Policy News Roundup: January 19, 2023

Key reads

SAMHSA and DEA remove buprenorphine waiver requirement

The Substance Abuse and Mental Health Services Administration (SAMHSA) issued a statement on removal of the buprenorphine waiver requirement in the Consolidated Appropriations Act, 2023. The law removes the requirement for practitioners to submit a Notice of Intent (have a waiver) to prescribe buprenorphine to treat opioid use disorder (OUD). Effective immediately, SAMHSA will no longer be accepting waiver applications. All practitioners who have a current Drug Enforcement Administration (DEA) registration that includes Schedule III authority may now prescribe buprenorphine for OUD if permitted by state law, and SAMHSA encourages them to do so. SAMHSA and DEA are working on implementation of a separate provision in the law related to training requirements for DEA registration that becomes effective in June. DEA sent a letter to registrants on the elimination of the waiver. Going forward, all prescriptions for buprenorphine only require a standard DEA registration number, and there are no patient caps.

Source: Removal of DATA Waiver (X-Waiver) Requirement (Substance Abuse and Mental Health Services Administration)

Hospitals struggle to treat addiction in endocarditis patients

Hospitals often have few protocols for treating endocarditis patients who use opioids. A study found that the incidence rate of endocarditis among patients with opioid or cocaine use disorder significantly increased between 2011 and 2022, with acceleration between 2021 and 2022 and an association with COVID. Endocarditis patients with addiction are often not treated for the severity of withdrawal symptoms. Even when they are, they often get released from the hospital without linkage to care. When addiction remains untreated, patients often are readmitted for repeat infections, leading to frustration and stigma from providers. Some doctors seek long-term care facilities for patients, but skilled nursing facilities often refuse to accept patients with addiction. The American Heart Association issued recommendations for endocarditis care that revolve around treating underlying addiction. The Justice Department issued guidance and announced settlements/lawsuits to force facilities to admit patients prescribed medications for opioid use disorder. Most hospitals do not have addiction experts, forcing cardiologists and infectious disease specialists to treat addiction, which they are sometimes ill-equipped to do.

Source: The addiction crisis is causing a spike in endocarditis cases. Hospitals are struggling to respond (STAT)

FDA releases new youth smoking prevention ads

The Food and Drug Administration’s “The Real Cost” Youth Cigarette Prevention Campaign launched two new ads, which for the first time will focus on the negative mental health effects of cigarette smoking and withdrawal in an ad. One ad highlights the fact that cigarette withdrawal can lead to anxiety, and the other highlights the fact that three out of four teens who smoke will continue to smoke into adulthood. Both ads will be placed nationally on youth-focused channels across digital platforms, social media and streaming radio, as well as on TheRealCost.org. When youth click on the ads, they will receive more information and resources for those struggling with nicotine addiction, mental health and more.

Source: FDA Releases New Ads, including First Focused on Mental Health Effects of Cigarette Smoking among Youth (Food and Drug Administration)

States continue to spend little of tobacco settlement funds on tobacco prevention and cessation

The Campaign for Tobacco-Free Kids released a report highlighting how states continue to shortchange programs designed to prevent kids from using tobacco products and help tobacco users quit. In FY 2023, states will collect $26.7 billion from the 1998 tobacco settlement and tobacco taxes, but they will spend just 2.7% ($733.1 million) on tobacco prevention and cessation. This is a $14.5 million increase from last year but still less than a quarter of total funding recommended by the Centers for Disease Control and Prevention (CDC). The increase can be attributed primarily to Oregon, Maine, Connecticut, Maryland and Oklahoma. Despite these increases, only Oregon and Maine currently fund tobacco prevention and cessation at or above CDC-recommended levels, and only seven other states provide even half the recommended amount. In contrast, the tobacco industry spends $9.1 billion annually to market their products in the U.S. Tobacco companies spend more than $12 to market tobacco products for every $1 states invest to reduce tobacco use.

Source: New Report: States Continue to Shortchange Tobacco Prevention Programs, But Several Show a Welcome Increase (Campaign for Tobacco-Free Kids)

R.J. Reynolds marketing new cigarettes following California's flavor ban

Anti-smoking experts argue that R.J. Reynolds is trying to circumvent California’s new ban on flavored tobacco by luring smokers with what it says are new non-menthol versions offering “a taste that satisfies the senses” and “a new fresh twist.” The campaign is viewed by critics as a provocation of California authorities who are supposed to enforce the ban, which includes a provision outlawing packaging or claims that suggest a product has a flavor. R.J. Reynolds said the products comply with requirements and that the new cigarettes are not subject to the ban because they do not have a distinguishable taste or aroma other than tobacco. Fliers for the new products were mailed to Reynolds’s customers who had sought coupons. The products being marketed as “new” may also challenge Food and Drug Administration (FDA) authority, as new products must be cleared by the FDA according to the Tobacco Control Act.

Source: R.J. Reynolds Pivots to New Cigarette Pitches as Flavor Ban Takes Effect (The New York Times)

Missouri launching statewide prescription drug monitoring program

After years of Republican resistance, Missouri is set to launch a statewide prescription drug monitoring program. The state is contracting with Bamboo Health, which was already overseeing a county-level program operated by St. Louis County. The effort to establish a statewide program was largely blocked by former Sen. Rob Schaaf, who expressed concerns about patient privacy. St. Louis established its program in 2017, and 75 local jurisdictions agreed to participate, covering 85% of the state. Health officials said opioid prescriptions decreased dramatically once the county established the program. A law for a statewide program was finally enacted in 2021. Under the plan, pharmacists who dispense controlled substances will be required to enter prescriptions into the database, which would then be made accessible to doctors.

Source: State-run opioid monitoring program ready to launch in Missouri (St. Louis Post-Dispatch)

Illinois fines insurer for parity violations

The Illinois Department of Insurance announced a $500,000 fine for Quartz Health Insurance Corporation for violating parity, as revealed in the department’s comprehensive market conduct exam. The company failed to utilize statutory and American Society of Addiction Medicine (ASAM) requirements by imposing prior authorization on substance use disorder (SUD) claims; failed to include all SUD medications on the formulary (did not include brand-name prescription drugs); created consumer access barriers (prior authorization) to naltrexone; created a barrier to access without disruption to anti-anxiety and antipsychotic medications by limiting maximum fill to 30 days (rather than 90); and improperly imposed step therapy.

Source: Pritzker Administration Announces a $500,000 fine for Quartz Health Insurance Corporation for Violation of the Mental Health Parity and Addiction Equity Act (Illinois.gov)

New Jersey expands access to addiction treatment in homeless shelters

The New Jersey Department of Human Services awarded contracts to increase access to medications for addiction treatment at homeless shelters. Under the program, licensed providers will provide medication for addiction and support services for individuals who reside or drop in at homeless shelters. The providers will help the individual maintain treatment with medication or transition the individual to a community provider to do so. Providers will identify and designate staff in the shelter who will lead the efforts; initiate same-day medications; contact or employ staff with credentials to prescribe; and contact or employ case/care managers and peers to engage patients in treatment and social services and assist with care transitions. They will also create a welcoming and non-stigmatizing atmosphere; dispense naloxone; connect individuals to an affiliated federally qualified health center for treatment of physical and mental health and chronic pain; and implement harm reduction strategies and interventions to address addiction.

Source: Human Services Awards Contracts to Provide Medication that Supports Addiction Recovery at Homeless Shelters (New Jersey Department of Human Services)

New Jersey pharmacies can provide naloxone for free and anonymously

Following an announcement in New Jersey Governor Phil Murphy’s State of the State address, the Department of Human Services detailed how individuals would soon be able to anonymously obtain naloxone for free at participating pharmacies at any time. Those 14 years and older will be able to request and obtain naloxone at participating pharmacies for free without having to provide a name or reason. The program will be funded with federal grant money.

Source: Human Services Commissioner Details Plan to Enable Pharmacies to Provide Individuals with Life-Saving Naloxone for Free and Anonymously (New Jersey Department of Human Services)

Study shows better retention for pharmacy-based buprenorphine treatment

In a pilot study of pharmacy-based buprenorphine induction in Rhode Island, researchers documented the experiences of 100 patients who started taking buprenorphine after visiting a specially trained pharmacist for care. Once stabilized on the medication, 58 patients were randomly assigned to receive either continued care in the pharmacy or usual care in a clinic or physician’s office. After one month, the patients in the pharmacy group showed dramatically higher rates of retention – 89% continued to receive treatment in the pharmacy compared to 17% in the usual care group. A third of patients in the study identified as Black, Indigenous or people of color, and almost half were without a permanent residence. The opportunity to open pharmacies for addiction treatment is expanding in 2023, as recent changes signed into law will make it easier for health professionals to prescribe buprenorphine. Currently, 10 states allow pharmacists to obtain authorization to prescribe controlled substances such as buprenorphine.

Source: Pharmacists can start patients on road to recovery from opioid use disorder, study shows (Brown University)

Better data needed to encourage insurance coverage for longer duration of addiction treatment