines: September 7, 2020