Policy News Roundup: April 20, 2023

Key reads

CMS guidance encourages states to provide Medicaid coverage prior to reentry

The Centers for Medicare and Medicaid Services announced a new opportunity for states to help increase care for individuals who are incarcerated in the period immediately prior to their release. The new Medicaid Reentry Section 1115 Demonstration Opportunity would allow state Medicaid programs to cover services that address various health concerns, including substance use disorder and other chronic health conditions. The goal of the demonstration is to help Medicaid enrollees establish connections to community providers to better ensure their health care needs are met during reentry. It will allow states to cover a package of pre-release services for up to 90 days prior to the individual’s expected release date that could not otherwise be covered by Medicaid due to the longstanding statutory exclusion that prohibits Medicaid payment for most services provided to most people in the care of a state or county carceral facility.

Source: HHS Releases New Guidance to Encourage States to Apply for New Medicaid Reentry Section 1115 Demonstration Opportunity to Increase Health Care for People Leaving Carceral Facilities (Department of Health and Human Services)

Providing MOUD to incarcerated individuals reduces overdose deaths

A study found that offering medications for opioid use disorder (MOUD) to incarcerated individuals could reduce overdoses. Specifically, offering all three medications (buprenorphine, methadone and naltrexone) is the most effective at saving lives and is more cost-effective than offering no medication or only naltrexone. Among 30,000 incarcerated people with opioid use disorder, offering no MOUD was associated with nearly 41,000 treatment starts and 1,259 overdose deaths over five years. Offering naltrexone at release led to more than 10,400 additional treatment starts and 40 fewer overdose deaths. Offering all three medications at intake led to 12,000 additional treatment starts and 83 fewer overdose deaths. Among everyone with opioid use disorder in Massachusetts, offering only naltrexone averted 95 overdose deaths over five years (0.9% decrease in state-level overdose mortality), compared to 192 overdose deaths with all three medications (1.8% decrease). Offering all three medications was more cost effective than offering naltrexone only.

Source: Getting Anti-Addiction Meds to Prisoners Can Cut Overdose Deaths (HealthDay)

FDA requires updates to opioid safety labels

The Food and Drug Administration is requiring updates to the prescribing information for opioid analgesics. They include a new warning about opioid-induced hyperalgesia, a condition where opioids cause an increase in pain or increased sensitivity to pain. The changes are intended to provide clarity on appropriate patient populations for opioid treatment, appropriate dosage and administration and updated information on the risks associated with opioid use. The changes include stating that the risk of overdose increases as dosage increases for opioid pain medicines; immediate-release opioids should not be used for an extended period of time unless pain remains severe enough to require them and alternative treatment options continue to be inadequate; many acute pain conditions treated in the outpatient setting require no more than a few days of opioid medicine; and it is recommended to reserve extended-release/long-acting medicines for severe and persistent pain that requires extended treatment with a daily opioid and for which alternative treatment options are inadequate.

Source: FDA announces new safety label changes for opioid pain medicines (Food and Drug Administration)

DOJ, Treasury and State announce actions to target illicit fentanyl trafficking

The Department of Justice announced charges against several leaders of the Sinaloa Cartel. The sons of El Chapo, known as the Chapitos, allegedly took over as leaders after El Chapo was arrested and extradited to the U.S. (2016/2017). The indictments demonstrate that the cartel has been engaged in drug trafficking activities into the U.S. and violence, spanning over a decade and a half. The Chapitos are alleged to have consistently transported lethal amounts of cocaine, heroin, methamphetamine and fentanyl. Fentanyl trafficking, weapons and money laundering charges were unsealed against 28 defendants; narcotics, money laundering and firearms charges against four of the Chapitos; and narcotics, firearms and witness retaliation charges against one of the Chapitos’ leading assassins. The Treasury designated two entities and five individuals in China and Guatemala for supplying precursor chemicals to cartels in Mexico for production of illicit fentanyl intended for U.S. markets, and the State Department announced rewards offers for information leading to the arrest or conviction of 27 individuals for illicit fentanyl activity.

Source: Justice Department Announces Charges Against Sinaloa Cartel’s Global Operation (Department of Justice); U.S. Sanctions Suppliers of Precursor Chemicals for Fentanyl Production (Department of the Treasury); U.S. Actions Targeting Transnational Criminals for Illicit Fentanyl Activity (Department of State)

CMS rule expands behavioral health care access

The Centers for Medicare and Medicaid Services announced measures through the 2024 Notice of Benefit and Payment Parameters Final Rule that will make coverage more accessible, expand behavioral health care access, simplify choice and make it easier for millions of Americans to select a health plan in 2024. The rule establishes a permanent policy allowing Marketplaces to implement a new special enrollment period for people losing Medicaid/CHIP coverage and allows Assisters to provide more convenient and efficient help to consumers. It includes two new essential community provider (ECP) categories critical for delivering behavioral health care – Substance Use Disorder Treatment Centers and Mental Health Facilities. The rule will expand access to care by extending the requirement for plans to contract with at least 35% of available ECPs in a plan’s service area to apply to Federally Qualified Health Centers and Family Planning Providers. The rule also includes other expanded network adequacy requirements.

Source: HHS Finalizes Policies to Make Coverage More Accessible and Expand Behavioral Health Care Access for Millions of Americans in 2024 (Department of Health and Human Services)

CMS approves expansion of Medicaid funding for school-based services

The Centers for Medicare and Medicaid Services (CMS) approved a state plan amendment that will provide Illinois more Medicaid funding for children receiving Medicaid-covered health care services in schools, including mental health services. It allows schools to receive more Medicaid funding for services for all children with Medicaid, rather than only children with Individualized Education Programs (IEPs), programs tailored for children with disabilities. Illinois joins 11 other states that have expanded Medicaid payment for school-based health care services. Last year, the Departments of Health and Human Services and Education issued letters to states encouraging them to leverage federal resources, especially Medicaid, to expand school-based mental health services, and CMS released guidance outlining best practices for the delivery of health services in schools. CMS expects to release a Comprehensive Guide to Medicaid Services and Administrative Claiming, launch a school-based services Technical Assistance Center and provide grants to states to strengthen school-based health services.

Source: CMS Approves Illinois Proposal to Expand Access to Care for Kids in Schools (Centers for Medicare and Medicaid Services)

R.J. Reynolds uses new cigarettes to skirt California law, raising doubts about federal menthol ban

Sales of new cigarettes that mimic menthol are rising in California after the state banned flavored tobacco, a sign that the industry is undermining the new law and raising doubts about the Biden administration’s plans to ban menthol cigarettes. R.J. Reynolds launched cigarettes that contain an artificial, flavorless cooling chemical when the state’s ban when into effect in December. By March, sales were on pace to replace nearly half of menthol sales compared with last year. RJR has been packaging the new cigarettes in boxes similar to menthols and aggressively marketing them to menthol smokers. RJR claims the new products do not violate California law because they do not have a “distinguishable taste or aroma” other than tobacco. The proposed federal rule defines flavor as “the multisensory experience (i.e., taste, aroma and cooling or burning sensations in the mouth and throat) of a flavor during use of a tobacco product.”

Source: RJR uses California as test market for skirting coming national menthol cigarette ban (Politico)

Pennsylvania grapples with whether to spend opioid settlement funds on law enforcement or treatment

Pennsylvania is expected to receive more than $1 billion in opioid settlement funds. The governor has described the funding as earmarked for treatment, but county governments will control most of the funds, and some want to spend it on law enforcement. Counties have proposed spending money on, for example, a drug task force to prevent dealers from “preying on the community,” a device that can quickly identify substances and coroners to respond to opioid overdose deaths whose investigations could lead to criminal charges against whoever provided them. A 13-member oversight board is responsible for ensuring counties and local governments spend money appropriately. In February, it provided guidance on the law enforcement issue, but questions remain about how much discretion counties will have, and how transparent the decision-making process will be. Advocates are concerned that law enforcement spending could crowd out priorities that research has shown can reduce overdose deaths or other risks (such as naloxone, syringe services programs and medications for opioid use disorder).

Source: Expecting more than $1 billion in opioid settlement money, Pa. grapples with policing versus treatment (Spotlight PA)

Seattle mayor issues executive order to address the fentanyl crisis

Seattle Mayor Bruce Harrell issued an executive order to address the fentanyl crisis. It will direct the police department to prioritize efforts to disrupt distribution and sale of narcotics in concert with other law enforcement partners; launch a pilot expansion of the fire department’s Health One program to include an overdose response unit dedicated to quickly engaging overdose survivors to increase acceptance of services or referrals for support; pilot a contingency management program administered where people live instead of in a medical clinic; and site, explore funding for and work with public health partners to establish a post-overdose diversion facility where people can be brought after nonfatal overdoses to recover, get stabilized on medication and access resources. The order will also expand access to treatment and overdose reversal medications; and form a Public Health Work Group and Law Enforcement Task Force to analyze current strategies and programs and design improvements to increase effectiveness.

Source: DOWNTOWN ACTIVATION PLAN: Mayor Harrell Announces Immediate Actions to Revitalize Downtown; Issues Executive Order to Address Fentanyl Crisis (Seattle Office of the Mayor)

States increasingly restricting xylazine

States are increasingly looking to restrict access to xylazine. Pennsylvania announced yesterday that it will add xylazine to the state’s list of controlled substances (Schedule III), tightening regulations on the drug and allowing authorities to charge people who violate those rules. Last month, Ohio’s governor signed an executive order restricting xylazine through the state’s Board of Pharmacy, and West Virginia’s governor signed legislation to make it a controlled substance. The designations in Pennsylvania, Ohio and West Virginia allow veterinarians to continue using it but put them under tighter regulations on how it must be handled, tracked and stored. Xylazine is already a Schedule I controlled substance in Florida, and the state’s attorney general has urged the federal government to immediately add it to the controlled substances list.

Source: States restrict ‘tranq,’ animal sedative linked to overdoses (Associated Press)

More is needed to make naloxone accessible beyond OTC status

Jonathan JK Stoltman (Opioid Policy Institute, Reporting on Addiction) and Mishka Terplan (Friends Research Institute, Opioid Policy Institute) argue the victory of over-the-counter (OTC) naloxone may be overstated. OTC status will not meaningfully improve access for people who need it most. It will likely do little besides increase pharma profits and may decrease access. To increase access, solutions need to address medication affordability and distribution, as well as stigma. There are several reasons to think that OTC naloxone will not be priced much cheaper than prescribed naloxone. Just because OTC naloxone can be sold in more places does not mean that it will be. Many pharmacies do not stock buprenorphine or naloxone because of stigma. States remain the major purchasers, and to increase sales to individuals, pharma can create a market through fear, not stigma reduction. To reduce cost and increase access, the first step would be to explore allowing the federal government to take over naloxone manufacturing. In parallel, states should explore manufacturing generic nasal naloxone.

Source: OTC naloxone is a baby step toward making the life-saving medication accessible (STAT)