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.

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.

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.

As Washington attempts to address the soaring costs of prescription medications, some experts are attempting to shed light on the many complicated aspects of the drug pricing issue. The free-market system has countless moving parts, and perhaps so-called big government ownership isn’t the answer to inflating drug costs. As the author aptly states, “From a public-relations standpoint, drug companies are often their own worst enemies. Occasionally, a breathtakingly awful company taints the image of the whole industry.”

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.   

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.

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.

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.

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.

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.

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.

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.

Efforts to curb the national opioid epidemic have taken shape in several ways, including redefined prescription guidelines. However, many insurers are now refusing to cover certain pain medications 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 ONS helps policy leaders understand that patients with cancer often struggle with issues related to severe pain management, quality of life, and end-of-life care.

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.

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.

After a contentious 35-day-long shutdown, President Trump announced on January 25, 2019, plans for a temporary deal to reopen the government for a three-week period while talks continue on border security and immigration. Neither party seems optimistic that compromise can happen by the February 15 deadline, and the future is still uncertain.

Debates like the one facing the constitutionality of the Affordable Care Act (ACA) are what American democracy is built on. Checks and balances for each branch of government—often with authority undulating back to state governments—provide numerous opportunities for policy issues to change and develop through legislative, regulatory, and judicial review. Recently, U.S. Senator Patty Murray (D-WA) and Senator Maria Cantwell (D-WA) have reintroduced a resolution that authorizes Senate Legal Counsel to defend Americans with preexisting conditions against a Republican Attorneys General lawsuit facing the ACA.

Short-term insurance plans were developed as an attempt to circumvent the Affordable Care Act (ACA) and the rising costs for its health plans after deep funding cuts to the law. But, in doing so, the Trump administration has allowed new, seemingly unregulated temporary insurance plans to emerge that appear to prey on vulnerable policyholders, offering limited coverage at high prices. On January 8, Democrats pressed the president for further answers on short-term insurance plans.

Although the Democrats have yet not formally taken control of the House of Representatives, many are primed and passionate about holding the Trump administration accountable after the November midterm elections. Through involvement in committees and as incoming chairs of powerful oversight panels, lawmakers are questioning officials about healthcare policy.

As efforts continue to drive down the soaring costs of prescription medications, Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR) proposed a bipartisan bill looking to close loopholes used by pharmaceutical companies to drive up profits. The bill would give the Department of Health and Human Services the ability to address companies that misclassify products to pay lower rebates.

On October 25, 2018, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar announced an advanced notice of proposed rulemaking (ANPRM) calling for a demonstration project to more closely align Medicare payment for certain Medicare Part B drugs and biologics with international prices, which an HHS analysis showed to be 1.8 times lower on average than in the United States. The proposal is a follow-up to the president’s prescription drug blueprint and HHS request for information to reduce patient out-of-pocket costs for prescription drugs. HHS estimates a savings of $17.2 billion over five years.

Developed to combat the nation’s opioid crisis, a comprehensive opioid addiction bill has finally made its way to the president’s desk. On October 25, 2018, President Trump signed the opioid package into law. The new law allots more than $8 billion to address addiction, drug trafficking, and recovery issues. 

Fighting the cost of soaring prescription medications is a winning issue with tremendous bipartisan support. And reigning in exorbitant drug prices means patients will be the real winners. Recently, President Trump lauded his administration’s work to fight against high prescription drug costs, citing new efforts to reduce other countries from taking advantage of drug pricing.

Addressing the high cost of prescription medications has been an ongoing focus for the Trump administration. Its latest move, requiring drug companies to list their product’s market price on consumer ads, is an added level of transparency that didn’t exist before. Whether the decree will have an impact remains to be seen, but it may add some trust to the process.

For months, bipartisan lawmakers have worked together to build an opioid package aimed to tackle the nation’s abuse epidemic. After rounds of revisions and finally making it through both chambers of the House and Senate, the legislation is on its way to the president’s desk. The bill focuses funding efforts on addiction recovery programs and cracking down on the illegal medication trafficking.

The rising price of prescription drugs is an ongoing priority for the Trump administration. As part of the president’s blueprint to lower drug costs, the Department of Health and Human Services (HHS) secretary, Alex Azar, elevated the prescription cost issue throughout many federal agencies to help determine a new course of action.

A cancer diagnosis at a young age can lead to serious hardship after completing treatments and moving into survivorship. Such was the case for Matthew Zachary after his cancer diagnosis at age 21. An interesting component to Zachary’s story—and that of many others like him—is that despite the higher number of insured Americans after the Affordable Care Act, costs and complications still plague patients. Access to health care can be a double-edge sword. It means more people are seeing providers, but it doesn't mean that people can afford those treatments.

The Kaiser Family Foundation released a report stating that coverage for pre-existing conditions ranks highest among healthcare campaign issues for American voters. According to the report, the issue cuts across all parties, including Democrats, Republicans, and voters living in battleground states. Since attempting to repeal and replace the Affordable Care Act, 58% of those polled say that President Trump’s administration and the Republicans in Congress are responsible for problems with the healthcare law moving forward.

On July 16, 2018, Kevin Brady (R-TX), House Ways and Means Committee chair, announced that he’s working with the Trump administration to restore funding to key Affordable Care Act (ACA) payments. Previously, the White House suspended more than $10.4 billion in payments to insurers, which brought criticism from Democrats and stern warnings of rising healthcare premiums.

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?

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.

It’s been a long time coming, but the Childhood Cancer Survivorship, Treatment, Access and Research (STAR) Act was finally signed into law on June 6 by President Trump. The act focuses on advancing pediatric cancer research and treatments along with improving screening programs and supporting patients into survivorship. As with many issues in the U.S. capital, the issue had two sides: many healthcare professionals see it as a win to support childhood cancer survivors, but it raised concerns for others about potential coverage issues.

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.

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.

Polypharmacy is the use of several medications simultaneously for different medical conditions. Data confirm that polypharmacy is prevalent in older adults with cancer, with one study reporting a minimum of four prescriptions to define polypharmacy. Many medications prescribed during cancer care are intended to treat other comorbid conditions that occur prior to a patient’s cancer diagnosis (e.g., heart disease, hypertension, hyperlipidemia, reflux disease). Reportedly, one third of individuals older than 65 years use more than one pharmacy to fill prescription medications. This can lead to further confusion for patients regarding medication management.

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.

The Centers for Medicare and Medicaid Services (CMS) finalized a rule on November 1, 2017 that would reduce the current Medicare Part B drug payment to 340B hospitals from average sales price (ASP) plus 6% to ASP minus 22.5%.  However, rural sole community hospitals (SCHs), children’s hospitals, and PPS-exempt cancer hospitals are excluded from this payment adjustment in 2018.

Since the campaign trail prior to the presidential election, Donald Trump has been drawing focus to the issue of high drug prices in the United States. In an effort combat the pricing issues, Trump appointed U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, who recently announced the creation of the “drug competition action plan.” The plan would reduce the high cost of drugs in U.S. healthcare market by increasing the efficiency of approving generic medications of name-brand drugs.