Hospitals Take Shot At Opioid Makers Over Cost Of Treating Uninsured For Addiction

While thousands of cities and counties have banded together to sue opioid makers and distributors in a federal court, another group of plaintiffs has started to sue on their own: hospitals.

Hundreds of hospitals have joined in a handful of lawsuits in state courts, seeing the state-based suits as their best hope for winning meaningful settlement money.

“The expense of treating overdose and opioid-addicted patients has skyrocketed, straining the resources of hospitals throughout our state,” said Lee Bond, CEO of Singing River Health System in Mississippi in a statement. His hospital is part of a lawsuit in Mississippi.

Hospitals may discover downsides to getting involved in litigation, said Paul Keckley, an independent health analyst.

“The drug manufacturers are a soft target,” he said. But the invasive nature of litigation may generate “some unflattering attention” for hospitals, he added. They’d likely have to turn over confidential details about how they set prices, as well as their relationships with drug companies.

So, despite representing the front lines of the opioid epidemic, most hospitals have been hesitant to pile on.

Just about every emergency room has handled opioid overdoses, which cost hospitals billions of dollars a year, since so many of the patients have no insurance. But that’s just the start. There are also uninsured patients, like Traci Grimes of Nashville, who end up spending weeks being treated for serious infections related to their IV drug use.

“As soon as I got to the hospital, I had to be put on an ice bath,” Grimes said of her bout with endocarditis over the summer, when bacteria found its way to her heart. “I thought I was going to die, literally. And they said I wasn’t very far away from death.”

Grimes is in recovery from her opioid addiction but still getting her energy back after spending a month being treated through a special intravenous line to her heart at Vanderbilt University Medical Center. Most patients could be sent home with a PICC line, but not someone with a history of illicit IV drug use who could misuse it to inject other substances. Vanderbilt and other academic medical centers recognize the problem and have established special clinics to manage these complex patients.

Grimes, 37, said she’s grateful for the care she received, which included multiple procedures and treatment for pneumonia, hepatitis A and hepatitis C. But like most patients in her situation, she’s uninsured and strapped for cash.

“I can’t pay a thing. I don’t have a dime,” she said. “So they do absorb all that cost.”

Hospitals estimate treating complicated patients like Grimes costs an average of $107,000 per person, according to court documents. The total costs to U.S. hospitals in one year, 2012, exceeded $15 billion, according to a report cited in the suits. And most patients either couldn’t pay or were covered by government insurance programs.

The expense is a leading reason cited by the hospitals who’ve banded together in a handful of lawsuits in Tennessee, Texas, Arizona, Florida, Kentucky, Mississippi and West Virginia. These suits are separate from the consolidated federal case in Ohio that includes cities and counties around the country. But the most prominent hospitals in those states, like Vanderbilt, have opted not to join the litigation.

West Virginia University President E. Gordon Gee, who oversees the state’s largest hospital system, has been urging others to join the suits. He and former Ohio Gov. John Kasich established an organization meant to highlight the harm done to hospitals by the opioid crisis.

“I think the more hospitals we have that want to be involved in this in some way, the better off we are,” he said. “You know, there’s always safety in mass.”

By “safety,” Gee acknowledged a central concern for hospitals weighing the risk versus reward of going to court. They may have the tables turned on them by the pharmaceutical companies since, until recently, patients in the hospital were often prescribed large quantities of opioids, contributing to the epidemic.

“I suspect there are some hospitals … who are afraid that if they get into it, those who are on the defense side will point out, well, maybe hospitals were really the problem,” he said.

The lead defendant in the suits, Purdue Pharma, did not respond to requests for comment.

Gee said hospitals can claim they were victims of dubious opioid marketing.

Still, many high-profile hospitals are sitting out the lawsuits, even though they’re typically the ones that treat the most complicated and expensive patients.

Health analyst Keckley said if hospitals join the litigation, they may be forced to cough up actual totals for their opioid-related financial damages. That could force hospitals to reveal how much more they charge for some services, compared with the actual costs of providing the care.

“Hospitals basically have charged based on their own calculations and the underlying cost of delivering that care has been virtually nontransparent,” Keckley said. “Then you open a whole new can of worms.”

Big academic medical centers especially, Keckler said, have relationships with drugmakers that they may not want publicly highlighted.

Still, hospitals might benefit without having to put their names on lawsuits and exposing themselves to risk. In Oklahoma, the state won an early opioid lawsuit in August. The payout does not direct money to hospitals, per se. However, Patti Davis, president of the Oklahoma Hospital Association, said they’re happy to see some of the money was earmarked for treatment.

“When we see treatment, we get very excited because it’s our hospitals providing a lot of the treatment,” she said.

But nationally, hospitals can’t count on potential settlement money to trickle down to their bottom lines, said Don Barrett, a Mississippi litigator helping hospitals sue in state courts.

Two decades ago, when the target of litigation was Big Tobacco, Barrett was working for states. He said hospitals didn’t join in, to his surprise. And when the states won those suits and started getting paid damages, hospitals missed out. Only about a third of the money was even spent on health or tobacco control, according to one watchdog’s estimate.

“I guess they thought that the states were going to take care of them, that these local governments were going to take this money and give it to the hospitals where it would do some good,” he said. “Of course, they didn’t give them a damn penny.”

Some states did set up trust funds that might help patients in the hospital stop smoking. But many are using the money to fill potholes, pay teachers and otherwise close gaps in state budgets.

Though not detailed in the lawsuits, many of the participating hospitals are in varying levels of financial distress, and not always primarily because of the opioid epidemic. Facilities owned by Community Health Systems make up a large share of the hospitals suing in Alabama, Florida, Mississippi, Tennessee and Texas. The investor-owned hospital chain, based in Franklin, Tenn., has been struggling mostly because of an outsize debt load taken on during a rapid period of expansion.

A CHS spokesperson declined to comment, citing a policy not to talk about pending litigation.

But Barrett said he expects more hospitals to join the cause rather than relying on states to determine how settlement money is spent.

“We’re not going to allow that to happen this time,” he said. “We can’t afford to allow it to happen this time.”

This story is part of a partnership that includes Nashville Public Radio, NPR and Kaiser Health News.



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Moved Overseas For School, Stayed For Insulin

KHN correspondent Shefali Luthra reported this story from Germany as a 2019 Arthur F. Burns Fellow.

HAMBURG, Germany ― Every now and then, Katie West considers returning to the United States. She moved to Germany for graduate school three years ago and now works as a health systems researcher in Hamburg. Her family is an ocean away. Then she remembers why she stays.

West, 30, has had Type 1 diabetes since she was 3. Back in Seattle, where she used to live, she typically paid $70 per month for insulin and another $130 for pump supplies. That was a relative steal in the U.S., made possible by her excellent health insurance, which she got through her employer. But still, it was a financial strain.

In Germany, she pays about 10 euros, roughly $11. Every three months.

“I don’t ever have to worry,” she said. “There is not a day I ever have to worry about if I can pay for something, or manage something.”

The price of insulin has increased globally in recent years, but no high-income country has felt the impact as acutely as the U.S., where the cost has more than doubled since 2012, going from an average $344 per prescription that year to $666 in 2016, according to the Health Care Cost Institute, and continually climbing since. Like Germany, many Western nations, including England and Canada empower their governments to actively negotiate prescription drug prices, which has held consumer costs in check. (The U.S. has no such system in place.)

Last year, over 10% of American adults with diabetes rationed their insulin, according to research by the Centers for Disease Control and Prevention. That doesn’t account for people who kept paying for medication but skimped on other things, like groceries.

West, like 90% of German residents, is on one of the country’s many public insurance plans, which are administered through nonprofit insurance companies. She pays for that benefit: Maybe a third of her paycheck is withheld each month for taxes, health care and other social services. But in exchange, the coverage — including that of prescription drugs — is generous.

Germany has an easier time financing prescription coverage because these drugs cost less there. When a new drug comes to the German market, an independent panel assesses its effectiveness and whether its treatment value is commensurate with the manufacturer’s proposed price. Drugs serving a similar purpose or delivering the same benefit get grouped together. The panel sets a maximum price that insurers will pay for these medications ― a practice known as “reference pricing.” Since most German residents are on public health insurance plans, and these plans are tightly regulated, there aren’t many ways for insurance providers to compete with one another. One option they do have, however, is to negotiate lower prices on prescription meds with drug manufacturers.

German law requires public plans to cap out-of-pocket health care costs and to cover all medically necessary treatment, including insulin. For people with chronic conditions — like West — the out-of-pocket limit is set at 1% of household income. For those without such a condition, out-of-pocket costs are capped at 2%. After you hit the limit, the plan pays the rest; that’s why West’s insulin costs are so low. In fact, German diabetes patients have some of the lowest out-of-pocket costs in the world for insulin, according to T1 International, an advocacy group for people with Type 1 diabetes.

Meanwhile, in the U.S., the climbing price of insulin has lit up both Capitol Hill and the 2020 presidential campaign trail, especially as voters say prescription drug prices are reaching “unreasonable” heights, and large majorities support government intervention, per October polling by the Kaiser Family Foundation. A KFF poll in February also showed that almost two-thirds of respondents supported more government regulation of drug pricing. (KHN is an editorially independent program of the foundation.)

Lawmakers in D.C. have proposed legislation to that effect, like the bipartisan “Insulin Price Reduction Act,” which specifically targets the diabetes drug, and the “Affordable Drug Manufacturing Act,” proposed by Democratic Sen. Elizabeth Warren, which includes regulating insulin pricing as one of a series of broader proposals. Legislators have also hauled in insulin manufacturers for congressional questioning, but these efforts have foundered in the face of congressional legislative inertia, partisan in-fighting over the best path forward and intense pharmaceutical industry lobbying.

Ken Inchausti, a Novo Nordisk spokesman, says a reference-pricing approach like Germany’s is incompatible with the American market. Instead of tackling drug prices, he said, policymakers should look at how insurance plans pay for insulin. A White House proposal first floated last fall to tie Medicare payments for some drugs to prices paid in European countries ― including Germany ― would do just that, at least for the public sector.

But that plan, which does align with ideas put forth by House Speaker Nancy Pelosi, has elicited vocal pushback from the pharmaceutical industry and other conservative groups, which have blanketed Washington in advertisements criticizing the proposal. Powerful Senate Republicans have come out against this idea as well, including Republican Senate Finance Chair Chuck Grassley of Iowa, who argued this summer it would hamper innovation.

Germany’s system isn’t perfect. West now pays more for basic over-the-counter medicines than for insulin, she said. She asks her family to bring her ibuprofen when they visit, for example, because the price she would pay in Germany is roughly double the U.S. price.

Still, West is happier in Germany overall. “Why would I go back? It’s thousands of dollars a year I’m going to have to spend on the same [insulin] I get here for nothing.”

The peace of mind alone makes it worth it. “A third of my income may go to taxes and health care here, but honestly, that’s fine. Take it. Take it!” she said. “I don’t have to worry.”

The fellowship is an exchange program for German, American and Canadian journalists operated by the International Center for Journalists and the Internationale Journalisten-Programme.



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Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Where this year’s unsubstantiated and yet viral Halloween candy scare — that people are giving children THC-laced edibles — is a good reminder to get your best spooky haiku into us for our fabulous competition before the winner is picked. The deadline is approaching!

Since KHN was closed for most of the week, this is going to be a particularly breezy Breeze, but I still have some good highlights for you!

For the second consecutive year, premiums for the health law’s most popular plan dipped slightly. Health and Human Services Secretary Alex Azar — while making sure to get a dig in about how the health law is “still unaffordable for far too many” — attributed the price decrease to actions taken by President Donald Trump. That’s not quite the picture health experts paint: They say the drop is the marketplace correcting itself after the tumultuous first few years.

The New York Times: Obamacare Premiums To Fall And Number Of Insurers To Rise Next Year

Meanwhile, Seema Verma, the head of the Centers for Medicare & Medicaid Services, dodged sharp questions from Democrats on the House Energy and Commerce Committee about the administration’s contingency plan if the health law is ruled unconstitutional. The title of the hearing where she was grilled — “Sabotage: The Trump Administration’s Attack on Health Care” — really set the tone of the day. The lawmakers touched on topics from “junk” insurance plans to Medicaid work requirements to coverage for preexisting conditions, only to be left frustrated with Verma’s answers.

Modern Healthcare: Verma To Democrats: Some Insurance ‘Better Than No Insurance At All’


If a tax on the middle class is really the third rail of left-leaning politics, what are the other options for paying for “Medicare for All”? Experts say that some of the more appealing options are raising payroll taxes (since employers will be saving a ton of money on workers’ benefits) or slashing military spending (but that in itself is a third-rail for many lawmakers).

Politico: How Warren Could Pay For ‘Medicare For All’


From December 2017 to June 2019, more than a million children have fallen off Medicaid rolls. The administration said this is a success story, because in theory it could signal a stronger economy (with the parents moving off government aid to employer plans). But a look at the numbers suggests that, really, kids are just going without insurance after years of progress made toward universal coverage.

The New York Times: Medicaid Covers A Million Fewer Children. Baby Elijah Was One Of Them


Suboxone — a medication meant to help treat addiction — is center stage in a major settlement made this week between two Ohio counties and drug companies accused of fueling the opioid epidemic. The companies have agreed to donate the drug to help fight the continuing crisis. But experts worry that might be a raw deal. The main barriers to treatment aren’t the cost of the drug, they said. And a one-size-fits-all approach really misses the mark on the actual pain points states have.

Stateline: In Opioid Settlements, Suboxone Plays A Leading Role


Biogen created lots of buzz and hype this week as it announced that it was resurrecting its Alzheimer’s drug that it says reduces the rate of a patient’s cognitive decline. But in a field where disappointment is the devastating norm rather than the exception, a lot of people are recommending the news be taken with the largest grain of salt possible.

Stat: Experts Parse Biogen’s Alzheimer’s Data: An Effective Drug Or A Mirage?


Could North Carolina — one of the few remaining holdouts for Medicaid expansion — really be one of the most innovative states to watch when it comes to health care? Arguably so. The reason? Not only is it prioritizing value-based care and eliminating social detriments to good health, it’s doing it in a uniquely broad, collaborative and fast-paced way. Our friend and frequent “What the Health” guest Joanne Kenen takes a deep dive into what’s going on in the state.

Politico: Why North Carolina Might Be The Most Innovative Health Care State In America


The startling geographical disparities when it comes to abortion have no clearer example than Illinois and Missouri. A new Planned Parenthood clinic in Illinois will be one of the largest abortion clinics in the Midwest — and it’s only about 15 miles away from the border with Missouri, a state where the last remaining clinic is in danger of closing. Advocates say that living under the credible threat to Roe v. Wade, this kind of thinking is crucial. People can no longer think in states, it’s time to go regional, they say.

The New York Times: New Illinois Abortion Clinic Anticipates Post-Roe World


In the miscellaneous file for the week:

• We tend to think of things like algorithms as being above the frequent racial bias we see in the rest of the health care landscape, but we would be wrong in this case. A new study finds that a widely used product that predicts which patients will benefit from extra medical care dramatically underestimates the health needs of the sickest black patients, favoring white patients’ needs over theirs.

The Washington Post: Scientists Detected Racial Bias In A Product Sold By Optum, But The Problem Likely Extends To Algorithms Used By Major Health Systems And Insurers

• Anyone who has kids in their lives knows very well that they are absolute sponges (especially when you slip and say a swear word!). This proves true with gender and racial norms too, of course. A new study found that by age 6, when asked to picture a “brilliant” person, many will name a white male.

Los Angeles Times: By Age 6, Kids Tend To See White Men As More ‘Brilliant’ Than White Women

• Wildfires aren’t a devastating anomaly. They happen frequently and every year now. So how are we going to adapt as humans in an environment that’s prone to burn? (The pictures on this story alone are worth checking it out!)

The New York Times: A Forecast For A Warming World: Learn To Live With Fire


Have a great weekend! LET’S GO NATS!



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Pharma Sells States On ‘Netflix Model’ To Wipe Out Hep C. But At What Price?

When a long, black bus bearing the logo of drugmaker AbbVie rolls through Washington state next year, it will promote a new effort to eradicate hepatitis C infections.

The state is paying for the marketing campaign as part of a deal to give AbbVie the exclusive right to treat its citizens who have the potentially deadly liver disease. Armed with its medication, Mavyret, AbbVie beat out rivals Merck and Gilead Sciences in a blind bidding process.

It’s the second time this year that a state has struck a novel deal with a pharmaceutical company to obtain drugs that can cure hepatitis C ― with discounts from a price that came to market at $84,000 for a course of treatment.

The drugmakers are in a race to treat the 2.4 million people in the U.S. with the viral infection. Left untreated, its most chronic form can cause liver damage, including cirrhosis, as well as liver cancer and death. States are weighing the price of curing those infected with hep C using the new drugs against the medical and economic costs of long-term care for those with untreated infections. The state bears the medical expenses of the Medicaid and prison populations as well as public employees and retirees.

The money paid to AbbVie buys a package of services that includes outreach and testing to identify patients as well as the drugs to treat them. But the price and other details of the deal are secret under the Washington state Public Records Act, even though they involve massive commitment of taxpayer dollars.

Washington officials said they’re prohibited from releasing details by federal rules that hide drug pricing to protect what companies consider trade secrets. Lawyers for the three pharmaceutical firms that submitted bids vowed to go to court to halt the release of bid documents requested by Kaiser Health News under state public records laws.

Without transparency about the details, however, it is impossible to evaluate whether the spending amounts to smart public policy or a boondoggle that primarily benefits manufacturers hoping to lock down payments of perhaps $10,000 per patient for drugs from Medicaid. The same drugs from the same manufacturers can cost less than $100 per course of treatment in other parts of the world.

The secrecy troubles Dr. John Scott, medical director of the University of Washington’s Hepatitis and Liver Clinic at Harborview Medical Center in Seattle, which treats most of the 65,000 hepatitis C patients in the state ― even as he welcomes the curative drugs and wider access to treatment.

“I absolutely support greater transparency,” Scott said. “I think the public needs to know how much these things cost.”

Many people don’t realize that such obscurity is “baked into the system,” said Pam Curtis, director of the Center for Evidence-Based Policy at Oregon Health & Science University.

“That definitely hamstrings our ability to weigh the facts in front of us,” she said. “You want policy to be driven by the highest-quality evidence.”

Other states are eyeing the experiments “with a healthy skepticism but a high level of interest,” said Jennifer Reck, project director for the National Academy for State Health Policy.

In Washington, officials would describe the terms of the AbbVie contract only in the broadest terms. After federal rebates, the state spent about $80.4 million in 2018 on the drugs, known as direct-acting antivirals, to treat more than 3,300 patients, figures show.

Under the new contract, officials expect to spend about the same amount of money per year, while treating twice as many patients, said Dr. Judy Zerzan, chief medical officer for the Washington State Health Care Authority.

That works out to more than $321 million to treat about 30,000 patients over four years, with options for two-year extensions.

But that would be an improvement over the nearly $387 million state officials have spent since 2014 to treat just 10,377 people, according to state records. That works out to an average cost of $37,259 apiece, though actual fees vary by program.

Washington’s request for proposals included a provision that other states could join its program in the future ― also a potential benefit to AbbVie.

“There’s probably an alignment of interests all the way around here,” said Alan Carr, a senior analyst focusing on biotechnology with the Wall Street firm Needham & Co.

Another reason it’s a race for the drugmakers: The overall market for hepatitis C drugs has been “falling fast,” as more patients are treated and cured, Carr said.

“The companies are trying to find a way to ensure the remaining patients use their drug,” Carr said. “[They] have a lot less leverage than they once had, and that’s why they’re willing to do these deals.”

Many patients with hepatitis C have no symptoms and are silent carriers. Only a fraction of people with the virus will develop the serious consequence of the disease, liver failure or cancer. Still, most public health experts urge screening ― and treatment.

The new contracts ― sometimes referred to as “the Netflix model” because they mimic that media-streaming service ― call for capped costs or flat-rate subscriptions for cheap access to the drugs.

But the plan is much broader than creating a drug discount for the state, said Michael Staff, AbbVie’s vice president of U.S. market access.

“Simply stating you want to eradicate hepatitis C without a very detailed plan is probably not going to be effective,” he said. AbbVie’s contract includes payments for services that include outreach, such as the bus, to identify infected patients.

In Washington, the arrangement would treat about half of those in the state infected with hepatitis C, but the average per-patient cost would be about 40% less than before the deal, Zerzan said.

In Louisiana, the first state to announce a flat-rate hepatitis C drug agreement, Asegua, a subsidiary of Gilead, will provide an unlimited amount of its drug, Epclusa, for a set price — roughly $58 million a year for five years, or up to $290 million. Louisiana plans to treat about 31,000 of 39,000 Medicaid patients and prisoners believed to have the disease. Costs could drop to less than $10,000 per patient, according to the contract, which the state health agency made available after a public records request.

The flat-rate concept was put forward by Dr. Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, and his colleagues. Australia implemented a similar arrangement in its national health plan. England’s National Health Service has one as well.

In Egypt, which has the highest hepatitis C rate in the world, negotiations and generic pricing have reduced costs to $84 for a course of treatment.

U.S. drugmakers likely wouldn’t have considered such a plan when they first introduced their medications. Gilead’s Sovaldi, the first antiviral for hepatitis C, launched at $84,000 for a course of treatment; the second, Harvoni, started at $94,500. Three years later, AbbVie introduced Mavyret at $26,400.

Now, Bach said, drugmakers are staring down a sharp decline of their once-hot market.

“They were losing market share and price per share,” Bach said. “If payers [like state Medicaid programs] can give them the same revenue with much more certainty, they’ll prefer that to uncertainty over what’s happening now.”

Hepatitis C poses dilemmas for public health officials and drugmakers alike.

Louisiana has been under pressure from the American Civil Liberties Union regarding prisoners who said they were denied effective hepatitis C treatment. And Washington state’s Department of Corrections faces at least one lawsuit from a prisoner who said he was denied timely care for his disease.

In Washington, Gov. Jay Inslee directed health officials last year to negotiate the best deal to eliminate hepatitis C in the state by 2030, which mirrors goals of global health agencies.

The federal Centers for Disease Control and Prevention warned last month that new hepatitis C infections are on the rise ― 44,300 in 2017, the seventh consecutive annual increase. New cases of hepatitis C have spiked among adults in their 20s and 30s, largely because of the opioid epidemic, according to the CDC.

Between 15% and 25% of people with acute hepatitis C will clear the infection on their own; the rest become chronically infected with the virus.

Hundreds of thousands of people have been treated ― and cured ― since the drugs were introduced early this decade. Deaths from hepatitis C fell from almost 20,000 in 2014 to a little more than 17,000 in 2017, which could be an effect of the new drugs.

“It’s just been transformational,” said Scott, of the University of Washington’s Hepatitis and Liver Clinic. Previous treatments for hepatitis C had to be taken for a year, had toxic side effects and helped only 40% of patients, he added.

The Center for Evidence-Based Policy has advised Washington state in the effort to eradicate hep C, Curtis said. She noted that the arrangements Washington and Louisiana struck share an overall goal of reining in runaway drug prices, especially in state-run Medicaid programs, which can’t shift costs like the commercial market and would be forced instead to cut services.

“States are already struggling,” Curtis said. “A larger and larger part of their budget is being eaten up by these new high-cost drugs.”

“This is not a solution,” she said, “but it’s a step in the right direction.”



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A Million-Dollar Marketing Juggernaut Pushes 3D Mammograms

When Dr. Worta McCaskill-Stevens made an appointment for a mammogram last year, she expected a simple breast cancer screening ― not a heavy-handed sales pitch.

A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis.

“She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer.

A short time later, a technician asked again: Was the patient sure she didn’t want 3D?

Upselling customers on high-tech breast cancer screenings is just one way the 3D mammography industry aggressively promotes its product.

A KHN investigation found that manufacturers, hospitals, doctors and some patient advocates have put their marketing muscle ― and millions of dollars ― behind 3D mammograms. The juggernaut has left many women feeling pressured to undergo screenings, which, according to the U.S. Preventive Services Task Force, haven’t been shown to be more effective than traditional mammograms.

“There’s a lot of money to be made,” said Dr. Steven Woloshin, director of the Center for Medicine and Media at The Dartmouth Institute for Health Policy and Clinical Practice, who published a study in January showing that the health care industry spends $30 billion a year on marketing.

KHN’s investigation shows that industry money has shaped policy, public opinion and patient care around 3D by:

  • Paying influential doctors. In the past six years, 3D equipment manufacturers ― including Hologic, GE Healthcare, Siemens Medical Solutions USA and Fujifilm Medical Systems USA ― have paid doctors and teaching hospitals more than $240 million, including more than $9.2 million related to 3D mammograms, according to a KHN analysis of the Medicare Open Payments database. Just over half of that money was related to research; other payments covered speaking fees, consulting, travel, meals or drinks. The database shows that influential journal articles ― those cited hundreds of times by other researchers ― were written by doctors with financial ties to the 3D industry.
  • Marketing directly to consumers. Manufacturers have urged women to demand “the better mammogram,” using celebrity spokeswomen such as breast cancer survivor Sheryl Crow. Manufacturers spent $14 million to market 3D screening over the past four years, not including spending on social media, according to Kantar Media, which tracks the advertising industry.
  • Lobbying state lawmakers. Private insurers in 16 states are now legally required to cover 3D screenings, along with Medicaid programs in 36 states and Washington, D.C. Officials at Hologic, the leading manufacturer, told KHN that about 95% of insured women have coverage for tomosynthesis.
  • Funding experts and advocates. Hologic has given educational grants to the American Society of Breast Surgeons, a medical association that recently recommended 3D mammograms as its preferred screening method, according to the group’s website. Hologic declined to reveal amounts. Hologic also has funded patient advocates such as the Black Women’s Health Imperative, which lobbies for access to 3D mammograms.

Enthusiasm for 3D has sparked a medical technology arms race, with hospitals and radiology practices competing to offer the newest equipment. Patients have caught the fever, too. When rural hospitals can’t afford 3D machines, foundations often pitch in to raise money. More than 63% of mammography facilities offer 3D screenings, first approved for sale in 2011.

Taxpayers write the check for many 3D screenings, which add about $50 to the cost of a typical mammogram. Medicare, which began paying for 3D exams in 2015, spent an additional $230 million on breast cancer screenings within the first three years of coverage. By 2017, nearly half the mammograms paid for by the federal program were 3D, according to a KHN analysis of federal data.

Hologic’s Peter Valenti said the company’s marketing is educational. His company is a “for-profit organization, but our premise is to try to improve the health care for women globally,” said Valenti, president of Hologic’s breast and skeletal health solutions division.

The debate over 3D mammograms illustrates the tension in the medical community over how much research companies should do before commercializing new products. In a statement, officials at Hologic said it would be “irresponsible and unethical” to withhold technology that detects more breast cancers, given that definitive clinical trials can take many years.

On average, 3D screenings may slightly increase cancer detection rates, finding about one extra breast tumor for every 1,000 U.S. women screened, according to a 2018 analysis in the Journal of the National Cancer Institute. Most studies also show that 3D screenings cause fewer “false alarms,” in which women are called back for procedures they don’t need, said Dr. Susan Harvey, a Hologic vice president.

Yet newer tech isn’t necessarily better ― and it can cause harm, said Dr. Otis Brawley, a professor at John Hopkins University. “It’s unethical to push a product before you know it helps people,” he said.

A Fuzzy Picture

As a senior researcher at the National Cancer Institute, McCaskill-Stevens didn’t need a glossy brochure to learn about 3D mammograms. She helped design a $100 million federally funded study of 165,000 women, which will measure whether women are helped or hurt by 3D testing. The study, now recruiting patients, will follow the women for five years.

“Can we say that 3D is better?” asked McCaskill-Stevens. “We don’t know.”

The American Cancer Society, Susan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms.

When the Food and Drug Administration approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective at finding breast cancer ― not at improving survival.

“The companies do the minimal research needed to get FDA approval, and that usually means no meaningful evidence of how it helps patients,” said Diana Zuckerman, president of the National Center for Health Research.

Valenti said Hologic presented strong evidence to the FDA. “The data was overwhelming that 3D was a superior mammogram,” Valenti said.

Describing a breast exam as 3D may conjure up images of holograms or virtual reality. In fact, tomosynthesis is closer to a mini-CT scan.

Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.

Yet some studies suggest that 3D mammograms are less accurate than 2D.

A 2016 study in The Lancet Oncology found that women screened with 3D mammograms had more false alarms. A randomized trial of 29,000 women published in The Lancet in June showed that 3D detected no more breast tumors than 2D mammograms did.

And, like all mammograms, the 3D version carries risks. Older 3D systems expose women to twice as much radiation as a 2D mammogram, although those levels are still considered safe, said Diana Miglioretti, a biostatistics professor at the University of California-Davis School of Medicine.

Valenti said the newest 3D systems provide about the same radiation dose as 2D.

Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them ― or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need.

A 2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the preventive services task force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, “we could potentially hurt women,” Krist said.

Some experts worry that patients, who tend to overestimate their risk of dying from breast cancer, are acting out of fear when they choose treatment.

“If there was ever an audience susceptible to direct-to-consumer advertising, it’s women afraid of breast cancer,” Zuckerman said.

Some proponents of 3D mammograms imply that women who opt for 2D are taking a risk.

Dr. Liane Philpotts, chief of breast imaging at Yale School of Medicine, championed a 2016 Connecticut bill to mandate insurance coverage for 3D screenings. “When I look at a 2D mammogram now, I don’t know how we read them with any degree of confidence,” Philpotts said in a letter of support. “They seem grossly inadequate.”

Philpotts’ letter did not mention she has worked as a consultant for Hologic, which paid her $13,500 from 2013 to 2018, mostly for research, according to Open Payments. In an interview, Philpotts said her work for Hologic has not influenced her medical advice. “[Tomosynthesis is] just so much better for patients,” she said. “I feel very passionately about it.”

Dr. Linda Greer, a community radiologist in Phoenix, has said she was “shocked” by how many more tumors were detected with 3D than 2D. In a 2013 interview, she told Everyday Health, “We got scared about what we were missing for so many years” with 2D mammograms. Greer has accepted more than $305,000 from makers of mammography machines, including $222,000 related to 3D products, according to the Open Payments database.

Greer noted she maintains her intellectual independence by writing her own presentations, even if Hologic pays for her travel. “I don’t think I could be bought,” she said.

Building A Brand

The first question many women have about 3D mammograms is: Are they less painful?

In ads, Hologic claims its 3D device was less painful for 93% of women. But that claim comes from a small, company-funded study that hasn’t been formally reviewed by outside experts, Zuckerman noted. Given the limited data provided in the study, it’s possible the findings were the result of chance, said Zuckerman, who called the ads “very misleading.”

Valenti said peer review is important in studies about cancer detection or false alarms. But when it relates to “general patient satisfaction or patient preference, those are data that we get in other ways,” he said. “Plenty of [doctors] have the [3D] system now and you can get feedback from them. “

While screenings may not generate a lot of income, they can attract patients who need other, more profitable hospital procedures.

“Anytime you diagnose more tumors, you can treat more tumors,” said Amitabh Chandra, director of health policy research at Harvard University’s John F. Kennedy School of Government

Changing The Law

For years, women who wanted a 3D screening had to pay an extra $50 to $100 out-of-pocket.

Valenti said Hologic wanted more women to have access to the technology. So Hologic launched a public campaign ― with a website, paid celebrity tweets and billboards ― to pressure private insurers  to cover 3D.

Hospitals and radiology practices ― who stand to benefit from an expanded pool of paying customers ― are also fierce advocates for insurance coverage.

In 2017, a doctor at New York’s Memorial Sloan Kettering Cancer Center asked a local assemblywoman to introduce a bill mandating insurance coverage for 3D screenings.

In a statement, an official at Memorial Sloan Kettering said the hospital supported the bill to improve patient care. “Our patients deserved the most optimal screening available,” said Dr. Elizabeth Morris, chief of the hospital’s breast imaging service.

Supporters of 3D mammograms also rallied around an insurance mandate in Texas in 2017. Registered supporters included HCA Healthcare, a for-profit chain that manages 185 hospitals, and the Black Women’s Health Imperative. That group also testified before an FDA panel in 2010 to advocate approving Hologic’s device.

Linda Goler Blount, the group’s president and CEO, said the organization was advocating for early detection long before its partnership with Hologic began in 2016.

“If you’re low-income, you’re much less likely to get 3D mammography than if you’re upper-income,” Blount said.

Blount noted that her group remains “independent and free to speak our mind.”

Paying Doctors

Dr. Stephen Rose has been an especially active advocate for 3D screenings.

Rose, a radiologist, testified on behalf of the Texas insurance bill twice. The practice where Rose works, Solis Mammography, put out press releases in favor of the legislation. In 2010, Rose testified in favor of 3D screenings at an FDA advisory panel.

In the past six years, he has received $317,000 from companies that manufacture mammogram machines, including more than $50,000 related to specific 3D products, according to the Open Payments database. Twelve percent of Rose’s 3D-related payments were related to research.

Rose said industry money hasn’t influenced him. “I can tell you it had zero impact,” Rose said.

In 2014, Rose co-wrote an influential paper that described the benefits of 3D mammograms.

Collectively, Rose and 12 of his co-authors accepted more than $1 million from the four leading manufacturers of 3D equipment over the past six years, including $589,000 related to 3D products, according to a KHN analysis of Open Payments data. In addition, Hologic contributed $855,000 to research in which many of these authors took leading roles.

Valenti said Hologic doesn’t expect anything in return for the payments: “We let the product and the doctor speak for themselves.”

A Web Of Relationships

The American Society of Breast Surgeons, lists Hologic as a corporate partner. In May, the society recommended 3D mammograms as its preferred screening method.

“There is no connection between the society’s educational grants and statement development,” said Sharon Grutman, a society spokeswoman.

Fran Visco, president of the National Breast Cancer Coalition, has advocated for women for decades. But she said she’s at a loss for a solution to curtail industry influence in medicine.

“It’s incredibly troubling,” said Visco, a breast cancer survivor. “Everyone has a different stake in all this, and it all seems to be tied to financial gain.”

KHN data editor Elizabeth Lucas contributed to this report.



from Health Industry – Kaiser Health News

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Must-Reads Of The Week From Brianna Labuskes

Happy Friday! Today is the day I’m going to challenge you to stretch those creative muscles and enter our Halloween Health Care Haiku Competition. Yes, it is going to be exactly as awesome as it sounds! The entries are already pouring in, check out the rules here. To kick things off, KHN’s very own talented and brilliant haiku master-in-residence Stephanie Stapleton wrote this one: “Goblins wear white coats, and not much is spookier, than the health system.”

Now on to what you might have missed this week.

Democrats packed themselves onto a crowded stage this week for what already feels like the umpteenth debate but was only the fourth or the sixth (depending if you count the two-nighters separately).

Going by the amount of heat she took, it seems safe to say Sen. Elizabeth Warren (D-Mass.) is considered by her rivals to be one of the race’s front-runners. With that spotlight, though, comes a target on her back.

South Bend Mayor Pete Buttigieg and Sen. Amy Klobuchar (D-Minn.) – who are both vying to become the alternative for former Vice President Joe Biden’s moderate voters – were particularly sharp in their demands for Warren to reckon with the costs of “Medicare for All.” The question of how she would pay for such a plan has been one she’s been managing to dodge, but her rivals tried to hold her feet to the fire on Tuesday. “At least Bernie’s being honest,” Klobuchar said at one point in reference to Sen. Bernie Sanders’ (I-Vt.) admission that the proposal will raise taxes.

FWIW: Despite being pressed to answer the direct question: “Will you raise taxes on the middle class to pay for it? Yes or no?” Warren still didn’t let herself be pinned down. Something that, the day after the debate, Biden jumped on as well.

The New York Times: Warren Draws Fire From All Sides, Reflecting A Shift In Fortunes In Race

The New York Times: Joe Biden Ramps Up Attacks On Elizabeth Warren’s ‘Credibility’

Health care is possibly the broadest (or at least one of the broader) topics that the candidates could talk about, and yet all it seems they’ve been discussing at the debates is health care coverage. Friends, you are not alone if you’re frustrated by not seeing a more diverse range of questions. Even Sen. Kamala Harris (D-Calif.) was fed-up enough to redirect the conversation toward abortion rights and reproductive health. Considering it’s such a viscerally hot-topic at the moment, the omission seems glaring.

Los Angeles Times: Kamala Harris Slams Republicans On Abortion, Says They’re Killing Poor Women Of Color

But it’s not just reproductive health that the moderators could ask about. Axios came up with at least four great questions that I think a lot of people in the field would like to have answered. Like: Many of the things that make people sick are not the fault of bad health care — they’re social factors like poverty, low-quality housing, etc. Should it be part of the health care system’s job to address them? (Hint, hint moderators.)

Axios: Four Health Care Questions For Tonight’s Democratic Debate

Don’t get me wrong, there were a few other health-related moments beyond “Medicare for All” bickering… including one of the more heated exchanges of the night. Beto O’Rourke said Democrats need to be courageous in their policies and not be scared of polls, to which Buttigieg responded: “I don’t need lessons from you on courage.”

The Wall Street Journal: Democratic Debate: The Moments That Mattered

Meanwhile, amid all this focus on “Medicare for All,” a new study counsels that there are many paths toward universal coverage—it doesn’t have to be “Medicare for All” or bust.

The Associated Press: Study: ‘Medicare For All’ Not Only Way To Universal Coverage


A big decision on the constitutionality of the health law is expected to drop sometime in the coming weeks. Although in theory, the Trump administration wants a certain outcome, if the court decides the ACA is unconstitutional, it could be a big ole headache for the White House heading into 2020. A ruling like that could not only foster confusion right around open enrollment, but also allow the Democrats to re-frame the health narrative in a way that could appeal to independent and moderate voters more than the current back and forth about “Medicare for All.”

The New York Times: How Pending Decision On Obamacare Could Upend 2020 Campaign


Rep. Elijah Cummings (D-Md.) passed away this week at 68 from complications of longstanding health problems. House Speaker Nancy Pelosi (D-Calif.) announced that she’ll be renaming her signature drug pricing policy after Cummings as he was a long-time champion of reigning in such costs.

Some might remember that it was Cummings who took Martin Shkreli, of “pharma bro” fame” to task at a hearing.

“It’s not funny, Mr. Shkreli,” Cummings said as Shkreli smirked. “People are dying, and they’re getting sicker and sicker.”

The Baltimore Sun: U.S. Rep. Elijah Cummings, Key Figure In Trump Impeachment Inquiry And Longtime Baltimore Advocate, Dies At 68

Stat: Pelosi: Democrats Will Name Marquee Drug Pricing Bill For Late Rep. Cummings


In a high-stakes, eleventh hour gambit Judge Dan A. Polster is summoning the drug CEOs involved in the massive, nationwide opioid trial to try to agree to a massive $50 billion settlement. Although the talks center around the big players involved — like AmerisourceBergen, Cardinal Health and McKesson — plaintiffs’ lawyers say they hope such a deal would have a domino effect on the remaining defendants.

Although the reports seem hopeful, those familiar with the talks say that the cities and counties are hesitant because they’re worried they’re not going to see their fair share of the money.

(This is as of press time! It’s happening today, so there could be developments depending when your read this—ah, the excitement of live news!)

The New York Times: Judge Summons Drug C.E.O.S For Talks On Sweeping Opioid Settlement

In a sea of heartbreaking stories on the opioid epidemic, this one stands out. The Washington Post took a look at West Virginia’s crisis and how court victories against drug companies aren’t really the panacea they’re sometimes made out to be.

The Washington Post: Inside West Virginia’s Opioid Battle: ‘They Looked At Us Like An Easy Target’


These two court stories feel like they happened ages ago, but really it was just last Friday post-Breeze. If you caught them happening in real time, there’s nothing to update, but I wanted to make sure I included them for anyone who wasn’t glued to their computer on a Friday evening.

The New York Times: Judges Strike Several Blows To Trump Immigration Policies

The Associated Press: US Appeals Court Skeptical Of Trump’s Medicaid Work Rules


This binge-worthy story needs no other introduction than the one ProPublica already wrote for it, so I’m going to quote them: “Welcome to Coffeyville, Kansas, where the judge has no law degree, debt collectors get a cut of the bail, and Americans are watching their lives — and liberty — disappear in the pursuit of medical debt collection.”

ProPublica: When Medical Debt Collectors Decide Who Gets Arrested

And, on a related note, if you’ve missed my colleague Jay Hancock’s coverage of UVA’s lawsuits against their patients, make sure to check out all the developments here.


Meanwhile, in the miscellaneous story file this week:

— Melody Petersen of LAT won the holy cannoli award this week with her investigation into the practice of harvesting body parts—and the coroners that go along with it. My face when reading the entirety of the article was an exact replica of the “shocked and distressed” emoji.

Los Angeles Times: In The Rush To Harvest Body Parts, Death Investigations Have Been Upended

— Deaths, poor quality of care, and other problems have absolutely plagued the Indian Health Service for years, and Native Americans are sick of it. They want to take over running their own health care system, but the task would be daunting.

The New York Times: Fed Up With Deaths, Native Americans Want To Run Their Own Health Care

— You can’t swing a cat these days without hitting some new CBD product. It seems inevitable that that kind of lucrative, thriving marketplace would draw pharma’s attention. Here’s a look at what companies are developing new drugs to tap into those profits. (PSA: but don’t actually swing any cats, please.)

Stat: These Four Companies Are Betting Big On CBD-Based Prescription Drugs

— If you want a fentanyl drug ring story that reads like a thriller, check this article out.

The New York Times: The China Connection: How One D.E.A. Agent Cracked A Global Fentanyl Ring


That’s it from me! Have a great weekend and don’t forget to get your flu shot!



from Health Industry – Kaiser Health News

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Whistleblower Alleges Medicare Fraud At Iconic Seattle-Based Health Plan

Group Health Cooperative in Seattle, one of the nation’s oldest and most respected nonprofit health insurance plans, is accused of bilking Medicare out of millions of dollars in a federal whistleblower case.

Teresa Ross, a former medical billing manager at the insurer, alleges that it sought to reverse financial losses in 2010 by claiming some patients were sicker than they were, or by billing for medical conditions that patients didn’t actually have. As a result, the insurer retroactively collected an estimated $8 million from Medicare for 2010 services, according to the suit.

Ross filed suit in federal court in Buffalo, N.Y., in 2012, but it remained under a court seal until July and is in the initial stages. The suit also names as defendants two medical coding consultants, consulting firm DxID of East Rochester, N.Y., and Independent Health Association, an affiliated health plan in Buffalo, N.Y. All denied wrongdoing in separate court motions filed late Wednesday to dismiss the suit.

The Justice Department has thus far declined to take over the case, but said in a June 21 court filing that “an active investigation is ongoing.”

The whistleblower suit is one of at least 18 such cases documented by KHN that accuse Medicare Advantage managed-care plans of ripping off the government by exaggerating how sick its patients were. The whistleblower cases have emerged as a primary tool for clawing back overpayments. While many of the cases are pending in courts, five have recovered a total of nearly $360 million.

“The fraudulent practices described in this complaint are a product of the belief, common among MA organizations, that the law can be violated without meaningful consequence,” Ross alleges.

Medicare Advantage plans are a privately run alternative to traditional Medicare that often offer extra benefits such as dental and vision coverage, but limit choice of medical providers. They have exploded in popularity in recent years, enrolling more than 22 million people, just over 1 in 3 of those eligible for Medicare.

Word of another whistleblower alleging Medicare Advantage billing fraud comes as the White House is pushing to expand enrollment in the plans. On Oct. 3, President Donald Trump issued an executive order that permits the plans to offer a range of new benefits to attract patients. One, for instance, is partly covering the cost of Apple Watches as an inducement.

Group Health opened for business more than seven decades ago and was among the first managed-care plans to contract with Medicare. Formed by a coalition of unions, farmers and local activists, the HMO grew from just a few hundred families to more than 600,000 patients before its members agreed to join California-based Kaiser Permanente. That happened in early 2017, and the plan is now called Kaiser Foundation Health Plan of Washington. (Kaiser Health News is not affiliated with Kaiser Permanente.)

In an emailed statement, a Kaiser Permanente spokesperson said: “We believe that Group Health complied with the law by submitting its data in good faith, relying on the recommendations of the vendor as well as communications with the federal government, which has not intervened in the case at this time.”

Ross nods to the plan’s history, saying it has “traditionally catered to the public interest, often highlighting its efforts to support low-income patients and provide affordable, quality care.”

The insurer’s Medicare Advantage plans “have also traditionally been well regarded, receiving accolades from industry groups and Medicare itself,” according to the suit.

But Ross, who worked at Group Health for more than 14 years in jobs involving billing and coding, said that from 2008 through 2010 GHC “went from an operating income of almost $57 million to an operating loss of $60 million. Ross said the losses were “due largely to poor business decisions by company management.”

The lawsuit alleges that the insurer manipulated a Medicare billing formula known as a risk score. The formula is supposed to pay health plans higher rates for sicker patients, but Medicare estimates that overpayments triggered by inflated risk scores have cost taxpayers $30 billion over the past three years alone.

According to Ross, a GHC executive attended a meeting of the Alliance of Community Health Plans in 2011 where he heard from a colleague at Independent Health about an “exciting opportunity” to increase risk scores and revenue. The colleague said Independent Health “had made a lot of money” using its consulting company, which specializes in combing patient charts to find overlooked diseases that health plans can bill for retroactively.

In November 2011, Group Health hired the East Rochester firm DxID to review medical charts for 2010. The review resulted in $12 million in new claims, according to the suit. Under the deal, DxID took a percentage of the claims revenue it generated, which came to about $1.5 million that year, the suit says.

Ross said she and a doctor who later reviewed the charts found “systematic” problems with the firm’s coding practices. In one case, the plan billed for “major depression” in a patient described by his doctor as having an “amazingly sunny disposition.” Overall, about three-quarters of its claims for higher charges in 2010 were not justified, according to the suit. Ross estimated that the consultants submitted some $35 million in new claims to Medicare on behalf of GHC for 2010 and 2011.

In its motion to dismiss Ross’ case, GHC called the matter a “difference of opinion between her allegedly ‘conservative’ method for evaluating the underlying documentation for certain medical conditions and her perception of an ‘aggressive’ approach taken by Defendants.”

Independent Health and the DxID consultants took a similar position in their court motion, arguing that Ross “seeks to manufacture a fraud case out of an honest disagreement about the meaning and applicability of unclear, complex, and often conflicting industry-wide coding criteria.”

In a statement, Independent Health spokesman Frank Sava added: “We believe the coding policies being challenged here were lawful and proper and all parties were paid appropriately.

Whistleblowers sue on behalf of the federal government and can share in any money recovered. Typically, the cases remain under a court seal for years while the Justice Department investigates.



from Health Industry – Kaiser Health News

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