Breaking News: The Liver Illness Visibility, Education and Research (LIVER) Act of 2019 (HR 3016)
Breaking News: The Liver Illness Visibility, Education and Research (LIVER) Act of 2019 (HR 3016)
Introduced on May 23, 2019 by Representative Nydia Velazquez (D-NY), the bill takes bold steps to increase investments in research, prevention, and awareness activities to address liver disease and liver cancer, which continues to grow in incidence and is the 2nd deadliest cancer.
International NASH Day 2019 Kicks off the future of NASH Awareness
I am pleased to announce the successful launch of International NASH Day 2019 which occurred last month. We witnessed dozens of NASH awareness activities and great media penetration globally.
Nonalcoholic Steatohepatitis (NASH) is a potentially fatal condition affecting up to 12% of adults worldwide, an estimated 115 million people around the globe, yet in a recent survey, only 6% of at-risk individuals had ever heard of the condition.
On IND, I was joined by many leaders in liver health advocacy, in declaring NASH a “hidden epidemic.” June 12th acted as the perfect moment to shine a spotlight on NASH and raise awareness of the little-known symptoms of this disease and the need for better diagnosis and treatment options.
We coordinated dozens of organizations and events worldwide to educate on this disease and advocate for patients who have and are at risk for NASH.
Within 2 hours over 135 outlets picked up International NASH Day news reaching millions of people. News wire, print, and television outlets were all represented and involved. We are also pleased to announce that social media was also hopping on June 12th.
Finally, our Capitol Hill Briefing titled, The Rising Risks of Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH), was a resounding success. The educational briefing included a panel with representation from the American Gastroenterological Association and INOVA Fairfax, the Endocrine Society and the University of Virginia, Pinnacle Clinical Research, and a NASH patient advocate.
The briefing began with presentations on Global and U.S. prevalence, the connection between NASH and other diseases, a NASH patient story, and how clinical research can lead to treatments for NASH. The presentations were then followed by a full panel discussion that included a call to action for a national response and plan to attack this “hidden epidemic.” The event was widely attended, including over 15 Congressional offices representing the U.S. House of Representatives and Senate.
However, even with the positive response to IND, our NASH advocacy does not stop. June 12th only acted as a kickoff, and pinpoint moment to open the conversation and show that there is an urgent need around NAFLD and NASH. We will continue to press and make sure that these liver diseases are included in every healthcare conversation, most importantly, when obesity and diabetes are mentioned going forward.
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
Breaking News: The Liver Illness Visibility, Education and Research (LIVER) Act of 2019 (HR 3016)
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 email@example.com with any questions.
International NASH Day on June 12, 2019
International NASH Day (IND) was held June 12, 2019. GLI coordinated dozens of organizations and events worldwide to educate on NASH and advocate for patients who have and are at risk for NASH.
Even though IND has passed, GLI continues to invite all organizations that promote liver health and public health to join in raising awareness about NASH. Questions? Please head to our IND website,or contact us at firstname.lastname@example.org.
GLI Signs onto Dx Reform Letter
This past month GLI joined many organizations in urging Congress to enact legislation to modernize the statutory oversight of clinical laboratory diagnostics, including laboratory developed tests (LDTs) and in vitro diagnostics (IVDs). Last year a similar letter was signed by over 80 stakeholders. This most recent letter demonstrates a continued and collective commitment to Dx reform.
GLI Signs onto Shared Decision-Making Comment Letter on Interoperability
The current CMS rulemaking on interoperability had public comments due on Monday, June 3, 2019, and included a reference to the impact of their proposed rule on advancing shared decision-making. The CMS Interoperability and Patient Access Proposed Rule introduces new policies that will expand access to health information and improve the seamless exchange of data in healthcare. GLI joined many patient advocacy organizations in embracing the opportunity to reach out to CMS on this important issue.
The submitted comment letter narrowed down for CMS simple concrete steps for advancing shared decision-making:
CMS should reinforce the importance of person-centered communication skills development among providers.
CMS should work with stakeholders, including patient representatives, to establish appropriate standards for achieving high quality shared decision-making.
CMS should work with stakeholders with expertise on shared decision-making and the patient advocacy community to identify a path forward for the certification of patient decision aids.
CMS should consider many common preference sensitive conditions as priorities for building communication skills among relevant providers and certification of decision aids for those conditions.
GLI Signs onto PIPC’s 2020 Value Assessment Framework Comment Letter
GLI joined the Partnership to Improve Patient Care (PIPC), and over 30 patient and disability groups in outlining concerns about ICER’s 2020 Value Assessment Framework. Click here to read the letter.
The letter calls on ICER to abandon its use of the quality-adjusted-life-years (QALY) metric, as well as other metrics that discriminate against patients and people with disabilities. PIPC also emphasized that ICER must develop novel measures of value to account for patient differences and priorities, as well as models that are open-source, transparent, and available to all patients and researchers. “Above all, we urge ICER to put patients and people with disabilities at the center of all of your assessments,” the letter states. “While we share your interest in lowering healthcare spending and addressing affordability, we do not believe that generating value assessments in a manner that leads to restricted access and discrimination is a necessary tactic or ethical strategy for achieving these goals.”
Metrics for measuring the “cost effectiveness” or value of treatments often rely on discriminatory methods, like the quality-adjusted life year (QALY), which values the lives of people with disabilities and serious chronic conditions as worth less than those of non-disabled people. QALYs and similar metrics are increasingly at the center of state and federal discussions about drug pricing and coverage of treatments. GLI stands with many disability rights advocates in fighting against the use of QALYs and ensuring that patients and people with disabilities are protected from discrimination and policies driving a one-size-fits-all health system. Please head to the Value Our Health website to learn more.
GLI Signs on to Support the “Treat and Reduce Obesity Act of 2019”
GLI joined the Obesity Care Advocacy Network (OCAN) and many other organizations in sending a letter to Congress urging offices to sign on in support and become cosponsors of The Treat and Reduce Obesity Act of 2019 (S 595/HR 1530). TROA was introduced in eary 2019 in the Senate and House by Senators Bill Cassidy (R-LA) and Tom Carper (D-DE) and Representatives Ron Kind (D-WI), Brett Guthrie (R-KY), Tom Reed (R-NY) and Raul Ruiz (D-CA), respectively. The bill aims to effectively treat and reduce 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.
GLI Signs on to Letter Supporting Continued Coverage for Pneumococcal Vaccines
GLI joined many advocacy organizations in submitting a letter to support maintaining coverage for pneumococcal vaccines. Vaccinations keep healthcare costs down, and act as a key preventive measure.
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.
FOR YOUR CALENDAR
14th Euro-Global Gastroenterology Conference (Gastro Congress 2019) July 8-9
Paris NASH Meeting July 11-12
7th International Conference on Hepatology (Hepatology 2019) July 15-16
16th World Congress on Gastroenterology & Therapeutics (World Gastroenterology 2019) July 15-16
International Aids Society 2019 Conference July 21-24
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
American Public Health Association November 2-6
American Association for the Study of Liver Disease, The Liver Meeting November 8-12
New NASH Policy Report Launched on International NASH Day by Health Policy Partnership
On International NASH Day 2019, a new policy report on non-alcoholic steatohepatitis (NASH) was launched by The Health Policy Partnership (HPP) in collaboration with a steering committee consisting of Ms. Donna R. Cryer, President & CEO of Global Liver Institute, Professor Quentin M. Anstee, Dr. Farhana Bin Lootah, Dr. Hannes Hagström, Dr. Jeffrey V. Lazarus, Professor Michael P. Manns, Professor Manuel Romero-Gómez, Professor Lawrence Serfaty and Professor Zobair M. Younossi.
The report aims to prompt a measured policy response to the anticipated rise of NASH in years to come. Focused on Europe and the Middle East, it offers up-to-date estimates of the epidemiology and impact of NASH, and highlights key strategic issues to improve clinical management and health system preparedness from a policy perspective. The report proposes five key recommendations for action for policymakers. The report was initiated and funded by Gilead Sciences Europe. Gilead had no input into the report content. Follow @HealthPolicyPtp for more information.
Check in on Tartu Call for a Healthy Lifestyle
Over the last two years the Tartu Call for a Healthy Lifestyle, an initiative launched by Commissioners Tibor Navracsics, Vytenis Andriukaitis and Phil Hogan, has marked significant progress in promoting a healthy lifestyle in the EU. Highlights from the initiative:
More budget has been allocated to promoting healthy lifestyles at EU level.
Targeted awareness raising campaigns and activities to promote healthy diets and physical activity have been organised.
The European Commission supported the EU Member States and civil society by collecting, compiling sharing useful evidence and implementing relevant best practices.
The European Parliament and the Council have actively cooperated with the European Commission to promote healthy lifestyles.
Internal cooperation has been further strengthened among European Commission services.
Considering that this is only a first step and that further work needs to be done to address this important societal challenge, Commissioners Navracsics, Andriukaitis and Hogan call on civil society and the EU Member States to:
Make the best use of available EU funding to carry out relevant initiatives, in particular addressing inequalities.
Use sports as a powerful tool to promote healthy lifestyles, using the potential of sport clubs, non-organised sport, as well as existing key instruments such as the European Week of Sport.
Take ambitious actions to promote and establish healthy diets among EU citizens to reduce obesity and non-communicable diseases. Raise awareness, notably among youth, of the importance of healthy diets and make the best use of the EU school fruit, vegetables and milk scheme.
Enhance cooperation across relevant sectors including health, sports, education and agri-food, but also research, transport, marketing and urban planning.
Promote physical activity and healthy diets at the workplace, to have a positive impact on overall employee behaviour.
U.S. Federal Budget
On June 19th , the House of Representatives passed 226-203 the first FY 2020 “minibus” four-bill spending package, including funds for Labor-HHS including a $2 billion increase for NIH. The House-approved spending bill continues the sustained funding momentum of the last four years by supporting the base budgets of all NIH institutes and centers while also continuing funding for specific initiatives, such as programs established in the 21st Century Cures Act. As of the writing of this update there is still no timeline for Senate appropriators to mark up their FY 2020 Labor-HHS bill.
GLI applauds the House of Representatives for continuing the commitment to medical research supported by the NIH.
The $2 billion increase included in this bill enables the sustainable, predictable growth above inflation necessary to realize the invaluable promise of new cures, diagnostics, and treatments offered through NIH.
We also continue to be mindful that completing the appropriations process will require lawmakers and the White House to finalize a deal to raise the budget caps imposed by the Budget Control Act of 2011.
GLI will continue to push to protect the funding of federal agencies that protect patient lives, and promote the development of valuable new therapies for all Americans, especially those impacted by liver health complications.
Congress, White House Continue Budget Negotiations
Senate Republicans on June 12th met with members of the Trump administration to continue discussions on budget caps for FY 2020 and the debt ceiling. Senate Appropriations Committee Chair Richard Shelby (R-Ala.) noted that Congress will continue to push for a two-year budget caps deal, though is unsure of the administration’s preference for a one- or two-year deal. On June 19th Speaker Nancy Pelosi, Senate Majority Leader Mitch McConnell and other top lawmakers huddled with White House budget negotiators. They need a bipartisan deal to sort out raising the debt limit and overall spending levels. Already, they are behind last year's schedule, and that ended in a 35-day shutdown.
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.
The administration's final rule to eliminate rebates from Medicare Part D and Medicaid drug programs moved to the White House's Office of Management and Budget for review the morning of June 11th, the final step before the rule is published. CMS said earlier this year that the rule would not be finalized before the June 3 deadline for plans to submit their Medicare Part D bids for 2020. The agency could still implement the new system in 2020 through an optional demo program it described to Part D plans in an April memo.
As a reminder, on January 31st HHS proposed a rule that would upend the rebate system. It would ban rebates tied to a percentage of list price that drug makers pay to Medicare Part D plans, Medicaid managed care, and pharmacy benefit managers by taking away the long-standing exemption for rebates in anti-kickback law. Critics of the proposed rule point out that it would raise premiums and likely increase government spending. However, the proposed rule repeatedly states that its effects are uncertain and depend on the behavior of drug makers, insurers and pharmacy benefit managers.
GLI focuses on access and affordability of medications for patients while recognizing that a sustainable solution (not just a slogan) also ensures that innovation in drug development must be incentivized.
However, GLI is actively concerned with any changes that can potentially raise costs for patients.
A May CBO analysis estimated that government spending would rise $177 billion, primarily in Medicare. CBO also predicted that list prices would not actually drop under the rule and that the upfront discounts negotiated between drugmakers and pharmacy benefit managers would be about 15 percent smaller than current rebates on the same drugs
New Study Shows Declining Obesity Rate Among WIC Children
A new report found that the obesity rate declined among children ages 2 to 4 enrolled in the special U.S. federal nutrition program known as WIC. In 2016, nearly 14 percent of children participating in the Supplemental Nutrition Program for Women, Infants, and Children were obese. That was down 2 percentage points from nearly 16 percent in 2010, according to data published today in JAMA. Before 2010, the prevalence of obesity had been on the rise. According to the authors the reasons for the decline are unclear. However, the report said, one possible reason could be guidance on preventing obesity that the Centers for Disease Control and Prevention sent to communities, childcare centers, schools and health care providers.
Many States Target Pharmacy Benefit Managers
Pharmacy benefit managers (PBMs) have recently been under fire by many state lawmakers. Specifically, Ohio, Louisiana and Oklahoma, have all passed laws and regulations attempting to regulate the “middlemen” who negotiate prices and rebates with drug companies on behalf of health plans. Most recently, New York and Maine announced a new level of regulation for PBMs.
Recently the Maine Legislature passed a bill that prohibits PBMs from retaining rebates from manufacturers. If signed by Gov. Janet Mills, it would require that any rebates be passed directly to consumers. Earlier in June, Gov. Mills signed a bill curbing the use of step therapy, which some PBMs and health insurers use to control costs.
The New York Assembly unanimously passed and sent to Gov. Andrew Cuomo legislation that requires PBMs to work "for the best interests primarily of the covered individual." Similar arrangements in the past have been struck down in court, but lawmakers believe the New York bill can withstand legal scrutiny because it avoids the specific term "fiduciary relationship" to describe PBMs' responsibilities to patients. The bill also is unique in granting individuals and pharmacists the right to sue if they feel harmed by a PBM's decision, and requires PBMs to disclose revenues and business practices to the state insurance superintendent and health plans with which they contract.
Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.
NAMES TO KNOW
Commissioner Vytenis Andriukaitis is Lithuania's European Commissioner, a heart surgeon, and a co-signatory to the 1990 Act of the Re-Establishment of the State of Lithuania. Commissioner Adriukaitis is now the European Commission’s Commissioner for Health and Food Safety, and one of the leader’s of the Tartu Call for a Healthy Lifestyle.
TERMS TO KNOW
The Institute for Clinical and Economic Review (ICER) is an independent research organization that evaluates the clinical and economic value of prescription drugs, medical tests, and other health care and health care delivery innovations.