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Patients Squeezed in Fight Over Who Gets to Bill for Pricey Infusion Drugs

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by Samantha Liss
Wed, 05 Jul 2023 09:00:00 +0000

Health insurers and medical providers are battling over who should supply high-cost infusion for patients, with the tussle over profits now spilling into statehouses across the country.

The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called “white bagging,” or, more rarely, to patients, in what is called “brown bagging.” That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs.

Insurers say the policies are needed because hospital markups are too high. But hospitals argue that adding an intermediary results in unnecessary risks and delays, and they say some insurers have their own or affiliated pharmacy companies, creating financial motives for controlling the source of the medications. The patients, meanwhile, are left to deal with the red tape.

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Paula Bruton Shepard in Bolivar, Missouri, is among those caught in the middle. Flares of lupus, an autoimmune disease, rob Shepard of her mobility by attacking her joints. She relies on monthly infusions to treat her symptoms. But at times, she said, her treatments were delayed due to UnitedHealthcare's white bagging infusion policy. And interruptions to her treatments exacerbated her symptoms.

“I once had to use a toilet lift and it was kind of demoralizing to say, ‘I'm a 50-year-old woman and I have to use a toilet lift,'” Shepard said of the medication delays.

This is a tug of war over profits between insurers and medical providers, said Ge Bai, a professor of accounting and health policy at Johns Hopkins . While insurers claim the arrangement reduces costs, she said, that doesn't mean insurers pass along savings to patients.

“I don't think we should have more sympathy toward one party or the other,” Bai said. “Nobody is better than the other. They're all trying to make money.”

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The savings from white bagging can be significant for expensive infusion drugs, according to a report from the Massachusetts Health Policy Commission. For example, Remicade, used to treat a variety of inflammatory diseases, including Crohn's, cost on average $1,106 per unit in 2015 under hospitals' traditional buy-and-bill system, the commission found in its review of state claims data. That same drug cost an average of $975 per unit under white bagging, a 12% savings.

But the also found patients, on average, faced higher cost sharing — what they are responsible for paying — for Remicade and other drugs when white bagging was used. While some patients had only modest increases to their costs under the policy, such as $12 more for a medication, the review found it could mean much greater cost sharing for some patients, such as those on Medicare.

At Citizens Memorial Hospital in rural Bolivar, more than 1 in 4 patients who regular infusions are being forced to use an outside pharmacy, said Mariah Hollabaugh, the hospital's pharmacy director. Shepard was among them.

Even if the hospital has the exact drug on the shelf, patients must wait for a separate shipment, Hollabaugh said, potentially interrupting care. Their shipped drugs may sometimes be unusable when the doctor needs to change the dosage. Or the medicine in a nondescript package that doesn't get immediately flagged for the pharmacy, potentially subjecting the drugs to damaging temperature fluctuations. For patients, that can mean delays in care.

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“They're in pain, they're uncomfortable,” Hollabaugh said. “They may be having symptoms that don't allow them to go to work.”

Siteman Cancer Center, led by physicians from Washington University School of Medicine in St. Louis, has confronted the same issue. But the cancer center's size has helped it largely avoid such insurer policies.

John DiPersio, a Siteman oncologist and researcher who led the university's oncology division for more than two decades, said Siteman reluctantly allows white bagging for simple injectables but refuses to accept it for complicated chemotherapies. It does not accept brown bagging. Occasionally, he said, that means turning patients away.

“You're talking about cancer patients that are getting -threatening treatments,” DiPersio said, referring to the dangers of chemo drugs, which he said can be fatal if used improperly. “It doesn't make any sense to me. It's all stupid. It's all lunacy.”

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At least 21 states, including Missouri, introduced some form of white or brown bagging legislation during the most recent legislative session, according to the American Society of Health-System Pharmacists. And in the past two years, the trade group said, at least 13 states have already enacted restrictions on white bagging, including Arkansas, , and Virginia.

ASHP has created model legislation to limit insurers from requiring the practices as a condition of coverage.

“This is a major issue,” said Tom Kraus, a vice president at the trade group. “We see this as central to our ability to coordinate patient care.”

At the heart of the tension is an often-litigated federal program that allows certain hospitals and the clinics they own to purchase drugs at deep discounts. The 340B program, named for a section of the law that created it, allows hospitals to buy certain drugs for much less — sometimes for a total cost of a single penny — than what they are later paid for those drugs. Hospitals are not required to pass along 340B savings to patients.

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The program was intended to help hospitals spread scarce resources further to treat patients in poor and vulnerable communities, but it has morphed into a means of enriching hospitals and their affiliated clinics, researchers said in a 2014 Health Affairs report. Hollabaugh said many rural facilities such as Citizens rely on the revenue generated from the 340B drugs to subsidize infusions that have no profit margin.

The number of participating hospitals and their affiliated outpatient clinics has increased significantly since the 340B program was created in 1992. More than 2,600 of the nation's roughly 6,100 hospitals were participating in the 340B program as of January 2023. That gives them access to discounts that can knock off as much as 50% of a drug's cost, according to the Health Resources & Services Administration, which oversees the program.

The insurance industry argues that hospital markups, especially when made on top of those discounts, have gotten out of control.

“The fact is, people got greedy,” Shannon Cooper, a lobbyist for Blue Cross and Blue Shield of Kansas , said during a Missouri state Senate hearing in March.

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Markups are not unique to 340B hospitals, said Sean Dickson, who helps lead pharmaceutical policy for AHIP, a trade group formerly known as America's Health Insurance Plans. The markups thrusted on commercial plans are “widely out of line” with what Medicare will pay, he said, and that is driving up costs without providing additional value.

Legislation that targets white bagging hinders an insurer's ability to rein in such costs, Dickson said, especially when an area lacks competition.

“What we're really trying to focus on here is putting pressure on those markups that are not related to cost or safety,” Dickson said.

Anthem Blue Cross and Blue Shield lobbyist David Smith testified during the March hearing in Missouri that even the idea of white bagging elicited a quick response and that almost every major hospital system in the state said they would drop their prices and come back to the negotiation table.

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For now, Citizens Memorial Hospital and other Missouri medical facilities will have to continue to tango with the insurers: Legislation to limit white and brown bagging did not pass during the Missouri General Assembly's recent session.

Shepard, though, won't need such legislation.

UnitedHealthcare had been sending her lupus infusion through other pharmacies on and off since 2021, unwilling to cover the drugs if they came from Citizens' in-house pharmacy. Shepard had to authorize each shipment before it was sent. If she missed the monthly call, she said, it was a “bureaucratic mess” trying to get the medication shipped.

“We are driving unnecessary costs out of the system to help make care more affordable, while also maintaining drug safety, effectiveness and quality of care,” UnitedHealthcare spokesperson Tony Marusic wrote.

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But after KFF Health inquired about Shepard's case, Marusic said UnitedHealthcare stopped white bagging Shepard's medication to “prevent potential delays in shipping.” And during her latest infusion in June, her hospital was again able to supply Shepard's medication directly.

“I'm just so relieved,” Shepard said. “I don't have to take phone calls. I don't have to reply to emails. I just show up.”

By: Samantha Liss
Title: Patients Squeezed in Fight Over Who Gets to Bill for Pricey Infusion Drugs
Sourced From: kffhealthnews.org/news/article/patients-squeezed-pricey-infusion-drugs-whitebagging-brownbagging/
Published Date: Wed, 05 Jul 2023 09:00:00 +0000

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The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care

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Michelle Andrews
Fri, 17 May 2024 09:00:00 +0000

For many patients, seeing a nurse practitioner has become a routine part of primary care, in which these “NPs” often perform the same tasks that patients have relied on for.

But NPs in specialty care? That's not routine, at least not yet. Increasingly, though, nurse practitioners and physician assistants are joining cardiology, dermatology, and other specialty practices, broadening their skills and increasing their income.

This worries some people who track the workforce, because current trends suggest primary care, which has counted on nurse practitioners to backstop physician shortages, soon might not be able to rely on them to the same extent.

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“They're succumbing to the same challenges that we have with physicians,” said Atul Grover, executive director of the Research and Action Institute at the Association of American Medical Colleges. The rates NPs can command in a specialty practice “are quite a bit higher” than practice salaries in primary care, he said.

When nurse practitioner programs began to proliferate in the 1970s, “at first it looked great, producing all these nurse practitioners that go to work with primary care physicians,” said Yalda Jabbarpour, director of the American Academy of Family Physicians' Robert Graham Center for Policy Studies. “But now only 30% are going into primary care.”

Jabbarpour was referring to the 2024 primary care scorecard by the Milbank Memorial Fund, which found that from 2016 to 2021 the proportion of nurse practitioners who worked in primary care practices hovered between 32% and 34%, even though their numbers grew rapidly. The proportion of physician assistants, also known as physician associates, in primary care ranged from 27% to 30%, the study found.

Both nurse practitioners and physician assistants are advanced practice clinicians who, in addition to graduate degrees, must complete distinct education, , and certification steps. NPs can practice without a doctor's supervision in more than two dozen states, while PAs have similar independence in only a handful of states.

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About 88% of nurse practitioners are certified in an area of primary care, according to the American Association of Nurse Practitioners. But it is difficult to track exactly how many work in primary care or in specialty practices. Unlike physicians, they're generally not required to be endorsed by a national standard-setting body to practice in specialties like oncology or cardiology, for example. The AANP declined to answer questions about its annual workforce survey or the extent to which primary care NPs are moving toward specialties.

Though data tracking the change is sparse, specialty practices are adding these advanced practice clinicians at almost the same rate as primary care practices, according to frequently cited research published in 2018.

The clearest evidence of the shift: From 2008 to 2016, there was a 22% increase in the number of specialty practices that employed nurse practitioners and physician assistants, according to that study. The increase in the number of primary care practices that employed these professionals was 24%.

Once more, the most recent projections by the Association of American Medical Colleges predict a dearth of at least 20,200 primary care physicians by 2036. There will also be a shortfall of non-primary care specialists, a deficiency of at least 10,100 surgical physicians and up to 25,000 physicians in other specialties.

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When it to the actual work performed, the lines between primary and specialty care are often blurred, said Candice Chen, associate professor of health policy and management at George Washington .

“You might be a nurse practitioner working in a gastroenterology clinic or cardiology clinic, but the scope of what you do is starting to overlap with primary care,” she said.

Nurse practitioners' salaries vary widely by location, type of facility, and experience. Still, according to data from recruiter AMN Healthcare Physician Solutions, formerly known as Merritt Hawkins, the total annual average starting compensation, including signing bonus, for nurse practitioners and physician assistants in specialty practice was $172,544 in the year that ended March 31, slightly higher than the $166,544 for those in primary care.

According to forecasts from the federal Bureau of Labor Statistics, nurse practitioner will increase faster than jobs in almost any other occupation in the decade leading up to 2032, growing by 123,600 jobs or 45%. (Wind turbine service technician is the only other occupation projected to grow as fast.) The growth rate for physician assistants is also much faster than average, at 27%. There are more than twice as many nurse practitioners as physician assistants, however: 323,900 versus 148,000, in 2022.

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To Grover, of the AAMC, numbers like this signal that there will probably be enough NPs, PAs, and physicians to meet primary care needs. At the same time, “expect more NPs and PAs to also flow out into other specialties,” he said.

When Pamela Ograbisz started working as a registered nurse 27 years ago, she worked in a cardiothoracic intensive care unit. After she became a family nurse practitioner a few years later, she found a job with a similar specialty practice, which trained her to take on a bigger role, first running their outpatient clinic, then working on the floor, and later in the intensive care unit.

If nurse practitioners want to specialize, often “the doctors mentor them just like they would with a physician residency,” said Ograbisz, now vice president of clinical operations at temporary placement recruiter LocumTenens.com.

If physician assistants want to specialize, they also can do so through mentoring, or they can receive “certificates of added qualifications” in 10 specialties to demonstrate their expertise. Most employers don't “encourage or require” these certificates, however, said Jennifer Orozco, chief medical officer at the American Academy of Physician Associates.

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There are a number of training programs for family nurse practitioners who want to develop skills in other .

Raina Hoebelheinrich, 40, a family nurse practitioner at a regional medical center in Yankton, South Dakota, recently enrolled in a three-semester post-master's endocrinology training program at Mount Marty University. She lives on a farm in nearby northeastern Nebraska with her husband and five sons.

Hoebelheinrich's new skills could be helpful in her current hospital job, in which she sees a lot of patients with acute diabetes, or in a clinic setting like the one in Sioux Falls, South Dakota, where she is doing her clinical endocrinology training.

Lack of access to endocrinology care in rural areas is a real problem, and many people may travel hundreds of miles to see a specialist.

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“There aren't a lot of options,” she said.

——————————
By: Michelle Andrews
Title: The Lure of Specialty Medicine Pulls Nurse Practitioners From Primary Care
Sourced From: kffhealthnews.org/news/article/nurse-practitioners-trend-primary-care-specialties/
Published Date: Fri, 17 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/clean-needles-save-lives-in-some-states-they-might-not-be-legal/

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Clean Needles Save Lives. In Some States, They Might Not Be Legal.

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Mahon, Spotlight PA and Sarah Boden, WESA
Fri, 17 May 2024 09:00:00 +0000

Kim Botteicher hardly thinks of herself as a criminal.

On the main floor of a former Catholic church in Bolivar, Pennsylvania, Botteicher runs a flower shop and cafe.

In the former church's basement, she also operates a nonprofit organization focused on helping people caught up in the drug epidemic get back on their feet.

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The nonprofit, FAVOR ~ Western PA, sits in a rural pocket of the Allegheny Mountains east of Pittsburgh. Her organization's home county of Westmoreland has seen roughly 100 or more drug overdose deaths each year for the past several years, the majority involving fentanyl.

Thousands more residents in the region have been touched by the scourge of addiction, which is where Botteicher comes in.

She helps people find housing, jobs, and , and works with families by running support groups and explaining that substance use disorder is a disease, not a moral failing.

But she has also talked publicly about how she has made sterile syringes available to people who use .

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“When that person comes in the door,” she said, “if they are covered with abscesses because they have been using needles that are dirty, or they've been sharing needles — maybe they've got hep C — we see that as, ‘OK, this is our first step.'”

Studies have identified public health benefits associated with syringe exchange services. The Centers for Disease Control and Prevention says these programs reduce HIV and hepatitis C infections, and that new users of the programs are more likely to enter drug treatment and more likely to stop using drugs than nonparticipants.

This harm-reduction strategy is supported by leading health groups, such as the American Medical Association, the World Health Organization, and the International AIDS Society.

But providing clean syringes could put Botteicher in legal danger. Under Pennsylvania law, it's a misdemeanor to distribute drug paraphernalia. The state's definition includes hypodermic syringes, needles, and other objects used for injecting banned drugs. Pennsylvania is one of 12 states that do not implicitly or explicitly authorize syringe services programs through statute or regulation, according to a 2023 analysis. A few of those states, but not Pennsylvania, either don't have a drug paraphernalia law or don't include syringes in it.

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Those working on the front lines of the opioid epidemic, like Botteicher, say a reexamination of Pennsylvania's law is long overdue.

There's an urgency to the issue as well: Billions of dollars have begun flowing into Pennsylvania and other states from legal settlements with companies over their role in the opioid epidemic, and syringe services are among the eligible interventions that could be supported by that money.

The opioid settlements reached between drug companies and distributors and a coalition of state attorneys general included a list of recommendations for spending the money. Expanding syringe services is listed as one of the core strategies.

But in Pennsylvania, where 5,158 people died from a drug overdose in 2022, the state's drug paraphernalia law stands in the way.

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Concerns over Botteicher's work with syringe services recently led Westmoreland County to cancel an allocation of $150,000 in opioid settlement funds they had previously approved for her organization. County Commissioner Douglas Chew defended the decision by saying the county “is very risk averse.”

Botteicher said her organization had planned to use the money to hire additional recovery specialists, not on syringes. Supporters of syringe services point to the cancellation of funding as evidence of the need to change state law, especially given the recommendations of settlement documents.

“It's just a huge inconsistency,” said Zoe Soslow, who leads overdose prevention work in Pennsylvania for the public health organization Vital Strategies. “It's causing a lot of confusion.”

Though sterile syringes can be purchased from pharmacies without a prescription, handing out ones to make drug use safer is generally considered illegal — or at least in a legal gray area — in most of the state. In Pennsylvania's two largest cities, Philadelphia and Pittsburgh, officials have used local health powers to provide legal protection to people who operate syringe services programs.

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Even so, in Philadelphia, Mayor Cherelle Parker, who took office in January, has made it clear she opposes using opioid settlement money, or any city funds, to pay for the distribution of clean needles, The Philadelphia Inquirer has reported. Parker's position signals a major shift in that city's approach to the opioid epidemic.

On the other side of the state, opioid settlement funds have had a big effect for Prevention Point Pittsburgh, a harm reduction organization. Allegheny County reported spending or committing $325,000 in settlement money as of the end of last year to support the organization's work with sterile syringes and other supplies for safer drug use.

“It was absolutely incredible to not have to fundraise every single dollar for the supplies that go out,” said Prevention Point's executive director, Aaron Arnold. “It takes a lot of energy. It pulls away from actual delivery of services when you're constantly having to find out, ‘Do we have enough money to even purchase the supplies that we want to distribute?'”

In parts of Pennsylvania that lack these legal protections, people sometimes operate underground syringe programs.

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The Pennsylvania law banning drug paraphernalia was never intended to apply to syringe services, according to Scott Burris, director of the Center for Public Health Law Research at Temple University. But there have not been court cases in Pennsylvania to clarify the issue, and the failure of the to act creates a chilling effect, he said.

Carla Sofronski, executive director of the Pennsylvania Harm Reduction Network, said she was not aware of anyone having faced criminal charges for operating syringe services in the state, but she noted the threat hangs over people who do and that they are taking a “great risk.”

In 2016, the CDC flagged three Pennsylvania counties — Cambria, Crawford, and Luzerne — among 220 counties nationwide in an assessment of communities potentially vulnerable to the rapid spread of HIV and to new or continuing high rates of hepatitis C infections among people who inject drugs.

Kate Favata, a resident of Luzerne County, said she started using heroin in her late teens and wouldn't be alive today if it weren't for the support and community she found at a syringe services program in Philadelphia.

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“It kind of just made me feel like I was in a safe . And I don't really know if there was like a come-to-God moment or come-to-Jesus moment,” she said. “I just wanted better.”

Favata is now in long-term recovery and works for a medication-assisted treatment program.

At clinics in Cambria and Somerset Counties, Highlands Health provides free or low-cost medical care. Despite the legal risk, the organization has operated a syringe program for several years, while also testing patients for infectious diseases, distributing overdose reversal medication, and offering recovery options.

Rosalie Danchanko, Highlands Health's executive director, said she hopes opioid settlement money can eventually support her organization.

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“Why shouldn't that wealth be spread around for all organizations that are working with people affected by the opioid problem?” she asked.

In February, legislation to legalize syringe services in Pennsylvania was approved by a committee and has moved forward. The administration of Gov. Josh Shapiro, a Democrat, supports the legislation. But it faces an uncertain future in the full legislature, in which Democrats have a narrow majority in the House and control the Senate.

One of the bill's lead sponsors, state Rep. Jim Struzzi, hasn't always supported syringe services. But the Republican from western Pennsylvania said that since his brother died from a drug overdose in 2014, he has come to better understand the nature of addiction.

In the committee vote, nearly all of Struzzi's Republican colleagues opposed the bill. State Rep. Paul Schemel said authorizing the “very instrumentality of abuse” crossed a line for him and “would be enabling an evil.”

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After the vote, Struzzi said he wanted to build more bipartisan support. He noted that some of his own skepticism about the programs eased only after he visited Prevention Point Pittsburgh and saw how workers do more than just hand out syringes. These types of programs connect people to resources — overdose reversal medication, wound care, substance use treatment — that can save lives and lead to recovery.

“A lot of these people are … desperate. They're alone. They're afraid. And these programs bring them into someone who cares,” Struzzi said. “And that, to me, is a step in the right direction.”

At her nonprofit in western Pennsylvania, Botteicher is hoping lawmakers take action.

“If it's something that's going to someone, then why is it illegal?” she said. “It just doesn't make any sense to me.”

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This story was co-reported by WESA Public Radio and Spotlight PA, an independent, nonpartisan, and nonprofit newsroom producing investigative and public-service journalism that holds power to account and drives positive change in Pennsylvania.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).

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By: Ed Mahon, Spotlight PA and Sarah Boden, WESA
Title: Clean Needles Save Lives. In Some States, They Might Not Be Legal.
Sourced From: kffhealthnews.org/news/article/clean-needles-syringe-services-programs-legal-gray-area-risk-pennsylvania/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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Watch: John Oliver Dishes on KFF Health News’ Opioid Settlements Series

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Fri, 17 May 2024 09:00:00 +0000

Opioid manufacturers, distributors, and retailers are paying tens of billions of dollars in restitution to settle lawsuits related to their role in the nation's overdose epidemic. A recent of “Last Tonight With John Oliver” examined how that money is being spent by and local governments across the United States.

The segment from the KFF Health “Payback: Tracking the Opioid Settlement Cash.” You can learn more about the issue and read our collection of articles by Aneri Pattani here.

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Title: Watch: John Oliver Dishes on KFF News' Opioid Settlements Series
Sourced From: kffhealthnews.org/news/article/watch-john-oliver-kff-health-news-payback-opioid-settlements-series/
Published Date: Fri, 17 May 2024 09:00:00 +0000

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