POLICY PERSPECTIVE

As you all are well aware, 2020 is a U.S. presidential election year. As one might expect, this added pressure increases the well known partisan gulf between Democrats and Republicans and truncates the timeline for actual legislation to pass.

However, how does an election year in a divided congress affect liver disease policy initiatives in 2020?

All the Democratic presidential candidates, and the incumbent have already, as expected, made healthcare a key element of their campaigns, articulating diametrically opposed options for a post-ACA future. Yet, there are specific topline issues like drug pricing and surprise medical bills that continue to remain primary concerns of voters leading Congress to feel renewed urgency to act.

This synchronization between a few top health care priorities could provide an opportunity. While a majority of Washington may shift their focus to political campaigns, there may be a last minute push on some of these priorities. It is true that both parties are wary of letting the other claim victory on any issue, but the pressure from the American public to generate some sort of healthcare win provides hope.

A Congress and Administration that start off 2020 energized to generate wins? Is there a better time to elevate the liver as an organ, modernize systems in place, and establish a foundation for future liver disease advocacy efforts?

The LIVER Act, now introduced in both the House and Senate remains our top policy priority for 2020. The LIVER Act enjoys bipartisan support and offers a unifying policy platform for a growing number of liver and GI advocacy organizations. The Act would strengthen the federal infrastructure for prioritization and funding of liver research and additional resources for community-based prevention efforts.

And as we focus on 2020 and beyond the election, I co-authored and introduced the Day One Project paper entitled, “Addressing the Organ-Donation Crisis.” By way of background, the Day One Project is an initiative designed to develop key actionable policy objectives for Day One of the new presidential term, no matter the political party of the next administration.

For more insight on how GLI develops its policy priorities as we advocate for all liver health issues to take their proper place on the global public health agenda please see our new GLI Policy Framework.

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

GLI Releases 2020 Policy Action Framework

With this Framework, GLI will establish a body of transparent fundamental policy pillars of outreach to which the organization will advocate for in 2020 and beyond. This framework will also act as guidelines for GLI levels of commitment on third party advocacy issues.

Read the Policy Action Framework

GLI Joins STOP Obesity Alliance

This past month GLI joined the Strategies to Overcome and Prevent (STOP) Obesity Alliance. The STOP Obesity Alliance is made up of a diverse group of business, consumer, government, advocacy, and health organizations dedicated to reversing the obesity epidemic in the United States.

World Cancer Day: Shining the Spotlight on Liver Cancer

World Cancer Day, to be held on February 4th this year, aims to save millions of lives by achieving greater equity in cancer care.

This goal mirrors the Global Liver Institute’s (GLI) vision for liver health to take its proper place on the global public health agenda consistent with its prevalence and impact. Liver cancer is the second leading cause of cancer death globally, accounting for more than 700,000 deaths worldwide each year.

GLI joins the Union for International Cancer Control “I Am And I Will” campaign, which is designed to elevate awareness and inspire individuals across the world to take action. Donna Cryer, Chief Executive Officer, will share her liver disease journey and respond to the “I Am And I Will” campaign on February 4th through GLI’s Facebook and Twitter pages (@Globalliverinstitute).

GLI encourages you to participate in the campaign by posting a response to “I Am and I Will.”

LIVER Act

On December 17th Senator Tammy Duckworth (D-IL) introduced S.3074, a bill to amend the Public Health Service Act to provide for and support liver illness visibility, education, and research, and for other purposes. S. 3074 is the Senate companion to HR. 3016, the Liver Illness Visibility, Education and Research (LIVER) Act of 2019.

As a nonprofit patient advocacy organization committed to improving the lives of individuals and families impacted by liver disease, we could not be more appreciative of Senator Duckworth’s recognition of the need for federal support and leadership for this critical public health issue affecting numerous Americans. GLI also greatly commends the inclusion of other critical liver diseases that act as crucial drivers of liver cancer, most importantly, nonalcoholic steatohepatitis (NASH). Of the many causes of liver cancer, NASH has emerged as a significant contributor to this disease.

With the introduction of both a Senate and House version of the LIVER Act, our work is not done. Please stay tuned for ways you can help advance these critical pieces of legislation.

GLI Signs Onto Ad Hoc Group for Medical Research FY 2021 NIH Funding Recommendation

For FY 2021, the Ad Hoc Group recommends $44.7 billion for the NIH, a $3 billion (7.2%) increase over the FY 2020 program level. This funding level includes the full $404 million NIH is scheduled to receive in FY 2021 from the Innovation Account established in the 21st Century Cures Act for specific programs.

GLI strongly supports additional funding for liver disease research. It is necessary for consistent sustained funding increases for federal agencies like NIH to develop treatments and find cures for a wide range of liver diseases.

GLI Responds to Pacific Business Group on Health’s (PBGH) RFI

PBGH made a call for public comment regarding their cooperative agreement with The Centers for Medicare & Medicaid Services (CMS) to develop and test patient-reported outcome-performance measures (PRO-PMs) for oncology care.

GLI applauds PBGH’s efforts to develop and expand quality measures for use in the Quality Payment Program, and their inclusion of public comment during their development process. However, we believe there is a critical omission from the current pre-testing measure information form. It is disappointing to see that PBGH is developing and testing patient-reported outcome-performance measures (PRO-PMs) regarding health-related quality of life (HRQOL) and pain for patients without considering liver cancer.

According to the American Cancer Society, 70% of liver cancer cases could be prevented. It is critical to understand the health-related quality of life (HRQOL) and pain that these patients experience to better develop response strategies and slow the rise of this life threatening cancer.

Day One Project

Over the last year, GLI has been actively working with the Administration, HHS, CMS, and Capitol Hill on these critical issues. As stated previously, we believe that there is a clear disconnect between the organs that are being donated and the ones that are being made available for transplant.

With almost 2,000 liver patients dying every year waiting for an organ, we are proud to announce the introduction of the Day One Project entitled, “Addressing the Organ-Donation Crisis.” Donna Cryer, along with a few other key thought leaders, wrote the proposal with the goal of minimizing the number of people waiting on the organ transplant list by increasing the number of available organs for transplantation.

The proposal outlines key requests for the next Administration around holding organ procurement organizations accountable, ramping up the efforts to increase organ recovery and donation, increasing the coverage for living donor organ donations, and more.

Please click here for the full proposal.

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 to apply, or email a3@globalliver.org with any questions.

National Cancer Institute (NCI)

In 2020, through the guidance of Dr. Jonathan Hernandez, the NCI will be launching a clinical initiative to improve survival rates for patients with operable gastrointestinal tumors. Currently, the study is hoping for patients with cholangiocarcinoma or liver metastases to enroll in the clinical study in order to develop the research behind gastrointestinal cancers.

To learn more about this trial, visit the NCI website.

Clinicaltrials.gov Identifier: NCT03801915

Title: Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers

Prevent Cancer Advocacy Workshop

The Prevent Cancer Advocacy Workshop will be held on March 25, 2020 at the FHI 360 Conference Center in Washington, DC.

The Workshop is an annual event that convenes stakeholders to discuss pressing issues that impact cancer prevention and early detection, as well as novel approaches to address these issues through policy and advocacy. It is an open forum that allows participants to immerse themselves in engaging presentations and facilitated conversations, and to build capacity for creative solutions through collaboration with other attendees. Save the Date: Prevent Cancer Advocacy Workshop 2020.

National Organization for Rare Disorders (NORD)

This year NORD is celebrating its 30 year anniversary of investigating and researching rare diseases.

NORD has launched a survey and is encouraging all patients and advocates who are affected by rare diseases to complete the anonymous survey in order to provide more information about their disease.

FOR YOUR CALENDAR

February 4: World Cancer Day

February 25-28: Rare Disease Week and Hill Day. Washington, DC.

February 29: Rare Disease Day

March 1-2: Digestive Disease National Coalition Annual Spring Public Policy Forum. Washington, DC.

March 2- Obesity Care Advocacy Network Advocacy Day 2020. Washington, DC.

March 4- World Obesity Awareness Day

March 4-8: Asian Pacific Association for the Study of the Liver Conference. Bali, Indonesia

March 13-14: Swiss Autoimmune Liver Disease Meeting: Lugano, Switzerland.

April 2-3: Virginia Clinical Research Conference: Collaboration 2020. Richmond, Virginia.

Let us know about events we can add to our calendar. Send notices to info@globalliver.org

GLOBAL NEWS

3rd Swiss Autoimmune Liver Disease Meeting 2020

GLI’s very own Richard Gelula will be speaking at the 3rd Swiss Autoimmune Liver Disease Meeting. Richard will be joined by GLI’s European team member, Livia Alimena, as the conference explores the current state of autoimmune disease and what steps need to be taken to address liver health on the global level. The conference will take place March 13-14 in Lugano, Switzerland.

World Health Organization (WHO)

To start the new year in 2020, the World Health Organization has published a report on the status of the Global Vaccine Action Plan over the past decade. The plan not only touches on the progress made over the decade but also outlines the goals for the next decade as well. Specifically regarding liver disease, the action highlights current information on vaccinations for hepatitis and how to spread these vaccines on a global level, particularly in northern Africa and Egypt.

British Liver Trust

The British Liver Trust has aligned with five other health charities that form part of the Less Survivable Cancer Taskforce, has published a manifesto calling on the new government to do more for less survivable cancer patients in the United Kingdom. In particular, the manifesto outlines an emphasis on liver cancer as liver cancer has had the largest increase in mortality over the past decade compared to all other cancers.

European Association for the Study of the Liver (EASL)

As of December 2019, EASL has launched a free initiative to improve patient education of hepatology and liver disease by utilizing a technology-savvy eLearning hub called EASL Campus. This is an online center filled with research articles, online courses, and briefs regarding a variety of liver diseases and how patients can gain more information about their diseases.

U.S. Federal NEWS

United States House of Representatives: Subcommittee on Health

On January 8th 2020, the sub-committee on Health convened in order to hold a hearing on “Legislation to Improve Americans’ Health Care Coverage and Outcomes”. The relevant bill to track was HR 5534. This bill, sponsored by representative Ron Kind (D-WI), is focused on extending Medicare coverage of immunosuppressant drugs for patients who have undergone kidney transplants beyond the currently allotted 36 months.

Currently, Medicare only covers the costs of these drugs for 36 months after the transplant surgery. Witness testimony emphasized that this length of coverage is not nearly enough. It was also made clear that Medicare would ultimately save money by extending the coverage of these drugs for the rest of the patient’s life.

Many similar if not identical immunosuppressant drugs are used for liver transplants.

United States Senate Briefing: Turning the Tables: Innovator Meets Regulator

The Friends of Cancer Research held a briefing at the United States Senate on Jan 7, 2020 to urge the FDA to continue with its expedited approval programs for drug therapies.

Food and Drug Administration (FDA)

This past month FDA approved the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors. Ayvakit is a targeted drug therapy that is primarily used to treat gastrointestinal stromal tumor (GIST).

GIST primarily occurs in the stomach or the small intestine; however, there is a large rate of metastases that spreads to the liver and can cause liver complications. GIST can occur due to a rare mutation in the DNA of gastrointestinal cells that lead to uncontrolled cell proliferation; however, Ayvakit is a targeted therapy to rectify this mutation and ultimately prevent cancerous spread.

U.S. Department of Health and Human Services (HHS)

At the end of last year, two major new proposed policies from the Trump Administration were announced that bring accountability, and take important steps towards repairing our broken organ donation and recovery system.

Reg. 0938-AU02, is the first major overhaul of organ procurement standards by the Centers for Medicare and Medicaid Services (CMS) since 2006. The proposal implements a more stringent evaluation process for OPOs. A second proposed rule from the Health Resources and Services Administration (HRSA), Reg. 0906–AB23, was implemented. It aims to ease the financial burden on living patients donating organs by reimbursing them for lost wages, childcare and eldercare expenses.

Both of these proposals are key pieces of President Trump’s Executive Order, Advancing American Kidney Health, that was highlighted on July 10 and 30, 2019.

The executive order, and now both of these proposals, rightfully implement measures that reform the organ procurement and management system to increase the supply of transplantable organs and protect living donors.

National Institutes of Health (NIH)

A brand new report was recently released by the NIH that documents the mortality of alcohol related deaths on the American population. According to the report, since 1999-2017 there have been approximately one million recorded deaths due to alcohol. Incredibly shocking about the report is that deaths involving alcohol have doubled from 35,914 in 1999 to 72,558 in 2017. Furthermore, approximately 31% of alcohol related deaths are connected to liver disease and liver failure; this corresponds to 22,245 cases of liver failure in regards to alcohol related deaths.

Centers for Medicare and Medicaid Services (CMS)

On December 20th, CMS issued the Exchange Program Integrity Final Rule to implement policies that will protect taxpayer dollars by ensuring that health insurance marketplace enrollees are accurately determined eligible for subsidies. The rule’s goal is to more accurately collect data on the patients that actually receive subsidies from the government, and curb excess government funding to patients who do not qualify for programs. The accompanying fact sheet explains in greater detail.

National Academy of Sciences

The National Academy of Sciences has announced their report on opportunities to improve opioid use disorder and infectious disease services within the United States. Currently, infectious diseases related to opioid use disorder include HIV and Hepatitis A, B, C.

The National Academy has identified 11 specific programs by which opiod drug care and its connection to infections could be improved.

U.S. State News

Delaware: The Delaware state legislature passed SCR13, a resolution that recognizes February 12 as World Cholangiocarcinoma Day in the state of Delaware. Cholangiocarcinoma is a rare, but extremely aggressive type of liver cancer that occurs in the bile ducts in and around the liver. Cholangiocarcinoma has a survival rate of about 25-30%.

Florida: A new bill, H1187, was introduced to the Florida house of representatives on January 9th, 2020 that hopes to extend health insurance coverage to organ donors in the state of Florida. The bill would prevent insurance companies from limiting or excluding coverage on the sole basis that the insured person is an organ donor.

Hawaii: The Hawaii state senate has introduced a measure, HI SB95, in order to allocate more funding to the University of Hawaii cancer center to determine why Hawaii has the highest incidence of liver and bile duct cancer. In particular, liver cancer incidence is significantly increasing amongst non-white men in Hawaii.

Iowa: In an effort to expand Medicaid services for Iowa citizens, the Iowa state senate introduced SF17, a bill designed to cover direct acting antiviral drugs for patients living with chronic hepatitis C viral infection.

NGO News

Patient-Centered Outcomes Research Institute (PCORI)

At the start of 2020, PCORI has announced it will make $76 million dollars in funding available with a focus on health and laboratory research. PCORI is attempting to establish a patient centered research approach that investigates healthcare options and optimal ways to deliver care.

While there is a focus on maternal mortality as well as intellectual and developmental disabilities, PCORI will accept proposals for study on any topic.

GRANT OPPORTUNITIES

Conducting Public Health Research in Georgia. Funding from the Center for Disease Control and Prevention. Application deadlines: March 9th, 2020

Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility (R21 Clinical Trial Not Allowed). Funding available from the NIH. Application Deadlines: May 7, 2021.

Silvio O. Conte Digestive Diseases Research Core Centers (P30 Clinical Trial Optional). Funding available from the NIH. Application Deadlines: July 1, 2021

NAMES TO KNOW

Dr. William Dietz - Dr. Dietz is the Director of the Sumner M. Redstone Global Center for Prevention and Wellness at the Milken Institute School of Public Health at The George Washington University. He is also the Sumner M. Redstone Center Chair. Dietz is a member of the National Academy of Medicine (formerly the Institute of Medicine) and serves as a consultant to the Roundtable on Obesity Solutions. He is also the Director of the STOP Obesity Alliance at The George Washington University.

TERMS TO KNOW

Jaundice - the yellowish tinge to the skin and to the whites of the eyes as a result of a high level of bilirubin in the blood often a sign of liver dysfunction.

Liver Disease Policy During an U.S. Election Year