CEO Update 193
FDA & FTC Issue Warnings to Crack Down on Illegal Sales of Food Products with Delta-8 THC
The Food and Drug Administration (FDA) and the Federal Trade Commission this week issued warnings to five companies to crack down on illegal sales of food products containing delta-8 THC.
The products’ packaging resemble familiar snacks and candies, potentially leading to accidental ingestion or overconsumption. The agencies are especially concerned about the appeal to children and potential impurities or unpredictable effects from processes used to synthesize delta-8 THC, the psychoactive cannabinoid from the Cannabis sativa plant.
The companies have 15 working days to submit written responses detailing how they will address these violations and prevent future ones. If the violations are not addressed promptly, the agency may take legal action.
From Jan. 1, 2021, to Dec. 31, 2023, the FDA received more than 300 adverse event reports involving children and adults who consumed delta-8 THC products. In response, the agency issued a warning to customers in June 2022. Meanwhile, between Jan. 1, 2021, and May 31, 2022, national poison control centers handled 10,448 single substance exposure cases involving edible products containing THC, 77% of them for people 19 or younger.
Adverse effects can include hallucinations, vomiting, tremor, anxiety, dizziness, confusion and loss of consciousness, the agency said.
Joint Commission’s Revised Guidelines for Restraint and Seclusion to Begin Next Year
The Joint Commission has announced new and revised requirements will apply to behavioral healthcare and human services organizations that use restraint and/or seclusion starting on Jan 1, 2025.
The changes include revising the definition of restraint; reducing redundancies; streamlining processes; and removing requirements for physical holding of a child or youth and incorporating this concept into the requirements for restraint and seclusion because physical holding that restricts freedom of movement is a type of restraint.
Click here to learn more.
DEA Rule on Telehealth Slated for September
The Drug Enforcement Administration is expected to issue its highly anticipated telehealth prescribing rule in September, according to an article in Inside Telehealth, an Inside Health Policy publication.
“A last-minute title change of the proposed rule may indicate that the registration could allow for prescribing controlled substances across state lines, sources say,” the article noted.
The article also said the rule’s title was updated to “Special Registrations for Telemedicine and Limited State Telemedicine Registration,” according to DEA’s spring regulatory agenda published July 5.
NIH Study: Doctors Reluctant to Treat Addiction Report Lack of Support as Barrier
A new National Institutes of Health study found “instiutional environment” as the most frequently reported reason why physicians are reluctant to intervene in addiction treatment.
“Institutional environment” refers to factors such as lack of support from a physician’s institution or employer; insufficient resources, such as staff and training; challenges in organizational culture; and competing demands. This reason for reluctance was cited in 81% of the studies reviewed, followed by insufficient skill (74%), lack of cognitive capacity to manage a certain level of care (74%), and inadequate knowledge (72%).
Meanwhile, about 66% of studies cited negative social influences – or beliefs about public and community acceptance of addiction care – while 56% of studies cited fear of harming the patient-physician relationship as deterrents for physicians to intervene in addiction.
The study’s findings highlighted the need for institution-wide changes to improve the adoption of evidence-based substance use disorder treatment practices among physicians, such as increasing organizational support, leadership and staff buy-in, and education and training.
Kaiser Family Foundation to Host ‘Beyond Chevron: How the SCOTUS Decision will Affect Healthcare Policy Decisionmaking’ Webinar Next Week
The Kaiser Family Foundation (KFF) will host a webinar next week to discuss the potential challenges stemming from the U.S. Supreme Court’s decision on June 28 to overturn the Chevron precedent that required federal courts to defer to reasonable agency decisions when federal law is unclear.
Moderated by KFF Executive Vice President for Health Policy Larry Levitt, the discussion will address questions such as: How will the decision change how regulators approach drafting new regulations? What type of health policy regulations are likely to be most vulnerable to future court challenges? How will it alter the legislative process and the ability to pass new laws? And to what extent will Congress be able to provide greater specificity in delegating authority to federal agencies in future legislation?
The 45-minute webinar will be held on Thursday, July 25 at Noon ET. Click here to register.
Behavioral Health Business to Examine ‘How AI is Making Healthcare More Human’ in August Webinar
The publication Behavioral Health Business will host a webinar next month to explore how AI could potentially enhance humanity in behavioral health.
The discussion will examine how AI could extend to underserved communities, improve patient outcomes, and increase both clinician and patient satisfaction.
It also promises to highlight new research involving 130,000 patients that shows people are significantly more likely to begin therapy when their experience starts with Limbic, an AI-powered clinical assessment, with the most positive effects observed among minority groups.
The webinar will be held Thursday, Aug. 22 at Noon ET. Click here to register.
Reminder: SAMHSA Announces Funding Opportunity to Enhance Capacity of Women’s Behavioral Health Providers
SAMHSA is accepting applications for its Women’s Behavioral Health Technical Assistance Center to enhance capacity of women’s behavioral health providers, general healthcare providers, and others involved in the holistic care of women with or at risk for mental health and substance use conditions—including women who were greatly affected by the COVID-19 pandemic.
The agency said it has a total of $12.5 million for five years and anticipates granting one award. Applications are due by Tuesday, Aug. 20, 2024. Click here to learn more.
Reminder: Please Submit Data to NABH’s Denial-of-Care Portal
We urge all NABH members to join those already submitting data to our Denial-of-Care Portal.
We are beginning to use aggregated portal data to illustrate and compare prior authorization practices for commercial, Medicare Advantage, and Medicaid managed care denials.
Policymakers have expressed particular interest in our aggregate estimate on days of uncompensated charity care, as well as the length of delayed health plan responses to prior-authorization requests.
To support this advocacy push, we strongly encourage all NABH members to submit data to the portal. Please contact NABH Associate Manager for Congressional Affair Emily Wilkins with questions about the data metrics that we are collecting and/or the data-submission process.
Fact of the Week
Early population estimates from the Centers for Disease Control and Prevention (CDC) show that around 7% of the entire U.S. adult population reported having Long COVID in 2022. “Some of the most common mental health conditions associated with Long COVID include fatigue, sleep disturbances, depression, anxiety, psychosis, cognitive impairment, obsessive-compulsive disorder, and posttraumatic stress disorder,” the Substance Abuse and Mental Health Services Administration (SAMHSA) reported recently. “Both COVID-19 and Long COVID can result in new onset of behavioral health conditions in those who have not previously reported these conditions, and aggravate complications for those with pre-existing mental health conditions and substance use disorders.”
For questions or comments about this CEO Update, please contact Jessica Zigmond.