Policy News Roundup: December 1, 2022

Key reads

COVID pandemic likely has varied effects on youth substance use

Partnership to End Addiction’s Vice President of Prevention Research and Analysis Linda Richter discusses the effects of COVID-19 on youth substance use risk. COVID provided protective benefits for some, while contributing to risk factors for others. A new study on alcohol use behaviors among Canadian youth shows a decline in youth drinking during the initial phase of the pandemic, when stay-at-home mandates were prevalent, with an uptick in the second pandemic year once restrictions loosened. The early decrease was more prominent among less frequent drinkers, supporting the idea that pandemic restrictions may have been the most protective for less vulnerable youth and not as protective for those at higher risk. The usual demographic variables (gender, age, race/ethnicity, socioeconomic status) remain important to explore but only scratch the surface of strengths and vulnerabilities impacted by the pandemic that likely impact youth substance use. To better understand the effects of the pandemic on youth substance use risk, key variables to consider include family dynamics, adult modeling of substance use, social isolation, time spent with parents, school stress, sleep, reduced access to substances and age of initiation.

Source: Taking Stock of the Downstream Effects of COVID-19 on Youth Substance Use Risk (Journal of Adolescent Health)

NIDA's Nora Volkow supports eased methadone regulations

National Institute on Drug Abuse Director (NIDA) Nora Volkow said that American doctors should “absolutely” be allowed to prescribe methadone directly to patients. She said that in countries where physicians provide methadone, the outcomes are as good as at methadone clinics. The comments represent perhaps the strongest call yet from a high-profile government official in favor of broad deregulation of methadone. She said that methadone is underutilized in part because of its stringent requirements. Volkow advocated for pharmacists to be allowed to dispense methadone to patients in consultation with a physician. She also gave her de facto endorsement to supervised injection. She said that some data is available from facilities in Canada and Australia and that the ones that have done the research have shown that it has saved a significant percentage of patients from overdosing. She also argued that NIDA should be renamed to the “National Institute of Drugs and Addiction” to eliminate the word “Abuse.”

Source: Top U.S. addiction researcher calls for broad deregulation of methadone (STAT)

HHS issues proposed rule revising 42 CFR Part 2 privacy rules

The Department of Health and Human Services (HHS) announced proposed changes to 42 CFR Part 2, which protects patient privacy and records concerning substance use treatment from unauthorized disclosures. The proposed rule increases coordination among providers and increases protections concerning records disclosure. The rule would implement Sec. 3221 of the CARES Act, which requires HHS to bring Part 2 into greater alignment with HIPAA. Proposed changes include permitted use and disclosure of Part 2 records based on patient consent given once for all future uses and disclosures for treatment, payment and health care operations; permitted redisclosure in any manner permitted by HIPAA, with certain exceptions; new patient rights to obtain an accounting of disclosures and to request restrictions on certain disclosures; expanded prohibitions on the use and disclosure of records in civil, criminal, administrative and legislative proceedings; new HHS enforcement authority, including imposition of civil monetary penalties for violations; updated breach notification requirements; and updated HIPAA requirements to address uses and disclosures of Part 2 records and individual rights with respect to those records.

Source: HHS Proposes New Protections to Increase Care Coordination and Confidentiality for Patients With Substance Use Challenges (Substance Abuse and Mental Health Services Administration)

FDA issues warning letters to companies illegally selling e-cigarettes and CBD

The Food and Drug Administration (FDA) issued warning letters to five firms for the unauthorized marketing of 15 different e-cigarette products packaged to look like toys, food or cartoon characters and likely to promote use by youth. None of the manufacturers submitted a premarket application for any of the unauthorized products. The products include e-cigarettes that are designed to look like toys and youth-appealing electronics like glow sticks, Nintendo Game Boy and walkie-talkies; feature youth-appealing characters from TV shows, movies and video games; or imitate foods like popsicles. The FDA also posted warning letters to five companies for illegally selling CBD products, including products that people may confuse with traditional foods or beverages, which may result in unintentional consumption or overconsumption. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning. Some are illegally selling CBD products that claim to cure, mitigate, treat or prevent various diseases or that add CBD to animal foods.

Source: FDA Warns Firms for Selling Illegal E-cigarettes That Look Like Toys, Food, and Cartoon Characters (Food and Drug Administration); FDA Warns Companies for Illegally Selling Food and Beverage Products that Contain CBD (Food and Drug Administration)

Senators introduce bill to improve behavioral health network adequacy

Senators Tina Smith (D-Minn.) and Ron Wyden (D-Ore.) introduced the Behavioral Health Network and Directory Improvement Act to crack down on ghost networks and create stronger enforcement standards to protect those seeking mental health care. The bill would require health plans and the federal government to conduct audits on the accuracy of plans’ provider networks; authorize the federal government to issue civil monetary penalties against plans for failure to comply with network adequacy and directory accuracy requirements; and require providers to regularly update the information they submit to plans, including information on whether they can accept new patients. The bill would also raise network adequacy standards, including by considering the ratios of providers to patients, appointment wait times and geographic accessibility of providers; establish ombudsman programs to educate individuals on their parity rights and require plans to inform enrollees of plans with ghost networks that they may be eligible for a refund if they see a provider incorrectly listed as in-network; and require federal agencies to establish a standard for parity in reimbursement for mental and physical health services by private plans.

Source: Senators Smith, Wyden Introduce Legislation To Strengthen Mental Health Care Coverage, Hold Insurance Companies Accountable (Tina Smith)

Methamphetamine use plays an overlooked role in HIV

National Institute on Drug Abuse Director Nora Volkow writes in a blog for World AIDS Day on December 1 that even with multiple forms of HIV prevention now available, transmission rates remain elevated. Increased methamphetamine use may play an overlooked role. Meth use is more prevalent among gay and bisexual men than other men, and it often accompanies sex. The disinhibiting effects of meth can increase certain sexual behaviors that make HIV transmission more likely. Meth may also make the body more vulnerable to HIV acquisition and contribute to disease progression. We must recognize and respect the complexity and needs of sexual and gender minorities who use substances. People commonly experience stigma around sexuality and substance use, as well as racism, in health care settings, and clinicians must work with patients to rebuild trust. “Meeting people where they are” should apply to prevention and treatment of HIV and SUD. It is important to ensure access and coverage for HIV prevention and treatment and to expand education regarding substances and HIV, reducing stigma and overcoming other barriers to care.

Source: To Save Lives, We Must Dismantle Stigma at the Intersection of HIV and Methamphetamine Use (National Institute on Drug Abuse)

DEA issues alert on rise of lethality of fentanyl-laced pills

The Drug Enforcement Administration (DEA) issued a public safety alert in response to a sharp nationwide increase in the lethality of fentanyl-laced fake prescription pills. The DEA Laboratory has found that, of the fentanyl-laced fake prescription pills analyzed in 2022, six of ten now contain a potentially lethal dose of fentanyl, an increase from the DEA’s previous announcement in 2021 that four of ten contained a potentially lethal dose.

Source: DEA Laboratory Testing Reveals that 6 out of 10 Fentanyl-Laced Fake Prescription Pills Now Contain a Potentially Lethal Dose of Fentanyl (Drug Enforcement Administration)

Teva and AbbVie finalize opioid settlements

Teva and AbbVie finalized the terms of settlements worth more than $6.6 billion to resolve opioid lawsuits. Teva will pay up to $4.25 billion, including a supply of naloxone. AbbVie will pay up to $2.37 billion. The final amounts will depend on how many state and local governments opt into them. Teva and AbbVie did not admit wrongdoing. As part of the settlements, the companies have resolved a dispute between them over responsibility for claims stemming from generic opioid business that Allergan sold to Teva in 2016.

Source: Teva, AbbVie finalize $6.6 billion U.S. opioid settlements (Reuters)

NY issues first marijuana retail dispensary licenses

The New York Cannabis Control Board approved 36 businesses and nonprofits for licenses for the first retail marijuana dispensaries in the state, selecting them from 903 applicants. They are mostly businesses owned and controlled by people who have been convicted of cannabis-related offenses or their close relatives, as well as a few nonprofits that serve people with histories of arrest or incarceration. The first wave of applicants are vying for a total of 175 licenses, which allow operators to open up to three dispensaries. The Board advanced to a 60-day public comment period regulations on application and license selection/renewal processes, the role municipalities play in regulation, social and economic equity programs, environmental and sustainability standards, ownership and true party of interest prohibitions and general business operating requirements. It also voted to advance revised regulations on packaging, labeling, marketing and advertising and laboratory permitting, oversight and testing to a final comment period.

Source: These 36 Finalists Are Likely to Be New York’s First Marijuana Retailers (New York Times); Cannabis Control Board Approves First Conditional Adult Use Retail Dispensary Licenses (Office of Cannabis Management)

Oregon pardons marijuana possession offenses

Oregon Governor Kate Brown announced that the state will pardon prior offenses of simple possession of marijuana, weeks after President Biden urged governors nationwide to use their authority to do so. The pardon will impact about 45,000 individuals across the state and forgive more than $14 million in associated fines and fees. It will expunge 47,144 convictions for possession of a small amount of marijuana from individual records.

Source: The latest: After Biden call, Oregon governor grants pardons for marijuana offenses (Washington Post)

Overdose deaths seem to be plateauing, but experts urge caution

Preliminary data suggests that overdose deaths may have stopped rising, but experts are urging caution, noting that past plateaus did not last. Provisional data indicates that overdose deaths fell three months in a row. However, only eight states reported declines, while the others showed continued increases. Only four states reported sizable decreases of 100 or more (Maryland, Ohio, Pennsylvania, West Virginia), and they have some of the highest overdose death rates in the nation. Officials in these states said there was no single explanation but believe recent efforts may be paying off, citing public education/awareness campaigns, expanding treatment and naloxone distribution. Some researchers think a spike occurred during the COVID pandemic, when lockdowns isolated those with addiction and made treatment harder to get, and we are just returning to pre-COVID levels. More data is needed to confirm that, as numbers are still far above pre-pandemic levels.

Source: US overdose deaths may be peaking, but experts are wary (Associated Press)