Policy News Roundup: November 18, 2021

Key reads

Overdose deaths reached record high 100,000 in 12-month period

In the 12-month period ending in April 2021, more than 100,000 Americans died from drug overdose deaths, an almost 30% increase from the previous year, when 78,000 overdose deaths were reported. This is the first time there have been over 100,000 estimated overdose deaths in a 12-month period. Opioids like fentanyl are fueling most of the rise in deaths, but methamphetamine deaths also increased. Deaths have risen in every state except South Dakota, New Hampshire and New Jersey. Partnership to End Addiction’s Vice President of Health Law and Policy Lindsey Vuolo explained the possible impact the COVID-19 pandemic had on overdose deaths, as well as what needs to be done to address the crisis. This includes increasing access to naloxone and medications for opioid use disorder, integrating addiction treatment with the mainstream health care system, ensuring insurance companies cover addiction treatment, expanding prevention efforts that promote healthy youth development and reduce risk factors, expanding family support services and eliminating stigma.

Source: Over 100,000 Americans Died From Drug Overdoses in One Year: Report (HealthDay)

Physicians concerned about missing drug misuse in patients during pandemic

A report found that almost 70% of primary care physicians fear they missed signs of prescription medication misuse among their patients during the pandemic. Nearly all reported seeing more patients experiencing mental health issues and feared a correlation with medication misuse. The Quest Diagnostics report found 75% believe telehealth visits limit the ability to determine if patients are at risk for or are misusing prescription medications. While 91% felt confident they could recognize signs of misuse during in-office interactions, only 50% felt confident via telehealth. The report found 88% felt confident they can identify patients at risk for misuse, but Quest data shows that nearly half of patients tested in 2020 showed signs of drug misuse. Nearly 90% believe better guidelines would help ensure clinical drug testing is used equitably, and 69% reported needing more tools to address racial and ethnic disparities in medication addiction management. Only 34% said they were very confident in their ability to prescribe naloxone. Partnership to End Addiction was an advisor to the report’s development.

Source: Majority of Physicians Worry Signs of Addiction Were Missed During Pandemic, Finds New Quest Diagnostics Health Trends® Report (Quest Diagnostics)

Biden nominates Califf to lead FDA

President Biden nominated former Food and Drug Administration (FDA) Commissioner Robert Califf to return to the role. He was the deputy commissioner overseeing tobacco products when the FDA was finalizing fundamental e-cigarette regulations, and as commissioner, he was charged with implementing them. However, the White House struck out a provision that would have banned flavored products. He previously created a plan for regulating tobacco that includes lowering nicotine in cigarettes to non-addictive levels, banning over-the-counter vape products and mandating that future e-cigarettes only be sold with a prescription for smoking cessation. It is unclear whether he would push the plan if confirmed. While deputy commissioner, Califf released a plan to overhaul how the FDA reviews opioids, which included reexamining the benefits/risks assessment, convening expert advisory panels when considering new opioids and requiring new warnings on opioids. As commissioner, he required all immediate-release opioids to include new warnings on their label. The plan required opioid makers to submit data testing whether opioids were safe to use long-term, but only some of the studies have been completed.

Source: Biden taps Califf to head FDA — an agency where he has plenty of unfinished business (STAT)

ONDCP releases model state law to increase naloxone access

The Office of National Drug Control Policy released a model law (Model Expanded Access to Emergency Opioid Antagonists Act) for states to help expand access to naloxone. It would provide states with a roadmap to expand access to and availability of emergency opioid antagonists, address the critical need to provide uniformity in the ability of citizens in states to access opioid antagonists, encourage citizens to obtain emergency opioid antagonists, protect individuals administering opioid antagonists from unjust prosecution, require health insurance coverage of opioid antagonists and prohibit discriminatory life and health insurance practices related to the possession of naloxone, provide increased access to opioid antagonists in educational institutions and correctional settings, establish a pilot program for bystander access and promote initiatives that educate citizens on the life-saving potential of emergency opioid antagonists.

Source: White House Releases State Model Law to Help Make Access to Naloxone Consistent Across the Country (Office of National Drug Control Policy)

Washington trial against opioid distributors begins

Having rejected the settlement offer with distributors earlier this year, Washington’s trial against McKesson, Cardinal Health and AmerisourceBergen began this week. The move is not without risk, as the opioid litigation loss by California counties earlier this month demonstrates. Washington Attorney General Bob Ferguson stressed, however, that the relevant Washington laws differ from California’s and called the cases “apples and oranges.” The state is seeking $38 billion to pay for treatment services, criminal justice costs, public education campaigns and other programs over a 15-year period, plus billions more in additional damages. Johnson & Johnson also faces a separate lawsuit from Washington scheduled to go to trial next year.

Source: Washington seeks over $38 million from opioid distributors (Associated Press)

North Carolina announces lawsuit and investigation of e-cigarette industry

North Carolina Attorney General Josh Stein announced several actions against the e-cigarette industry due to ongoing concerns about kid-friendly flavors, youth marketing and poor age verification. He is suing Juul’s founders, alleging that they personally participated in Juul’s marketing strategy to attract young users to their product. He is launching a statewide investigation into Puff Bar, a company with kid-friendly flavors, retailers that sell flavored-cigarettes, including several located near middle and high schools, and distributors. Stein is also urging Food and Drug Administration Commissioner Nominee Robert Califf to protect kids from flavored e-cigarettes.

Source: Attorney General Josh Stein Announces Lawsuit and Statewide Investigation on E-Cigarettes (North Carolina Department of Justice)

Public nuisance argument in opioid litigation at risk

This month, a California trial judge and the Oklahoma Supreme Court both found no merit to plaintiffs’ argument that, under state law, opioid companies created a “public nuisance” by overplaying the benefits and downplaying the risks of opioids. The rulings highlight the question of whether this strategy, which critics say requires an unprecedented, expansive reading of public nuisance laws, was the best approach. If upcoming cases have similar results, it could shift the ground in ongoing settlement talks. The opinions could prod cities and counties to capitulate to settlement deals brokered by states and fuel the resolve of pharmacy chains to fight even harder against settlements. It is turning out to be difficult to establish an incontrovertible link between a public nuisance and the discrete actions of so many types of companies that provide a federally approved medication prescribed by doctors and that is supposed to be monitored by state and federal agencies.

Source: The Core Legal Strategy Against Opioid Companies May Be Faltering (New York Times)

Poll finds broad public support for mental health crisis services

A National Alliance for Mental Illness poll found dissatisfaction with the state of mental health treatment and strong opposition to law enforcement responses to mental health crises. It found that 86% of Americans agreed that mental health crisis services can prevent people from cycling in and out of emergency rooms, arrests, incarceration and homelessness. The poll found 75% are not content with mental health treatment in the U.S. While 72% reported a favorable opinion of law enforcement in their community, 80% believe mental health professionals should be the primary first responders when someone is having a mental health or suicide crisis rather than law enforcement. In addition, the poll found 90% support the creation of 24/7 mental health, substance use and suicide crisis call centers, 87% support requiring health insurers to cover mental health crisis services, 81% support providing follow-up mental health care regardless of ability to pay, 85% support state and federal funding for 988 and 73% would be willing to pay a monthly fee on phone bills to support it. However, 80% have never heard of 988.

Source: As Launch of 988 Mental Health Crisis Number Looms, NAMI Poll Finds Broad Support for the System and Fees to Fund It, Opposition to Police Response to Mental Health Crises (NAMI)

Beyond increasing treatment capacity, we must increase effectiveness and accessibility

In an opinion piece for The Hill, contributor Lisa Clemans-Cope argues that while federal and state policymakers can take steps to expand access to treatment, redirecting resources away from criminalization of addiction and toward a health-centered approach would create a more effective, accessible and non-punitive treatment system. Officials, she writes, could end the moratorium and restrictions on new opioid treatment programs, make pandemic-related treatment flexibilities permanent, remove remaining restrictions on mobile methadone treatment vans, abolish the buprenorphine prescribing waiver and ensure that pharmacies stock buprenorphine. Beyond expanding treatment supply, she continues, policymakers could expand access to naloxone by eliminating generic naloxone’s prescription requirements and limiting the price of higher-dose brand-name naloxone, establish reimbursement and payment incentives for health care professionals to provide harm reduction services and expand health-led, locally focused behavioral health crisis interventions. In the long term, she writes, policymakers could prioritize providing funding to community organizations to conduct community needs assessments, training addiction care providers in culturally informed practices and increasing Medicaid reimbursement rates for addiction services.

Source: Expanding treatment for the opioids crisis is critical to saving lives, but isn’t enough (The Hill)

Employers expanded mental health insurance benefits during the pandemic