National

The Drug Enforcement Administration (DEA) announced Tuesday that it seized over 379 million doses of potentially deadly fentanyl in 2022, including more than 50.6 million fentanyl-laced fake prescription pills and more than 10,000 pounds of fentanyl powder.

Why it matters: Fentanyl, a highly addictive man-made opioid that is 50 times more potent than heroin, is considered the deadliest drug threat in the U.S. — and a growing threat to teenagers.

The DEA has documented a sharp nationwide increase in the lethality of fentanyl-laced fake prescription pills in particular.

"Just two milligrams of fentanyl, the small amount that fits on the tip of a pencil, is considered a potentially deadly dose," the agency noted in a press release.

Details: The trafficked fentanyl is primarily mass produced at secret factories in Mexico with chemicals largely sourced from China, according to the DEA.

The pills are often "made to look identical to real prescription medications — including OxyContin®, Percocet®, and Xanax® — but only contain filler and fentanyl," the DEA said.

Given their prevalence online, the DEA warned that people should only use medication directly prescribed by a trusted medical professional and dispensed by a licensed pharmacist.

What they're saying: Administrator Anne Milgram said the DEA's 2022 seizures are "enough deadly doses of fentanyl to kill every American."

"DEA’s top operational priority is to defeat the two Mexican drug cartels — the Sinaloa and Jalisco (CJNG) Cartels — that are primarily responsible for the fentanyl that is killing Americans today," Milgram said in a statement.

The big picture: Illegal fentanyl is now the leading cause of death for people in the U.S. ages 18 to 49, a Washington Post investigation found.

The epidemic poses a growing threat to teens, who officials say may more frequently encounter the drug disguised in unexpected forms.

Go deeper: Opioid abuse treatments don't reach those most at risk

DEA seized enough fentanyl in 2022 to kill everyone in the U.S.

"Just two milligrams of fentanyl, the small amount that fits on the tip of a pencil, is considered a potentially deadly dose."

A bag of assorted pills and prescription drugs dropped off for disposal on April 24, 2021 in Los Angeles, California. Photo: Patrick T. Fallon/AFP via Getty Images

Fentanyl

Opioids

The U.S. faces a range of health care flashpoints — unaffordable drugs, opioids, vaping — as we debate whether to adopt universal care. For now, the Affordable Care Act is the law of the land, but Republicans want to issue it a final death blow.

Health

President Biden has made the COVID-19 crisis and a post-Trump return to national unity and traditional democratic ideals his top priorities. From vaccinations to stimulus to schools, Biden is seeking bipartisan compromise while showing a willingness to use executive authority and bare Democratic majorities in the U.S. House and Senate to implement his policies. Republican leaders are navigating deep party divisions over if and how to move beyond former President Trump.

Politics & Policy

Axios Pro Policy

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Health Care Policy Thought Bubble

There's plenty for health care interest groups in Congress' year-end spending package, but some had to make significant concessions: There will be no pandemic commission, doctors will have to swallow some Medicare payment cuts and FDA oversight of diagnostic tests will not change.

Why it matters: The health care riders in the year-end spending package reflect which health care interests have clout, and which issues lawmakers want to punt into next year, when Congress will be divided and deals may be more elusive. 

Doctors cuts: The package will stave off 2.5 percentage points of a scheduled 4.5% cut to the Medicare physician fee schedule in 2023, and 1.25 percentage points of cuts in 2024.

Providers practicing in independent or small practices had said the cuts, combined with inflation and staffing pressures, could be economically devastating and prompt more mergers and buyouts.

American Medical Association president Jack Resneck expressed disappointment Congress didn't go all the way with relief on Monday and raised the prospect some practices will stop taking new Medicare patients.

Medicaid coverage: People could begin to be bumped from the safety net program if they don't meet eligibility requirements starting on April 1, but the process will occur over a one-year period so there is not a cliff where lots of people are kicked off at once.

The decision begins to unwind measures Congress put in pandemic relief legislation that increased the share of federal Medicaid spending if states offered continuous coverage to enrollees, suspending the program's usual churn. 

The savings from that policy will in part be used on 12 months of Medicaid postpartum coverage, and continuous Medicaid eligibility for kids for one year. The advocacy group Protect Our Care said the steps would especially help families in communities of color and rural areas.

Puerto Rico also is getting a five-year funding deal for its Medicaid program through fiscal year 2027.

FDA oversight: Several FDA reforms which had bipartisan support in the House made it into the package. They include revamping a fast-track drug approval process that lets drugmakers sell their products based on preliminary evidence.

The year-end package also would give FDA added power to recall cosmetics that could cause harm and force manufacturers to disclose ingredients. And it would ensure more diversity in clinical trials, addressing a health equity issue that that was put into the spotlight during the pandemic.

But language aimed at modernizing a patchwork of diagnostic testing oversight at FDA was left out of the package. 

Pandemic preparedness: Parts of a pandemic preparedness bill made it into the legislation, but the deal won't create a 9/11-style commission to examine the COVID response. It will, however, make the CDC director into a Senate-confirmed position, among other things.

Public health advocates have called for a much stronger legislative response, including more funding for next-generation vaccines and therapeutics.

Telehealth: Medicare telehealth flexibilities will also be extended for two years. The provisions have already been extended for 151 days after the end of the COVID-19 public health emergency.

This includes an extension of telehealth flexibilities for high-deductible health plans coupled with Health Savings Accounts.

Opioids: The omnibus also will include a bill to remove a requirement that health care providers get a special waiver from the Drug Enforcement Administration before being able to prescribe buprenorphine, a treatment for opioid addiction.

A version of this story was published first on Axios Pro. Get news like this by subscribing. Use code POLICY100 which gives you $100 off.

Congress saves big health care decisions for last

The health care riders in the year-end spending package that emerged on Monday reflect which health care interests have clout, and which issues lawmakers want to punt into next year.

Illustration of the US Capitol forming the top of a red cross symbol.

Congress

Public health

A bipartisan bill to increase access to treatment for opioid addiction has a good chance of being rolled into a year-end package during the lame-duck session, congressional aides tell Axios.

Why it matters: Advocates point to federal data showing only one in 10 people with opioid use disorder receive medication for it.

How it works: The bill would remove a requirement that health care providers get a special waiver from the Drug Enforcement Administration before they can prescribe buprenorphine, an addiction treatment that reduces the risk of future overdoses.

What they're saying: Rep. Paul Tonko (D-N.Y.), one of the lead sponsors of the bill, told Axios he is "very confident" it will make the omnibus. "Leadership is working hard to get it done," he said, calling the bill a "lifesaver."

Nearly 200 organizations sent a letter to Congress this week urging its passage, including the National Association of Counties, the American Medical Association and the National Sheriffs' Association. 

The path forward: Backers say they have not encountered a large amount of opposition, but there is still a lot of uncertainty around how big the end-of-year package will be and what will make it in.

There is at least some opposition from certain House Republicans, including members who are doctors, like Indiana Rep. Larry Bucshon. Bucshon said earlier this year that the bill is "making it easier to prescribe a medication known to be highly diverted and misused."

Some doctors remain unwilling to prescribe buprenorphine for use at home without supervision, and there’s also concern about a lack of data about the drug’s effectiveness in those who misuse multiple substances.

At least at the moment, though, backers do not think the opposition will be enough to stop it from making it into the bill. 

The list of cosponsors in the Senate includes members from across the ideological spectrum, including Maggie Hassan (D-N.H.), Bernie Sanders (I-Vt.), Rand Paul (R-Ky.) and Marsha Blackburn (R-Tenn.).

In the House, Chris Krepich, a spokesman for House Energy and Commerce Committee ranking Republican Cathy McMorris Rodgers, said it is a priority for her to get the House's mental health package, which includes the bill language, passed and signed into law in this Congress.

The package got over 400 votes in the House earlier this year. 

Year-end package could increase access to addiction treatment

A bipartisan bill to increase access to treatment for opioid addiction has a good chance of being rolled into a year-end package during the lame-duck session, congressional aides tell Axios' Peter Sullivan.

Illustration of a gavel made of a pill bottle, touching a gavel rest made of a white pill.

Opioid addiction

The Biden administration is giving $1.5 billion in funding to states and territories to help curb the U.S. opioid crisis, the White House said Friday.

Why it matters: Deaths from overdoses hit a new record of more than 107,000 throughout the 12-month period ending in December 2021, according to provisional data released by the Centers for Disease Control and Prevention. 

Synthetic, natural, and semi-natural opioids accounted for a bulk of those overdose deaths.

More recently, drug deaths have fallen slightly to around 103,000 over the 12-month period ending in April 2022, the provisional data shows.

The funding comes after the Biden administration sent its first national drug control strategy to Congress earlier this year.

What they're saying: "This funding goes to life-saving programs and policies," White House press secretary Karine Jean-Pierre said in a briefing Friday.

"President Biden recognizes the devastating impact the opioid overdose epidemic has had on our nation, reaching large cities, small towns, tribal lands and every community in between," Jean-Pierre added.

The big picture: The funding comes from the Department of Health and Human Services' Substance Abuse and Mental Health Services Administration, the White House said.

The grants will help states and territories boost access to treatment programs for substance use disorder and "remove barriers to public-health interventions like naloxone," which can quickly reverse the effects of an opioid overdose.

The White House said that more than $104 million will go toward "public, private, and non-profit entities working to expand access to treatment and prevention services for substance use disorder in rural communities." 

$20.5 million in funding will also go toward organizations "that help connect individuals who have substance use disorders with community resources," the White House added.

America's fentanyl problem a growing threat for teens

Drug treatment center admissions fell 23% during COVID

White House announces $1.5 billion to curb opioid crisis

Overdose deaths hit a new record of more than 107,000 at the end of last year.

Used syringes collected by a counselling service in Washington, D.C., in April 2022.

Opioid epidemic

Joe Biden

Bureaucratic red tape at the state and federal levels is hindering access to treatments for opioid use disorder, a new analysis from the Pew Charitable Trusts shows.

Why it matters: Pew found that nearly all states have rules governing opioid treatments that are not based in evidence and, in turn, limit access to care or worsen the patient experience.

What they found: 19 states and the District of Columbia require a certificate of need to open a new facility that can dispense methadone, and experts say is critical to reducing overdose deaths.

16 states require opioid treatment programs to have a pharmacy license or registration.

Every state except South Dakota and Massachusetts allows programs to terminate a person if they use drugs while receiving treatment, despite federal guidelines and research recommending against this.

Federal guidelines require eight drug tests per year as a part of methadone treatment, but 26 states require more than the federally-required amount.

Despite opioid dispensing rates decreasing in the last decade, the painkillers still play a role in many overdose deaths; in 2020, opioids were involved in 68,630 such fatalities, per the CDC.

The majority of people needing treatment for opioid-use disorder don't get it, and if pandemic-era reforms expire, it's possible even more people will lose access.

State and federal rulemaking hampers opioid treatment, study finds

A new Pew analysis found that both state and federal regulations make access to opioid treatment burdensome.

Illustration of a roll of red tape in a tape dispenser. 

Pandemic-era reforms allowed more Medicare beneficiaries to use telehealth to obtain opioid-use disorder drugs, stay in treatment and avoid overdoses, a new JAMA Psychiatry study found.

Why it matters: The vast majority of people who need treatment for a substance-use disorder don't get it, and the researchers fear the addiction crisis could worsen if COVID-19 allowances on telehealth and prescribing aren't made permanent.

What they found: Researchers compared two cohorts of Medicare beneficiaries before and during the pandemic and found that more people during the pandemic had access to treatments like methadone, buprenorphine and extended-release naltrexone and had lower odds of having to be treated for overdoses.

But very few people were still receiving treatment 80 days after initiating it.

About one in eight Medicare patients studied received telehealth services for their opioid-use disorder during the pandemic, compared to one in 800 pre-pandemic. 

Black people had lower odds of getting telehealth treatment for their opioid-use disorder and staying in treatment, and overdose rates were higher among Black people, Native Americans, Asian people and Pacific Islanders.

Go deeper: Treatment for opioid-use disorder and other substance-use disorders was heavily regulated prior to the pandemic, from in-person prescribing requirements to limited treatment center locations.

Some researchers fear that the expiration of pandemic reforms with the end of the public health emergency will reverse progress and are advocating for telehealth and take-home dosing to continue.

"This study adds to the evidence showing that expanded access to these services could have a longer-term positive impact if continued," Wilson Compton, deputy director of the National Institute on Drug Abuse and study author, said in a news release.

Pandemic telehealth reforms increased access to opioid-use disorder meds

Relaxed regulations around treating opioid-use disorder during the pandemic led to more people receiving treatment and less overdoses among them.

Illustration of a phone wearing a doctor's coat and a stethoscope. 

Telehealth

A federal judge on Wednesday ordered three of the country's largest pharmacy chains — CVS, Walgreens and Walmart — to pay $650 million to two Ohio counties, claiming the way they distributed opioids to customers caused severe harm to communities and created a public nuisance, AP reports.

Why it matters: It is the first ruling by a federal judge that assigns a set money figure against the pharmacy chains for their role in the opioid crisis, and could set a precedent for other local governments that seek to hold pharmacies accountable.

U.S. District Judge Dan Polster said in the ruling that the money will be used to abate a continuing opioid crisis in Lake and Trumbull counties, outside Cleveland, per AP.

Attorneys for the counties put the total price tag at $3 billion for the damage done to the counties.

Details: According to the ruling, Lake County is to receive $306 million over 15 years, while Trumbull County is to receive $344 million over the same period.

The judge ordered the companies to immediately pay nearly $87 million to cover the first two years of the abatement plan.

He also ordered the companies to comply with a series of rules to ensure that they improve how they dispense opioids and spot potential problems.

What they're saying: “Today marks the start of a new day in our fight to end the opioid epidemic,” Lake County Commissioner John Hamercheck told AP in a statement.

Frank Fuda, Trumbull County Commissioner, praised the ruling in a statement, saying “the harms caused by this devastating epidemic” can now be addressed.

What's next: CVS, Walmart and Walgreens disagreed with the court decision, and said they will appeal the ruling.

Go deeper: Jury holds pharmacies responsible in groundbreaking opioids case

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A daily look at the most significant and interesting stories affecting Columbus. Written by Tyler Buchanan and Alissa Widman Neese.

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CVS, Walgreens, Walmart to pay $650 million in Ohio opioids case

The ruling could set a precedent for other local governments that seek to hold pharmacies accountable.

Photo: Paul Weaver/SOPA Images/LightRocket via Getty Images

Change in drug overdose deaths per 100k people, by race/ethnicity

Data: Kariisa, et al., 2022, "Vital Signs: Drug Overdose Deaths, by Selected Sociodemographic and Social Determinants of Health Characteristics — 25 States and the District of Columbia, 2019–2020";  Chart: Simran Parwani/Axios

Drug overdose deaths surged by 30% during the first year of the pandemic, with Black and Native American communities bearing a disproportionately higher burden, the CDC reported on Tuesday.

Why it matters: The pandemic highlighted long-overlooked disparities in health care and how social determinants like poverty, housing and transportation can hinder access to care, including substance use treatment.

Fentanyl has accelerated the opioid crisis and is often being laced into other drugs, sometimes unbeknownst to the user.

Takeaways: Overdose rates were highest in areas with the most treatment options available, in 25 states and the District of Columbia, where data was available, the report found.

"Just because there's availability of services doesn't meant they're necessarily accessible," Mbabazi Kariisa, a CDC health scientist, told reporters.

Systemic racism, income inequality, and lack of reliable housing, transportation and health insurance all play a role in why drug overdoses are disproportionately affecting Black and Native American people, CDC officials said.

By the numbers: In 2020, there were 91,799 Americans who died of a drug overdose, according to HHS, and from 2019 to 2020 overdose rates increased the most among teens and young adults.

Black youths and young adults ages 15 to 24 years old experienced the largest overdose death rate increase at 86%.

Native American people ages 25 to 44 years old saw an increase of 49% in the rate of overdose deaths.

White people ages 15 to 24 years old had a 34% increase in overdose death rate.

The bottom line: The landscape is evolving, CDC officials said, and illicit drug use as well as poly-substance use is a major cause for concern in communities, especially when fentanyl can kill a person who uses it once.

Overdose deaths soared in 2020, highlighting racial disparities

New data from the CDC show that Black and Native American people were disproportionately impacted by unintentional drug overdoses in 2020.

Opioid overdose deaths

McKinsey & Company found opportunities to boost opioid manufacturers' sales amid the addiction crisis from 2004 to 2019, new documents published by the University of California at San Francisco and Johns Hopkins University show.

Why it matters: When one opioid fell out of favor with federal regulators, drugmakers created and marketed another, further stoking the crisis. 

The more than 114,000 pages of documents show how McKinsey had a much broader role advising the companies than was previously documented, providing growth and turnaround plans to combat the loss of revenue from opioid lawsuits, advice on how to deal with regulators and strategies to boost sales while concern about the addictive properties of the painkillers grew. 

Flashback: Nearly half a million people died from an opioid-related overdose from 1999 to 2019, according to the CDC, and the proliferation of prescription opioid addiction gave way to heroin then synthetic opioid use, which continued the upward trajectory of opioid deaths through 2019.

Despite lawsuits, regulation and backlash during the height of the opioid epidemic, McKinsey continued to consult with leading opioid drugmakers Purdue Pharma, Endo Pharmaceuticals, Johnson & Johnson and Mallinckrodt, the new documents show.

The new documents reveal "a sweeping and detailed depiction of a firm that became a trusted adviser to companies at the core of an epidemic that has claimed half a million American lives," the New York Times reported.

The other side: In 2019, McKinsey cut ties with opioid manufacturers, and in early 2021, the company reached a $573 million settlement agreement with 47 states, five territories and the District of Columbia, which called for the release of the internal documents.

"As we have said before, we recognize the terrible consequences of the opioid epidemic and have acknowledged our role in serving opioid manufacturers," a McKinsey spokesperson said in a statement in response to the documents being published on Thursday. 

Documents reveal McKinsey's role increasing opioid sales until 2019

More than 114,000 documents reveal the role McKinsey played in consulting with drug companies at the height of the opioid epidemic.

Illustration of the score line on a pill in the shape of an upward arrow instead of straight across.

Estimated number of U.S. drug overdose deaths

Data: CDC; Chart: Erin Davis/Axios Visuals 

Drugs for treating opioid abuse aren’t reaching most high-risk patients, potentially widening gaps in care as overdose deaths hit record highs.

The big picture: New provisional data show a 15% surge in overdose deaths during the pandemic, rekindling a debate over whether enough Americans in the throes of the addiction crisis have access to potentially life-saving treatments.

Driving the news: Nearly 53% of patients with opioid use disorder were not prescribed buprenorphine, which reduces the risk of future overdoses, according to a new analysis of insurance claims from about 180,000 people.

More than 70% of opioid users who also misuse other substances, such as alcohol or methamphetamine, weren’t prescribed the drug, per the analysis in JAMA Network Open, which was based on data that predated the pandemic.

The analysis also found buprenorphine was better at helping prevent future overdoses than another commonly used addiction treatment, naltrexone.

What they’re saying: “This is equivalent to giving those with advanced cancer a less aggressive treatment,” said co-author Laura Bierut, a professor of psychiatry at Washington University. 

“It seems obvious to many of us that we should be giving the most aggressive and effective treatments to those who are most seriously ill.”

Many doctors remain reluctant to prescribe buprenorphine for use at home without supervision. Some experts say there’s also a lack of data about the drug’s effectiveness in those who misuse multiple substances.

A 2020 VA study of veterans found a lower likelihood of buprenorphine treatment for patients with multiple substance use disorders.

The American Medical Association recommends other strategies, such as making the easy-to-use opioid overdose antidote naloxone available over-the-counter and legalizing the use of strips that test drugs for the synthetic opioid fentanyl, which remain illegal in about half the states.

Where it stands: The National Center for Health Statistics said at least 107,622 people died from overdoses in 2021 -- more than in any other year on record and a major increase from the estimated 93,655 deaths in 2020.

A growing number of deaths involve fentanyl, which is often mixed with other drugs, and the stimulant methamphetamine.

The Biden administration last month sent Congress its first national drug control strategy, which emphasizes addressing untreated addiction through harm reduction strategies and evidence-based treatments and clamping down on drug trafficking.

Harm reduction, which includes steps like expanded access to needle exchanges, has drawn controversy, as well as skepticism from health experts who say it won't make a major dent in overdose deaths. 

The big question: It remains to be seen if the worsening addiction crisis leads to more prescribing of buprenorphine -- or a broader reevaluation of treatment strategies. 

Opioid abuse treatments don't reach those most at risk

The three dominant prescription drug distributors — AmerisourceBergen, Cardinal Health and McKesson — and Johnson & Johnson have agreed to pay a combined amount of $26 billion to settle allegations that they fueled the country's opioid crisis.

Why it matters: The companies, which have admitted no wrongdoing, are paying a sum of money that equates to 4% of their combined annual revenue. Meanwhile, a record 70,000 Americans died from opioid overdoses during the pandemic in 2020.

By the numbers: The $26 billion settlement, announced by a group of state attorneys general, varies by company and will be paid out over time.

AmerisourceBergen: $6.4 billion over 18 years

Cardinal Health: $6.4 billion over 18 years

Each of the three drug distributors have already set aside funds in anticipation of a settlement.

The big picture: All states, except for West Virginia, and local governments will now have a chance to sign on to the settlement.

"The substantial majority of the money is to be spent on opioid treatment and prevention," the state AGs said.

What they're saying: "Distributors can easily bear this burden," analysts at stock market firm Baird wrote this week. "We think [Wall] Street is more than ready for substantial resolution, even if not all-encompassing ... We haven't popped the champagne yet, but the bottle is definitely chilling."

Flashback: In 2018, executives at AmerisourceBergen, Cardinal Health and McKesson told Congress they did not think their companies contributed to the opioid crisis.

What to watch: Settlements have still not been finalized with Purdue Pharma, other opioids manufacturers like Teva and pharmacies, although Purdue is working on a settlement through bankruptcy. Native American tribes also are pursuing legal action.

Drug distributors, J&J reach $26 billion opioids settlement

The amount equates to 4% of the companies' combined annual revenue.

An amber drug vial with white painkiller pills falling out.

Four key opioid companies have reached a near-global settlement. Photo: John Moore/Getty Images

After a record economic expansion, the coronavirus pandemic sent the U.S. economy into a recession as unemployment soared to staggering heights. The country now faces urgent questions about how much stimulus is needed for reeling consumers and businesses, and what a recovery might look like.

Economy & Business

Data: Mental Health Treatment and Research Institute; Chart: Axios Visuals

As suicide and overdose rates have increased, mental health and substance abuse insurance coverage has gotten worse, according to a new Milliman report commissioned by the Mental Health Treatment and Research Institute.

Why it matters: Behavioral health treatment often isn't covered by insurance, and it's often unaffordable — including for patients for whom treatment is a matter of life and death.

By the numbers: Coverage of substance abuse treatment was especially bad compared to physical health treatment.

The numbers for residential treatment facilities are particularly rough; in 2017, more than 50% of care in these facilities was out of network.

Behavioral health providers are also paid less than physical health providers. 

Behavioral health providers are paid, on average, less than the Medicare rate, while primary care doctors and physical health specialists make more than the Medicare rate.

These low rates can discourage providers from joining insurance networks.

My thought bubble: If we're going to make a serious attempt to tackle suicide and overdose rates, enforcing the requirement that mental health care be covered the same way physical health care is would be a good place to start.

 Go deeper: Why we're failing to stop teen suicide

Mental health coverage is getting worse

That's happening as opioid overdoses and suicide rates rise.