A significant contracting shift is on the horizon for behavioral health providers in California. As of January 1, 2026, Blue Shield of California (BSCA) is expected to bring all behavioral health services in-house, ending its current behavioral health network relationship with Magellan.

While Blue Shield has not yet issued a formal announcement, Magellan has confirmed through multiple contract discussions that it will not renew behavioral health contracts with BSCA. Under regulatory requirements, BSCA must provide providers with at least 90 days’ notice—a formal announcement is anticipated by late August or early September 2025.

What’s already in effect:
As of January 1, 2025, BSCA began managing non-ABA behavioral health utilization management and reviews internally—but only for the following plan types:

• Self-funded PPO plans (ASO, Shared Advantage, Shared Advantage Plus)

• CalPERS Platinum/Gold PPO plans
  

What this means for your facility:
If you currently hold in-network contracts with Magellan, now is the time to consider beginning the direct contracting process with Blue Shield of California to help maintain continuity of care and network participation into 2026.

We’ll continue to monitor updates and share them with the community as they unfold.

Continued Info on Payor Changes of 2025: Key Insurance Changes

As we move into 2025, several significant changes are coming to key insurance payors that will impact coverage and provider operations. In case you missed previous updates, please reference this page.

This summary outlines the upcoming modifications for BCBS of Montana, Blue Shield CalPERS, BCBS of Oklahoma, and GEHA to help healthcare providers stay informed and prepared.

Starting in 2025, BCBS of Montana's fully funded exchange plans with the prefix YDG will no longer offer out-of-state coverage. Representatives have indicated that facilities can apply for a waiver, but the waiver will be denied if adequate care is available within the state or in contiguous counties.

Effective January 1, 2025, employer-based Blue Shield plans under the group number W0051411 will be handled directly by Blue Shield instead of MHSA.

For more details, refer to the CalPERS official page: CalPERS PERS Gold & Platinum Behavioral Health Programs.

As of 2025, BCBS of Oklahoma's fully funded exchange plans with the prefix YUQ will no longer provide out-of-state coverage. A waiver is available for facilities but will be denied if sufficient care can be accessed within the state or in contiguous counties.

On January 1, 2025, the Government Employees Health Association (GEHA) transitioned from UnitedHealthcare Shared Services to full-service UMR operations.

For updated claim address details and further resources, visit: GEHA Transition Information

Navigating Recent Payor Changes: BCBS Policies and TRICARE Management Updates 

As 2024 comes to close, significant updates impacting substance use treatment and healthcare access are unfolding. Below, we outline vital changes involving Blue Cross Blue Shield (BCBS) policies and TRICARE management that may affect treatment providers and beneficiaries in various regions.

BCBS Out-of-State Coverage Limitations for 2025: IL, NC, and OK

Beginning January 1, 2025, BCBS plans in certain states will implement new out-of-state (OOS) coverage limitations. These policies may hinder access to care for members traveling or residing near state borders.

BCBS Illinois

• Members enrolled in Blue Choice Preferred PPOSM and MyBlue Plus POSSM plans, whether purchased on or off the marketplace exchange, will face restricted OOS coverage beyond the border counties of Wisconsin, Iowa, Missouri, Kentucky, and Indiana.

More information: BCBSIL OOS Coverage Update

BCBS North Carolina

• Blue Cross NC’s new HMO plan, Blue Care®, launching in 2025, will provide statewide coverage but limit OOS benefits to urgent and emergency services at the in-network level.

More information: BCBSNC Provider News

BCBS Oklahoma

• Members enrolled in Blue Advantage PPOSM and Blue Preferred PPOSM plans, whether purchased on or off the marketplace exchange, will only have OOS coverage within border counties of Kansas, Colorado, New Mexico, Texas, Arkansas, and Missouri.

More information: BCBSOK OOS Benefits Update

TriWest to Manage TRICARE West Effective January 1, 2025

Starting January 1, 2025, TriWest Healthcare Alliance will oversee the TRICARE West Region, impacting healthcare management across 26 states. This shift is crucial for providers and beneficiaries navigating TRICARE’s operational landscape.

Key Details:

• Region Coverage: The TRICARE West Region includes states such as Alaska, Arizona, California, Colorado, Texas, and Washington, among others.

• Out-of-Network Providers: Specific guidance for OON providers will be available as the transition progresses.

• Learn More About TRICARE: TriWest TRICARE Overview

• Frequently Asked Questions: Transition FAQs

• Provider Lookup Tool: Find Network Providers

• Contract Request: Join Our Network

We will continue to share updates as more information becomes available. Providers are encouraged to stay informed and evaluate how these changes may affect their services and patient access.

As of September 9th, a major victory for mental health parity was achieved. Health plans will now be required to apply the same pre-authorization and other nonquantitative limitations to behavioral health as they do to physical health. 

The Breakdown:

The Biden administration has introduced a new rule that updates mental health parity compliance, ensuring that behavioral health benefits are treated on par with physical health benefits. This rule strengthens oversight on how health plans handle nonquantitative treatment limitations (NQTLs), such as:

• Prior authorization requirements, for both types of care.

• Frequency of medical record requests

• Pre-certification timeline penalties  

Additional Details

• This new rule expands upon the 2008 Mental Health Parity and Addiction Equity Act (MHPAEA), which aimed to eliminate disparities in coverage between mental health, addiction services, and physical health care.

• Starting in 2025 (for group plans) and 2026 (for individual plans):

  • Health plans must collect and compare data on NQTLs' impact on access to care.

  • Plans must address disparities between behavioral and physical health services.

  • Comparative analyses must be shared with federal agencies.

• Advocates believe the rule will reduce barriers to accessing behavioral healthcare.

• Critics in the insurance industry argue the rule is vague and burdensome.

• The rule pushes for equitable access to behavioral healthcare, though reimbursement disparities and out-of-network care issues remain.

• https://www.whitehouse.gov/briefing-room/statements-releases/2024/09/09/fact-sheet-biden-harris-administration-lowers-mental-health-care-costs-by-improving-access-to-mental-health-and-substance-use-care/ 

• https://bhbusiness.com/2024/09/09/biden-administration-releases-historic-final-rule-on-behavioral-health-physical-health-parity/ 

The Strain of 'Payor Ghosting' on Health Plan Relationships

The recent article from Behavioral Health Business brings "payor ghosting" to the forefront, likening it to dating, only this time, the insurers abruptly stop communication on claim reimbursement.  Umm… hello?

Unlike typical payment issues, ghosting leads to confusing recourse. 

The behavioral health industry's lack of parity, along with slim profit margins, leaves providers struggling to address financial shortfalls. Payors may assume providers lack the resources to challenge their actions, or maybe it’s due to profit-driven incentives for large health plans, or perhaps they’re understaffed… regardless of their ‘why,’ the need for strengthened parity enforcement must be emphasized.

Organizations are advised to reach decision-makers, explore legal options, and review contract rights. It’s even been suggested that we eliminate private health insurance altogether. 

While more news will be shared, experts will provide valuable insight, and facilities will hire legal teams, we feel strongly that the biggest impact will come from us coming together, as cliche as it sounds.  With that, if you haven’t yet joined our monthly ‘Masterminds’ discussion, we welcome you with open arms. ROC aims to connect and align organizations while elevating the two R’s - Relationships and Reimbursement. 

The Expected Future Regulatory Landscape

The BHB article outlines the key regulatory issues in behavioral health for 2024, with a primary focus on the anticipated impact of the Biden administration's parity rule. Other pending concerns include the lapsed SUPPORT Act, EHR adoption challenges, potential reforms in patient privacy regulations, and forthcoming DEA regulations on telehealth and controlled substances. 

In closing, as we underscore the need for more comprehensive regulatory considerations, the digital divide in behavioral health, particularly in marketing standards, is highlighted, along with legal challenges and warnings regarding data sharing. 

Learn More

Stay hopeful, friends… we’re in this together.

Resources:

https://bhbusiness.com/2023/11/27/payer-ghosting-marks-evolution-in-the-fraught-relationship-between-behavioral-health-and-health-plans/ 

https://bhbusiness.com/2023/11/17/behavioral-health-regulatory-outlook-fight-over-parity-changes-to-telehealth-spill-into-2024/ 

Power in Numbers

If you missed it, MHN is terminating contracts for many behavioral health facilities, providing no exact reasoning. Whether your facility is currently being affected by this or not, we are asking all Rehab Owners Community members to join us in advocating on behalf of the behavioral health community as a whole.

Learn More

How the ROC Community Can Make a Difference

We are gathering an official list of every individual or treatment facility that would like to participate in the 'MHN Coalition of the Willing’ as a response to the terminations going on in California. 

AGG and ROC will gather information (with your help) to draft a response letter on behalf of as many providers as we can.  

This coalition will be taking a multi-faceted approach to this advocacy coalition. 

• Education – Our goal is to make individuals in California aware of what is going on, how to navigate it, and how to be involved (if desired). 

• Payor Awareness – As a team, we will stay true to our mission and advocate for what we believe in. Remember that there is power in numbers, and we want to recognize the end goal payors and providers (should) have: Helping more people recover. 

• Political Pressure – We will use a PR approach targeting more local and national politicians' eyes on this case and coalition through media and news outlets. 

Next Steps

If you are interested in participating, please follow the directions below. 

Email Nicole, with AGG, with the details below.

Subject Line: MHN – [Insert your facilities name]

Email Text:

Facility Name – Mention your corporation name and state (include DBA as well)

Mailing Address

Primary Contact

Email Address

Phone  

For more details, costs, and timelines, please contact Nicole Wemhoff. 

nicole.wemhoff@agg.com 

There is power in numbers, and together we will make a difference! Let’s do this.

As of recently, MHN is terminating contracts for many behavioral health facilities, providing no exact reasoning. Whether your facility is currently being affected by this or not, we are asking all Rehab Owners Community members to join us in advocating on behalf of the behavioral health community as a whole.

Join us after the Masterminds discussion on Tuesday, May 9, as we briefly discuss what is happening and how we can make an impact together.  

Add to Your Calendar Here

Here's the breakdown of what's happening.

MHN is issuing termination notices to many—maybe all—of their behavioral health facilities in California. MHN is terminating contracts both with-and-without cause with limited notice. Often, providers are subject to audits for retrospective reviews, which may lead to overpayment determinations and/or prepayment reviews for future services rendered. In these cases, patients are forced to find a new provider or pay more for out-of-network treatment. These terminations hurt both the patient and the provider.

Whose Involved or Affected

This affects all currently contracted and recently terminated MHN providers and patients in California who may find themselves without an in-network behavioral health treatment provider due to the narrowed network.

Why This is Happening

MHN appears to be motivated by financial incentives to drive down the cost of behavioral health. MHN has historically paid very low rates for out-of-network care and can lower costs by narrowing its network.

How the ROC Community Can Make a Difference

ROC is organizing a provider coalition to team up with the law firm Arnall Golden Gregory, LLP led by healthcare litigator Matt Lavin, to challenge these mass terminations for providers and patients. More provider participation will get greater attention from the State and media.

How You Can Come Prepared

If your facility is currently in network with MHN or you have had your contract recently terminated by MHN, stay after the ROC meeting on May 9, 2023, to learn more and how other providers are getting involved. 

Add to Your Calendar Here

Questions in the meantime? 

Contact Erin@hanseisolutions.com 

(AGG contact if desired) Matt.Lavin@agg.com 

In New Mexico, the news that the state will soon receive close to $200 million as part of a legal settlement from drug distributors McKesson, AmerisourceBergen and Cardinal Health for their role in exacerbating the opioid epidemic should be good news. Indeed, it’s a potential lifeline for a state whose increase in fentanyl overdose more than tripled the rest of the country in from 2020 to 2021, according to a recent article in the Santa Fe Reporter. Still, the money will do little to alleviate the struggle faced by with addiction and overdose without a concrete plan for where – and how – to use that money.

“This is money coming out of the sky,” NM Attorney General Hector Balderas said in the Santa Fe Reporter article, but “elected leaders and health officials are in the dark. I see it as a real game-changer, but we’re underprepared on the delivery side.”

New Mexico is not alone in its struggle to formulate the best plan for the use of settlement money or other sources of funding. Other states and communities have already – or are poised to – receive compensation from negligent companies for their roles in creating the opiod epidemic the nation faces. For example, the state of Oklahoma recently received a $250 million settlement from opioid distributors.

Meanwhile, a federal initiative, launched by the Biden-Harris administration will direct $1.6 billion directed Communities Facing Addiction. “The investments made through SAMHSA’s State Opioid Response (SOR) and Tribal Opioid Response (TOR) grant programs and HRSA’s rural communities opioid response programs will help communities looking to leverage every tool at their disposal – from prevention to harm reduction to treatment and recovery supports for people in need,” writes Mark Shandrow in Rehab News.

But how will these sources of funding be used? Where will the money go and how can it benefit the most people? Those questions are still up in the air.

Solutions for the addiction crisis

In Colorado, where drug overdose deaths doubled over four years, according to an article in the Denver Post, one popular solution is expanding the accessibility of residential treatment to uninsured and poor people, as well as increasing the number of beds available. The article reports: “To (Mary) Brewer (founder and president of New Beginnings Recovery Center), one of the most critical solutions to the drug crisis is more money to make treatment accessible to people of all income levels and ages. It’s unknown how many treatment beds there are in the Denver area, but it’s clear there are few options for minors, few options for poor people and few options for people living in rural Colorado. There’s an urgent need for hundreds, if not thousands, of more beds in the state, she said.”

In New Mexico, the “New Mexico Opioid Allocation Agreement,” stipulates that settlement money that has already been received be used for opioid abatement and treatment, or “strategies that directly mitigate harms of opioid addiction.” Examples include “investing more in overdose reversal drugs; treating expecting mothers with addictions; building new treatment programs to target areas of need; supplementing pre-existing successful programs to increase the numbers of patients being served; community education; and harm-reduction programs.”

One thing is clear: Rehab programs that can create community-centered programs that prioritize low-income victims of the drug crisis can potentially help more people if they can create programs that meet criteria for the windfall of federal funding and legal settlements.

Either through partnerships with government-approved entities or applying for grants funded by the settlements, private rehab centers may be able to help more addicts, work to rectify inequities within addiction treatment - and benefit from the additional funding.

Join the discussion

Do you have experience with receiving federal funding or settlement money for your drug treatment programs? Do you have ideas you’d like feedback on? Share them with us in the Comments section.

Here is a recap of some of the top industry-related news stories of the week:

Trafficker-Quantities of “Rainbow Fentanyl” Arrive in New York

One person was arrested and approximately 15,000 fentanyl pills were seized as part of an ongoing investigation into a fentanyl trafficking organization. The fentanyl pills, in various colors, were destined for distribution throughout New York City and had been concealed in a LEGO box to deter law enforcement attention. The fentanyl pills were also imprinted with “M” and “30” to resemble “30 M”, Oxycodone Hydrochloride 30 mg pills.

This significant seizure, the largest to date in New York City, signals more widespread distribution of these dangerous colorful pills. The case highlights Mexican cartels’ most recent tactics to attract the public while deceiving them about the lethal drugs. The Sinaloa Cartel and Jalisco New Generation Cartel are mass-producing fentanyl pills in rainbow colors to not only brand their products, but use colors and dyes to mimic candy and/or legitimate prescription drugs.

“Rainbow fentanyl is a clear and present danger, and it is here in New York City,” said DEA Special Agent in Charge Frank Tarentino. “Approximately forty percent of the pills we analyze in our lab contain a lethal dose; and in a recent 15-week enforcement operation, DEA New York seized half a million lethal pills. These staggering statistics underscore the importance of reminding the public that just one pill can kill; and this operation alone removed the equivalent of 500,000 lethal doses of fentanyl from circulation in the Empire State. In the same reporting period, DEA seized the equivalent of over 36 million lethal doses nationally.” 

See the original article.

Explainer: Marijuana Pardons in U.S. Help Thousands, Leave Others in Prison

U.S. President Joe Biden's pardon for thousands of Americans convicted of simple marijuana possession under federal law has a profound impact, experts and individuals say, even if it affects fewer people than similar state and local initiatives. Biden has called on governors to issue similar pardons regarding state marijuana offenses.

Biden's pardons announced Oct. 6 affect about 6,500 people convicted of cannabis possession at the federal level. None remain in prison. Without a felony on their record, they won't be challenged when applying for a job or trying to rent an apartment. Research by the American Civil Liberties Union has shown Black Americans are nearly four times as likely as whites to be arrested for marijuana possession.

Biden's pardon does not affect some 3,000 people convicted of higher-level marijuana crimes who remain in federal prisons, and as many as 30,000 who are still in prison in several states, according to the advocacy group the Last Prisoner Project. Those numbers do not reflect people with convictions for marijuana possession at the state level, although approximately 2 million marijuana convictions have been expunged or pardoned by states where the drug is now legal.

See the original article.

Hospitals and Insurance Companies Stole Billions from Medicare

Anthem, a large insurer now called Elevance Health, paid more to doctors who said their patients were sicker. Executives at UnitedHealth Group, the country’s largest insurer, told their workers to mine old medical records for more illnesses — and when they couldn’t find enough, sent them back to try again.

Each of the strategies — which were described by the Justice Department in lawsuits against the companies — led to diagnoses of serious diseases that might have never existed. But the diagnoses had a lucrative side effect: They let the insurers collect more money from the federal government’s Medicare Advantage program. Medicare Advantage, a private-sector alternative to traditional Medicare, was designed by Congress two decades ago to encourage health insurers to find innovative ways to provide better care at lower costs. If trends hold, by next year, more than half of Medicare recipients will be in a private plan.

See the original article.

If you are interested in joining the ROC community, please complete this form for consideration: https://tinyurl.com/5btxe39z

Here is a recap of some of the top industry-related news stories of the week:

Narcan to be Provided at all LAUSD Schools After Recent Teen Overdoses

The Los Angeles Unified School District announced it will make the anti-overdose medication Narcan available at all of its campuses by mid-October.

The announcement comes in response to recent fentanyl overdoses by students, including the death of a 15-year-old girl in the bathroom of Bernstein High School in Hollywood.

Doses of Narcan, or naloxone, will also be provided to all LAUSD School Police officers, Superintendent Alberto Carvalho said. The doses will be provided by the county Department of Public Health at no cost.

The superintendent also announced plans for a district-wide education campaign, including a "peer-to-peer" effort to teach students about the consequences of fentanyl use.

See the original article.

Biden-Harris Administration Awards More Than $1.6 Billion in Funds for Communities Addressing Addiction and Overdose Crises

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Health Resources and Services Administration (HRSA), is awarding more than $1.6 billion in investments to communities throughout the country addressing the addiction and overdose crises, as a part of President Biden’s comprehensive effort to prevent overdoses and save lives.

The investments made through SAMHSA’s State Opioid Response (SOR) and Tribal Opioid Response (TOR) grant programs and HRSA’s rural communities opioid response programs will help communities looking to leverage every tool at their disposal – from prevention to harm reduction to treatment and recovery supports for people in need. In President Biden’s first State of the Union, he named addressing the opioid crisis and overdose epidemic a top priority of his Administration, and earlier this year released his National Drug Control Strategy to expand access to treatment for addiction and overdose, and to disrupt drug trafficking.

“Providing access to evidence-based, person-centered care is a central part of HHS’ strategy for ending the overdose crisis,” said Secretary Becerra. “I have heard many stories of despair from individuals battling addiction and from families who have lost loved ones to overdose. Through these grants, we are investing in evidence-based supports and services for individuals, families, and communities on the road to recovery. Through these grants, we are investing in hope.”

See the original article.

Opioid Crisis Cost U.S. Nearly $1.5 Trillion in 2020 -Congressional Report

Fueled by the COVID-19 pandemic, the economic toll of the opioid addiction and overdose crisis on the United States reached nearly $1.5 trillion in 2020 alone and is likely to grow, a congressional report shows.

The committee said in a Wednesday report that after adapting a method used by CDC scientists and adjusting for inflation, it found that the crisis cost the U.S. economy $1.47 trillion in 2020, a $487 billion increase from 2019.

"JEC is valuing all the various loss that happens with addiction. There's loss of productivity, folks in the job force, all the medical health costs, just a huge number of costs," said Trone, a Democrat who previously chaired the bipartisan U.S. Commission on Combating Synthetic Opioid Trafficking.

President Joe Biden announced nearly $1.6 billion to fund access to medications for opioid overdoses, sanctions against traffickers, and increased funding for law enforcement.

See the original article.

If you are interested in joining the ROC community, please complete this form for consideration: https://tinyurl.com/5btxe39z

Here is a recap of some of the top industry-related news stories of the week:

DEA Warns of Brightly-Colored Fentanyl Used to Target Young Americans

The Drug Enforcement Administration is advising the public of an alarming emerging trend of colorful fentanyl available across the United States. In August 2022, DEA and law enforcement partners seized brightly-colored fentanyl and fentanyl pills in 18 states. Dubbed “rainbow fentanyl” in the media, this trend appears to be a new method used by drug cartels to sell highly addictive and potentially deadly fentanyl made to look like candy to children and young people.

“Rainbow fentanyl—fentanyl pills and powder that come in a variety of bright colors, shapes, and sizes—is a deliberate effort by drug traffickers to drive addiction amongst kids and young adults,” said DEA Administrator Anne Milgram. “The men and women of the DEA are relentlessly working to stop the trafficking of rainbow fentanyl and defeat the Mexican drug cartels that are responsible for the vast majority of the fentanyl that is being trafficked in the United States.”

Brightly-colored fentanyl is being seized in multiple forms, including pills, powder, and blocks that resemble sidewalk chalk. Despite claims that certain colors may be more potent than others, there is no indication through DEA’s laboratory testing that this is the case. Every color, shape, and size of fentanyl should be considered extremely dangerous.

See the original article.

Deep brain stimulation may be treatment for binge eating disorder, study suggests

A well-timed jolt of high-frequency electricity to a region of the brain implicated in food cravings appears to tamp down the impulses at the heart of binge eating disorder, researchers report.

Out-of-control eating that causes shame, regret, or health problems is psychiatry’s most recently recognized eating disorder.

In a feasibility study that involved just two female patients, researchers at Stanford and the University of Pennsylvania tried treating binge eating disorder with a form of deep-brain stimulation similar to that used for epilepsy, obsessive-compulsive disorder, depression, and Parkinson’s disease.

Expanding on work conducted on mice, the team discovered that the cravings just before an episode of binge eating set off a specific low-frequency electrical pattern in a part of the brain called the nucleus accumbens. That structure plays a key role in one of our most primitive mammalian behaviors: the pursuit of pleasure.

Once researchers identified the exact signature of the participant’s brain waves before, during, and after an episode of out-of-control eating, the electrodes were repurposed. When the system detected the distinctive electrical patterns of an impending episode, it delivered a brief — and to the women, undetectable — burst of high-frequency electrical stimulation that was intended to scramble the indiscriminate “Eat!” signal.

If the pre-binge electrical pattern didn’t immediately respond, the stimulation was repeated until it did. Each woman got an average of roughly 10 minutes a day of electrical stimulation — a far more limited use than is common in the treatment of disorders like OCD.

The intervention showed promise in both patients. Over the six months of the study’s initial phase, it reduced the frequency and severity of out-of-control eating episodes and prompted weight loss — about 18 pounds in one patient and 13 pounds in the other. For one subject, that was 4.5% of her body weight; for the other, 5.8%.

See the original article.

Out-of-Pocket Cost of Naloxone Soars for Uninsured Individuals

While the cost of naloxone has declined for individuals with health insurance, the cost has sharply risen for uninsured individuals in recent years, according to new data from RAND Corporation.

Despite concentrated legislative efforts to improve access to naloxone by passing laws that ease requirements around prescribing and dispensing the medication, many states are falling short by failing to address financial barriers, study lead author Evan Peet, an economist at RAND, said in a news release.

“The price of naloxone is almost certainly an impediment to more-widespread adoption among the uninsured,” Peet said. “Policymakers who want to further expand access to naloxone—particularly among the uninsured and vulnerable—need to pay greater attention to the out-of-pocket costs.”

RAND researchers’ findings were based on an analysis of more than 700,000 prescription records from 2010 to 2018 for both generic and name-brand naloxone. More than 70% of US retail pharmacies were accounted for in the data. In 2014, the average per-prescription out-of-pocket cost for naloxone was $27 among insured individuals, compared to $35 for those who were uninsured. By 2018, the out-of-pocket cost for those without insurance soared to $250, compared to just $18 for those with health insurance.

During the period studied, the total number of naloxone prescriptions grew exponentially, with 386,249 prescriptions written in 2018, up from 11,432 in 2010.

See the original article.

If you are interested in joining the ROC community, please complete this form for consideration: https://tinyurl.com/5btxe39z

Here is a recap of some of the top industry-related news stories of the week:

Fentanyl overdose murder case is first of its kind in Tallahassee

A Tallahassee man is now among a growing list of accused drug dealers who are charged with murder in connection with deadly fentanyl overdoses.

A grand jury indicted Kurstin Hinson last week on first-degree murder charges in the death of 18-year-old Megan Hoffman.

Prosecutors call it a first in Leon County.

“This is the first case of its kind in our office involving a fentanyl-related death,” prosecutor Jon Fuchs said.

Florida’s murder statutes now include fentanyl when it is illegally distributed and “when such substance or mixture is proven to be the proximate cause of death of the user.”  That change was passed by the legislature and signed by Florida Governor Rick Scott in 2017.

See the original article.

Coolants in Puff electronic cigarettes present health hazard

Electronic cigarettes, or ECs, contain nicotine, solvents, and flavor chemicals, and are especially popular among young adults. In 2020, the FDA banned cartridge-based flavored EC pods, but this ban did not extend to “disposable” flavored EC products, such as Puff ECs. Unfortunately, the chemical composition and toxicity of the fluids in Puff ECs are largely unknown.

Researchers at the University of California, Riverside and Portland State University report in the journal Chemical Research in Toxicology that the chemicals in disposable Puff ECs are at high levels and cytotoxic — or toxic to living cells. 

“Our data support the regulation of flavor chemicals and synthetic coolants in Puff ECs to limit their potentially harmful health effects,” said Esther Omaiye, a former graduate student in the Environmental Toxicology Graduate Program. “The high levels of nicotine, flavor chemicals, and synthetic coolants in Puff ECs, which exceed those used in other consumer products, bring into question the safety of Puff products.”

See the original article.

Secret behind ‘nic-sickness’ could help break tobacco addiction

If you remember your first hit on a cigarette, you know how sickening nicotine can be. Yet, for many people, the rewards of nicotine outweigh the negative effects of high doses.

University of California, Berkeley, researchers have now mapped out part of the brain network responsible for the negative consequences of nicotine, opening the door to interventions that could boost the aversive effects to help people quit smoking. Though most addictive drugs at high doses can cause physiological symptoms that lead to unconsciousness or even death, nicotine is unique in making people physically ill when inhaled or ingested in large quantities. As a result, nicotine overdoses are rare, though the advent of e-cigarettes has made “nic-sick” symptoms like nausea and vomiting, dizziness, rapid heartbeat and headaches more common.

Stephan Lammel, UC Berkeley associate professor of molecular and cell biology said “What we found is that the brain circuits that are activated after a high aversive dose are actually different from those that are activated when nicotine is delivered at a low dose. Now that we have an understanding of the different brain circuits, we think we can maybe develop a drug so that, when nicotine is taken at a low dose, these brain circuits can be coactivated to induce an acute aversive effect. This could actually be a very effective treatment for nicotine addiction in the future, which we currently do not have.”

See the original article.

If you are interested in joining the ROC community, please complete this form for consideration: https://tinyurl.com/5btxe39z

Here is a recap of some of the top industry-related news stories of the week:

This startup wants to use magic mushrooms to end alcoholism

Scores of pharmaceutical companies and academic institutions have been researching the potential for psychedelics like MDMA, ketamine, LSD, and even DMT to be used in treating mental health issues such as PTSD and treatment-resistant depression for years. Even though the social stigma behind the drugs largely remains, they hold a lot of promise when it comes to treating some of the most pernicious public-health issues in society today.

“We’re just scratching the surface,” Brian Pilecki, a psychotherapist and psychedelic-assisted therapy researcher, told The Daily Beast. “Most have only been small trials that were highly controlled, but we’re seeing that the people who are in these trials are doing very well. These treatments have also been outperforming current treatments [for mental health issues.]”

“What it really comes down to is we want to help patients with alcohol use disorder,” Damian Kettlewell, CEO and co-founder of Clairvoyant, told The Daily Beast. “We want to enrich their lives, so we looked at all the different research out there and found a lot of promise with psilocybin.”

His company is about to launch Phase 2 clinical trials of a new study into psilocybin’s effectiveness in treating alcohol use disorder. It will be a blind study taking place in Canada and the E.U., and will include 128 patients with the goal of completing a report in 2023. The trial, Clairvoyant hopes, will give a window into what a future for magic mushroom-assisted therapy might look like for those struggling with alcohol.

“This isn’t something where you take a pill and go home,” Kettlewell said. “It’s going to include 20 plus hours of psychotherapy.”

See the original article.

Why it could be so important to recognize pre-addiction

Nora Volkow, director of the National Institute on Drug Abuse, and two other prominent thinkers in the addiction treatment field, recently proposed the term “pre-addiction” to describe mild-to-moderate substance use disorder (SUD).

The term ‘pre-addiction’ gives a readily understandable name to a vulnerable period of time in which preventive care could help avert serious consequences of drug use and severe substance use disorders.

Why do people with alcohol and drug addiction need to hit rock bottom before their condition is recognized and treated?

If this designation takes hold, it will hopefully force the healthcare establishment (including insurers) to recognize and target resources for the pre-addiction stage. Also, people with pre-addiction will be better able to recognize it and seek treatment for it.

The idea is that the condition will be caught early when it’s easier to get a handle on and before serious interventions like detox or inpatient treatment become necessary.

A key point to keep in mind: By the time a person hits full-blown addiction to drugs or alcohol, their brain chemistry and structure have been reconfigured. Those changes can be reversed over time, but that takes months of sobriety. Meanwhile, the altered brain chemistry makes it more difficult to stay on track with recovery.

Here’s why targeting treatment at the pre-addiction stage makes so much sense:

• You have a better chance of arresting the progression of the disease.

• You are better able to make your own lifestyle changes and other important course corrections to head off addiction.

• Your available treatments and therapies are less expensive and easier to obtain.

• Your prognosis for long-term recovery is significantly better

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Why it’s important to think about social media use as a form of dissociation, rather than addiction

When online, dissociation can reflect zombie-like behavior - scrolling for hours without realizing it, not being aware of one’s surroundings while scrolling, or scrolling on autopilot and then realizing you haven’t actually paid any attention to what you’ve read.

Typically, behavior like this is classified as smartphone or internet addiction.

However, researchers have begun to push back against the narrative of addiction to describe excessive smartphone use, explaining that the behavior – even if it’s a source of distress – should not be considered addiction if it’s better explained by an underlying disorder, is a willful choice, or is part of a coping strategy.

Understanding social media overuse as a byproduct of dissociation, rather than addiction, can help destigmatize social media use while empowering users. This framing also helps explain why social media sits in a paradoxical position: people have frustrating relationships with social media platforms that they are simultaneously unwilling to quit.

When users spend much more time dissociating online than they would have consciously chosen for themselves, they become frustrated and conflicted. Past research shows that many people would appreciate reminders to log off before 30 minutes of use. Otherwise, they become disappointed with the time they’ve spent.

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An extreme plan to end fentanyl overdose deaths in NJ

NJ state Sen. Paul Sarlo is sponsoring legislation that would make it a first-degree crime to sell, possess, or manufacture more than 10 grams of fentanyl, punishable by up to 20 years in prison and a fine of up to $200,000.

His measure also stipulates selling or possessing any amount of fentanyl up to 10 grams would be a second-degree crime, which carries 5 to 10 years in prison and a fine of up to $150,000.

“It’s very lethal, this is not about drug addiction, this is about killing somebody, no different than pulling out a gun and shooting somebody,” he said.

She said the DEA has now started investigating drug overdose deaths, and if they were caused by ingesting fentanyl, the case will be treated not as accidental but as a homicide.

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A decisive blow to the serotonin hypothesis of depression

Almost as soon as it was floated in 1965 by Harvard psychiatrist Joseph Schildkraut, the serotonin hypothesis of depression—reduced and simplified by pharma marketing to the “chemical imbalance” theory of depression and anxiety—has been subject to critical research and found wanting.

Revisiting the history of this controversy raises several still-relevant details. In December 2005, as advertising for SSRI antidepressants flooded American magazines, talk shows, and network TV, the result of multibillion-dollar campaigns pitched in this case directly to consumers, Florida-based professors and researchers Jeffrey Lacasse and Jonathan Leo asked “Are the claims made in SSRI advertising congruent with the scientific evidence?”

“There is no such thing as a scientifically established correct ‘balance’ of serotonin,” Lacasse and Leo cautioned more than a decade ago, joining numerous other experts then and now. Additionally, both aspirational claims rest on a hypothesis that follow-up studies would end up contradicting repeatedly. In short, both the hypothesis and the expensive marketing that pushed it into American living rooms rested on a hedge: “Scientists believe that it could be linked with an imbalance of a chemical in the brain called serotonin.”

“The popularity of the chemical imbalance idea of depression has coincided with a huge increase in the use of antidepressants,” note Moncrieff and coauthor Mark A. Horowitz in the study’s press release. “Prescriptions for antidepressants have sky-rocketed since the 1990s.”

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Family alcohol history may put you at risk of junk food addiction

People with a parent with a history of alcohol problems are at greater risk for showing signs of addiction to highly processed foods, according to a new study.

These foods, such as ice cream, chocolate, pizza, and fries, contain unnaturally high amounts of refined carbohydrates and fats that may trigger an addictive response in some people.

The researchers wanted to know if a major risk factor for addiction—a parent with alcohol problems—predicted an increased risk of addiction to highly processed foods.

“People who have a family history of addiction may be at greater risk for developing a problematic relationship with highly processed foods, which is really challenging in a food environment where these foods are cheap, accessible, and heavily marketed,” says Lindzey Hoover, a psychology graduate student at the University of Michigan, and lead author of the study in Psychology of Addictive Behaviors.

But addictive responses didn’t end with food, as people with food addiction were also more likely to exhibit personal problems with alcohol, cannabis, tobacco, and vaping, the research shows.

“Public health approaches that have reduced the harm of other addictive substances, like restricting marketing to kids, may be important to consider to reduce the negative impact of highly processed foods,” Hoover says.

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U.S. announces $1.2 billion healthcare crackdown tied to telehealth, cardiovascular tests

The U.S. Justice Department unveiled a $1.2 billion healthcare fraud crackdown, revealing criminal charges against 36 defendants for alleged fraudulent billing schemes tied to telemedicine, genetic and cardiovascular testing, and equipment.

The criminal charges target clinical laboratory owners, marketers, medical professionals, and telemedicine executives.

“The cases announced today include charges against people who brazenly used Medicare funds to purchase luxury items, medical professionals who corruptly approved testing and equipment, and business owners who submitted false and fraudulent claims for services patients did not need," Kenneth Polite, the head of the department's criminal division, told Reuters in a statement.

Although telemedicine played a role in prior fraud schemes, its use has greatly expanded since the pandemic, as U.S. regulators relaxed certain rules to make telemedicine more accessible to patients.

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Teva reaches proposed $4.35 billion settlement of U.S. opioid lawsuits

Teva announced a $4.35 billion proposed nationwide settlement that could resolve thousands of lawsuits over the drugmaker’s alleged role in the U.S. opioid epidemic.

The proposal calls for Teva to pay state and local governments up to $3.7 billion in cash over 13 years plus a contribution of $1.2 billion worth of the opioid overdose reversal drug naloxone. Israel-based Teva also will pay approximately $100 million to Native American tribes and pay attorneys fees incurred by the states, local governments and tribes.

Teva’s proposed settlement would allow state and local governments to opt for additional cash in lieu of an allotment of the overdose medication, at a value of 20% of the drug’s list price.

The settlement’s cash portion is higher than Teva’s chief executive suggested in May. CEO Kare Schultz told analysts at the time that he expected the company to pay around $2.6 billion in cash and medicine to reach a nationwide settlement.

For the Teva deal to take effect, Allergan must reach its own nationwide opioid settlement, and the two companies must settle a dispute over the amount Allergan owes Teva for claims filed prior to the 2016 sale.

U.S. states, cities and counties filed more than 3,000 lawsuits against opioid manufacturers, distributors and pharmacies, accusing them of downplaying their addiction risk and failing to stop pills from being diverted for illegal use.

The company’s insistence on including drugs as a major component of its opioid settlements has been a sticking point in past negotiations.

Teva in 2019 proposed to settle its nationwide opioid liability for $250 million in cash and $23 billion in contributed medicines that was rejected by state and local governments.

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High-strength cannabis linked to addiction and mental health problems

As the strength or potency of cannabis products has increased internationally over the years, so have rates of people being treated for cannabis addiction, say the authors of a new study.

The new study, published in The Lancet Psychiatry, suggests that people who use high potency cannabis are more likely to experience addiction than those using low potency products. It also suggests that people using high potency cannabis are more likely to experience a psychotic disorder, such as schizophrenia.

These findings may help to explain why more people have received treatment for cannabis problems over recent years. Data from the European Monitoring Centre for Drugs and Drug Addiction show a 76% increase in people entering treatment for cannabis addiction in the past decade.

Based on these new results, the authors argue that public health guidelines and policies to help make cannabis use safer should be encouraged.

Lead author, Kat Petrilli from the University of Bath’s Department of Psychology explained: “Our systematic review found that people who use higher potency cannabis could be at increased risks of addiction as well as psychosis when compared to people who use cannabis products with lower potencies.

“These results are important in the context of harm reduction which aims to minimize the negative consequences associated with drug use. While the safest level of use for cannabis is of course ‘no use’, it is important to acknowledge that a significant number of people across the world use cannabis regularly and to ensure they can make informed decisions that could reduce any possible harms associated with it.”

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The New 988 Mental Health Hotline is Live. Here's What to Know

People experiencing a mental health crisis have a new way to reach out for help in the U.S. They can simply call or text the numbers 9-8-8.

Modeled after 911, the new three-digit 988 Suicide & Crisis Lifeline is designed to be a memorable and quick number that connects people who are suicidal or in any other mental health crisis to a trained mental health professional.

"If you are willing to turn to someone in your moment of crisis, 988 will be there," said Xavier Becerra, the secretary of the federal Department of Health and Human Services, at a recent press briefing. "988 won't be a busy signal, and 988 won't put you on hold. You will get help."

The primary goal of the new number is to make it easier for people to call for help. Lawmakers and mental health advocates also see this launch as an opportunity to transform the mental health care system and make care easily accessible everywhere in the United States. The Biden administration has invested more than $400 million in beefing up crisis centers and other mental health services to support the 988 system.

Currently, the majority of people experiencing a mental health emergency end up dialing 911.

The problem is that 911 wasn't set up to address mental health needs. Either callers end up in a frenetic emergency room, waiting for hours and sometimes days to get care, or they end up interacting with law enforcement, which can lead to tragedy or trauma.

"Unlike other medical emergencies, mental health crises overwhelmingly result in a law enforcement response," says psychologist Benjamin Miller, president of Well Being Trust. "If you look at the data from the police, about 20% of their total staff time is spent responding and transporting individuals who are experiencing a mental health crisis."

Just last year, he adds, more than "2 million people with serious mental illness were booked in jail." And nearly a quarter of fatal shootings by the police in recent years have involved people with mental illness, he adds.

"Over time, the vision for 988 is to have additional crisis services available in communities across the country, much the way emergency medical services work," said Miriam Delphin-Rittmon, the HHS assistant secretary for SAMHSA, in a statement.

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Doctors Urge Access to Psychedelic Therapies in New Mexico

Physicians and researchers are urging New Mexico legislators to allow the use of psychedelic mushrooms in mental health therapy aimed at overcoming depression, anxiety, psychological trauma, and alcoholism.

A legislative panel on Tuesday listened to advocates who hope to broaden the scope of medical treatment and research assisted by psilocybin, the psychedelic active ingredient in certain mushrooms.

Oregon is, so far, the only state to legalize the therapeutic use of psilocybin.

Recent studies indicate psilocybin could be useful in the treatment of major depression, including mental suffering among terminally ill patients, and for substance abuse including alcoholism, with low risks of addiction or overdose under medical supervision.

Physician Lawrence Leeman, a medicine professor at the University of New Mexico, urged legislators to move forward without waiting for federal decriminalization or regulatory approval to expand responsible therapies using doses of psilocybin.

Leeman and other advocates outlined emerging psilocybin protocols, involving six-hour supervised sessions and extensive discussions about the experience in subsequent counseling. He warned legislators that public interest is spawning illicit, underground experimentation without safeguards.

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Researchers Surprised to Find Seven Adult Health Conditions Linked to Childhood Abuse

Researchers found a "significant" association between childhood physical abuse and seven health conditions. Two of those health conditions were mental health-related, and five were related to physical health. The five physical health conditions are diabetes, heart disease, arthritis, migraines, and cancers. The two mental health conditions are depression and anxiety. Both were found to occur later in life, and with disproportionate frequency, among adults who had been physically abused as children.

"The association between CPA [childhood physical abuse] and 2 mental health and 5 physical health conditions remained significant, even after controlling for sociodemographic characteristics, health behaviors, and other ACEs [adverse childhood experiences]," the authors explain. "Further research is needed to investigate potential pathways through which childhood physical abuse is linked to a wide range of later-life health problems."

"Health professionals serving older adults need to be aware that it is never too late to refer people for counselling," professor Esme Fuller-Thomson, who supervised the thesis, explained in a statement. "A promising intervention, cognitive behavioral therapy [CBT], has been tested and found effective at reducing post-traumatic stress disorder and depressive and anxiety symptoms among survivors of childhood abuse."

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‘Monumental’ Drug Bust: 5,000 Pounds of Meth Seized in National City

Authorities made one of the largest methamphetamine busts ever in San Diego County, seizing more than 5,000 pounds of the drug and arresting four Tijuana men as they worked to unload it in National City.

Sheriff’s detectives discovered the massive load of narcotics while tracking a truck that was connected to another large seizure of methamphetamine two months ago, according to an agent from the Drug Enforcement Administration.

Prosecutors charged the four men Friday in U.S. District Court on drug trafficking conspiracy charges. Federal officials said the seizure is “believed to be one of the largest” ever in San Diego County, calling it “monumental.”

The 20-foot box truck that was allegedly hauling the narcotics crossed the U.S.-Mexico border through the Otay Mesa Port of Entry’s commercial lanes, according to a probable cause statement written by DEA Special Agent Rashaad Scott.

Law enforcement officials were immediately notified of the truck’s international border crossing because, according to Scott, “the same box truck was associated with a 1,772-pound methamphetamine seizure” on May 12 in San Diego.

Prosecutors said the law enforcement officers found 148 bundles of methamphetamine that each weighed between 10 and 60 pounds, with a total weight of more than 5,000 pounds.

According to Scott, all four men denied knowing what exactly they were moving.

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Addiction Treatment Facilities’ Medical Director Sentenced in $112 Million Addiction Treatment Fraud Scheme

A Florida doctor was sentenced to 54 months in prison for engaging in a scheme that fraudulently billed approximately $112 million for substance abuse services that were never provided or were medically unnecessary.

According to court documents, Jose Santeiro, 62, of Miami Lakes, worked with others to unlawfully bill for approximately $112 million of addiction treatment services that were never rendered and/or were medically unnecessary at two addiction treatment facilities where Santeiro was the medical director. The facilities were Second Chance Detox LLC, dba Compass Detox (Compass Detox), an inpatient detox and residential facility, and WAR Network LLC (WAR), a related outpatient treatment program.

Santeiro and others admitted patients for medically unnecessary detox services, the most expensive kind of treatment the facilities offered. Patient recruiters offered kickbacks to induce patients to attend the programs and then gave them illegal drugs to ensure admittance for detox at Compass Detox. Evidence at trial also showed that Santeiro submitted false and fraudulent claims for excessive, medically unnecessary urinalysis drug tests that were never used in treatment. Santeiro and others then authorized the re-admission of a core group of patients who were shuffled between Compass Detox and WAR to fraudulently bill for as much as possible, even though the patients did not need the expensive treatment for which they were repeatedly admitted. Santeiro also prescribed Compass Detox patients a so-called “Comfort Drink” to sedate them, ensure they stayed at the facility, and keep them coming back. The evidence further showed that Santeiro’s log-in was used, with his knowledge, by others to sign electronic medical files to make it appear as if Santeiro had provided treatment himself when he did not.

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Drinking Alone in Young Adulthood Linked with Alcohol Problems Later in Life

Drinking alone in adolescence and young adulthood may be a “red flag” for alcohol problems later in life, especially for women, a new study has found.

Girls who drank alone were at particular risk of developing symptoms of alcohol abuse, dependence, and addiction by the time they reached their mid-30s.

“We see a strong signal that drinking alone is worrisome and predicts problems… We think it’s because these kids are using alcohol as a way to cope with feeling down and depressed and lonely.”

That strong warning signal was there even when researchers controlled for other “robust risk factors,” such as binge drinking, frequent drinking, and low socio-economic status, said Kasey Creswell, the lead study author and an associate professor of psychology at Carnegie Mellon University in Pittsburgh, Pennsylvania.

About 25% of adolescents and 40% of young adults reported drinking alone. This study’s data collection stopped in 2019, but newer research shows there’s been an increase in solo drinking during the pandemic, plus an increase in depression and anxiety, Creswell said.

“It could create this perfect storm where people might be developing a problematic relationship with alcohol as a way to cope with those negative emotions,” she warned.

The likelihood of reporting severe alcohol abuse symptoms at age 35 was 59% higher for adolescent solitary drinkers and more than two times as high for young adult solitary drinkers, compared to social drinkers.

“Rather than using adaptive coping mechanisms like socializing with friends or going to parties or exercising, these kids are developing a really worrisome and problematic relationship with alcohol early on. We think that’s why it’s predictive of future problems,” Creswell noted.

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Marijuana Users More Likely to Need Emergency Care and Hospitalization, Study Finds

A new study suggests recreational marijuana smokers may be at an increased risk of needing emergency room care or hospitalization compared with those who do not use cannabis. The goal of the study was to examine whether there was a link between marijuana use and respiratory-related hospitalizations or emergency room visits. While researchers found no strong association between marijuana use and respiratory-related hospital visits and deaths, they found overall visits to emergency rooms and hospitalizations for any reason was higher among those who used marijuana.

Cannabis users were 22% more likely than those who don’t use to land in the emergency room or become hospitalized for any reason, suggesting the use of the drug may be associated with negative health outcomes. Bodily injury was the top reason for emergency department visits and hospitalizations among marijuana users, while respiratory issues came in second.  

“Unlike tobacco, there is some uncertainty or controversy regarding the adverse health impacts of cannabis. Some individuals may perceive that cannabis has some health benefits and is otherwise benign. Our research highlights to those using – or considering to use – cannabis, that this behavior is associated with important negative health events.”  

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New, Dangerous Synthetic Opioid in D.C., Emerging in Tri-State Area

The DEA Washington Division is warning area residents of a new drug emerging in the D.C. metropolitan area that is as dangerous and deadly as fentanyl.

The DEA Washington Division brought local news outlets into their regional laboratory to see and discuss a dangerous class of drugs they are seeing emerge in the region: nitazenes. A drug that was never approved for medical use, nitazines are being sourced from China and being mixed into other drugs.

Isotonitazene (aka nitazene or "ISO”) is a particular synthetic opioid the DEA is seeing move into the area. First identified around 2019 in the Midwest, this dangerous drug has moved into the Southern states and, more recently, along the Eastern seaboard. Much more potent than heroin and morphine (similar to fentanyl), ISO is being mixed into and marketed as other drugs to make drugs more potent and cheaper to produce. The major concern is that this drug can and has caused deadly overdoses in unsuspecting victims.

In powder form, ISO can appear yellow, brown, or off-white in color. DEA regional forensic laboratories have seen this drug mixed into heroin and/or fentanyl and marketed as common street drugs with deadly consequences. However, in other parts of the country, ISO has already been seen pressed into counterfeit pills and falsely marketed as pharmaceutical medication like Dilaudid "M-8" tablets and oxycodone "M30" tablets.

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New Documents Show McKinsey’s Role in Opioid Epidemic

The Opioid Industry Documents Archive (OIDA), a project of the University of California, San Francisco (UCSF), and Johns Hopkins University, released more than 114,000 documents related to McKinsey & Company’s work as a management consulting firm for the opioid industry. They show how McKinsey advised opioid makers Purdue Pharma, Endo Pharmaceuticals, Johnson & Johnson and Mallinckrodt to help them increase sales, despite the growing public outcry over the opioid epidemic. The documents come from the company’s files between 2004 and 2019 and are being released under the terms of the $573 million settlement that McKinsey reached with 47 states, five U.S. territories, and the District of Columbia in February 2021.

The two research universities launched the OIDA in March 2021 as a free resource for anyone interested in learning more about the circumstances leading to the opioid crisis. The archive’s mission is transparency – to deliver to the public a wealth of information that those who have been personally affected, as well as researchers, policymakers, and others can now analyze to gain insights into the epidemic.

Materials include scopes of work, proposals, and invoices; presentations prepared for internal discussion and for clients (including Purdue Pharma and Endo Pharmaceuticals); spreadsheets outlining project staffing; and emails responding to news about increased restrictions on opioids. The collection also houses letters from regulatory agencies, including the U.S. Food and Drug Administration, in response to new drug applications from opioid manufacturers; preparation materials for regulatory advisory committee meetings; opioid-related transition documents for state and federal agencies; and other internal files.

“Researchers can leverage these litigation documents to see patterns of industry behavior that could be regulated to protect public health,” said Dorie Apollonio, PhD, MPP, a professor of clinical pharmacy in the UCSF School of Pharmacy. “This will be critical to identifying reforms that can protect against future epidemics like this.”

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U.S. Supreme Court Sides with Doctors Challenging Opioid Convictions

The U.S. Supreme Court gave two doctors found guilty of misusing their licenses in the midst of the U.S. opioid epidemic to write thousands of prescriptions for addictive pain medications another chance to challenge their convictions.

The justices ruled 9-0 in favor of Xiulu Ruan and Shakeel Kahn, who had argued in appealing their convictions that their trials were unfair because jurors were not required to consider whether the two physicians had "good faith" reasons to believe their numerous opioid prescriptions were medically valid.

Liberal Justice Stephen Breyer said that once defendants produce evidence that they were authorized to dispense controlled substances like opioids, prosecutors must prove they knew they were acting in an unauthorized manner.

States have sued drug companies and pharmacies to hold them liable, but another key element in the public health crisis has been the role of doctors in prescribing massive volumes of highly addictive pain medication.

Ruan, who practiced in Alabama, and Kahn, who practiced in Arizona and then Wyoming, were sentenced to 21 and 25 years in prison, respectively, in separate criminal cases.

Prosecutors said Ruan with a business partner ran a clinic in Mobile that issued nearly 300,000 controlled-substance prescriptions from 2011 to 2015 and was one of the top U.S. prescribers of certain fentanyl-based pain medications.

Prosecutors said Kahn regularly sold prescriptions for cash and unlawfully prescribed large amounts of opioid pills, resulting in at least one patient dying of an overdose.

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New Drugs With High Abuse Potential More Likely to Be Approved and Go to Market to Treat Pain

Despite the prevalence and societal costs of pain in the US, investment in pain medication development is low, due in part to poor understanding of the probability of successful development of such medications,” said the authors of a study published in Anesthesiology.

“The opioid crisis has highlighted the need for new therapeutics with low abuse potential to treat chronic pain,” they said.

“While pharmaceutical companies recognize this need, because of the subjective nature of pain… the conduct of clinical trials for new drug approval is a lengthy and costly proposition.”

The study found that 27.8% of drugs with high abuse potential made it all the way through the development process, compared to only 4.7% of new drugs with low abuse potential.

Although the number of drugs with high abuse potential being developed has decreased since the peak of the opioid epidemic in 2010, they are more likely to successfully complete the development process and receive regulatory approval than medications with lower abuse potential.

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White House Backs Extension of Telehealth Addiction Treatment

The Biden administration is making a play to set in stone the pandemic era expansion of telehealth access for people struggling with addiction, offering a series of suggestions for federal agencies and lawmakers in a new report.

The expansion, made possible by the declaration of a public health emergency for the Covid-19 pandemic, has opened new doors for treating Americans suffering from substance use disorder. But the White House’s Office for National Drug Control Policy says whether the impact will be positive in the long term remains to be seen, noting that both state and federal requirements will pose barriers to access upon the end of the pandemic emergency.

“Across the United States, fewer than 1 out of 10 people with substance use disorder get the care they need. That is unequivocally unacceptable,” Rahul Gupta, director of the ONDCP, said in a statement. Telehealth provides “a cost-effective way to increase access to care for vulnerable people with substance use disorder by meeting them where they are.”

The plan calls for the federal government to weigh legislation or other steps to knock down barriers between state licensing systems for medical professionals that ONDCP says stand in the way of enacting nationwide telehealth efforts.

It also asks that the government make permanent and expand telehealth regulatory changes made available during the public health emergency, such as the US Drug Enforcement Administration permanently authorizing qualified professionals to prescribe controlled substances remotely without an in-person evaluation.

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White House Pushes Strategy to Slow Overdoses as Street Drugs Grow More Deadly

The Biden administration says it plans to cut the number of fatal overdoses in the United States by 13% by 2025, potentially saving tens of thousands of lives.

That would mean reversing a catastrophic four-fold rise in drug deaths that began in the late 1990s and accelerated again during the pandemic.

"We must approach this crisis with a sense of urgency that prioritizes saving lives as our North Star," said Dr. Rahul Gupta, head of the Office of National Drug Control Policy (ONDCP). He spoke Wednesday before a Senate oversight committee.

Gupta also acknowledged the growing power of Mexican drug cartels and other international narcotics gangs that "operate seamlessly across borders and cooperate with remarkable efficiency."

According to government officials, the cartels now contaminate much of the illicit drug supply in the United States with fentanyl, driving the latest surge of fatal overdoses.

A report made by the General Accountability Office also found the ONDCP drug strategy document, unveiled in April, failed to detail resources needed to slow drug trafficking and reduce overdose deaths.

"We found that while the national drug control strategy outlines goals, it does not provide an estimate of the federal funding or other resources needed to achieve these goals," the analysis concluded.

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FDA Bans Juul E-Cigarettes as U.S. Pursues Broader Crackdown on Nicotine Products

The Food and Drug Administration announced that it is banning the sale of Juul e-cigarettes in the U.S.

Juul intends to seek a stay on the decision and is exploring options, which include appealing the decision or engaging with the FDA, Chief Regulatory Officer Joe Murillo said in a statement.

The ban is part of the FDA’s broader review of the vaping industry following years of pressure from politicians and public health groups to regulate the segment as strictly as other tobacco products after vaping became more common among high schoolers.

Juul had sought approval from the agency for its vaping device and tobacco- and menthol-flavored pods, which are available at 5% and 3% nicotine strengths. The flavors were not subject to a 2020 agency ban on mint- and fruit-flavored vaping products that were popular with teens.

The FDA said Juul’s applications gave insufficient or conflicting data about the potential risks of using the company’s products, including whether potentially harmful chemicals could leak out of the Juul pods.

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Canada Proposes Printing a Warning on Every Cigarette

Canada is poised to become the first country in the world to require that a warning be printed on every cigarette.

The move builds on Canada's mandate to include graphic photo warnings on tobacco products' packaging — a policy that started an international trend when it was introduced two decades ago.

"We need to address the concern that these messages may have lost their novelty, and to an extent, we worry that they may have lost their impact as well," Minister of Mental Health and Addictions Carolyn Bennett said at a news conference.

"Adding health warnings on individual tobacco products will help ensure that these essential messages reach people, including the youth who often access cigarettes one at a time in social situations, sidestepping the information printed on a package."

"This is going to set a world precedent," Cunningham said, adding no other country has implemented such regulations. He's hopeful that the warning will make a real difference.

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