POLICY PERSPECTIVE

Over the last few years Congress has shown a commitment to making sure our nation honors the longstanding commitment to improve and save lives through federal support and research. Each year has been a slow inch by inch march of progress, and we still have a great distance ahead.

This past month the President released his FY 2021 budget allocating around $38 billion towards the NIH; which is a 7.2% cut from last year’s budget. This cut would damage the recent progress made on research to find treatments and cures for patients nationwide.

It is especially concerning to see the Trump administration budget call for cutting Centers for Disease Prevention and Control (CDC) funding for chronic disease prevention by 34 percent. CDC is the federal agency in charge of surveillance and prevention. It also studies disease prevalence, identifies effective interventions t, and distributes money to states and localities. The proposal is part of a broader effort to pare back CDC activities that don't deal with infectious diseases and refocus the agency’s mission on the prevention and control of communicable diseases and on crises like the opioid epidemic.

Chronic diseases account for seven out of 10 U.S. deaths each year. Chronic liver disease, and cirrhosis is the 11th leading cause of death in the United States. This number is most likely underreported and inaccurate due to a lack of proper mortality statistics for many liver diseases, especially NASH.

Even if the President misses the mark on funding and priorities, he does understand that our agencies need to be reorganized and refocused to better address the rising concerns of many diseases. This is especially critical for liver diseases that require long term infrastructure to be put into place that appropriately characterizes and addresses their rapid and continued rise.

It is important to keep in mind that all liver disease is a risk factor liver cancer. NASH is comorbid with a wide range of diseases like diabetes, obesity, and hyperlipidemia. Liver dysfunction as a whole has a wide-ranging impact, so any future prevention effort that improves liver status overall will almost certainly have secondary impacts of value. Liver health is public health. As it stands currently, our health system is poorly prepared for the incoming burden of many liver diseases.

As we move into 2020 and beyond, GLI will continue to push to protect the funding of CDC, NIH, and other federal agencies that improve patient lives, and promote the development of valuable new therapies. We will also advocate for a reorganization of relevant agencies to better recognize the intrinsic link between diseases, and better address the unmet need of liver disease patients nationwide.

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

GLI Participates in The Friends of NIDDK Meeting with NIDDK Director on February 18th

The Friends of the National Institute of Diabetes and Digestive and Kidney Diseases (FNIDDK) held their annual meeting with NIDDK Director Griffin Rodgers and NIDDK staff Tuesday on the NIH campus. The meeting focused on current and future initiatives at NIDDK and how outside organizations can be of assistance.

Digestive Disease National Coalition Public Policy Forum

On Sunday, March 1st and Monday, March 2nd, the Digestive Disease National Coalition (DDNC) hosted its annual public policy forum and Hill Day. The DDNC is an advocacy organization that pushes for health policy advancements on behalf of the millions of Americans who are affected by digestive disease conditions. If you would like more information about the forum please click here.

At the DDNC forum and Hill day, Global Liver Institute’s Policy Director, Andrew Scott, spoke and led a group of GLI’s Advanced Advocacy Academy (A3) alumni to advance the LIVER act and other pieces of legislation related to digestive diseases.

GLI Responds to HRSA Proposed Rule Removing Financial Disincentives to Living Organ Donation

We appreciate this HRSA proposal as a positive initial step, however, we are disappointed in the inaction and delays on some of the key living donor protection sections of President Trump’s executive order. Most importantly, GLI is disappointed that tHRSA delayed the actions President Trump took to expand who can be reimbursed. Currently, only 8% of donors whose recipients earn less than 300% of the poverty line are reimbursed. Non-directed donors are not eligible. President Trump ordered this threshold to be moved, but it was not included in this proposal. Reimbursing as many donors as possible is critical. We recommend that donors whose recipients earn less than 600% of the poverty line must be reimbursed.

GLI Responds to CMS Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization

We support greater accountability of the organ procurement process. Patients, donor families, and the public deserve accountability on the front lines of organ donation, which is why GLI applauds this proposed rule. It follows through on the President’s executive order from July of 2019 that called for the establishment of more “transparent, reliable, and enforceable objective metrics for evaluating an Organ Procurement Organizations (OPO) performance.”

GLI joins AARDA in response to CMS Proposed Copay Accumulator Rule That Undermines Patients' Access & Adherence to Their Medicines

GLI joined AARDA and many other organizations to support people living with autoimmune diseases, serious illnesses, and chronic conditions by sending a letter to HHS. Recently, HHS proposed a Notice of Benefit and Payment Parameters Rule that would allow insurers not count copay assistance from drug manufacturers. For many, this is a lifeline to affordability and adherence, and critical to individuals and families as they manage their health and budgets. Specifically, the proposed rule would expressly allow insurance plans to exclude drug manufacturer copay assistance from counting towards patients’ annual limitation on cost sharing.

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.

Day One Project

With the rising concerns of many liver diseases like NASH, and liver cancer, GLI submitted a Day One Project proposal with the goal of better organizing the U.S. prevention and awareness efforts. Specifically GLI asked the next Administration to reorganize Centers for Disease Control and Prevention (CDC) to better respond to the intrinsic link between a wide range of liver diseases.

GLI signs onto letter for Transplant and Dental Access

Dental plans are allowed to participate in the ACA Marketplace, however due to a technical error at CCIIO,individuals can't choose a dental plan without purchasing a medical plan. In addition, changes to one’smedical but not dental plan automatically disenrolled individuals from dental coverage without notification, leaving many confused..

Oral health is a critical component of overall health and wellness and routine dental care is critical for transplant patients before and after surgery. Ensuring coverage of dental care has the potential to reduce costs while improving outcomes.

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 host its second annual A3 Hill Day, open to 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 questions.

President Trump’s Budget Request for Fiscal Year 2021; Ad Hoc Recommendation

This month, the president released his budget proposal for the fiscal year 2021. The president outlines not only immediate budgetary plans for FY 2021 but also elaborates on proposals if he were to be elected to another four year term. In regards to health care, the budget allocates around $38 billion towards the NIH; which is a 7.2% cut from last year’s budget.

This level of funding for the NIH has been deemed far too low by the Ad Hoc Group for Medical Research which recommends a funding level of $44.7 billion for NIH in FY 2021. In response to the proposal, the Ad Hoc Group issued a statement urging lawmakers to reject the proposal, as they have in the past, and to finalize a bipartisan budget agreement that raises the discretionary spending caps and enables robust investment in NIH. To endorse the opposition to President Trump’s proposal please email Joyce Buchanana (jbuchanan@aamc.org) to add your name to the list of sponsors.

PCORI Engagement Award Funding Opportunity

The Patient Centered Outcomes Research Institute (PCORI) announced three additional campaigns to itsEngagement Award Funding Opportunity. The areas of focus are capacity building, dissemination initiative, and stakeholder convening support. The overarching goal of all three initiatives is to increase the role that patients play in the research process and the dissemination of findings.

Royal Society: The Future of Liver Health

On April 15th 2020, Mrs. Donna Cryer will join Professor Sir Michael Brady at the Royal Society in London to discuss how physicians and health systems can better care for liver patients on a global scale Ses, and. email RoyalSociety2020@perspectum.com to register for the event.

National Cancer Institute (NCI)

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

To learn morel, 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

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

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

March 15-17: Fight Colorectal Cancer: Call on Congress. Washington, DC.

March 20-22: National Comprehensive Cancer Network: Orlando, Florida.

March 24-25: Annual Congress on Digestive Disorders and Liver Cancer. London, UK.

March 25: Prevent Cancer Foundation Advocacy Workshop. Washington, DC.

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

April 15: Royal Society: The Future of Liver Health Event. London, UK.

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

GLOBAL NEWS

Conference - Europe's Beating Cancer Plan: Let's strive for more

On 4 February – World Cancer Day – the European Commission started its outreach on Europe’s Cancer Plan at an event in the European Parliament in Brussels, supported by the MEPs Against Cancer Interest Group. While the EU has a long history in the fight against cancer, there are still many challenges ahead. This event aimed to demonstrate the EU’s strong commitment to fighting cancer and to harness the collective power for positive change

Livia Alimena, Director of GLI’s European Office attendance and met with the EU Commissioner for Health, Stella Kyriakides. Livia highlighted the value of increased efforts around liver cancer, and the interconnection to other liver diseases like NASH.

World Health Organization and FIND formalize collaboration on universal diagnostics:

The World Health Organization has announced a partnership with the Foundation for Innovative New Diagnostics (FIND) to increase diagnostic technology and procedures across the world but particularly in resource-poor communities. The partnership focuses on empowering primary care physicians to perform and gain access to more comprehensive diagnostic tests.

One in Five Young People in the UK have fatty liver disease

The British Liver Trust provided an update on the prevalence of NAFLD in the United Kingdom. The article recaps the study published in the Lancet Gastroenterology and Hepatology which found that one in five “healthy” young people in the United Kingdom have fatty liver disease and one in forty young people have already developed liver scarring. The population of study was “healthy” young people with no prior illness or major alcohol use before the assessment for fatty liver disease.

Furthermore, on February 6th, the Welsh government allocated 5.5 million pounds to tackling obesity in Wales. This is important as over a quarter of adults in Wales are obese and the money will be used as a part of the Healthy Weight: Healthy Wales Delivery Plan 2020-2022.

Mobile Hepatitis C Diagnostic Center

The Croatian Association for Liver Disease “Hepatos” launched its innovative Mobile InfoHep Center. This is a mobile vehicle that utilizes polymerase chain reaction technology to assess if hepatitis C virions or viral particles are circulating in the blood. This on-the-spot diagnostic measure is phenomenal. The service also links patients, who do test positive, to a local specialist as soon as possible.

WHO Outlines Steps to Save 7 Million From Cancer

The World Health Organization announced its intent to ramp up its cancer services specifically in low or middle-income countries. In these nations, a majority of health resources are placed on infectious disease or childbirth related deaths. Now WHO plans on improving cancer services. The WHO highlights a variety of proven interventions to prevent new cancer cases such as controlling tobacco use or vaccinating against Hepatitis B, prime contributor to liver cancer incidence.

U.S. Federal NEWS

President Trump’s Budget Request for Fiscal Year 2021

This month the President released his proposed budget plan for FY 2021 as well as programs that would carry on into the next four years, if he were to be re-elected. The overall budget is about $4.8 trillion dollars. The White House proposes to cut spending by $4.4 trillion over a decade. Of that, it targets $2 trillion in savings from mandatory spending programs, including $130 billion from changes to Medicare prescription-drug pricing, $292 billion from safety-net cuts—such as work requirements for Medicaid and food stamps--and $70 billion from tightening eligibility access to federal disability benefits.

NIH has been allocated $38 billion dollars, which is a 7.2% cut from the previous year.

While the budget is unlikely to pass in its current form due to the Democrat majority hold in the House of Representatives, the President’s cuts to important public health measures and medical research organizations is still a step in the wrong direction.

Trump’s Budget Pushes for Bipartisan Drug Pricing Deal

The White House fiscal 2021 budget request assumes $135 billion in savings over 10 years due to drug pricing reforms; however, it is not specified in the budget how exactly these drug pricing reforms are to be carried out. While the Trump administration has voiced support for drug pricing reform, Senate Republicans are disappointed that President Trump has not thrown more adamant support behind the Grassley-Wyden bill. Nonetheless, the assumption in the President’s budget is indicative of the president’s commitment to drug pricing reform.

Trump Budget would create CDC Chronic Disease Block Grant

The Trump administration budget calls for cutting CDC funding for chronic disease prevention by 34 percent and consolidating efforts addressing heart disease, diabetes and other conditions into a single block grant for states. The proposal is to ensure that the CDC focuses on infectious diseases instead of chronic diseases. However, chronic diseases account for seven out of 10 U.S. deaths each year. Many liver diseases like NASH fall within this category at CDC as well. The CDC should be encouraged and funded to perform work in both the infectious disease and chronic disease capacity.

Chairman Neal and Congressman Brady release text of Surprise Medical Billing Proposal

This past month, Ways and Means Committee Chairman Richard E. Neal (D-MA) and Ranking Member Kevin Brady (R-TX) released legislative text of the Consumer Protections Against Surprise Medical Bills Act of 2020, the Committee’s proposal to better shield patients from bankrupting surprise medical bills.

NIMBLE’s Letter of Intent on Non-Invasive Circulating Biomarkers accepted by FDA

NIMBLE Diagnostics, in coordination with the Foundation for the National Institutes of Health, recently had their letter of intent for the Circulating Biomarker Workstream accepted by the FDA Biomarkers Qualification Program. This acceptance is an important first step in allowing NIMBLE to use 4 biomarkers in a study to assess which biomarkers should be used as a measure of non-invasive testing for NASH. These biomarkers are an integral step in avoiding the invasive liver biopsy.

FDA Oncology Center Moving to Broaden Cancer Trial Populations

The Oncology Center for Excellence is working with Friends of Cancer Research and the American Society of Clinical Oncology to loosen traditional FDA regulation practices that restrict the number and types of patients that can participate in clinical trials. The new statement is focused on the patient being included in a trial by default, and then only excluded for safety reasons if necessary.

FDA Looking to Update Standards for Regulating On-Screen advice for doctors

The FDA has been trying for eight years to create a framework for regulating the software that physicians use to better care for their patients. Specifically, these software developments can be utilized to eliminate societal or individual biases present when treating a patient, and to use artificial intelligence to find patterns that doctors themselves may miss. Many leading Democratic senators, most notably Senator Warren and Senator Murray, have explained why they are opposed to a streamlined regulatory approach by the FDA in regards to approving these constantly upgrading software developments.

U.S. State News

Arkansas Court Rejects Trump Medicaid Work Requirements in Arkansas

A federal appeals court panel unanimously upheld a lower court ruling which strikes down the work rules for Medicaid recipients in Arkansas. The Trump administration has been attempting to implement broad measures that would require medicaid recipients to work, volunteer, or train for a job as a condition to receiving their government health care. The appeal court panel stated that the primary objective of Medicaid as defined under federal law is to provide health coverage to populations that otherwise cannot afford it; thus, a mandated work requirement would be contrary to the intention of the system.

California State Legislature

The California state legislature has been in deliberation on Senate bill SB 768 this past month. This piece of legislation directs for the funding of a three year Hepatitis A pilot project. The bill would empower the local public health department to work in coordination with San Diego, CA social services in order to assess and improve the health of the disproportionately impacted the city’s population.

Florida State Legislature

On February 6th, 2020 the Florida State legislature moved forward with the Senate version of a bill that would prevent health insurance companies from limiting or excluding coverage solely on the basis that the insured person is a living organ donor. This Senate bill, FL S1516, is the complement of the house version of the bill, H1187.

NGO News

Low Hepatitis C Treatment Uptake amongst Opioid Treatment Programs

Recently the Journal of Substance Abuse Treatment published a study that investigates barriers and facilitators of Hepatitis C treatment uptake among people who inject drugs enrolled in opioid treatment programs in Baltimore. The findings show that of the opioid treatment programs studied in Baltimore, only 20% of the patients received Hepatitis C treatment.

More Progress is Needed to Support Americans Living with Rare Disease

The National Organization for Rare Diseases released its annual report for 2019, in which key areas of improvement were outlined for the upcoming 2020 year. Specifically, the report emphasizes that more advocacy is needed to attain comprehensive Medicaid coverage that supports patients and families suffering from rare diseases. Furthermore, the report calls for more states to adopt a rare disease advisory council that can influence legislation on the state level to cover rare diseases and the costs associated with them. In 2019, five states created a rare disease advisory council and more action is needed in this arena to support families afflicted by rare diseases.

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

NAMES TO KNOW

Dr. Hillel Tobias M.D.- Dr. Tobias is the Chair, Board of Directors at Global Liver Institute. He is a professor at New York University and the Medical Director of the NYU Liver Transplant Service. Dr. Tobias, a leading gastroenterologist, was named to the New York Super Doctors List numerous times.

TERMS TO KNOW

LiverMultiScan® - This noninvasive diagnostic technology was created by Perspectum Diagnostics. LiverMultiScan® utilizes MRI to quantify and assess liver tissue and stiffness. Perspectum is only one of several companies, including Arrow Dx which was featured in GLI’s Liver Matters blog, that are revolutionizing the diagnosis of liver disease by creating noninvasive technologies that detect NASH and NAFLD without undergoing an invasive, risky, and expensive liver biopsy. Global Liver Institute will soon launch the Beyond the Biopsy campaign to increase awareness of these noninvasive alternatives.

Public Health is Liver Health