FDA Advance Notice of Proposed Rulemaking Triggers ONS Response to Reduce Nicotine, Ban Flavors, and Regulate Premium Cigars
In response to the U.S. Food and Drug Administration’s (FDA’s) Advanced Notice of Proposed Rulemaking (ANPRM) on setting a tobacco standard for nicotine levels in combusted cigarettes, ONS submitted comments urging the agency to lower nicotine levels in combusted cigarettes and all tobacco products. Specifically, ONS recommended lowering the level of nicotine to a maximum of 0.4 mg or lower and that the ratio of tar to nicotine stay around 1 to reduce addiction. ONS pointed out that even lower levels of nicotine are harmful to health. ONS also cautioned the agency about the harm of additives in tobacco, including sugar, that counteract reduced nicotine levels.
HHS Drug Reform RFI Aims to Help Patients Better Afford Cancer Drugs
ONS shared the perspective of nurses caring for patients who may struggle to afford cancer drugs in comments submitted to the Department of Health and Human Services (HHS) on its Prescription Drug Reform Request for Information.
HHS Releases Blueprint for Affordable Prescription Drugs
Health care is arguably the top domestic policy issue and of major concern to most Americans. Coverage, access, and, most importantly, affordability are not abstract political concepts discussed in elite coffeehouse circles but rather are real-world problems that people struggle with daily. Do I need to see a physician for this problem? What impact will a diagnosis have on my life? Can I afford the medication?
Trump Officials Again Slash Funding for Obamacare Outreach Groups; Pfizer Postpones Price Hikes After Trump Criticism; Medicare for All Is New Democratic Mantra in Congressional Races
Previously, reports had emerged that the Trump administration was considering cuts to funding for Affordable Care Act (ACA) outreach groups whose aim has been to educate and assist Americans interested in enrolling in the healthcare program. On July 10, 2018, the administration officially announced funding cuts to the outreach programs, reducing their funding from $36 million to $10 million for 2019.
Trump Officials Considering Cuts to Obamacare Outreach Groups; Those Who Don't Qualify for Government Aid Aren't Buying Obamacare Plans; Judge Blocks Kentucky Medicaid Work Requirement Hours Before Implementation
An initial proposal from the Trump administration might cut funds for outreach related to the Affordable Care Act (ACA). As of yet no decisions are finalized and funding may still remain consistent, but limiting funding for outreach of the ACA, known to most as Obamacare, isn't a new move for the current administration. In 2017, it cut funding for navigators who educated and enrolled Americans in the ACA marketplace, leading to confusion among potential applicants and lower enrollment numbers. If funding is cut again this year, new or returning enrollees are unlikely to find success when looking for coverage.
House Overwhelmingly Passes Final Opioid Package; Texas v. the United States Could Impact Patients With Preexisting Conditions; Lawmakers Who Forged ACA Look Back
Through tremendous bipartisan support, the House of Representatives passed comprehensive opioid legislation to address the national abuse epidemic in the United States on June 22, 2018. For many healthcare advocates, an opioid legislation package has been a long time coming. The opioid crisis has been in the news since before the 2016 presidential election but was brought to the forefront during that campaign.
Two ONS Priority Health Bills Make Progress Out of House Energy and Commerce Subcommittee on Health
On June 27, the House Energy and Commerce Subcommittee on Health passed by voice vote two health bills that have been among ONS’s top legislative priorities: the Palliative Care and Hospice Education and Training Act ([PCHETA], H.R. 1676) and the Title VIII Nursing Workforce Reauthorization Act (H.R. 959). The bills are now poised for consideration by the full House Energy and Commerce Committee.
In Reversal, Trump Orders Halt to His Family Separation Rule; New York Moves Toward Legal Marijuana With Health Dept. Endorsement; Cigarettes Have to Be Labeled 'Deadly' Now. Here's Why
Recently, immigration policies have come front and center in the news. The issue of separating children from their parents at the border was elevated to a public health issue, as the American Academy of Pediatrics—among other healthcare organizations—decried the Trump administration’s policies, noting the potential for irreparable harm to children. ONS was one of the many provider groups that sent formal letters to the Department of Homeland Security, encouraging change to immigration policies that separate children from their parents.
HHS Pain Task Force Examines Opioid Epidemic Impact on Patients, Providers
The Department of Health and Human Services (HHS) Pain Management Best Practices Inter-Agency Task Force held its first public meeting from May 30–31, 2018, in Washington, DC. Convened as part of 2016’s Comprehensive Addiction and Recovery Act, the task force has been charged to address the nation’s continued opioid abuse crisis. During the two-day meeting, the 28-member task force deliberated on the goals of an upcoming study, set to be released July 2019, that aims to update best practices and clinical guidelines, while also addressing gaps and inconsistencies in chronic and acute pain management.
Health Policy Advances Cancer Treatment Options in the Era of Biosimilars
Options and cost are a double-edged sword as biomedical research marches forward and the list of approved drugs expands. More targeted drugs for specific diseases means that more patients have treatment plans that can directly fight their specific disease, possibly resulting in cures.
National Capital Chapter Members Focus on Advocacy and Research Funding in DC
In our nation’s capital, healthcare policy meetings occur weekly for various government and private organizations whose aim is to improve care and conditions for patients with cancer. The ONS National Capital Chapter members are involved in lobbying on the Hill and attending meetings about improving cancer care through the ONS Capitol Hill Gang.
House and Senate Pass the Childhood Cancer STAR Act
On May 22, the U.S. House of Representatives passed S.B. 292, the Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act. The legislation will improve efforts to identify and track childhood cancer incidence, improve quality of life for childhood cancer survivors, ensure pediatric expertise at the National Institutes of Health by requiring the National Cancer Advisory Board to have at least one pediatric oncology expert on its board, and identify opportunities to increase childhood cancer research to better treat the 10,270 children diagnosed with cancer in the United States every year.
Federal Officials Say No to Lifetime Limits on Medicaid; Empowered Patients Are the Future of Health Care; Healthcare Jobs Continue to Grow Faster Than Jobs in the General Economy
On May 7, 2018, the White House told the Department of Health and Human Services to overturn Kansas’s new lifetime limit restrictions on Medicaid. Kansas has been leading the way for states looking to implement restrictions to federal benefits. The state previously implemented work requirements for Medicaid recipients and was trying to impose time limits for how long recipients could receive Medicaid for some time. Had its efforts stood, this would mark a fundamental shift in how the federal program is implemented at the state level.
ONS Greater Baltimore Chapter Advocates at the State Level
In today’s increasingly fractured political environment, with heightened partisanship, Washington, DC, has become toxic. New ideas and common-sense solutions are rare and promoting issues without politicization is literally a full-time job. Interest groups are now finding policy opportunities for success in the state capitals. Some advocacy initiatives have found easier, and faster, wins for their organizational efforts at the state legislature level.
NIH Wants 1 Million Americans to Contribute to New Pool of Gene Data; FDA Takes Action Against Misleading Companies Marketing to Kids; Conservative Groups Hope to Release New Obamacare Replacement This Month
With hopes for more than 1 million participants, the National Institutes of Health (NIH) has launched the All of Us initiative, a radical precision medicine campaign to amass a collective gene pool data repository. The NIH is aiming to shrink our differences and expand on the similarities found in our genetic data. For some, compiling genetic data of an entire country’s citizens may sound very reminiscent of Big Brother from the book 1984. But the amount of information that could be shared and learned from such a massive health database is remarkable.
Insurer Group Warns Against Short-Term Health Plan Proposal; Medicaid Won’t Look the Same in 2019; Rapid Autopsy Programs Seek Clues to Cancer Within Hours of Death
Earlier in 2018, the Trump administration proposed a new rule that would permit Americans to buy short-term health insurance for up to 12 months, breaking from an Obama-era regulation that limited short-term health plans to a maximum of three months. To some, the proposed extension would potentially extend coverage to Americans interested in insuring themselves and their families. However, the America’s Health Insurance Plans group is on the other side of the argument, insisting that temporary plans—for any length of time—are no substitute to real coverage. Short-term plans are not covered by Affordable Care Act regulations, and it could lead to patients with pre-existing conditions being charged more for temporary insurance.
Jill Biden Works With ONS Members and Others to Understand the Caregiver Experience
In coffee shops around the country, between clicking cups and grinding coffee beans, former second lady of the United States, Jill Biden, EdD, is quietly gathering small groups of oncology nurses, care coordinators, social workers, and family members who support patients with cancer to discuss the obstacles facing caregivers throughout the cancer journey. As part of the Biden Cancer Initiative’s (BCI’s) continued work to improve oncology care, this coterie of caregivers is heralding the trials and triumphs that come with addressing the physical, social, emotional, and spiritual needs of patients with cancer.
GOP Steers Away From Obamacare Repeal, Replace; Is Cigarette Prohibition on the Horizon?; Barbara Bush’s End-of-Life Decision Makes Waves
After a flurry of proposed legislation to repeal and replace Obamacare—the unofficial name for the Affordable Care Act (ACA)— the GOP has shifted its focus to other policy issues. In fact, many Republican senators and congressional representatives have removed any mention of the healthcare law from their websites. With the 2018 midterm elections approaching, GOP lawmakers are seemingly breaking with the Trump administration’s stance on the healthcare law, recognizing that their constituents may be in favor of the ACA’s many protections.
ONS Gathers Healthcare Experts, Government Agencies for Policy Summit
Nurse practitioners (NPs) are key to improving the quality of care for their patients with cancer through advocacy—both in institutions across the country and in legislative offices on Capitol Hill. With the intent to remove barriers so NPs can help move the needle for healthcare policy, ONS’s Center for Advocacy and Health Policy held the summit, “Policy Barriers and Opportunities to NPs in Oncology,” on April 10, 2018, in Washington, DC.
Medicare Is Greater Than the Sum of Its Parts
At the center of the President Lyndon B. Johnson’s great society was Medicare, a federal program designed as a partial safety net primarily for America’s older adults. It was signed into law on July 30, 1965. Controversial at the time, it is now sacrosanct and often referred to as the “third rail of politics”: touch it and die.
NIH Completes In-Depth Genomic Analysis; Senate Panel Unveils Draft Opioid Bill; Teenagers Struggle to Quit Vaping
Researchers for the PanCancer Atlas, a genomic data set reference tool, recently completed an analysis of molecular and clinical information from more than 10,000 different tumors spanning more than 33 cancer types. The PanCancer Atlas is the result of nearly a decade’s worth of work associated with the Cancer Genome Atlas—a multi-institutional program driven by the National Human Genome Research Institute and the National Cancer Institute (NCI). The results of the analysis were published as a set of 27 papers.
ONS Member Advocates for Patient Involvement in Clinical Pathways
I was selected to represent ONS as a panelist at the Cancer Innovation Coalition meeting held in Washington, DC in February 2018. The meeting, “Integrating Patient Perspective into Clinical Pathways: A Dialogue Between Stakeholders,” brought together patient advocates, healthcare professionals, and technology stakeholders to address and identify the importance of patient-centered care and involving patients in clinical pathways. The National Patient Advocate Foundation released an article outlining the topics covered in our discussion.
CDC Has New Director Designee
Presidential appointees come, and presidential appointees go. Recently, the Center for Disease Control and Prevention’s (CDC’s) director resigned for financial conflicts of interest. The new Department of Health and Human Services (HHS) secretary, Alex Azar, sought to fill the important public health role as soon as possible. With opioids, the flu, vaccine shortages, and cancer prevention under the purview of the CDC, finding a new director was crucial to continuing the agency’s work. Since many of the CDC’s top officials are often reported on in the news, replacing the director was also essential for public trust in public health.
President’s Cancer Panel Reports on Drug Costs and Value
Although it’s one of the less visible commissions, the President’s Cancer Panel monitors the activities of the National Cancer Program and reports on the burden of cancer. The panel reviews a number of topics and keeps current with demographic information and the latest cancer incidence research. After reviewing and recommending based on existing data, the panel releases a formal report to the president. In its most recent report, the panel found serious issues with barriers to access for cancer survivors, and it addressed the costs of drugs and the value therein.
Medicare Cracks Down on Opioid Prescriptions, Abuse; Health Care Tops Poll of American Worries; Leading Chemotherapy Researcher, Physician Dies at 92
An estimated 14.4 million Medicare recipients were prescribed some form of opioid treatment in 2016, paid for by their Medicare benefits. In an attempt to help curb the national opioid epidemic, officials from the Center for Medicare and Medicaid Services (CMS) announced that Medicare would no longer pay for long-term, high-dose prescription pain medication. Unsurprisingly, the plan received flak from patient and provider advocacy groups alike. Opponents to the CMS announcement decried the efforts, citing barriers to crucial medications needed for patients in chronic or severe pain—including those with cancer.
NIA Promotes Smoking Cessation
In a new message, the National Institutes of Health’s National Institute on Aging (NIA) division introduced a public health campaign concentrating on smoking cessation for senior citizens. The program elaborates on a central theme that says, “No matter your age, quitting smoking improves your health.” The agency lists the benefits of cessation, including the critical health impact that diseases have on those who continue to use tobacco.
Key Funding Increases for Cancer Research, Nursing, Public Health; Patients, Providers, or Politicians: Whose Choices Matter Most?; FDA Targets Flavored Tobacco Products
Racing against the clock to ensure the government stayed funded through September 2018, President Trump signed the Consolidation Appropriations Act, a $1.3 trillion spending bill that includes funding for a number of key nursing and public health initiatives. The bill, which had made its way through the House of Representatives and the Senate last week, also contains new clarifying language for the Dickey Amendment, ending a 22-year ban on government-funded gun violence research. ONS joined the Nursing Community Coalition—led in part by the efforts of the American Nurses Association—to support evidence-based inquiry into gun violence and its potential impacts on public health.
Right-to-Try Bill Fails to Pass House; Bipartisan Bill Introduced to Help Patients Navigate Cancer Care; President’s Cancer Panel Urges Action to Lower Drug Costs
Legislation ushering experimental drugs and treatments to patients without U.S. Food and Drug Administration (FDA) approval hit a snag on March 13, 2018, after it failed to garner enough votes in the House of Representatives. The right-to-try bill, a priority for the Trump administration, didn’t accrue the two-thirds majority vote needed to pass it along to the Senate. Lawmakers opposed to the bill had lingering questions about the safety concerns connected to bypassing FDA regulations for patients searching for new treatments. Patient advocacy groups have been speaking out against tenets of the bill, expressing concern for removing the FDA from the process.
National Agencies Recognize Oncology Nursing’s Role in Coordinated Patient Care
We live in the greatest age of scientific discovery and medical breakthroughs. Advances in the innovation and understanding of diseases are providing more insight into how we treat, and often cure, people with life-threatening illnesses. What was once deemed a death sentence diagnosis is now described as a chronic disorder, that can be handled with the help of the patient and a team of healthcare providers.
NIH Funds Precision Research for Childhood Cancer; Will Congress Lift Medicaid Ban for Opioid Epidemic?; FDA-Approved Breast Cancer Test May Impact Oncology Nurses
Cancer treatments aren’t one-size-fits-all, and they differ greatly depending on age. As the leading cause of disease-related death for children, pediatric cancers pose a critical threat to this population. According to the National Institutes of Health (NIH), one reason pediatric cancer mortality rates persist is because there’s “limited knowledge” related to the biological mechanisms affecting childhood cancers. NIH-funded studies are breaking ground and uncovering new information about the genomics of pediatric cancers.
FDA Approves First Metastasis-Free Endpoint Treatment for Prostate Cancer
Breakthroughs and new treatments are moving faster than ever. Getting treatments approved by the U.S. Food and Drug Administration (FDA) is crucial whenever new options are making way to patients with cancer. In February 2018, the FDA approved apalutamide for the treatment of nonmetastatic prostate cancer that continues to grow despite treatment with hormone therapy, the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer.
Cancer Prevention Is Political Pillow Talk
On February 14, 2018, Valentine’s Day, I had the honor of representing the ONS at the Congressional Families Caucus with Alec Stone, ONS director for public affairs, who made the connection between Congressional Families and ONS. The Congressional Families Caucus is made up of spouses of congressional members serving in the House of Representatives and Senate.
New HHS Secretary Azar Aims to Tackle Drug Prices, Affordable Care
On January 24, 2018, the Senate officially confirmed the nomination of Alex Azar, the newest secretary of the Department of Health and Human Services (HHS). Azar replaces former HHS secretary Tom Price, a physician who stepped down in late 2017. Although confirmed along party lines, Azar’s long governmental experience had plenty of support despite his past connections to the pharmaceutical industry.
Bipartisan Bill Unveiled to Fight Opioid Epidemic; FDA Renews Commitment to Curb Tobacco Use; Walker Embraces Obamacare for Wisconsin Residents
In 2016, former President Obama signed the Comprehensive Addiction and Recover Act (CARA) into law. Since then, some aspects of drug addiction have been decriminalized and refocused as medical issues, helping to remove some of the stigma associated with addiction. Although CARA is a start when tackling addiction issues, several senators—both Republican and Democrat—want to take it a step farther in the national fight against opioid abuse.
President’s Budget Proposal Recommends Severe Cuts to HHS
Putting together the federal budget is an arduous task. Department by department, suggestions for program funding increases and decreases are reviewed, discussed, analyzed, and submitted. Budget officials are trying to match the administration’s priorities and review the fiscal environment, not to mention craft spending items to gain support from congress, who ultimately votes on the budget.
2018 U.S. Budget Agreement Contains Key Wins for ONS—Plus an Area of Concern
The U.S. Congress continued its budget pattern in February, enacting another extension of the 2017 budget agreement into law on February 8, 2018. The current iteration of the budget law will raise caps on defense and non-defense spending over two years and keep the federal government running through March 23, but more importantly, it includes the following provisions of special interest to ONS.
States Have a Role in Creating Public Health Policies
The federal government structure in Washington, DC, is hard to ignore. U.S. children are taught about it in schools, and we hear about it regularly as elections, legislation, appointments, and the like are discussed in the news. Less recognized, though, is that each state has a similar legislative structure.
Trump Signs RAISE Act, Pledging Support Services to Family Caregivers
Family members are often the first people to step into the caregiver role when a loved one gets sick. However, studies show that caregivers face unintended burdens and potential consequence as a result of the support and care they give to loved ones.
First Session of the 115th U.S. Congress Will See Three Oncology-Related Acts
Thousands of pieces of legislation are introduced in each Congress, but only a small percentage make it through the entire process, especially in that first year. Bills that are not voted into law and signed by the president during that two-year period “die” when the second session is completed and Congress adjourns. According to congressional rules, “A bill may be introduced at any point during a two-year Congress. It will remain eligible for consideration throughout the duration of that Congress until the Congress ends or adjourns sine die.”
APNs Have a Role in Leading Value-Based Care
Recent care delivery models have focused on providing value-based care to patients. The changes provide opportunity for APNs to take a leadership role in implementing models and systems to effectively deliver that care. Here’s what APNs need to know about the new models.
White House Commission Reports on Drug Addiction and Opioid Epidemic
In the past few years, drug abuse and opioid addiction levels have grown to epidemic proportions. In 2016, Congress passed the Comprehensive Addiction and Recovery Act (CARA) to decriminalize drug use and reclassify addiction as a disease. After President Obama signed CARA into law, the bill allocated hundreds of millions of dollars to combat the epidemic, alongside funding for Americans in need of addiction treatment and support.
FDA to Improve Review of Shared REMS Strategies for Generic Drugs
U.S. Food and Drug Administration (FDA) commissioners will commonly use their roles to enact new changes that can have a lasting effect on public health for years to come. Despite only being in his position for a few months, Scott Gottlieb, MD, is on track to make a real impression as the head of the FDA.
Despite Awareness, 20% of American Adults Use Tobacco Products
It’s been 20 years since a panel of tobacco executives stood before Congress and admitted that their products were both addictive and linked to cancer. Since then, Americans have shifted their understanding about the use of tobacco products in ways not previously thought possible. These changes in perception and behavior are due in part to the public health initiatives and anti-tobacco campaigns of the last two decades.
How the FDA Provides New Approaches to Old Problems
Every quadrennial presidential cycle, as the newly elected leader moves into the Oval Office, he selects a core group of advisors who are philosophically aligned and eager to make changes in the federal government’s process. However, this is often not as simple as the new administration believes.
New Director Sworn in at NCI
For the past two years, an acting director has served at the head of the National Cancer Institute (NCI). However, President Trump recently selected Norman E. Sharpless, MD, as the 15th director of the NCI. Sharpless, an oncologist with research and clinical experience, said he was humbled by the selection and is looking forward to carrying on NCI’s great mission.
HHS Announces Opioid Crisis Prevention Program
Prescription drug abuse and overdose has reached epic proportions in the United States. In 2016, President Obama signed the Comprehensive Addiction and Recovery Act into law to reclassify drug abuse as a disease and not a crime. Additionally, millions of dollars of federal aid were set aside to help combat the scourge. In September 2017, the Department of Health and Human Services (HHS) released a statement committing the department to the cause.
Advocacy Can Make a Difference
As part of its mission, ONS honors and maintains nursing’s historical and essential commitment to advocacy for the public good. Working collaboratively with policymakers, cancer and nursing community advocates, and other stakeholders at the local, state, federal, and international levels, ONS seeks to integrate the nursing perspective throughout the policymaking process and urges that oncology nurses be appointed to all relevant federal panels, committees, commissions, and boards. During its September conference call, the ONS Board of Directors focused on two key areas of ONS advocacy.
Trump Cuts Obamacare Subsidies; Trump Announces Hargan as New Acting HHS Secretary; Norman Sharpless Sworn in as NCI Director
President Trump signed an executive order ending key payments to insurers selling plans in the Affordable Care Act (ACA) marketplace. The GOP has attempted to repeal and replace ACA, known as Obamacare, several times in 2017 with little success. Trump’s move is seen as the most recent attempt to dismantled Obamacare without the need for legislation. The Trump administration released a statement citing the legality of the funding as reason to withhold payments of more than $7 billion to health insurers as part of ACA’s cost-sharing reduction payments.
FDA Simplifies IRB Requirements for Individual Patient Expanded Access
On October 3, 2017, the U.S. Food and Drug Administration (FDA) announced updates to three final guidance documents, including Form FDA 3926 and its instructions, to simplify Institutional Review Board (IRB) review requirements for physicians seeking to treat an individual patient with an investigational drug under expanded access. The updates allow for a waiver of the requirement for review and approval at a convened IRB meeting if the physician instead obtains concurrence by the IRB chairperson (or a designated IRB member) before treatment use begins.