Addiction-related regulatory changes likely in 2024
Several federal regulatory changes related to addiction could happen this year. A revised proposed rule on telemedicine to treat opioid use disorder (OUD) is expected after COVID flexibilities were extended until November 2024. A finalized rule on confidentiality of addiction patient records is expected soon. A final rule revising treatment standards for methadone in opioid treatment programs (OTPs) is also expected. The proposed rule includes proposals to make permanent the pandemic-era methadone take-home allowances; use telehealth to initiate treatment with buprenorphine; expand the definition of practitioner to include advanced nurse practitioners, physician assistants, etc.; review accreditation standards; and remove the requirement that patients be diagnosed with OUD at least one year before OTP admission. Rules to prohibit menthol cigarettes and flavored cigars could also come in 2024. The Food and Drug Administration could expand access to buprenorphine doses above 24 mg. A proposed rule could permit coverage with no cost-sharing for certain over-the-counter products, including tobacco cessation products. There could be a reduction in barriers to contingency management through a potential safe harbor for evidence-based incentives. The federal government is likely to act on pending state Medicaid waivers to allow coverage of certain services for incarcerated individuals.
Source: ASAM Advocacy Previews 2024 Regulatory Agenda (American Society of Addiction Medicine)
Iowans impacted by opioid crisis skeptical of GOP rhetoric
Ahead of the Iowa caucuses, Republican presidential candidates were racing to outdo one another with what experts describe as ineffective or misleading ideas for combating the fentanyl crisis. Trump has accused undocumented immigrants of carrying illegal substances into the country and called for military strikes on cartels in Mexico. Haley has compared opioid deaths to war deaths to emphasize the scale of the crisis and has proposed sending U.S. Special Forces to Mexico to respond to fentanyl trafficking. DeSantis has frequently told the story of a toddler who ingested fentanyl in an Airbnb and said as president he would authorize the use of deadly force against anyone who appears to be sneaking fentanyl across the border. Campaigns focusing on Mexico and border security are an easier sell than focusing on the underlying reasons people use substances. Overdose prevention advocates say Biden and the Democrats are not nearly as vocal about the issue as Republicans. While the GOP rhetoric has been especially resonant with the conservative base, it has met skepticism by those affected by the crisis.
Source: ‘It’s just talk’: Iowans touched by fentanyl call out presidential candidates on rhetoric (The Washington Post)
NIDA study finds reduced substance use is a meaningful treatment outcome
A study from the National Institute on Drug Abuse assesses the validity of reduced stimulant use as an outcome measure in randomized controlled trials of pharmacological interventions for stimulant use disorder. More participants reduced frequency of primary substance use than achieved abstinence. Reduced use was significantly associated with decreases in craving for the primary substance, drug seeking behaviors and depression severity, as well as multiple measures of improvement in psychological functioning and severity of substance-related problems. Reduced frequency of stimulant use appears to be associated with meaningful improvement in various clinical indicators of recovery. Assessment of reduced use, in addition to abstinence, could broaden the scope of outcomes measured in trials of stimulant use disorders and facilitate the development of more diverse treatment approaches.
Source: Reduced drug use as an alternative valid outcome in individuals with stimulant use disorders: Findings from 13 multisite randomized clinical trials (Addiction); Reduced drug use is a meaningful treatment outcome for people with stimulant use disorders (National Institute on Drug Abuse)
FDA review on marijuana evidence released
The Department of Health and Human Services released the Food and Drug Administration (FDA) review that led it in August to recommend moving marijuana to Schedule III. It concluded that marijuana is less harmful than other dangerous substances and that there is some evidence of its medical benefits. The Drug Enforcement Administration will have final say in changes to marijuana’s classification, with a decision expected in coming months. The review was based on eight scientific criteria, including potential for misuse, the state of current scientific knowledge and the likelihood of psychological or physiological dependence. The FDA looked at using marijuana for anorexia, anxiety, epilepsy, inflammatory bowel disease, nausea and vomiting, pain and PTSD. The review identified “mixed findings of effectiveness across indications.” Schedule I classification indicates that there is no indication for medical use, which this review counters. The review concludes that while intentional misuse of marijuana produces clear evidence of harmful consequences, including addiction, they are relatively less common and less harmful than some other substances.
FDA issues marketing denial orders for SMOK products
The Food and Drug Administration issued marketing denial orders for 22 SMOK brand e-cigarette products, including devices, pods, atomizers and cartridges. The products are not sold with an e-liquid. A consumer instead adds their separately purchased e-liquid into the device. Therefore, the products have the potential to be used with any e-liquid on the market and available to the consumer, which could include tobacco-flavored and non-tobacco-flavored e-liquids. According to the 2023 National Youth Tobacco Survey, SMOK was the sixth most commonly reported brand among current youth e-cigarette users, with 11.3% of middle and high school students reporting past 30-day use of SMOK products.
Source: FDA Denies Marketing of SMOK E-Cigarette Products (Food and Drug Administration)
State and local news
States to drive health policy issues in 2024
State lawmakers are increasingly driving policy debates as Congress is at a growing impasse. With 40 state governments entirely controlled by one party, there is little risk of partisan gridlock. The biggest policy debates taking shape in states this year include a wide range of issues. State officials remain alarmed about the overdose crisis and could throw substantial sums, including from opioid settlements, at it. Lawmakers are facing pressure to boost transparency in settlement fund use. West Virginia lawmakers are advancing a bill that would require the foundation overseeing spending to make meetings public. Proposals to decriminalize fentanyl test strips, expand access to naloxone and establish parity are also top legislative priorities. State legislators are considering bills on psychedelics, including to fund more research, decriminalize them and/or legalize them for therapeutic use. Republican legislative leaders in a few states have signaled an openness to adopting full Medicaid expansion. State lawmakers across the country are seeking to bolster protections for children using social media.
Source: Here are the issues we are all going to be fighting about in 2024 (Politico)
States ask federal government to re-schedule marijuana and ban menthol cigarettes
Twelve state attorneys general sent a letter to the Drug Enforcement Administration asking that cannabis be moved from Schedule I to Schedule III. The states are seeking a greater degree of uniform regulation nationwide, which they say would allow them to bring in revenue from legal cannabis businesses and consumers’ sales tax. They said revenue could then be applied to public health and safety measures, and that the change would help eliminate unlawful and unmonitored marijuana use. Separately, 21 attorneys general sent a letter urging the Biden administration to complete its review and swiftly implement proposed rules to prohibit the sale of menthol cigarettes and flavored cigars. The coalition highlights calls for action by civil rights and public health groups to remove menthol products from the market to protect public health and address the systemic and disproportionate impact on minority communities and other vulnerable populations, including young people. They address unfounded claims that the ban would increase illicit trade or criminalize individual purchase, possession or use of menthol cigarettes and flavored cigars.
Source: Colorado, 11 other states ask feds to reclassify cannabis (CBS); Attorney General Bonta Leads Coalition to Urge Biden Administration to Implement Ban on Menthol Cigarettes and Flavored Cigars (California Attorney General)
Rhode Island using opioid settlement funds for family, basic need and trauma supports
The Rhode Island Foundation, in partnership with the Rhode Island Executive Office of Health and Human Services, is accepting applications for $1.7 million in grants to help address the opioid crisis, funded with opioid settlement funds. The Foundation will make grants in three categories – family supports, basic needs supports and trauma supports. In the Family Supports category, $450,000 is available to support programming by organizations made up of or serving families of people who use substances, people in recovery or people who have passed away because of an overdose. In the Basic Needs Support category, $250,000 is available for organizations that support individuals and families who are impacted by substance use or at risk of an overdose by providing funding for “care packages,” such as bedding, food, clothing and transportation, among other expenses. In the Trauma Supports category, $1 million is available to fund innovative, trauma-informed services targeting first responders, including peer harm reduction and recovery specialists, focused on addressing post-traumatic stress due to the sharp rise in overdoses.
Source: Nonprofits can apply for $1.7 million for opioid recovery and support services (Rhode Island Foundation)
Colorado announces plan for youth behavioral health
Colorado released a Children and Youth Behavioral Health Implementation Plan (summary), following years of stakeholder meetings, gathering testimony and input, system review, launching a new state department and auditing the behavioral health system. The vision for the children and youth behavioral health system in the state is to be a comprehensive, equitable, effective continuum of behavioral health services that meets the needs of children and youth in the right place, at the right time, to achieve whole-person health and wellbeing. State agencies will work together and support efforts to promote the wellbeing of children and youth; establish a comprehensive continuum of behavioral health services; create the foundation for a system of care framework unique to Colorado; reduce barriers to access and affordability of care; support a competent and adequate workforce; and have accountability and oversight to ensure a quality behavioral health system.
Source: Colorado Announces Statewide Strategy for Children’s Behavioral Health System ‘(Colorado Behavioral Health Administration)
Washington state offering naloxone to high schools
The Washington Department of Health is offering naloxone to all public high schools across the state. The department is partnering with the Educational Service Districts to offer all public comprehensive and alternative high schools two kits of intranasal naloxone. The offer is voluntary and supports the Washington law requiring school districts with 2,000 students or more to stock at least one set of opioid overdose reversal medication in each high school. Smaller districts may also choose to obtain and maintain naloxone in their schools.
Source: Department of Health offers naloxone to high schools to combat youth opioid overdoses (Washington State Department of Health)
New York providing information on youth vaping cessation services
The New York State Department of Health and the Education Department are working to provide students with materials that will inform them about free services available to help them successfully quit vaping. The health department has developed posters, palm cards and rack cards for middle schools and high schools/young adults, in both English and Spanish, to promote the services of ‘DropTheVape,’ a confidential text-based service, and the New York State Smokers’ Quitline. DropTheVape is a free, confidential text-based youth vaping cessation service for youth 13-17 and young adults 18-24. It is evidence-based and was developed by the Truth Initiative with input from young people who want to quit vaping. The messages show the benefits and challenges of quitting to help young people feel motivated, inspired and supported through their quitting process.
Source: New York State Department of Health Launches Effort to Reduce Vaping Among Youth (New York Department of Health)