CMS’s Final Medicare Part D Ruling Preserves Patient Access to Certain Cancer Drugs
Medicare Part D will continue to give patients access to certain cancer drugs, according Centers for Medicare and Medicaid Services’ (CMS’s) final ruling issued May 16, 2019. The final rule does not allow for utilization controls like step therapy and prior authorizations for patients who are already in an established treatment regimen; does not restrict drugs that have had certain price increases over a specified time period; and does not restrict new formulations of an existing protected class drug.
Lowy Appointed NCI Acting Director
Government service isn’t forever. Dynamic, transformative leaders enter and leave federally appointed positions for a variety of reasons and new appointments. Such was the case for the National Cancer Institute’s (NCI’s) former director Norman Sharpless, MD, who was appointed to head the U.S. Food and Drug Administration in April 2019 after Scott Gottlieb, MD, announced he would step down.
Washington Healthcare Option; Dems Campaign Complication; States Sue Drug Manufacturers
Washington is the first state in the country to offer a public insurance option to its residents after Governor Jay Inslee signed the bill into law on May 13, 2019. Is it any coincidence that Inslee is also running for president? Coming from a traditionally “blue” state with a strong progressive legislature allowed this Democratic candidate to deliver on a particularly interesting policy.
U.S. Reps Introduce Legislation to Honor Cadet Nurses
It’s never too late to honor those who served the United States with great valor, especially during times of war and hardship. In April 2019, a group of federal legislators submitted a bipartisan, bicameral bill to honor cadet nurses who served during World War II. At the time, cadet nurses were not recognized with veteran distinctions, despite often serving in active warzones and filling a desperate need for medical care.
Young and Jones Introduce Nursing Where It’s Needed Act
In an increasingly rare show of bipartisan common ground, U.S. Senators Todd Young (R-IN) and Doug Jones (D-AL) introduced the Nursing Where It’s Needed (Nursing WIN) Act in April 2019. The bill would assist nurses in underserved areas of the country—particularly rural communities—that are facing nursing staff shortages.
CDC’s Triple-Negative Breast Cancer Virtual Program Helps Patients Understand the Disease
Unlike other types of breast cancer, a triple-negative diagnosis doesn’t have any of the common receptors found in other breast cancers, presenting potential treatment challenges to patients and providers. To assist patients with triple-negative breast cancer, the Centers for Disease Control and Prevention (CDC) created a new virtual program, allowing patients to consult and ask questions to a virtual coach in the comfort of their own homes.
U.S. Rep Cummings Introduces Henrietta Lacks Enhancing Cancer Research Act
After recent a best-selling book-turned-movie detailed her story, Henrietta Lacks’ extraordinary impact on cancer research. However, many more are still unaware of how her story, struggle with cancer, and tumor cells changed the face of cancer care. For that reason, Representative Elijah Cummings (D-MD), along with a congressional delegation from both chambers, introduced legislation to both honor her role in history and improve access to medical research to traditionally underrepresented groups.
Changing Leadership Won’t Affect FDA’s Role in Public Health, Awareness, and Prevention
Nestled in the sleepy suburbs of Washington, DC, lies an influential agency that continues to have a growing impact on every American’s life. In fact, public opinion surveys indicate that the agency enjoys a broad range of support in the federal government and across the country in its work protecting people. Seen almost daily on the evening news, FDA encompasses a vast network of public health priorities important to many people’s daily lives.
Patient Social Determinants; Trauma in Nursing; House Overturns Obamacare Move
Through a combination of expert clinical knowledge, relationship-building skills, and routine selection as the most trusted profession in the United States, nurses are one of the most impactful healthcare professionals when it comes to addressing patient issues. Challenges—like financial toxicity and limited access to care—are central to nursing advocacy efforts, and oncology nurses know firsthand the negative impacts they have on patients with cancer.
Advocate in Your Own Backyard
Advocacy is a pillar for both ONS and me, personally. As a professor, organizer, chapter leader, and now ONS president, engagement in oncology nursing issues is an essential part of what I do and who I am. In March 2019, I accompanied ONS staff along with my ONS Pittsburgh Chapter colleague, Grace Campbell, PhD, MSW, RN, CRRN, assistant professor at the University of Pittsburgh, to meet with Congressional Representative Connor Lamb’s (D-PA) district office director.
Make Nicotine Nonaddictive to Reduce Tobacco-Related Disease and Death
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released a statement on March 28, 2019, about FDA’s new efforts to reduce tobacco-related disease and death through greater, far-reaching regulation on the tobacco industry. Coming on the heels of his announced departure from his role as of June 2019, the work would ensure his legacy as a staunch proponent of smoking cessation.
Opioid, Cancer, AIDS, and Biomedical Research Are Fiscal Year 2020 Budget Request Priorities
Each year, federal agency leaders submit their budget proposals to the U.S. Congress for review. Often, the committee of jurisdiction will request formal testimony from an agency, which provides an opportunity for the department to speak directly to the elected officials who have the authority to fund programs and projects of interest.
Bipartisan Drug Legislation; Curbing Youth Smoking; Nurses Back Medicare for All
Trying to find a path forward is a common theme among elected officials in Washington, DC, and drug pricing appears to be a bipartisan initiative. In that vein, Senator Chuck Grassley (R-IA)— working with representatives from both sides of the aisle—announced his plan to release a drug pricing proposal by the beginning of summer 2019.
Kentucky Illustrates Success of Medicaid Expansion
The state of Kentucky has seen some of the most success in reducing its uninsured rate thanks to the Affordable Care Act’s Medicaid expansion that took effect on January 1, 2014. The results of a new study, published in the Journal of the American College of Surgeons, showed that as the number of insured individuals rose, so too did important cancer screening rates.
Youth Tobacco Bills; GOP Pre-Existing Conditions Act; Patient Protections
In a bold move, Senate Majority Leader Mitch McConnell (R-KY) announced on Thursday that he would put forward a bill to raise the national age for tobacco product purchases to age 21. It’s a remarkable move on many levels, not the least of which is that McConnell is from Kentucky—a region of the country that produces tobacco products. More importantly though, McConnell made a public statement about the rise in youth consumption through vaping.
As Drug Pricing Tops Capitol Hill Interest, ONS Advocates for Patient Access to Care
Reducing the high cost of prescription drugs continues to be a priority focus for both the U.S. Congress and Trump administration, and ONS is closely monitoring and providing input on how key proposals could affect patient access to oncology care.
NCI’s Sharpless Appointed Acting FDA Commissioner
In March 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, surprised the healthcare community by announcing his resignation, set to take effect in June 2019. With 18 months still remaining in the commissioner’s term, speculation arose throughout the healthcare advocacy community as to who might fill the position. Not long after Gottlieb’s announcement, the Trump administration named National Cancer Institute (NCI) Director Ned Sharpless, MD, as the acting commissioner of the FDA.
PCHETA Is Reintroduced to Congress With Fast Tracked Status
For more than five years, the cancer advocacy community—along with the larger healthcare environment—has presented and promoted a comprehensive piece of legislation focusing on patient-centered care, palliative care training, and hospice education. Advocates are familiar with the Palliative Care and Hospice Education and Training Act (PCHETA)—an initiative that contains many of ONS’s policy priorities and one that ONS members have lobbied for on Capitol Hill.
Senators Investigate Juul; Dems Drug Pricing Woes; New Medicare for All
On April 8, 2018, nearly a dozen Democratic senators announced they would investigate the marketing practices of e-cigarette giant Juul along with a new deal to sell a minority stake of the company to Altria, maker of Marlboro cigarettes. Not long ago, the U.S. Food and Drug Administration (FDA) and Juul—along with others in the smoking cessation community—supported efforts to use electronic tobacco mechanisms to help 60 million Americans quit smoking. However, along the way, the U.S. surgeon general and FDA discovered that youth smoking and vaping have seen a dramatic increase from the advertising, marketing, and distribution of e-cigarettes.
Trump Releases 2020 Draft Presidential Budget—and Here’s What it Means for Health-Related Funding
Each spring marks a new budget season in Washington, DC. It’s a time of year that provides a glimpse into policy priorities for the fiscal year. In March 2019, the Office of Management and Budget released its 2020 funding allocations for the entire federal government. The budget was comprised after each federal department spent the preceding months looking at their previous year’s budget and outlined programmatic priorities that align with the president’s agenda.
$88 Billion for Health Care; Raising the Tobacco Age; 2020 Healthcare Push
According to a Gallup Poll released on April 2, 2019, Americans borrowed approximately $88 billion to pay for health care in 2018. At a National Academies of Science healthcare conference on April 4, the main takeaway was that many Americans surveyed reported that they could not afford to have a serious illness like cancer. The cost of care, even with insurance, is more than many can financially withstand. Oncology nurses know how patients must maneuver through the system to defer costs, sometimes resulting in delayed or alternative approaches to care.
Health Policy Begins With You: Educate Your Representatives in Cancer Care
As an oncology advanced practice nurse and administrator for cancer services, every day I care for patients and caregivers coping with cancer. I mentor nursing staff in best practices to deliver care, and I create a work environment conducive to advancing quality cancer care. However, my commitment to supporting people with cancer does not end at the walls of my workplace. Oncology nurses are called to be a visible change agent in our communities—and beyond—to continue the worthy work of championing quality care for people diagnosed with cancer, along with spreading prevention and early detection information.
Drug Pricing Discussions Make Headway in Congress
The 116th congressional session is well underway. Committee meetings are being held and policy discussions are taking shape all over Capitol Hill. In January 2019, the U.S. House and Senate held separate public hearings on the biggest healthcare issue from the 2018 midterm election: drug pricing.
Future of Nursing; Adults Ration Medication; Drug Parity Act
It’s been almost a decade since the Institute of Medicine—now the National Academies of Medicine (NAM)—released The Future of Nursing: Leading Change, Advancing Health report. Although many aspects of the nursing profession have been enhanced, still others are woefully lacking in change. Healthcare workplace safety incidents are still too high—up to 12 times higher than in the overall workforce—educational opportunities are still too expensive, and scope-of-practice authority is still too limiting in many states—all of which are ONS policy priorities.
Possible NIH Cuts; Sharpless FDA Commissioner; NPs on the Rise
The day the administration releases the president’s budget, outlining funding levels for federal departments and their respective programs, has become an annual event around the Beltway. When that document was unveiled on March 11, 2019, it arrived on Capitol Hill like a lead zeppelin. Under the proposed budget, the National Institutes of Health’s (NIH’s) budget would see a 13% cut, and the National Cancer Institute (NCI) would have its budget reduced by 15%. The dramatic cuts in domestic spending on health, education, and welfare programs were so stark that patient advocacy and provider groups released statements individually and through coalitions to respectfully—or less so—inform decision makers that efforts will begin immediately to advocate for maintained funding levels.
Providing Expert Testimony in the Virginia State Senate
In early January 2019, I had the opportunity to represent ONS before the Virginia State Senate Finance Committee on the growing epidemic of electronic cigarettes and vaping device use among youth. In Richmond, VA, I delivered testimony about the dangerous health ramifications of this newer trend of tobacco use.
CMS Projects Health Expenditures to Reach $6 Trillion by 2027
Health care remains a top domestic policy issue for Americans. Across the board—regardless of political ideology—Americans are concerned about the quality of health care, access to providers, and rising costs associated with medications and treatment. In February 2019, the Centers for Medicare and Medicaid Services’ (CMS) Office of the Actuary released a report outlining the projected growth in national health spending from 2018–2027.
Giroir Reflects on Public Health Programs After First Year at HHS
Washington, DC, and the larger federal government are filled with dedicated professionals who toil quietly, often anonymously, in support of programs, initiatives, and agency work in service of the American public. Such is true for the Department of Health and Human Services’ (HHS) lesser-known leaders like Admiral Brett Giroir, MD, assistant secretary for health, who reflected on his time at HHS as he helped guide the department’s efforts in public health.
More Nurses Are Obtaining BSN Degrees
After the Institute of Medicine’s (IOM) 2010 report on the “Future of Nursing,” the nursing field made a concerted effort to encourage current and incoming nurses to achieve higher education through a Bachelor of Science Nursing (BSN) degree or higher. As lifelong learners, nurses are committed to providing the best care possible and consistently furthering their education is part of that commitment. According to a report from AARP and the Robert Wood Johnson Foundation, 56% of U.S. nurses hold a BSN or higher, an all-time high for the profession.
Nursing Workplace Violence; Aggressive Drug Pricing Legislation; Gottlieb Steps Down
Although nurses are the number one trusted profession in the United States for the past 18 years in a row, they’re not necessarily the most protected sector. Hostile workforce environments and exposure to hazardous chemicals are still a part of too many nurses’ daily lives. Recently, the U.S. House Education and Labor Committee held hearings on workforce safety to better understand the what nurses and other healthcare workers endure.
Trump Administration Proposes Lower Drug Costs
For the past year, President Trump has championed efforts to lower drug prices for Americans to more accessible and affordable medications. Lowering soaring prescription costs is an issue with wide bipartisan support in Congress. To date, several Congressional committees have held hearings in early 2019 with pharmaceutical executives.
Ending HIV Epidemic a Priority for Trump Administration
In a statement during the 2019 State of the Union address, President Trump proposed ending the HIV epidemic by reducing new infections by 75% in the next five years and 90% in the next decade. Department of Health and Human Services (HHS) Secretary Alex Azar hailed Trump’s statement as an important public health initiative.
Dems' Budget Fight; Pharma CEOs Face Congress; Patient Financial Struggles
Democrats control the majority of the House of Representatives, and it’s their responsibility to provide and pass a U.S. budget. As with any Congress, it’s always easier said than done. With a larger, more progressive freshman class interested in pushing more environmental, health, and welfare policy issues forward, costs will be a concern.
Federal Furlough Forlorn: Cancer Care’s Constraints
On January 25, 2019, President Trump announced a deal to end the longest U.S. government partial shutdown in history—35 days of closed public places and programs, furloughed or unpaid federal employees, and an apprehensive American nation. What was its impact on health policy and, more specifically, cancer care?
Drug Pricing Talks; Clinical Trial Barriers; Survivorship Challenges
Rising prescription medication costs has been a major focus area for both the Trump administration and the 116th Congress. In January 2019, both the House and Senate committees of jurisdiction held public hearings on soaring drug costs. Despite constant media attention and mounting pressure from government officials, no pharmaceutical company executives chose to testify. Congress threatened to subpoena the industry if it happened again.
CMS Proposes Medicare Coverage for CAR T-Cell Therapy
To improve access to new cancer therapies and provide national consistency in coverage, on February 15, 2019, the Centers for Medicare and Medicaid Services (CMS) announced a proposed plan of coverage with evidence development for CAR T-cell therapy. The public is invited to share comments for the next 30 days.
FDA Commissioner Advocates Against Smoking, New Vaping Devices
When heads of federal regulatory agencies are health and medical professionals with years of research experience, their background helps guide the mission and vision of the department along with the direction of thousands of staff and employees engaged in implementing health policy. U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, is a clinician and activist, and he acts as a staunch advocate for public health issues—namely the dangers of tobacco use, especially among young Americans.
NIH Office of Disease Prevention Raises Profile
In an open letter to the research and advocacy community, National Institutes of Health (NIH) Director Francis Collins, MD, PhD, announced the Office of Disease Prevention’s (ODP) new strategic plan to “strengthen research through increased coordination and facilitation among NIH institutes, centers, and offices, including leveraging the power of new portfolio analysis tools, ensuring ongoing communications with stakeholders, and building trans-NIH partnerships to address gaps in prevention research.”
Opioid Access; Smoking Age Increase; House Medicare for All
Efforts to curb the national opioid epidemic have taken shape in several ways, including redefined prescription guidelines. However, many insurers are now like the ones commonly prescribed to patients with cancer. For years, ONS has been meeting with congressional offices to advocate that access to prescription opioids for cancer survivors should be exempt from the strict limits assigned to other diagnoses. It’s always been a successful strategy, because related to severe pain management, quality of life, and end-of-life care.
HRSA Awards $293 Million to Clinicians, Students to Enhance Workforce
The Health Resources and Services Administration (HRSA) announced $293 million in new funding through programs at the National Health Service Corps (NHSC) and Nurse Corps for the healthcare community to expand the clinician workforce. Strengthening care and support can help address gaps in care and limit growing socioeconomic disparities.
CDC Announces National Screen Out Cancer Health Campaign
Targeted to healthcare providers, the Centers for Disease Control and Prevention (CDC) has released a new public service health campaign to call attention to the importance of regular screenings for breast, cervical, and colorectal cancers. The Screen Out Cancer campaign is designed to raise awareness to ensure that patients and providers know that prevention begins with knowledge.
HHS Awards $1 Billion to Fight Opioid Crisis
Recognizing the continuing impact of the national opioid epidemic, the Department of Health and Human Services (HHS) has dedicated $1 billion in funding through a new awards program called the Five-Point Strategy to Combat the Opioid Crisis. The program will empower communities to implement strategies to curb opioid abuse and addiction.
Nurses in Congress; Defending the ACA; Biden's Moonshot Mission
The new 116th Congress has settled in, and a clearer picture of the diverse freshman class has come to light. In this case, . Lauren Underwood (D-IL) is an RN who ran on her , specifically to protect those with pre-existing conditions. She’s already a co-chair of the Congressional Nursing Caucus and has signed on to Title VIII nursing reauthorization legislation— . Representative Eddie Bernice Johnson (D-TX)—the first nurse ever elected to Congress—is entering her 13th term in the chamber and continues to offer a veteran nursing presence on the hill.
Experience the Power of Patient-Centered Research Through PCORI
How often have you gone to the mailbox, pulled out your latest issue of the or , and excitedly read about some innovative study with game-changing outcomes that’ll revolutionize the delivery of health care—only to find that it never moves off the pages of the journal? What does it take to move research from the proverbial bench to the community? That was the focus of the Fourth Annual Meeting of the Patient Centered Outcomes Research Institute (PCORI), “ ” held from October 31–November 2, 2018, in Washington DC.
President’s Cancer Panel Calls for Renewed Commitment to Vaccinate for HPV
For years, the human papillomavirus vaccination (HPV) has been recommended to young adult patients to help prevent certain forms of cancer. In a November 2018 report, the President’s Cancer Panel recommended to further the United States’ goal to prevent cancer associated with HPV.
HHS Proposes Policy Changes for Medicare Advantage, Part D Drug Pricing
U.S. drug pricing systems are difficult for patients to understand, cumbersome to maneuver, and limited in access and affordability. In Medicare’s current structure, certain medications are designated as a protected class of drug, and Medicare Part D plans are obligated to cover them.
Bipartisan Drug Debates; Youth Vaping Epidemic; Socioeconomic Disparities and Cancer
Congress has settled in after the shutdown, and new members have taken their place on committees to begin the real work in Washington, DC. This week, the House and Senate convened similar panels to discuss the bipartisan goal to lower soaring drug costs for all Americans. Patients and families provided emotional testimony about lost loved ones because of pricey prescription medications that were out of reach.
Surgeon General Declares Youth Vaping an Epidemic
Since their inception, e-cigarettes have made the public health sector uneasy. Initial reports suggested that e-cigarettes could be an opportunity for long-time adult smokers to step down their usage, acting as a bridge to smoking cessation. However, recent reports indicate that youth vaping and e-cigarette use has risen sharply in the past two years—creating an entirely new generation of smokers. U.S. Surgeon General Vice Admiral Jerome Adams, .