The Need to Support the Restart of Liver Disease Medical Research and Public Health Programs

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POLICY PERSPECTIVE

Over the years, federal research has responded by sparking significant breakthroughs and achievements like the cure for Hepatitis C. It’s clear that when federal agencies support liver disease, liver cancer research and liver public health programs, it leads to better health and well-being for people across the nation. Therefore, it’s disheartening that the recent American Rescue Plan (ARP), which Congress passed in early March, provided COVID-19-related public health programs and research support, but failed to address the impact of the pandemic on vital liver disease research and specific liver disease public health programs. 

Although there were many positive provisions included in the ARP, there was no funding for vital federal research agencies like the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has only exacerbated the variety of issues that Global Liver Institute (GLI) has heard from the liver research community over the last year. 

GLI has found that COVID-19 has made it difficult to consent and recruit patients for research studies, including, for example, obtaining blood and tissue samples from liver cancer patients. Clinical trial recruitment has been severely impacted due to concerns about the risk of COVID-19 infection during travel. Research expenses have skyrocketed due to research collaborators having to pay for specimen collection laboratories to visit patients at home, along with patients needing to delay evaluations, surgical and other treatments. This impact has not only been felt by patients directly, but within the laboratories and their staff as well. In the labs, initiatives have been hampered due to scientist transfer barriers, and the social distance requirement forcing teams to work in shifts thus delaying progress.

In total, according to a 2020 report from the Council on Government Relations, projected research output loss due to COVID-19 ranges between 20 to 40 percent, with a “potential impact approaching tens of billions of dollars across the entire U.S. research enterprise.” This is why over the last few weeks, on multiple advocacy days, the liver advocacy community has joined GLI in urging Congress to acknowledge the damaging impact of the pandemic on the agencies that support medical research and public health programs for liver disease. 

Even before COVID-19, there was already limited funding to support research of liver disease. For example, last year the NIDDK received a 0.8% increase in funding. Pairing the COVID-19 public health emergency with a low initial prioritization has resulted in many NIH-funded liver research laboratories being forced to either shut down or scale back significantly. Without additional funding, these agencies will not have the capacity to continue existing research projects, restart research nor undertake new research (especially on the connection between liver disease and COVID-19). If we do not support these vital federal agencies, it will impede critical U.S. research progress and, in turn, risk the lives of millions of patients who depend on this progress for any hope of receiving quality healthcare. This is why GLI, along with many other organizations in the liver advocacy community, strongly support the joint ask of $16 billion in emergency supplemental funding for NIH including specific funding for the NIDDK. As we continue to battle this global public health emergency, we urge Congress to maintain continuity of investment in these important medical research programs.

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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.

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POLICY DEVELOPMENTS AT GLI

GLI Responds to Organ Procurement and Transplant Network (OPTN) Winter 2021 Public Comments 

On March 23, GLI submitted a letter to James Trotter, Chair of the OPTN Liver and Intestinal Transplantation Committee, regarding two specific OPTN winter 2021 public comment proposals and one all-encompassing issue: 

  • Calculated Median MELD at Transplant around the Donor Hospital & Update Sorting within Liver Allocation

  • National Liver Review Board (NLRB) Guidance Documents and Policy Clarification

  • Reform for Liver Allocation

GLI voiced that the current scoring system does not suffice for the needs of the patient community. When patients are at the point where a liver transplant is required for survival, time is critical and irreplaceable. There should be an equal playing field when it comes to patient access to a donor liver, and it is time to explore new options for a more equitable system. GLI respectfully urged OPTN to listen to the concerns and recommendations regarding this matter. Any further delays in reform are a death sentence for many of our most vulnerable patients.

COVID-19 Prevention and Awareness Act and the American Response Plan

In early March the U.S. Congress passed the monumental American Response Plan (ARP) in response to the continued COVID-19 crisis. Many provisions within the package expanded upon critical sections from our early 2021 legislative ask, the COVID-19 Prevention and Awareness Act, H.R. 173. For example: 

  • $7.5 billion for Centers for Disease Control and Prevention (CDC) with explicit uses of funds for underserved populations and COVID-19-related activities in our communities, including community vaccination centers, mobile vaccination units and transportation for individuals to facilitate vaccinations, particularly for underserved populations. 

  • $1 billion in funding for vaccine confidence activities through the CDC. The goal is to increase vaccine confidence, increase education on the vaccine and improve vaccination rates. 

  • $47.8 billion in funding for COVID-19 testing, contact tracing and mitigation activities. The ARP includes partnerships with academic and research laboratories, community-based testing sites, community-based organizations and mobile health units, particularly in medically underserved areas. The funding can also be used to improve data collection and expand the public workforce.

  • $7.6 billion in funding for community health centers to provide vaccination, testing, tracing and community outreach and educational activities related to COVID–19.

GLI and A3 Alumni Participate in Multiple Capitol Hill Advocacy Days 

In March, GLI, along with many A3 alumni, participated in multiple virtual Capitol Hill Advocacy Days. GLI participated 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, advocated for these vital initiatives and others during the 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

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 April 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 opportunities happening in the month of April. On April 14, 2021, the Friends of NIDDK is planning a virtual Congressional briefing from 11:00am to 12:00pm EST on NIDDK Recent Advances and Emerging Opportunities. Registration and more information will be coming soon. The Liver Coalition of San Diego has an upcoming webinar on April 28, 2021, from 5:30pm to 6:30pm on Identifying and Managing NASH. For more information on registration for this event and others, go to livercoalition.org. Let us know about events we can add to our calendar. Send notices to info@globalliver.org.

GLOBAL NEWS

President of the European Union Commission Gives Speech on “Health Diplomacy”

This month at the “Conference on strengthening the role of the EU in Global Health”, President Ursula von der Lyen spoke about the role of the EU, specifically how health diplomacy is now central to a modern European foreign policy. She stressed the need for countries to come together to ensure that the virus is contained, on the basis of two pillars: team-play and a long haul mentality.

Israel Study Offers First Real-World Glimpse of COVID-19 Vaccines in Action

A new study published this month in The New England Journal of Medicine offers a promising early answer for the Pfizer vaccine. The study contains data from Israel, specifically 600,000 early recipients of the COVID-19 vaccine, and found that the risk of symptomatic COVID-19 infection dropped by 94% a week after the individuals had received both doses of the Pfizer vaccine. This suggests a substantial reduction in morbidity and mortality after large numbers of the population receive COVID-19 vaccinations.

U.S. FEDERAL NEWS

Recently Introduced or Reintroduced Liver Health Policy Legislation

STAT Act (H.R.1730 / S.670) - The Speeding Therapy Access Today (STAT) Act is a great accomplishment for the rare disease community and establishes a Rare Disease Center of Excellence at the FDA.

Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 (H.R.1946) - The bipartisan legislation promotes emerging advances in our nation’s fight against cancer by ensuring Medicare coverage for new, innovative tests that detect multiple types of cancer before symptoms develop.

Vietnam Veterans Liver Fluke Cancer Study Act (H.R. 1273) - This bill  directs the Secretary of Veterans Affairs to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era, and for other purposes.

SAFE Step Act (S.464) -  The bill requires that insurers implement a clear and transparent process for a patient or physician to request an exception to a step therapy protocol. The House bill, which will be the same as the Senate version, will be introduced soon.

Treat and Reduce Obesity Act (H.R.1577) - The purpose of the bill is to amend title XVIII of the Social Security Act to provide for the coordination of programs to prevent and treat obesity, and for other purposes. 

American Cures Act (S.962) - This bill would provide an annual increase in budget to four key biomedical research agencies: The National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Department of Defense Health Program, and the Veterans Medical and Prosthetics Research Program.

LIFT America Act (H.R.1848)- The Leading Infrastructure for Tomorrow’s America Act invests more funding into overall infrastructure improvement, specifically including a section on the nation’s health infrastructure, through funding more health initiatives and increasing overall capacity for community-based care in America.

Public Health Infrastructure Saves Lives Act (S.674) - This bill was introduced to strengthen our nation’s public health infrastructure, which the pandemic has exposed the flaws and overall neglect of health access across the nation and in regards to all demographic factors.

Telehealth Modernization Act (S.368) - This bill would provide crucial updates to Medicare’s statutory and regulatory barriers for telehealth access, continuing to generate support and increase access to high-quality health care services.

Pandemic Costs the National Institute of Health (NIH) $16 Billion in Delayed, Lost Medical Research 

The amount lost of $16 billion accounts for more than one-third of the NIH’s current spending level of $42.9 billion. The lack of funding available affects the NIH’s ability to do research in areas other than COVID-19. Dr. Fauci admitted that there has been a decrease in activity compared to before the pandemic, but that the agency would work to ensure “that nothing important slips in the other areas of research.”

More States Open Vaccines to those 16 Years of Age and Older, and Many Soon to Follow 

This month, Alaska, Mississippi, West Virginia, Texas, Georgia, Utah and Arizona announced that they have opened registration to any residents 16 years of age and older to receive one of the COVID-19 vaccines currently being distributed in the United States. Alaska was the first state to make the decision, and more states are beginning to announce when they will also open vaccinations to the same population. The second round of states: Indiana, Louisiana, North Dakota, Ohio and Oklahoma opened vaccines to all residents on March 29.

Update to Part D Payment Modernization (PDM) Model & Application Process for Calendar Year 2022

The Centers for Medicare & Medicaid Services (CMS) announced a new update expected to help better manage drug spending, increase engagement with enrollees, and to promote better enrollee understanding of their Part D benefit, out-of-pocket costs, and clinically equivalent therapeutic options. The CMS webpage contains a more in-depth explanation of the changes for the 2022 calendar year.

U.S. NGO NEWS

Study Identifies Cells that Maintain and Repair the Liver

A recent study, published in Science, uncovered the roles that different cells in the liver play in organ maintenance and regeneration after injury. The results will hopefully aid in providing an understanding to the workings of these processes and lead to the creation of new strategies to treat liver diseases and injury.

Recent NCCN Guidelines on Cancer Prioritization for COVID-19 Vaccines

The National Comprehensive Cancer Network (NCCN) COVID-19 Vaccination Advisory Committee released recommended guidelines for cancer patients and vaccinations. They use available, relevant studies to stress the need for the prioritization among cancer patients in the setting of limited vaccine availability, as well as vaccine safety and efficacy.

NAMES TO KNOW

John Sarbanes 

This month, Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) announced the six subcommittee vice chairs for the 117th Congress, with Representative John Sarbanes (D-MD) named vice chair to the subcommittee on health.

Xavier Becerra

Becerra has been sworn in as the 25th Secretary of the Department of Health and Human Services (HHS) with a narrow 50-49 margin in the Senate. In his role, he plans to focus on ensuring that all Americans have access to health care and health security. Over this past month, there have been at least 30 new appointees to HHS with some announced in the beginning of the month and the others after Becerra moved into his official position later in the month. We are still waiting to hear about a few other appointees of the Biden-Harris administration, including the final nominee to head the Food and Drug Administration (FDA).

Policy UpdatesDonna Cryer