Advancing American Kidney Health Executive Order and the Impact on Livers
POLICY PERSPECTIVE
Six people die everyday waiting for a liver transplant.
On July 10th the President signed an executive order focused on repairing our broken organ donation system. On the surface the order is focused on a series of initiatives designed to encourage more kidney transplants and treatment at home, but hidden behind the scenes were a few equally important measures that will impact all organ transplantation, especially livers.
The first measure calls for a complete reform of the organ procurement and management system in the United States to significantly increase the supply of transplantable organs. The second calls for removing financial disincentives to living donation and ensuring appropriate financial support for donors.
In previous Liver Health Policy Updates we have stated GLI’s position on organ procurement and management system reform. We believe that there is clearly a disconnect between the organs that are being donated and the ones that are being made available for transplant. The executive order rightfully calls for a complete reform of the organ procurement and management system to significantly increase the supply of transplantable organs, and establish objective, meaningful, and independently verifiable performance standards for Organ Procurement Organizations.
With more than 14,000 liver patients currently waiting for transplant it is important to also look beyond the first crucial measure and try to find additional pathways to increase the number of available organs.
If we shine a spotlight on the value of the living donor measure, we know that many people are willing to become living liver donors. In a recent survey by WebMD and UPMC, 70% of respondents said they would be willing to consider becoming a living liver donor for a family member or someone they knew. And 39% said they would be willing to be a living liver donor even for someone they did not know.
In practice, however, the numbers tell a different story. The number of living liver donations is a fraction of the total number of liver transplants. In 2018, there were only 401 living liver donations out of 8,874 transplants.
The truth is that there are financial barriers that keep many people from donating, and the President’s order seeks to ease the economic burden for living organ donation. The order will expand the living organ donation reimbursement program, and implement a pilot program to increase the qualifying expenses to include coverage for lost wages and family expenses.
We applaud the President’s actions, and the positive initial step taken to protect potential living donors and to ensure potential donors don’t face the hardships of child care expenses or foregoing lost wages. However, even with these positive initial steps we cannot stop until the waitlist is fully eliminated.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
“Request to Connect” - A New Way for Patients to Connect with FDA
The FDA Patient Affairs Staff has announced the FDA “Request to Connect” portal is now live
This new patient portal gives patients and caregivers a single entry point to the agency for questions and meeting requests.
POLICY DEVELOPMENTS AT GLI
Apply for GLI’s Advanced Advocacy Academy (A3) Class of 2019
Applications for GLI’s Advanced Advocacy Academy (A3) Class of 2019 are now open! A3 2019 will take place on November 1-2, 2019 at GLI Headquarters in Washington, DC. This year’s program will offer liver patients, caregivers, and professionals the opportunity to learn from experts in the fields of drug development, 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.
GLI Signs onto Drug Pricing Bill & J-code for Biosimilars/Biologics Letter
GLI joined a wide range of stakeholders in expressing support for the current Centers for Medicare and Medicaid Services (CMS) policy of unique Healthcare Common Procedure Coding System (HCPCS) billing codes (J-codes) for each biologic medicine, including innovator and biosimilar products. Recent reports mentioned that the Senate Finance Committee may direct CMS to change the current J-code billing system for biologics and biosimilars medicines.
Many liver disease patients rely on biologic medicines. Currently, each biosimilar receives a unique Healthcare Common Procedure Coding System (HCPCS) billing codes (J-codes). A few years ago many weighed in to support unique codes rather than lumping all into one code for reimbursement. Unique codes will lead to more treatment options and more options/competition could lead to better pricing for patients.
GLI Signs Letter Supporting Bipartisan Legislation to Protect Seniors’ Lab Benefits
In August 2018 more than 30 organizations signed onto a letter urging Congress to take immediate action to address the harmful cuts to the Clinical Laboratory Fee Schedule (CLFS) that were in effect as a result of the flawed implementation of the Protecting Access to Medicare Act (PAMA). In response, a bipartisan group of members of Congress has introduced the LAB Act – legislation to protect seniors’ lab benefits and improve data reporting under PAMA. The sign-on letter urges Congress to pass the legislation – which can be accessed here. The legislation would be a first step in both alleviating the steep year-over-year cuts to vital clinical diagnostics that adversely impact 53 million Americans facing and addressing a flawed data collection process that continues to erode Medicare lab benefits for the country’s most vulnerable seniors.
GLI Joins Cancer Support Community Liver Cancer Registry Advisory Committee
By participating in a recent Cancer Support Community advisory committee meeting, GLI has joined an effort to create an on-going patient registry focused on the needs and experience of liver cancer patients. The high liver cancer mortality rate has slowed such research in the past but with our focus on early detection through screening and additional treatments for liver cancer, GLI is joining efforts to learn as much as possible from survivors in order to further encourage diagnosis, early treatment, quality of life and survivorship.
GLI Became A Member Organization of The Friends of PCORI Reauthorization
GLI has been officially listed as a member organization of The Friends of PCORI Reauthorization Please check out their website to read more. As a reminder, GLI signed the House and Senate letters in support of PCORI reauthorization.
FOR YOUR CALENDAR
American Association of Diabetes Educators Conference August 9-12
European Society of Cardiology Conference August 31-September 4
European Reference Network,Rare Liver Diseases meeting, September 2-3
ECCO 2019: European Cancer Summit,September 12-14, Brussels
WHO Regional Committee for Europe, 69th Session, September 16-19, Copenhagen
International Liver Cancer Association Annual Meeting September 20-22
EASL - NAFLD Summit September 26-29 (Valencia, Spain)
European Society for Medical Oncology Congress September 27 - October 1 (Barcelona, Spain)
3rd NASH Summit EU October 23-25 London
NCI Liver Cancer Program: Special Conference on Tumor Metabolism October 28-29, Bethesda
Global Liver Institute Advanced Advocacy Academy, November 1-2, Washington
American Public Health Association November 2-6, Philadelphia
American Association for the Study of Liver Disease, The Liver Meeting November 8-12, Boston
GLOBAL NEWS
World Hepatitis Day
July 28th was World Hepatitis Day when the world unites to celebrate progress in eliminating viral hepatitis. The day combines the voices of all affected by hepatitis B and C and looks to raise awareness for the 325 million people currently living with either hepatitis B & C. This year World Hepatitis Alliance encouraged everyone to help Find the Missing Millions - those people living with viral hepatitis who remain undiagnosed - and encourage them to get tested. 1.4 million people die each year because of these diseases, despite there being a vaccine and effective treatment for hepatitis B and a cure for hepatitis C. Millions of lives are still at risk simply because people are unaware that they are living with viral hepatitis.
Viral Hepatitis recognised within the Universal Health Coverage (UHC) Political Declaration
The declaration seeks to strengthen efforts to address communicable diseases, including HIV/AIDS, tuberculosis, malaria and hepatitis as part of universal health coverage and to ensure that gains are sustained and expanded by advancing comprehensive approaches and integrated service delivery and ensuring that no one is left behind. The inclusion of viral hepatitis in the political declaration will be a powerful advocacy tool. The political declaration on UHC will be signed in September at the UN High-Level Meeting on UHC.
U.S. NEWS
The Liver Illness Visibility, Education and Research (LIVER) Act of 2019 (HR 3016)
Read Here About What The LIVER Act Will Do
GLI has been actively involved in advancing this first of its kind liver legislation. On July 9, 2019 GLI officially submitted a letter of support to Representative Nydia Velazquez (D-NY). Included in the letter of support, GLI asked that NASH be added to the list of conditions known to increase an individual’s risk of developing a major liver diseases including liver cancer.
U.S. Senator Todd Young (R-IN) Introduces Legislation to Bring Greater Accountability to Organ Donation System
On July 9, 2019 Senator Young introduced legislation that aims to deliver more life-saving organs to patients by establishing clear, accountable metrics for organ procurement organizations (OPOs).
GLI Highlight:
GLI has been actively involved and is mentioned as a supporting organization in Senator Young’s press release.
As a reminder, on March 12th GLI submitted a letter to Administrator Seema Verma asking CMS to substitute the metrics by which OPOs are evaluated for a new verifiable metric that is not open to self-reported interpretation.
The Trump Administration Announces a Series of Initiatives Focused on Organ Transplantation
On July 10, 2019 the Trump administration announced a package of initiatives focused on organ transplantation titled, Advancing American Kidney Health. Many of the initiatives are designed to encourage more kidney transplants and treatment at home, thus starting a process intended to overhaul a market in which the federal government spends more than $100 billion per year. However, one key initiative, similar to Senator Young’s bill, is designed to boost all organ transplantation and crack down on OPOs. President Trump will order Secretary Alex Azar of HHS to develop better ways of measuring OPO performance that are clearer, more reliable and easier to enforce. Another planned Trump proposal would increase payments to live donors of kidneys and livers to cover more of their expenses, possibly including lost wages and child care.
GLI Highlight:
GLI applauds the inclusion of both of these provisions within the executive order.
GLI will continue to be actively involved, and keep our fingers on the pulse of these important issues.
White House and Congressional Leaders Reach Budget Deal
On Monday July 22nd the White House and congressional leaders reached a fiscal deal that would lift the nation's debt limit and dramatically raise federal spending levels. Read a report from USA Today here. The agreement, negotiated by House Speaker Nancy Pelosi and Treasury Secretary Steven Mnuchin, passed the House the week of July 24th, and passed the Senate on the chamber's 60-vote threshold on August 1st, paving the way for final passage and President Donald Trump's signature — alleviating pressure ahead of a slew of high-stakes fiscal deadlines this fall. The agreement would eliminate the threat of dual fiscal crises and another government shutdown that have long been hanging over Washington — an unprecedented default on U.S. debt and massive across-the-board spending cuts that could paralyze key agencies.
The passage of this budget pact clears the way for Congress to consider its annual funding bills when lawmakers return from their August recess. Those bills need to pass by Sept. 30 to avert a government shutdown.
GLI Highlight:
GLI encourages Congress and the administration to quickly reach an agreement on lifting the budget caps for FY 2020 and FY 2021 and to establish topline spending levels that allow for timely enactment of the FY 2020 spending bills to avoid delays in lifesaving medical research.
GLI will continue to push for funding of federal agencies that protect patient lives, and promote the development of valuable new therapies for all Americans, especially those impacted by liver diseases.
Drug Pricing
On July 11th, the Trump administration withdrew its sweeping proposal to eliminate rebates from government drug plans. The proposal — a centerpiece of the Trump administration's strategy to reduce drug prices — had split HHS and the White House. On July 23rd, however, the Senate Finance Committee, with the backing of the Trump administration, unveiled legislation, The Prescription Drug Pricing Reduction Act, to address high prescription drug prices.
The draft would overhaul parts of Medicare and Medicaid. It also includes a controversial provision pushed by ranking member Ron Wyden (D-Ore.) that would crack down on drugmakers that raise prices higher than the rate of inflation.
Senators introduced 110 amendments to the drug pricing legislation. The legislation faces push back from both sides of the aisle.
The Senate Finance Committee voted 19-9 to send the bill to the chamber's floor, advancing a long-awaited effort from bipartisan leadership. The amendments that failed are likely to see debate on the Senate floor.
GLI Highlight:
GLI focuses on access and affordability of medications for patients while recognizing that a sustainable solution also ensures that innovation in drug development must be incentivized.
GLI was actively concerned with any changes that could potentially raise costs for patients, and applauds the dropping of the Administration’s regulatory proposal, and appreciates the bipartisan nature of this new drug pricing bill draft.
GLI will continue to digest, and actively monitor this new piece of legislation with the goal of making sure access and affordability of medications for patients is central.
U.S. Stateside
Hawaii Approves Liver and Bile Duct Cancer Legislation
State Representative John Mizuno (D - Kalihi Valley, Kamehameha Heights, Lower Kalihi), Chair of the Hawaii House Health committee and the bill's author stressed that HB654 is by far the most aggressive stride ever taken in the fight against liver and bile duct cancer in Hawaii. According to the Centers for Disease Control and Prevention and the University of Hawaii Cancer Center, Hawaii has the highest or second highest rate of liver cancer in the United States depending on the yearly data.
HB654 provides funding to the University of Hawaii Cancer Research Center (UHCRC) to determine the cause or connection from the environment and genetics for the high incidence of liver and bile duct cancer in Hawaii. The UHCRC will use the funding to research biomarkers such as infections, liver flukes, individual background, and environmental toxins which could be the cause of increased cancer incidence. The bill specifically highlights NASH as a potential influence of liver cancer.
GLI Highlight:
GLI applauds the passage of this key piece of legislation. The funding of critical research is the key to intervention and prevention of liver and bile duct cancer in Hawaii and the rest of the world.
Washington State Launches Plan to Eliminate Hepatitis C Virus
On July 26th, a group of state agencies and partners, in response to a directive from Gov. Jay Inslee, officially launched the Hep C Free Washington Plan to Eliminate Hepatitis C in Washington State by 2030.
Hepatitis C infection is the most common infection spread through blood in the United States with about 2.4 million people living with the hepatitis C virus (HCV). Hepatitis C is a public health crisis in Washington state. At the beginning of 2018, nearly 60,000 Washingtonians were estimated to be living with HCV.
GRANT OPPORTUNITIES
Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.
Conquer Cancer®, the ASCO Foundation, has awarded more than $126 million through nearly 2,100 grants and awards to medical students, trainees, young scientists, and oncologists at all stages of their careers. Many of their funding opportunities are currently accepting applications. While eligibility criteria differ for each award, all grants require that applicants be a member of ASCO to apply. Join ASCO and to submit a grant application.
NAMES TO KNOW
Congresswoman Nydia Velázquez (NY-07) is currently serving her twelfth term. In the 114th Congress, she is the Ranking Member of the House Small Business Committee and a senior member of the Financial Services Committee. She has made history several times during her tenure in Congress achieving many firsts. In 1992, she was the first Puerto Rican woman elected to the U.S. House of Representatives.
Most recently, Congresswoman Velázquez introduced the Liver Illness Visibility, Education and Research (LIVER) Act of 2019 (HR 3016).
TERMS TO KNOW
Biologics. A biologic is a medication manufactured in a living system such as a microorganism, or plant or animal cells. Most biologics are very large, complex molecules or mixtures of molecules. Many biologics are produced using recombinant DNA technology. In contrast, a drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. Source.
FURTHER READING
Medicare Advantage and Part D Rule: A win for patients, but out-of-pocket costs must be capped
WHO Urges countries to invest in eliminating Hepatitis
WHO: World hunger is still not going down after three years and obesity is still growing – UN report
ECDC Overview on the Hepatitis E in EU member countries (released in July 2019)