President’s Proposed Budget Would Hurt Patients and Set Medical Research Back Years
POLICY PERSPECTIVE
This past month the Administration released their 2020 Fiscal Year Budget Proposal. As a patient advocate, I could not be more disappointed with the proposal. Government funding plays a pivotal role in a wide range of sectors within our healthcare system from coverage to access, but also especially through supporting new therapy research and development.
Specifically, the President’s budget request would critically hurt the National Institutes of Health (NIH). 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 to go. The President’s proposal to cut funding for the NIH by more than 12% would undermine this recent progress on research to find treatments and cures for patients nationwide.
When we zoom in on liver health specifically these cuts become even more damaging. Liver Disease funding currently in total accounts for only 2% of NIH’s budget. Considering NASH alone, which affects 12% of adults in the U.S., it only accounts for 0.42% of the National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) total budget. NIDDK is a unit within NIH that houses a majority of liver health research. With the prevalence of NASH expected to increase by 63% by 2030 in the United States, we cannot move backwards with our funding for improving diagnostic tools and developing treatment options.
Thankfully, lawmakers in Congress on both sides of the aisle agree with our sentiment, and have rallied together to appropriately boost funding for NIH over recent years. At a recent hearing Members of Congress from both parties highlighted how hurtful proposed budget cuts would be to the progress we have made.
GLI recently signed onto a letter with 300 other like-minded organizations and institutions to support an increase in the NIH budget for FY 2020. We will continue to push to protect the funding of NIH, and other federal agencies that protect patient lives, and promote the development of valuable new therapies for all Americans, especially those impacted by liver health complications.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
OPEN ADVOCACY OPPORTUNITIES
AASLD/FDA DILI Conference (May 7-8, 2019)
Registration is open for the AASLD and FDA sponsored drug-induced liver injury (DILI) conference in Hyattsville, MD. All new drugs are evaluated for their effects on the liver.
This event will investigate current methods to assess and evaluate DILI risk in evolving therapies.
Register - early registration discounts end April 10.
“Request to Connect” - A New Way for Patients to Connect with FDA
The FDA Patient Affairs Staff would like to share an exciting announcement - the FDA “Request to Connect” portal is now live: www.fda.gov/RequestToConnect
This new patient portal gives patients and caregivers a single entry point to the Agency for questions and meeting requests.
Co-developed by the Patient Affairs Staff and the medical product centers, the portal will route inquiries to the appropriate medical product center or office to ensure that they are received and responded to in an effective and efficient manner. As patient populations and their needs evolve and become increasingly complex, Patient Affairs wants patients and those who advocate on their behalf to know their door is open. As a science-based agency, they continue to develop and engage programs that help FDA understand the patient perspective and advance the science of patient input.
NCI CCR Liver Cancer Program: Special Conference on Tumor Metabolism
Registration is Open and Call for Abstracts!
Dates: Monday, October 28 2019, 8:00 am - 5:30 pm and Tuesday, October, 29 2019, 8:30 am - 12:00 pm
Location: NIH (Building 10, Masur Auditorium), Bethesda, MD
From National Cancer Institute (NCI):
This meeting will bring together experts in the multidisciplinary field of liver cancer to update research progress and future directions, with a focus on tumor metabolism. The meeting will also foster collaboration and team science among various disciplines of liver cancer research including epidemiology and translational science.
This meeting includes outstanding speakers in the fields of liver cancer and metabolism and we are happy to announce that our keynote speaker will be Dr. Craig Thompson, a pioneer in studies of cancer cell metabolism.
Note: Registration is FREE! Abstract submission is now open and will close on June 25, 2019. Judging will be complete by July 31, 2019. Abstracts will be considered for poster presentations and the best judged abstracts will be selected for oral presentations and travel awards.
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 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.
GLI Attends CMS/CDC Joint ICD-10 Committee Meeting
This past month GLI’s proposed ICD-10 coding change was presented at CMS. As a reminder, GLI and the NASH Council submitted a letter to the Centers for Disease Control and Prevention. Within the letter we expressed concern with the current ICD-10-CM coding, specifically, that the current ICD-10-CM coding structure exists solely for hepatic fibrosis and cirrhosis, but does not distinguish patients with different stages of fibrosis.
Our presentation stressed that revisions to the coding are necessary to enable liver fibrosis to be classified more accurately and more consistently with current clinical perspectives and documentation, particularly in the context of nonalcoholic steatohepatitis (NASH).
May 10, 2019 is the deadline for receipt of public comments on proposed new diagnoses codes and revisions discussed at the March 5-6, 2019 ICD-10 Coordination and Maintenance Committee meetings for implementation on October 1, 2020. If you are interested in submitting comments please submit directly to Donna Pickett, Co-Chair, ICD-10-CM Coordination and Maintenance Committee, at nchsicd10CM@cdc.gov.
GLI Submits and Signs Onto Letters to Protect Liver Health Patients
Letter to Centers for Medicare and Medicaid Services (CMS)
Along with other like-minded patient organizations, GLI created and submitted a letter sent to CMS with the goal of drawing attention to the nation’s massive transplant waiting list and low organ recovery numbers. There are currently 115,000 people on the waiting list for organ transplants in the United States, and hundreds of thousands more who are likely to need transplants in the near future. A positive initial step to remedy this issue is for CMS to substitute the metrics by which Organ Procurement Organizations are evaluated for a new verifiable metric that is not open to self-reported interpretation. By making this change we expect an increase in the number of organs recovered and a decrease in the number of patients waitlisted.
This letter was also featured in a recent article by the Hill, “Organ transplant system desperately needs improvement.”
Letter to Support Living Donor Protection Act - H.R. 1224/S.511
GLI joined numerous groups that advocate on behalf of organ transplantation, including the American Association of Kidney Patients, American Society of Transplant Surgeons, the American Society of Transplantation, the National Kidney Foundation, the American Society of Nephrology, and the Renal Physicians Association, in signing a letter to Support Living Donor Protection Act.
The Living Donor Protection Act would protect living organ donors and promote organ donation in three ways:
Prohibits life, disability, and long term care insurance companies from denying or limiting coverage and from charging higher premiums for living organ donors
Amends the Family and Medical Leave Act of 1993 to specifically include living organ donation as a serious health condition for private and civil service employees
Directs HHS to update their materials on live organ donation to reflect these new protections and encourage more individuals to consider donating an organs
GLI, in partnership with the Ad Hoc Group for Medical Research, a coalition of more than 300 organizations and institutions across the NIH stakeholder community, recommended an appropriation of at least $41.6 billion for the NIH in FY 2020, a $2.5 billion increase over the NIH’s program level funding in FY 2019. This funding level would allow for meaningful growth above inflation in the base budget that would expand NIH’s capacity to support promising science in all disciplines. It also would ensure that funding from the Innovation Account established in the 21st Century Cures Act would supplement the agency’s base budget, as intended, through dedicated funding for specific programs. See the full statement and list of endorsers here.
FOR YOUR CALENDAR
April 3-6: American Pain Society (APS)
April 4-5: Community Oncology Alliance Annual Meeting
April 10-14: International Liver Conference (EASL)
April 11-13: American Conference for the Treatment of HIV
April 11-13: American College of Physicians (ACP) - Internal Medicine Meeting
April 24-26: National Association of ACOs Conference
April 24-28: American Association of Clinical Endocrinologists (AACE)
April 28-May 1: World Health Care Congress
FEDERAL NEWS
The Administration
Trump Releases new White House Budget
On March 11th, the President released his Fiscal Year 2020 budget request and HHS Budget in Brief (BIB) document.
Some of the topline priorities are as follows:
Cut back on spending by $2.7 trillion (This is the largest cut by any administration in American history). See impact on liver health below.
Strengthen border security (This includes $8.6B in funding for a border wall).
Invest in national defense
Address the opioid crisis
Healthcare for veterans
Modernize government technology
How does this impact Liver Health?
President Donald Trump's budget request envisions slashing HHS funding by 12 percent in 2020 to $87.1 billion.
It also calls for $1.25 trillion in mandatory savings from various health programs, including cutting hundreds of billions of dollars from Medicare.
The White House also highlights a series of initiatives aimed at lowering drug prices that it says will cut about $19 billion alone in Medicare spending through 2029.
If Congress agrees to the legislation, the changes to Medicare, Medicaid, the FDA and the 340B federal drug discount program could save the government more than $69 billion on drug costs over a decade.
The budget also proposes requiring that states allocate at least 10 percent of their budgets to protecting people with preexisting conditions.
The budget looks to focus funding on a few public health initiatives, specifically centered around ending HIV transmission in the United States over the next decade.
The proposal also cuts NIH's budget by $4.5 billion in 2020, and CDC’s budget by $1.27 billion.
The National Cancer Institute's budget would be slashed by $897 million.
The National Institute of Allergies and Infectious Diseases, which houses most of the agency's HIV research, would be cut by $769 million.
Institutes focused on aging, heart, lung and blood research, and general medicine would all see cuts of $400 million or more.
The proposal also includes a mandatory $150 million boost to Type 1 diabetes research at NIH.
How does this impact you?
The President’s budget request for the National Institutes of Health (NIH) would decimate the nation’s longstanding commitment to improving and saving lives through federal support for medical research.
The President’s proposal to cut funding for the NIH by nearly $5 billion, more than 12 percent below current levels, would undermine progress on research to find treatments and cures for patients nationwide while threatening our narrowing competitive edge in an increasingly innovation-based international marketplace.
The United States Congress
Senate Finance Committee Hearing on Drug Pricing
This past month the Senate Finance Committee held a hearing on drug pricing, which emphasized that the drug industry may no longer be able to take congressional Republicans' support for granted
The hearing included testimony from seven company executives on their pricing practices.
Senate Finance Chairman Chuck Grassley indicated he will go slow pursuing pricing legislation, but questions did arise around the abuse of the patent system to protect drugs from competition and more.
Previously Republicans took a more cautious approach, and warned other lawmakers against imposing regulations that could threaten research and innovation.
How this could impact you:
Drug pricing continues to be a top priority of Congress and this Administration.
GLI will actively monitor any potential changes that could impact Liver patients.
House Democrats unveil Medicare for All bill
On February 27th, a group of House Democrats introduced the "Medicare for All" plan.
The plan provides a roadmap for achieving a progressive goal that will loom large in the run-up to the 2020 election.
The bill, co-sponsored by 107 House Democrats, doesn't include a cost estimate or revenue-raisers for financing the new system.
Some suggested options to pay for the plan are a new tax on high earners or mandated employer contributions.
Also the plan pits a progressive base eager to make single-payer health care a defining issue against the more moderate Democratic establishment.
Democratic leaders are wary of advancing the plan, which Republicans have branded a "socialist" nightmare that would force hundreds of millions of people from their private plans into government-run coverage.
How this could impact you:
Going into the 2020 Presidential election “Medicare for All” will remain a top issue.
There is a low chance that any “Medicare for All” legislation will move forward, but GLI will continue to actively monitor any substantial change to our healthcare system that could impact liver patients.
Senate Finance calls 5 PBMs to April 9 drug pricing hearing
Five pharmacy benefit managers have been called and agreed to testify at an April 9 Senate Finance hearing on drug pricing in letters from Chairman Chuck Grassley (R-Iowa) and ranking member Ron Wyden (D-Ore.).
The companies include Cigna, which recently purchased Express Scripts; CVS Caremark and CVS Health Corporation; Humana; OptumRx; and Prime Therapeutics LLC.
This hearing follows the series by Congress, and the testimony from seven drug company executives on February 26th.
How this could impact you:
Congress continues to look for a target to fix the drug pricing situation in the United States.
Last month it was Pharma CEOs and next month it will be time for the PBMs.
GLI is grateful for the attention on access and affordability of medications for patients while always cognizant that a sustainable solution (not just a slogan) also ensures that we incentivize the continued development of new medications. However, the failure to ask the right questions and acknowledge the full array of interrelated issues involved continues to be an issue.
GLI will actively monitor this hearing next month.
New Investigation into Short-term, Limited Duration Insurance Market by Energy and Commerce Committee
The House Energy and Commerce Committee is launching a new investigation into the short-term, limited-duration insurance market that the Trump administration moved to expand last year as part of a broader push to loosen regulations on plans that don't comply with the Affordable Care Act.
The Trump administration approved a rule last year that allowed short-term plans to be used for a year — up from three months under the Obama administration.
House Democrats have introduced a bill to repeal this rule and bring back the previous limit.
The committee is also sending letters to a dozen entities that sell or promote short-term plans, demanding they provide their underwriting documents, marketing materials, health questionnaires that applicants have to fill out, the amount they're paying to brokers and agents, and any complaints they've received from insurance regulators or consumers.
How this could impact you:
GLI will actively monitor any potential changes to the ACA, and our health care system.
House Appropriations Labor-HHS Subpanel Looks Closely at the Administration’s Budget Proposal
This was the first budget hearing of 2019, and both Democrats and Republicans were unified in their disapproval of the suggested cuts to HHS.
Both sides of the aisle highlighted that the Administration’s proposed cuts would greatly weaken the U.S. public health system.
Specifically, the steady growth of NIH received bipartisan support over the years, and the cuts would reverse the positive progress made.
HHS Secretary Azar defended the budget proposal, telling lawmakers that it's a result of spending caps set by Congress that forced his agency to make "difficult choices."
He highlighted areas where funding would increase, including HIV eradication and addressing the opioid epidemic.
How this could impact you:
GLI attended this hearing. As an organization we are against cuts to NIH, CDC, or HHS at large. GLI Policy Director Andrew Scott said, “We cannot move backwards by cutting funding to HHS as we push to get liver health prioritized in the national public health agenda.”
Department of Health and Human Services (HHS)
Drug Companies Express Support for The Administration’s new rebate rule
The administration plans to create a new legal exemption for prescription drug discounts offered directly to patients.
Drug industry executives told the Senate Finance Committee they would likely lower list prices if HHS follows through on a major overhaul of the drug rebate system for federal health programs — and if the change was embraced by private insurers.
Drug companies have expressed many times that the substantial discounts they give payers are not passed through to patients by pharmacy benefit managers and insurers.
How this could impact you:
As previously mentioned, GLI appreciates the continued look at the drug pricing issue, but there is no silver bullet to the problem.
HHS Secretary Outlines Value-based plan for transforming kidney care
HHS Secretary Azar told kidney patients on March 6th that Medicare's innovation center is overseeing efforts to develop new payment models for patients with end-stage renal disease and stage 4 and 5 kidney disease.
Medicare spent an estimated $113 billion to treat people with chronic kidney disease in 2016, accounting for more than 1 in 5 dollars the health program spends annually, he said.
HHS is planning to incentivize at-home dialysis treatment.
The department is also looking at changing the payment structure to incentivize transplantation.
Please click here If you are interested in reading more about Secretary Azar’s comments.
Food and Drug Administration (FDA)
FDA Commissioner Gottleib Resigns
In a move that caught the entire healthcare industry by surprise, FDA Commissioner Scott Gottlieb announced that he will resign in April.
His agenda at FDA focused on a wide range of issues from tobacco to trans-fats.
Though he had tussles with some powerful interests and occasional clashes with other administration officials, he had strong backing from both President Donald Trump and Democrats in Congress, who supported many of his public health initiatives and his interest in bringing down drug prices.
His most high-profile advocacy came in the area of youth smoking, where he aggressively pressed e-cigarette manufacturers and retailers to halt marketing to teens.
Gottlieb also surprised the food industry and public health community by focusing on nutrition policy, something that's usually a lower-profile issue for FDA commissioners.
National Cancer Institute Director Norman “Ned” Sharpless Announced as Acting Commissioner of the FDA
The oncology doctor was appointed to head the institute, part of NIH, in June 2017 and quickly made modernizing research, diversifying clinical trials and improving outreach to underserved populations some of his signature issue areas.
Centers for Disease Control (CDC)
Alaska's former top public health official has been picked to lead the CDC's Office of Infectious Diseases
Jay Butler will take over as deputy director for the office.
Butler most recently served as Alaska's public health commissioner and chief medical officer, coordinating the state's response to the opioid crisis and other public health concerns.
The CDC infectious diseases office crafts policies and prevention strategies and monitors outbreaks across the country. It is a key piece of the Administration's efforts to halt new cases of HIV by 90 percent in the next decade.
How this could impact you:
Infectious disease is a huge factor in the liver health space, and GLI will actively monitor any change that impacts this space.
Centers for Medicare and Medicaid Services (CMS)
CMS announces guidance for Medicaid work requirement waivers
CMS released guidance on how it will review and approve state applications for work requirements in Medicaid programs, including templates for would-be applicants and instructions on how to conduct evaluations.
In an accompanying blog post, CMS Administrator Seema Verma argued that the new guidance for the controversial policy — which is facing multiple court challenges — would help strengthen the Medicaid program.
CMS already has approved Medicaid work requirements in seven states — Arkansas, Arizona, Indiana, Kentucky, New Hampshire, Michigan and Wisconsin. Applications from eight other states are still pending.
The Idaho legislature is mulling proposals to add work requirements and other restrictions to the state’s Medicaid expansion plan that was approved by voters in November and has yet to take effect.
How this could impact you:
GLI will actively monitor any changes to Medicare and Medicaid coverage.
CMS releases data on drug pricing
CMS released updated data this past month that shows that drugs for which there is only one manufacturer are responsible for the biggest spending increases in Medicare and Medicaid even when a range of treatments are available for a particular disease.
The figures raise questions about why there isn't more price competition among branded products, a solution commonly embraced by Republicans and some Democrats in Congress.
More than 120 Medicare Part D drugs had an increase in average unit price of at least $35 dollars between 2016 and 2017 — all but one are made by just one company.
STATESIDE
Expansion of Medicaid
Over the last month, many states continued to debate expanding Medicaid, and this debate is expected to continue over the year.
Fourteen states so far have not opted to expand Medicaid.
Wisconsin
Gov. Tony Evers put Medicaid expansion in his first budget but is expected to meet resistance from statehouse Republicans.
North Carolina
Gov. Roy Cooper called for Medicaid expansion during his State of the State address Monday but gave no hint how he'd convince skeptical Republicans who control the Legislature.
Georgia
The state Senate passed legislation, GA SB106 (19R), which authorizes expanding Medicaid up to the federal poverty line; the bill is now pending final action in the House.
Mississippi
Gov. Phil Bryant said at the governors association meeting that he is opposed to Medicaid expansion while a federal court decision declaring Obamacare unconstitutional is under review.
Kansas
The GOP-controlled House voted to approve a bill that could expand coverage to as many 150,000 people, after 29 GOP members sided with all 41 Democrats.
Idaho
The Idaho House passed legislation, ID H277 (19R), that would limit the Medicaid expansion that voters overwhelmingly approved.
The bill directs the state to request from the Trump administration a series of never-before-approved measures in exchange for expanding coverage to some low-income adults.
The bill also includes a Medicaid work requirement, making coverage for most adults contingent on reporting at least 80 hours of work or community engagement.
Nebraska
The state Department of Health and Human Services signaled that Medicaid expansion, which voters approved in a November initiative, may be paired with other requirements, according to the Lincoln Journal Star.
Virginia
Virginia officials say 233,000 people have newly enrolled in Medicaid since expansion took effect in January.
Other State Medicaid Announcements:
Medicaid Work Requirements
CMS has now approved Medicaid work requirements in eight states, including Ohio, Arkansas, Arizona, Indiana, Kentucky, New Hampshire, Michigan and Wisconsin.
CMS had also approved Maine's request, but the state withdrew the waiver this year under a new Democratic governor. Applications from seven other states are pending.
Also this past month advocates for Medicaid beneficiaries filed a third lawsuit in New Hampshire challenging the Trump administration’s continued approval of Medicaid work requirements.
The federal lawsuit argues that CMS exceeded its authority when it approved an 1115 waiver last year authorizing New Hampshire to require some Medicaid recipients to work 100 hours a month.
The case joins similar lawsuits challenging work-requirement waivers for Arkansas and Kentucky.
More than 18,000 residents have lost their health insurance since the rules took effect last summer.
New Mexico
The state will not charge Medicaid beneficiaries an $8 co-pay that was scheduled to take effect this past month for non-urgent use of hospital emergency rooms and non-preferred prescription drugs.
About 645,000 people would have owed co-pays, one of two ways — the other is premiums.
Texas
Lawmakers from both parties filed about a dozen bills this week addressing managed care in the wake of a 1.5-year Dallas Morning News investigation that exposed how MCOs denied treatment to Medicaid patients.
Hawaii
Hawaii State Medicaid has removed all fibrosis and sobriety restrictions for FFS and Managed Care plans (5 contracted plans statewide).
Currently, the Hawaii Department of Health is working with their local provider champions to ensure that this is implemented in all five managed care plans.
California
Universal Healthcare
21 bills were introduced this past month that are all part of California’s universal health care agenda for 2019.
Specifically, three of the 21 bills that were introduced are designed to focus on income eligibility and helping low-income seniors who rely on Medi-Cal to cover health care costs.
States are interested in following California’s Nursing to Patient ratio example
State lawmakers in Illinois, Michigan and New York are pushing to become the first states since California 20 years ago to set limits on the number of patients that hospital nurses can treat at a time.
Nurses in states with strong unions are rallying around the so-called staffing ratios, citing poor working conditions and safety concerns arising from nursing staff stretched too thin.
Powerful hospital groups, who've long opposed such measures, contend they would make it more challenging to rein in health care costs while failing to significantly improve patient safety. In a setback for nurses, a November ballot measure that would have imposed staffing ratios in Massachusetts was overwhelmingly rejected.
GRANT OPPORTUNITIES
Mechanisms of Disparities in Chronic Liver Diseases and Cancer (R21). Funding available from NIH. Application deadlines: April 5th, 2019.
Epidemiologic Research on Emerging Risk Factors and Liver Cancer Susceptibility. Funding available from NIH Application Deadlines: May 7th, 2021.
NAMES TO KNOW
Dr. Norman “Ned” Sharpless - Dr. Sharpless is moving from the National Cancer Institute to the Food and Drug Administration as the acting commissioner.
TERMS TO KNOW
ICD-10-CM Coding - The ICD-10-CM (International Classification of Diseases, Tenth Revision, Clinical Modification) is a system used by physicians and other healthcare providers to classify and code all diagnoses, symptoms and procedures recorded in conjunction with hospital care in the United States.