Policy News Roundup: August 15, 2024

Key reads

Adolescent substance use trends improving, but other well-being indicators worsening

The Centers for Disease Control and Prevention released 2023 Youth Risk Behavior Survey data, providing an analysis of health behaviors and experiences of high school students across the nation. Ten-year trends are continuing to improve in some areas of adolescent well-being, including sexual risk behaviors and substance use, but almost all other indicators worsened from 2013 to 2023. Since 2013, the percentage of students who currently drank alcohol, currently used marijuana or had ever used select illicit substances decreased. Since 2017 and 2019, respectively, the percentage who had ever or currently intentionally misused prescription opioids decreased. The percentage who had ever used select illicit substances (10%) and currently misused prescription opioids (4%) decreased. The percentage who currently drank alcohol (22%), currently used marijuana (17%) or had ever intentionally misused prescription opioids (12%) did not change. Female and LGBTQ+ students were more likely to engage in most substance use behaviors and to report higher rates of violence, poor mental health and suicidal thoughts and behaviors. Only about half of students felt close to people at school.

Source: CDC Data Show Improvements in Youth Mental Health but Need for Safer and More Supportive Schools (Centers for Disease Control and Prevention)

FDA rejects application for MDMA as PTSD treatment

The Food and Drug Administration (FDA) rejected Lykos Therapeutics’ application for MDMA and talk therapy as a post-traumatic stress disorder treatment. The FDA requested that Lykos conduct an additional Phase 3 clinical trial to further study MDMA’s safety and efficacy. Lykos plans to ask for a meeting with the FDA in hopes the agency will reconsider and discuss the possibility of resubmitting. Conducting another Phase 3 trial would take several years, and Lykos hopes that the FDA’s concerns can be addressed with the company’s existing data or other scientific literature. While Lykos’ trial had shown promising results, an independent review delivered a concerning assessment of the application this spring, and in June, the FDA’s expert advisory committee voted against recommending FDA approval. Veterans groups and many lawmakers had urged the FDA to approve the treatment. Last week, 80 members of Congress signed letters to President Biden and FDA Commissioner Califf arguing that the FDA should fast-track approving the treatment.

Source: FDA rejects MDMA as mental illness treatment (Politico)

HHS report examines barriers to marijuana research

The Department of Health and Human Services completed its review of federal barriers to marijuana research, which was mandated by Congress in 2022. The report found that the registration process for marijuana researchers is arduous, time-consuming and unclear; that obtaining marijuana presents challenges because federal regulations require the Drug Enforcement Administration to approve all sources of marijuana used in research, and no state-authorized dispensaries have been approved; and that the hemp loophole, created by the 2018 Farm Bill, has caused confusion as to whether research on hemp-derived intoxicating products require Schedule I registration or not. The report recommends that Congress pass the HALT Fentanyl Act; implementation of the Medical Marijuana and Cannabidiol Research Expansion Act; and innovative solutions to address the need for researcher access to state-authorized dispensary products.

Source: Report examines federal hurdles to studying marijuana (The Washington Post)

FDA approves Purdue's nalmefene overdose reversal medication

The Food and Drug Administration approved Zurnai, a new auto-injector opioid overdose reversal drug from Purdue. It is the first approval of a nalmefene auto-injector, and it will be available only by prescription. However, it is the latest in a string of recent approvals for nalmefene, essentially a more powerful version of naloxone. The approval is likely to spark anger for several reasons. Many view Purdue with suspicion due to its role in creating the overdose crisis and resent its attempts to address that crisis. As fentanyl has become the main driver of overdose deaths, overdose responders have reported that victims are slower to respond to standard doses of naloxone. This has led to what many experts view as a pharmaceutical industry arms race, with companies rushing to develop high-dose, mechanically complex versions of naloxone they can sell for hundreds or thousands of dollars. However, it is unclear whether the high-dose products are more effective, and they induce severe withdrawal, making people recently revived less likely to seek further care. Instead, adding rescue breathing and administering more doses of existing, cheaper naloxone, if needed, can help.

Source: FDA approves Purdue Pharma’s controversial new overdose-reversal medication (STAT)

Barriers to contingency management persist

Despite studies showing the effectiveness of behavioral incentives such as offering financial rewards (known as contingency management) and spiking meth overdose rates, contingency management is being held back by a $75 annual cap for services funded by select federal programs and the politics/optics that prevent that cap from being raised. Contingency management is most effective when the financial incentive is much larger. The advocacy push surrounding federal funding for contingency management has intensified, with groups urging the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase the cap. Advocates are pushing for $599, or roughly $100 per month for a 6-month period. Higher amounts could require patients to fill out complex tax paperwork as a condition of receiving the reward. While SAMHSA has not lifted the cap, the Department of Health and Human Services (HHS) noted in a report that research shows contingency management is most effective when incentive levels are $100-$200 per month and listed the $75 cap as a barrier to successful implementation; HHS Inspector General issued a notice in 2020 pledging not to pursue enforcement actions for “nominal” payments, alleviating concerns of violations of anti-kickback statutes; and the Centers for Medicare and Medicaid has approved waivers for state Medicaid programs to implement contingency management programs providing up to $600 per year.

Source: Politics is holding back the best tool for treating meth addiction (STAT)

NASEM report recommends changes to expand the Medicare, Medicaid and Marketplace behavioral health workforces

The National Academies of Sciences, Engineering, and Medicine released a report offering recommendations to expand the behavioral health workforce’s participation in Medicare, Medicaid and Marketplace insurance. It points to a need to strengthen support structures for behavioral care providers and alleviate the administrative and financial barriers to participating in Medicare, Medicaid and Marketplace plans, including by addressing reimbursement rates, prompt payment and claims denials, and prior authorization. It also recommends reducing credentialing, enrollment and licensing barriers, and focusing training programs and telehealth support where gaps are greatest for patients. The report calls for strengthening accountability for managed care plans and improving opportunities for behavioral health providers to increase their capacity for delivering care.

Source: New Report Recommends CMS, HHS Make Changes to Increase Participation of Mental Health and Substance Use Care Providers in Medicare, Medicaid, and Marketplace Health Insurance Plans (National Academies of Sciences, Engineering, and Medicine)

Baltimore reaches opioid settlement with CVS

Baltimore reached a $45 million opioid settlement with CVS, which will pay the entire $45 million amount this year. CVS has not yet reached a deal with the state of Maryland, so the city did not have the option to join a global settlement with CVS, though this settlement secures for Baltimore far more money than it expected under any global deal. With a prior $45 million Allergan settlement, the city has now recovered $90 million, approximately the same amount it would have recovered under all available global settlements. Of the CVS settlement, $5 million will go toward the Law Enforcement Assisted Diversion program, $5 million for Healing City Baltimore, $1 million for Roberta’s House and $1 million for From Prison Cells to PhD. The city’s litigation is proceeding against Johnson & Johnson, McKesson, Cardinal Health, AmerisourceBergen, Teva, Walgreens and former Insys owner John Kapoor.

Source: City of Baltimore Strikes $45 Million Deal with CVS to Resolve Ongoing Opioid Litigation – Bringing Total Recoveries for Baltimore to $90 Million (Mayor Brandon M. Scott)

Some colleges embrace harm reduction, but campus overdose prevention is lacking

The overdose death rate among young adults ages 18 to 24 has spiked in recent years, driven largely by fentanyl infiltrating illicit substances and fake pills, but too few colleges have specific plans to address overdose prevention on campus. A big reason for that lack of action is a dearth of data regarding deaths on college campuses. Some college administrators are resistant to stocking naloxone. Some schools use their pharmacy school students, for example, to train other students to recognize overdose and administer naloxone. Others hang boxes containing free naloxone and how-to videos in places like libraries and dorms, alongside first-aid kits and fire extinguishers. Some distribute fentanyl test strips. End Overdose works directly with students to distribute naloxone and provide training. Peer training can also be a critical source of emotional support for bystanders.

Source: Her son died of an overdose in his dorm room. Where was the Narcan? (NPR)

Milwaukee launches efforts to address the overdose crisis

Milwaukee announced seven projects funded by $8.5 million in opioid settlement funds. One of the proposed projects is a new public health campaign that targets the issue of opioid overdoses and the use of adulterants in Black and Brown communities. Another is an overdose prediction model pilot program, which would help individuals at risk for an overdose, help assess community needs and support integration of other data collected by the county. A third plan is to integrate treatment access during and after incarceration. The other projects include grief outreach and grief-informed care, expanded paramedic coverage, adding 20 harm reduction beds to a county-run center that services unhoused individuals and overall enhancement and alignment of treatment services. Separately, Milwaukee County also announced eight additional Harm Reduction Vending Machines, bringing the total number to 19. All are also now stocked with first-of-their-kind fentanyl/xylazine combination testing packs, in addition to nasal naloxone, drug deactivation pouches, medication lock bags and gun locks.

Source: Milwaukee County unveils new projects to stem tide of opioid overdose deaths (Wisconsin Watch); Milwaukee County Executive David Crowley Announces Placement of Eight Additional Harm Reduction Vending Machines (Milwaukee County)

Mississippi has yet to spend most opioid settlement funds

Mississippi is expected to receive approximately $203 million from the national opioid settlement with distributors and $167 million from settlements with other companies. The money is split into three buckets: 15% will go to the state government, 15% to counties and cities and 70% to an opioid abatement fund that will be controlled by the state legislature. To date, the state and abatement fund shares have been tapped only to cover attorneys fees. The state attorney general’s office has signaled some priorities for the money, including establishing a Center for Addiction Medicine at the University of Mississippi Medical Center, but lawmakers have not widely discussed the proposal, and confusion surrounds specifics. Few counties reported having concrete plans. The state has not implemented public reporting requirements. Localities do not have to say how much they have received or how it is being spent, and they also do not have requirements dictating how to use the money.

Source: Opioid Settlements Promise Mississippi a Windfall. What Happens Next? (KFF Health News)

State insurance regulators struggle with parity enforcement

As the Biden administration weighs updates to the Parity Act, which requires private insurers to treat mental health care on the same terms as other care, state insurance regulators largely responsible for monitoring compliance face significant barriers. Interviews with regulators in 10 states found that oversight tools have limits. Barriers identified include that few consumers are aware of protections, and fewer file complaints; a “close review” of potential barriers to care, like how insurers analyze claims for payment, can be difficult in annual reviews; and exams allowing regulators to analyze how insurers process and pay claims can take significant time and resources and only offer a retrospective look. Adding more consumer protection into insurance laws, including curbing prior authorization and creating medical necessity standards, can improve parity. The states agreed that the parity law is a strong foundation for bolstering access to care.

Source: Parity in Practice (Politico)