Opioid manufacturers, distributors and pharmacies have started to distribute the more than $50 billion in settlement funds they’ve agreed to pay for their role in the opioid epidemic. While most of the settlements require states to spend the majority of these funds on addiction treatment and prevention, there is little agreement on what that means. 

At the same time, overdose deaths, driven largely by fentanyl, continue to rise.

Experts say that, in the face of this grave public health crisis, expanding access to FDA-approved medications for opioid use disorder (MOUD), such as methadone and buprenorphine, should be a top funding and policy priority. Both are synthetic opioids that reduce withdrawal symptoms and cravings.

These medications are highly effective in treating opioid addiction. Both have been shown to substantially reduce risk of overdose, decrease transmission of diseases like Hepatitis C, and improve the overall well-being and stability of people in recovery. Many patients feel they are nothing short of life-saving. 

Yet these medications remain strictly regulated and, for the more than 2 million Americans estimated to have opioid use disorder, difficult to get. 

The barriers to accessing treatment remain so high that researchers estimate only about 11 percent of Americans who need these medications can get them. More than 70 percent of residential treatment centers in the United States do not offer MOUD. And 80 percent of U.S. counties don’t have a single certified Opioid Treatment Program, the only setting where patients can legally access methadone.

“Opioid addiction is actually highly treatable,” one expert told me. “But most people don’t have access to that treatment.” 

The federal government has recently moved to relax some rules around MOUD, for example by making buprenorphine easier to prescribe. Bipartisan bills introduced in Congress would allow patients to get methadone at their local pharmacy with a prescription from a physician who specializes in addiction.

At the same time, the federal Drug Enforcement Administration recently proposed rolling back changes that expanded access to buprenorphine through telemedicine, prompting backlash from patients and providers. Resistance remains at the local level, too: some of the states hardest hit by the opioid epidemic have the most restrictive policies around MOUD, and some providers have been slow to enact new flexibilities granted by the federal government.

Another expert put it to me this way: In the age of fentanyl, this just doesn’t make any sense. 

The barriers that prevent patients from getting this treatment are myriad, and are higher for low-income patients, patients of color and people living in rural communities. Accessing methadone, for example, almost always requires a daily visit to a clinic — a journey that can strain household budgets and disrupt patients’ ability to work and spend time with loved ones.

But the barriers aren’t just regulatory. Another is stigma. Many patients report feeling criminalized or shamed when they seek care. And many policymakers and health care providers remain resistant to the idea of using these medications to treat addiction, even though they are widely considered to be the gold-standard for treatment.

Regardless of what the barrier is, experts say that each creates consequences for patients that not only have the potential to disrupt their recovery, but also increase their risk of overdose.

This year, as a USC Center for Health Journalism 2023 National Fellow, I’ll be reporting a series of stories that unpack the obstacles to accessing MOUD and reveal the human cost of those obstacles: to patients, their families and their communities. I’ll dig into the historical roots of the strict government rules around medications like methadone and show how these regulations have contributed to inequities across class, race and geography. I also hope to highlight programs that work and explore the policy debate over expanding access to MOUD.

My reporting will focus on communities that have been hardest hit by the opioid epidemic, and on states that have the tightest restrictions. Key to my reporting will be sources with lived experience: people who use MOUD, the providers who care for them, and the researchers, activists and policymakers who are working to narrow this access gap. 

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Opioid manufacturers, distributors and pharmacies have started to distribute the more than $50 billion in settlement funds they’ve agreed to pay for their role in the opioid epidemic. While most of the settlements require states to spend the majority of these funds on addiction treatment and prevention, there is little agreement on what that means. 

At the same time, overdose deaths, driven largely by fentanyl, continue to rise.

Experts say that, in the face of this grave public health crisis, expanding access to FDA-approved medications for opioid use disorder (MOUD), such as methadone and buprenorphine, should be a top funding and policy priority. Both are synthetic opioids that reduce withdrawal symptoms and cravings.

These medications are highly effective in treating opioid addiction. Both have been shown to substantially reduce risk of overdose, decrease transmission of diseases like Hepatitis C, and improve the overall well-being and stability of people in recovery. Many patients feel they are nothing short of life-saving. 

Yet these medications remain strictly regulated and, for the more than 2 million Americans estimated to have opioid use disorder, difficult to get. 

The barriers to accessing treatment remain so high that researchers estimate only about 11 percent of Americans who need these medications can get them. More than 70 percent of residential treatment centers in the United States do not offer MOUD. And 80 percent of U.S. counties don’t have a single certified Opioid Treatment Program, the only setting where patients can legally access methadone.

“Opioid addiction is actually highly treatable,” one expert told me. “But most people don’t have access to that treatment.” 

The federal government has recently moved to relax some rules around MOUD, for example by making buprenorphine easier to prescribe. Bipartisan bills introduced in Congress would allow patients to get methadone at their local pharmacy with a prescription from a physician who specializes in addiction.

At the same time, the federal Drug Enforcement Administration recently proposed rolling back changes that expanded access to buprenorphine through telemedicine, prompting backlash from patients and providers. Resistance remains at the local level, too: some of the states hardest hit by the opioid epidemic have the most restrictive policies around MOUD, and some providers have been slow to enact new flexibilities granted by the federal government.

Another expert put it to me this way: In the age of fentanyl, this just doesn’t make any sense. 

The barriers that prevent patients from getting this treatment are myriad, and are higher for low-income patients, patients of color and people living in rural communities. Accessing methadone, for example, almost always requires a daily visit to a clinic — a journey that can strain household budgets and disrupt patients’ ability to work and spend time with loved ones.

But the barriers aren’t just regulatory. Another is stigma. Many patients report feeling criminalized or shamed when they seek care. And many policymakers and health care providers remain resistant to the idea of using these medications to treat addiction, even though they are widely considered to be the gold-standard for treatment.

Regardless of what the barrier is, experts say that each creates consequences for patients that not only have the potential to disrupt their recovery, but also increase their risk of overdose.

This year, as a USC Center for Health Journalism 2023 National Fellow, I’ll be reporting a series of stories that unpack the obstacles to accessing MOUD and reveal the human cost of those obstacles: to patients, their families and their communities. I’ll dig into the historical roots of the strict government rules around medications like methadone and show how these regulations have contributed to inequities across class, race and geography. I also hope to highlight programs that work and explore the policy debate over expanding access to MOUD.

My reporting will focus on communities that have been hardest hit by the opioid epidemic, and on states that have the tightest restrictions. Key to my reporting will be sources with lived experience: people who use MOUD, the providers who care for them, and the researchers, activists and policymakers who are working to narrow this access gap. 

Find your latest news here at the Hemet & San Jacinto Chronicle

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WASHINGTON (AP) — A federal judge heard arguments Wednesday in a lawsuit that poses a threat to the nationwide availability of a leading abortion medication. The hearing comes as a conservative Christian group seeks to reverse federal approval of the drug mifepristone.

A two-pill combination of mifepristone and another drug is the most common form of abortion in the U.S. and the ruling would affect states where abortion is legal as well as those that outlaw it. The case has raised concerns about court transparency and so-called judge shopping.

Here’s a look at some of the legal issues surrounding the case:

HOW DID THE ABORTION PILL CHALLENGE START?

Abortion opponents who helped overturn Roe v. Wade filed a lawsuit in November, asking a judge in Texas to reverse the approval of mifepristone.

Research shows that medication-induced abortions are safe and effective, and they were approved by the Food and Drug Administration more than 20 years ago.

But the group, Alliance Defending Freedom, argued in the lawsuit that the FDA process was flawed for mifepristone. It also took aim at more recent changes that have eased access to the drug.

The suit was filed in Amarillo, Texas, which meant that it was assigned to U.S. District Judge Matthew Kacsmaryk, a former attorney at a Christian law firm who previously wrote critically about Roe. He was appointed by former President Donald Trump and confirmed over fierce opposition from Democrats.

WHY IS IT IMPORTANT?

Medication is the most common form of abortion in the U.S., according to the Guttmacher Institute, a research group that supports abortion rights. It’s become more available as the FDA allowed it to be prescribed online and sent through the mail. Demand continued as states began banning abortion after Roe was overturned and more women traveled for access, or sought medication online.

If Kacsmaryk reverses the approval of mifepristone, it could restrict access nationwide. Such a ruling would be an unprecedented challenge to the FDA, which approved mifepristone in combination with a second pill, misoprostol, as a safe and effective method for ending a pregnancy in 2000.

That would be “nothing short of catastrophic,” a group of 22 Democratic-led states said in court documents filed in the case. Another group of 22 Republican states filed briefs supporting the reversal. They argue the ability to order pills by mail undermines their laws banning abortion.

WHY IS THIS IN THE HANDS OF ONE TEXAS JUDGE?

Kacsmaryk is a federal judge and one of the major tasks of the U.S. court system has always been deciding whether laws and policy are constitutional. That means any judge weighing a case challenging a federal law or policy could make a decision that has ripple effects across the nation.

Lawyers on either side of a case can appeal a ruling, however, and federal appeals courts can block or overturn a decision. In this case, an appeal would go to the 5th Circuit Court of Appeals, which also leans conservative. It upheld Kacsmaryk’s decision in another high-profile case requiring the Biden administration to continue the “Remain in Mexico” immigration policy implemented by Trump. The ruling was later overturned by the Supreme Court.

The case has also raised concerns about judge shopping, a term for litigants seeking to file cases in front of judges they consider sympathetic to their cause. It’s a tactic that’s been utilized by groups across the ideological spectrum, but the volume of cases filed before Kacsmaryk and other Texas judges has raised concerns among experts.

WHAT SET OFF TRANSPARENCY ALARM BELLS?

Kacsmaryk set the first hearing in the closely watched case on a conference call with attorneys. He also asked them to for the “courtesy” of not publicizing the upcoming arguments, according to a court transcript.

He said he planned to delay making the hearing public until the evening before, making it difficult for many to attend because Amarillo is hours away from major cities. Such a delay is highly unusual in the American judicial system, where hearing notices are typically quickly made public and often scheduled weeks or months in advance.

After news reports about the call, the hearing was placed on the public docket a day and a half before it was scheduled.

WHAT HAPPENS NEXT?

A ruling in the case could come any time after the arguments conclude. A decision against the FDA would almost certainly be swiftly appealed by the Justice Department.

A ruling reversing approval 20 years later is all but unprecedented, so it’s not clear exactly what would happen next or how quickly access might be curtailed. If mifepristone is sidelined, clinics and doctors that prescribe the combination say they would switch to using only misoprostol, the other drug in the two-drug combination, an approach that is slightly less effective.

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MEDICATION FOR OPIOID USE DISORDER WAS LOWEST AMONG ADOLESCENTS AND ADULTS AGES 50 AND OLDER

Despite strong evidence that medication is the most effective treatment for opioid use disorder (OUD), adolescents and most adults with a need for OUD treatment reported a lack of medication for OUD in the past year, according to a study by researchers at Columbia University Mailman School of Public Health. Among those who may have needed opioid use treatment, only 28 percent received medication for OUD. Until now, national studies on medication for OUD were lacking. The findings are published in JAMA Network Open.

“Our nationally representative research revealed critical gaps in treatment engagement and use of medication for opioid use disorder. Increased efforts to address barriers to care are critically needed,” said Pia Mauro, PhD, assistant professor of epidemiology at Columbia Mailman School and the study’s lead author. “Evidence supporting the effectiveness of medication for opioid use disorder such as methadone, buprenorphine, or naltrexone is unequivocal, but most people who needed OUD treatment in the U.S did not receive this gold standard treatment.“

The findings were based on data from the 2019 National Survey on Drug Use and Health. Participants were community-based, and data excluded people who were institutionalized or homeless not in shelters. The researchers identified adolescents and adult respondents who may benefit from medication for OUD defined as meeting criteria for a past-year opioid use disorder, reporting past-year medication for OUD, or receiving past-year specialty treatment for opioid use.

The data showed that 57 percent received no treatment for the disorder, and 15 percent received only services without medication. Notably, adolescents (aged 12-17 years) did not receive (medication for opioid use disorder) MOUD in the past year and only 13 percent of adults 50 years and older received medication for the disorder. “Our findings support calls for additional MOUD engagement and retention strategies tailored for both adolescents,” noted Mauro.

Among adults, the likelihood of past-year MOUD receipt compared to no treatment was also lower for people aged 50 years and older, versus for those 18 to 25 years of age. “Our finding that a minority of adults and no adolescents received MOUD indicates substantial gaps in access,” observed Mauro. “These results provide critical evidence to inform national efforts needed to increase equitable access to MOUD.”

Nearly one-third of non-Hispanic white people in need of OUD treatment received medication, compared with approximately 20 percent of people identifying as non-Hispanic Black or multiracial groups and 15 percent of Hispanic people. In contrast, roughly similar proportions of each racial and ethnic group received non-medication services, revealing significant disparities specifically for access to medication treatment among people of color.

MOUD was lower among women, more likely among adults with at least some college, and less likely in small metropolitan areas versus large metropolitan areas. While contacts with the health care system (85 percent) and criminal legal system (61 percent) were common, most people encountering these systems did not report receiving MOUD (30 percent and 39 percent, respectively). 

Starting in 2020, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act mandated that Medicaid cover all three U.S. Food and Drug Administration–approved medications for OUD, including methadone in certified opioid treatment programs. 


“Policies that expand Medicaid coverage for these medications is an important population-level strategy to potentially increase access to effective opioid use disorder treatment in the publicly insured population,” said Hillary Samples, PhD, assistant professor at the Rutgers School of Public Health and study senior co-author. “In any case, our findings provide further evidence that investments are needed to increase MOUD prescribing and referrals in ambulatory settings.”

Co-authors are Sarah Gutkind and Erin Annunziato, Columbia Mailman School of Public Health.

The study was supported by the National Institute on Drug Abuse (grant numbers DA045224, DA049950, DA031099).  

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WASHINGTON (AP) — A new $56,000-a-year Alzheimer’s drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Wednesday.

The drug, called Aduhelm, was approved by the Food and Drug Administration only this week. It’s the first Alzheimer’s medication in nearly 20 years, though it doesn’t cure the life-sapping neurological condition. Some experts question whether Aduhelm provides any benefit to patients, but the FDA determined it can reduce harmful clumps of plaque in the brain, potentially slowing dementia.

Wednesday’s analysis by the nonpartisan Kaiser Family Foundation comes as congressional Democrats are trying to build consensus around legislation that would empower Medicare to negotiate prescription drug prices.

The chairman of the Senate Finance Committee, Democratic Sen. Ron Wyden of Oregon, said the list price for the Alzheimer’s drug was “unconscionable.” Although President Joe Biden has called for granting Medicare negotiating authority, prospects for the bill are uncertain.

The Kaiser report estimated that if just 500,000 Medicare recipients are prescribed Aduhelm, it would cost the program nearly $29 billion a year, far more than any other medication.

“At this price, the cost of this one drug alone could top all others covered by Medicare, if it is used widely,” said Tricia Neuman, coauthor of the report.

Medicare has not made a formal determination on covering Aduhelm, but cost traditionally does not enter into such considerations. Drugmaker Biogen has said it priced Aduhelm responsibly.

Alzheimer’s affects about 6 million Americans, the vast majority old enough to qualify for Medicare. “The approval of Aduhelm provides the latest high-profile example of the potential budgetary consequences of Medicare’s role as a price-taker in the pharmaceutical marketplace,” the Kaiser analysis concluded.

In addition to higher taxpayer costs, the domino effects would include higher “Part B” premiums for Medicare’s outpatient coverage and increases in monthly premiums for millions with supplemental “Medigap” plans. As an infusion drug that would be administered in a doctor’s office, Aduhelm is covered by Medicare’s outpatient care benefit. The Part B standard premium, paid by most enrollees, is currently $148.50 a month.

Beyond monthly premiums, there would also be impacts on out-of-pocket costs. Many patients taking the medication, including those signed up in Medicare Advantage plans from private insurers, could face thousands of dollars in copayments,. The maximum could reach about $11,500, researchers estimated.

That upper-bound cost out of patients’ budgets would translate to nearly 40% of the $29,650 estimated median income for Medicare beneficiaries.

“Because Aduhelm is not a cure for Alzheimer’s disease, patients could incur these annual out-of-pocket costs over multiple years,” the report noted.

Biogen, which developed the Alzheimer’s drug with Japan’s Eisai Co., said earlier this week that it expects a gradual uptake and not a sharp “hockey-stick” spike.

Biogen priced the drug after careful research, said Chirfi Guindo, Biogen’s head of global product. Biogen has committed to no price increases for four years.

Guindo said that the company looked at prices for advanced medications to treat cancer and other complex conditions. “We have priced Aduhelm at roughly a third the level of the cancer immunotherapies,” he said during a teleconference this week. “So, we consider this to be a really responsible price and we consider this to be a price that is sustainable for the system.”

Medicare has a review process known as a National Coverage Determination to evaluate new treatments that could have far-reaching implications for the program. Officials have not yet said how the program will proceed with Aduhelm. It’s possible Medicare could set conditions for covering the drug, based on clinical effectiveness.

The program covers more than 60 million people, including those 65 and older, as well as people who are disabled or have serious kidney disease. Medicare spending is approaching $1 trillion a year.

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