Policy News Roundup: February 8, 2024

Key reads

SAMHSA releases final rules updating OTP regulations

The Department of Health and Human Services (HHS) marked two years of its Overdose Prevention Strategy by announcing new actions to combat overdose. The Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule to update regulations governing opioid treatment programs (OTPs), the first substantial changes in more than 20 years. Provisions include making permanent COVID-era flexibilities that expand eligibility for methadone take-home doses; allowing initiation of treatment via telehealth, including methadone via audio-visual and buprenorphine via audio-only technology; allowing nurse practitioners and physician assistants to order medications in OTPs; removing the requirement for patients to have addiction for a year before OTP admission; allowing patients to initiate medications while awaiting further services; and promoting patient-centered models of care. The rule also removes stigmatizing language. HHS also announced that certain grant funds may be used to purchase xylazine test strips, and SAMHSA released the updated Overdose Prevention and Response Toolkit, providing updated guidance on preventing and responding to overdoses.

Source: Biden-Harris Administration Marks Two Years of Advancements in HHS’ Overdose Prevention Strategy with New Actions to Treat Addiction and Save Lives (Substance Abuse and Mental Health Services Administration)

States use Medicaid to address opioid crisis

States are using a variety of approaches to address the opioid crisis through Medicaid. Most states have removed prior authorization requirements for certain buprenorphine treatments, but other barriers remain and are complicated by fentanyl. Nearly all states now cover at least one standard formulation and dosage of oral buprenorphine without prior authorization, but hurdles such as counseling mandates or prior authorization requirements for higher doses remain. Most Medicaid programs cover buprenorphine induction via telehealth, but the policy is dependent on evolving federal regulations. At least one-third of states have or plan to add over-the-counter (OTC) Narcan to fee-for-service Medicaid OTC formularies. Many states are pursuing 1115 waivers to cover opioid use disorder services for inmates prior to release. States also reported other initiatives, including expanding access to services by removing copays, expanding provider types or adjusting reimbursement; innovative programs or solutions; and alternative opioid treatment or safe opioid prescribing.

Source: State Approaches to Addressing the Opioid Epidemic: Findings from a Survey of State Medicaid Programs (KFF)

SAMHSA announces $28 million for grants to expand SUD treatment

The Substance Abuse and Mental Health Services Administration (SAMHSA) announced $28 million for two grant programs aimed at expanding access to substance use disorder (SUD) treatment services among pregnant and postpartum women and through adult and family treatment drug courts. SAMHSA said $24.4 million in Grants to Expand SUD Treatment Capacity in Adult and Family Treatment Drug Courts will expand SUD treatment and recovery support services in existing drug courts and support a continuum of care, including prevention, harm reduction, treatment and recovery services, for individuals with SUD involved with the courts. In addition, $3.6 million for the State Pilot Grant Program for Treatment of Pregnant and Postpartum Women will enhance flexibility of funds designed to support family-based services for pregnant and postpartum women with SUD, help state agencies address the continuum of SUD care, including outpatient services for pregnant and postpartum women, and promote a coordinated state system managed by state substance use agencies by encouraging new approaches and models of service delivery.

Source: Biden-Harris Administration Announces $28 Million in Funding Opportunities for Grants Expanding Treatment Services for Substance Use Disorder (Substance Abuse and Mental Health Services Administration)

FDA takes action against e-cigarette retailers and manufacturers

The Food and Drug Administration (FDA) issued complaints for civil monetary penalties against 21 brick-and-mortar retailers for sale of unauthorized Esco Bars e-cigarettes, a popular youth-appealing brand. The FDA previously issued each retailer a warning letter, but follow-up inspections revealed that the retailers failed to correct the violations, and the FDA is now seeking the maximum penalty amount of $20,678 from each retailer. The FDA also issued marketing denial orders to Fontem US LLC for four blu disposable and one myblu brand e-cigarette products. The denied products include a prefilled menthol e-liquid and several flavored disposable e-cigarettes.

Source: FDA Seeks $20K+ Fines Against Retailers Selling Unauthorized Youth-Appealing E-Cigarettes; FDA Roundup: February 6, 2024 (Food and Drug Administration)

CDC's new Tips From Former Smokers ads include messages on the harms of menthol

The Centers for Disease Control and Prevention’s Tips From Former Smokers campaign returned with new ads to encourage people to quit smoking. This year, seven new people are featured in the ads sharing their stories about how cigarette smoking and smoking-related diseases have negatively impacted their lives. Many of this year’s new ads include messaging about the harms of menthol cigarettes, which can contribute to tobacco-related health disparities.

Source: CDC’s Tips From Former Smokers® Launches New Ads to Encourage People to Quit Smoking (Centers for Disease Control and Prevention)

DOJ reaches settlement with eBay over pill press machines sold on the site

EBay will pay $59 million in a settlement with the Department of Justice (DOJ) over thousands of pill press machines sold on the platform. The DOJ says the company failed to verify buyers’ identities and keep records required by law, and many people who bought pill presses on eBay have been prosecuted in connection with trafficking illegal counterfeit pills. EBay maintains it did not break the law. The company said it had removed pill-making equipment on its own and blocked “tens of thousands” of listings before the DOJ got involved. Still, the DOJ says there were thousands of cases where people bought pill presses on eBay, including high-capacity presses capable of producing thousands of pills per hour. Hundreds of buyers also got counterfeit molds or dies that allowed them to make pills mimicking prescription pills.

Source: EBay will pay $59 million settlement over pill presses sold online as US undergoes overdose epidemic (Associated Press)

More work is needed to move beyond stigma in addressing SUD

In a blog for the National Institute on Drug Abuse’s (NIDA) 50th anniversary, director Nora Volkow highlights progress made and the long way to go on addressing addiction and moving beyond stigma. Even if medical science has changed its views on addiction, policies and social structures have been slower in moving toward a public health approach. Effective, cost-effective prevention initiatives are not widely implemented, and evidence-based treatment remains hard to access and is unevenly distributed. Providers who could prescribe buprenorphine still don’t, potentially from a lack of confidence in treating addiction, stigma or inadequate reimbursement. Methadone is only available at specialized clinics. We still do not have medications to treat other substance use disorders. NIDA is looking at new compounds, drug targets and other novel treatment approaches; is increasing funding for implementation research; is funding research and capacity building efforts to address racial and other health disparities; and is conducting harm reduction research.

Source: 50 years after founding, NIDA urges following science to move beyond stigma (National Institute on Drug Abuse)

States reach opioid settlements with advertising agency Publicis and opioid manufacturer Hikma

State attorneys general secured $350 million from Publicis Health for the company’s role in the opioid crisis. Publicis, one of the largest health care advertising companies, developed predatory and deceptive marketing strategies for Purdue to increase opioid prescriptions and sales. This is the first opioid settlement with an advertising agency. Publicis worked with Purdue between 2010 and 2019 to develop marketing campaigns and materials promoting opioids, including materials that promoted OxyContin as safe and unable to be intentionally misused. Publicis also conspired with McKinsey and Practice Fusion to push false and deceptive strategies to increase opioid sales. Publicis will pay $350 million within 60 days to address the crisis and is prohibited from accepting future contracts/engagements related to opioid marketing/sales. Publicis must release internal documents detailing its work for opioid manufacturers and with McKinsey and Practice Fusion. Attorneys general also reached a $150 million multistate settlement in principle with opioid manufacturer Hikma Pharmaceuticals, alleging it failed to monitor and report suspicious opioid orders from potentially illegal distributors between 2006 and 2021.

Source: Attorney General James Secures $350 Million from Publicis for its Role in the Opioid Crisis; Attorney General James Secures $150 Million Multistate Settlement in Principle with Hikma Pharmaceuticals to Help Combat Opioid Crisis (New York State Attorney General)

Boston dedicates some opioid settlement funds to families of those who died from overdose

Boston plans to create a $250,000 annual fund using a small portion of the more than $22 million in opioid settlements the city expects to receive through 2038 to provide money to families coping with an overdose death. Families will be able to apply to the fund for help with funeral costs, legal expenses or child care. This is the first concrete plan the city has announced for spending settlement funds. The $250,000 is just 4% of the city’s first-year payment of $6 million, but family assistance was the top priority for more than 600 residents and addiction services providers who responded to a survey or attended listening sessions about settlement spending. Groups tracking the use of opioid settlement funds nationwide said they do not know of another municipality giving money to bereaved families.

Source: Boston dedicates small portion of opioid settlement funds to grieving families (WBUR)

Providence approves Rhode Island's first overdose prevention center

More than two years ago, Rhode Island became the first state to authorize overdose prevention centers. Last week, the Providence City Council approved the establishment of what will be the state’s first site. Minnesota is the only other state to approve the sites, but no facility has opened there yet. The Providence center, located next to the campus of Rhode Island Hospital, will be run by the nonprofit Project Weber/RENEW and VICTA, a privately owned outpatient substance use disorder and mental health treatment program. A majority of funding for the center will come from opioid settlement money. The center will be subject to regulation by the state health department. The center is set to offer substance use-related resources, as well as services including food and showers, case management and housing support. Officials hope the center can open later this year.

Source: Providence Officials Approve Overdose Prevention Center (The New York Times)

Study finds high schoolers who use cannabis, alcohol or nicotine were more likely to report mental health disorder symptoms

A study based on a survey of 15,000 high school students across Massachusetts 2022-2023 found that high school students who reported using cannabis, alcohol or nicotine were more likely to have thoughts about suicide, feel depressed or anxious, have unusual experiences and exhibit inattention or hyperactivity. Alcohol use, cannabis use and nicotine use were each associated with an increased prevalence of suicidal thoughts, depression/anxiety symptoms, psychotic experiences and ADHD symptoms. Thoughts of suicide were five times more prevalent among high school students who used substances daily or near daily compared with those who did not. Increases in psychiatric symptoms were detected even among adolescents with relatively low levels of use. The findings were replicated when responses from a national survey conducted in 2021 were examined.

Source: High school students who report using alcohol, cannabis or nicotine at higher risk for suicidal thoughts and other mental health disorders (Massachusetts General Hospital)