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The FTC Is Attacking Drugmakers’ ‘Patent Thickets’

The Federal Trade Commission has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines, like inhalers and autoinjectors, in an effort to increase competition and potentially lower some prices.

The FTC says drugmakers illegitimately use the patents to prevent competitors from offering cheaper generic alternatives.

It’s the first time the FTC has tried the tactic, said Hannah Garden-Monheit, director of the FTC’s Office of Policy Planning.

“We are using all the tools we have to bring down drug prices and reduce barriers to generic competition,” she said in an interview.

President Joe Biden has instructed his Federal Trade Commission to be more aggressive in reining in the pharmaceutical industry. Under its chairperson, Lina Khan, the agency is aggressively testing the limits of its powers in pursuit of that goal.

The targeted patents cover devices that propel medicines for asthma and emphysema into the lungs or inject epinephrine to treat a severe allergic attack. Drugmakers list them in the FDA’s “Orange Book,” which can afford the products greater protection from generic competition.

Many of the medicines delivered by the devices are decades old, years off patent. But manufacturers have long tweaked the delivery methods, patenting the changes, in ways that sometimes make the drugs more convenient to administer.

They might, for example, change the propellant in an inhaler or add a counter that tells a patient how many doses are left. Autoinjectors mean patients don’t see a needle or syringe but merely press a device with a hidden needle against the skin to deliver the medicine. Some autoinjectors even talk patients through the process.

Though there has long been a procedure for disputing the validity of Orange Book-listed patents, it is rarely used.

In challenging Orange Book listings, the FTC is trying to cut away at what are known as patent thickets. While a single patent once would cover a single active medicine, many drugs today are protected by half a dozen patents or more, creating additional obstacles for cheaper generics seeking to enter the market.

The move is critically important because drugmakers frequently extend the 20-year patent protection of a drug by changing the delivery device or method. For example, instead of a pill, they make a capsule. Or instead of a dose every six hours, they create a longer-acting, once-a-day version. They can also alter the process by which a drug is made — so-called “process patents.”

Each tweak gets a new patent, which the manufacturer then adds to its official compendium of drug patents. There is no advance scrutiny of listings by regulators.

Generic drugmakers wishing to make a copycat version of a branded drug generally have to challenge the patents in court. But merely listing a patent in the Orange Book automatically triggers a 2½-year delay of FDA approval of a litigating generic competitor.

The FTC says patent law protects active ingredients, not delivery methods.

The pharmaceutical industry, already battling the Biden administration’s plan to negotiate prices of some drugs for Medicare patients, says it wants more clarity about which aspects of its products can be patented.

“The underlying statute is not clear about listing certain types of drug delivery device patents, and the industry has long asked for the FDA to provide guidance,” said Megan Van Etten, a spokesperson for Pharmaceutical Research and Manufacturers of America, the industry trade group, in an email. “We’re disappointed that the FTC has characterized companies as acting inappropriately rather than help seek the clarity the industry needs to ensure compliance.”

After an FTC challenge, companies have 30 days to withdraw or amend the patent or show it is valid. Some have already backed down.

“We’ve had some significant wins,” Garden-Monheit said. After the FTC’s challenge, drugmaker GSK, formerly GlaxoSmithKline, withdrew all patents on two popular inhalers for asthma, Advair and Flovent, both of which contained old off-patent medicines but nonetheless cost hundreds of dollars. Amneal Pharmaceuticals withdrew patents on its epinephrine injector.

Still, the deadline for companies to respond to the first set of warning letters has passed and only about 30% of those that received them answered, leaving the commission to ponder its next steps. The FTC could take a drugmaker to court to seek a cease-and-desist order.

And Garden-Monheit said the agency is poised to look at other types of patents that may be invalid, which pile up to add to the thicket. There are thousands of patents in the Orange Book.

“We are taking a close and active look at this,” Garden-Monheit said. “Companies who haven’t received a letter from us challenging a patent shouldn’t think they’re off the hook.”

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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Ketamine Therapy for Mental Health a ‘Wild West’ for Doctors and Patients

In late 2022, Sarah Gutilla’s treatment-resistant depression had grown so severe, she was actively contemplating suicide. Raised in foster care, the 34-year-old’s childhood was marked by physical violence, sexual abuse, and drug use, leaving her with life-threatening mental scars.

Out of desperation, her husband scraped together $600 for the first of six rounds of intravenous ketamine therapy at Ketamine Clinics Los Angeles, which administers the generic anesthetic for off-label uses such as treating depression. When Gutilla got into an Uber for the 75-mile drive to Los Angeles, it was the first time she had left her home in Llano, California, in two years. The results, she said, were instant.

“The amount of relief I felt after the first treatment was what I think ‘normal’ is supposed to feel like,” she said. “I’ve never felt so OK, and so at peace.”

For-profit ketamine clinics have proliferated over the past few years, offering infusions for a wide array of mental health issues, including obsessive-compulsive disorder, depression, and anxiety. Although the off-label use of ketamine hydrochloride, a Schedule III drug approved by the FDA as an anesthetic in 1970, was considered radical just a decade ago, now between 500 and 750 ketamine clinics have cropped up across the nation.

Market researcher Grand View Research pegged industry revenues at $3.1 billion in 2022, and projects them to more than double to $6.9 billion by 2030. Most insurance doesn’t cover ketamine for mental health, so patients must pay out-of-pocket.

While it’s legal for doctors to prescribe ketamine, the FDA hasn’t approved it for mental health treatment, which means that individual practitioners must develop their own treatment protocols. The result is wide variability among providers, with some favoring gradual, low-dosage treatments while others advocate larger amounts that can induce hallucinations, as the drug is psychedelic at the right doses.

“Ketamine is the wild West,” said Dustin Robinson, the managing principal of Iter Investments, a venture capital firm specializing in hallucinogenic drug treatments.

Ketamine practitioners stress that the drug’s emergence as a mental health treatment is driven by a desperate need. Depression is the leading cause of disability in the United States for individuals ages 15-44, according to the National Institute of Mental Health, and around 25% of adults experience a diagnosable mental disorder in any given year.

Meanwhile, many insurance plans cover mental health services at lower rates than physical health care, despite laws requiring parity. Thus many patients with disorders receive little or no care early on and are desperate by the time they visit a ketamine clinic, said Steven Siegel, chair of psychiatry and the behavioral sciences at the University of Southern California’s Keck School of Medicine.

But the revelation that “Friends” star Matthew Perry died in part from a large dose of ketamine, along with billionaire Elon Musk’s open use of the drug, has piqued fresh scrutiny of ketamine and its regulatory environment, or lack thereof.

Commercial ketamine clinics often offer same-day appointments, in which patients can pay out-of-pocket for a drug that renders immediate results. The ketamine is administered intravenously, and patients are often given blankets, headphones, and an eye mask to heighten the dissociative feeling of not being in one’s body. A typical dose of ketamine to treat depression, which is 10 times lower than the dosage used in anesthesia, costs clinics about $1, but clinics charge $600-$1,000 per treatment.

Ketamine is still shadowed by its reputation as the party drug known as “Special K”; Siegel’s first grant from the National Institutes of Health was to study ketamine as a drug of abuse. It has the potential to send users down a “K hole,” otherwise known as a bad trip, and can induce psychosis. Research in animals and recreational users has shown chronic use of the drug impairs both short- and long-term cognition.

Perry’s death in October raised alarms when the initial toxicology screening attributed his death to the acute effects of ketamine. A December report revealed Perry received infusion therapy a week before his death but that the fatal blow was a high dose of the substance taken with an opioid and a sedative on the day of his death — indicating that medical ketamine was not to blame.

A Variety of Protocols

Sam Mandel co-founded Ketamine Clinics Los Angeles in 2014 with his father, Steven Mandel, an anesthesiologist with a background in clinical psychology, and Sam said the clinic has established its own protocol. That includes monitoring a patient’s vital signs during treatment and keeping psychiatrists and other mental health practitioners on standby to ensure safety. Initial treatment starts with a low dose and increases as needed.

While many clinics follow the Mandels’ graduated approach, the dosing protocol at MY Self Wellness, a ketamine clinic in Bonita Springs, Florida, is geared toward triggering a psychedelic episode.

Christina Thomas, president of MY Self Wellness, said she developed her clinic’s procedures against a list of “what not to do” based on the bad experiences people have reported at other clinics.

The field isn’t entirely unregulated: State medical and nursing boards oversee physicians and nurses, while the FDA and Drug Enforcement Administration regulate ketamine. But most anesthesiologists don’t have a background in mental health, while psychiatrists don’t know much about anesthesia, Sam Mandel noted. He said a collaborative, multidisciplinary approach is needed to develop standards across the field, particularly because ketamine can affect vital signs such as blood pressure and respiration.

The protocols governing Spravato, an FDA-approved medication based on a close chemical cousin of ketamine called esketamine, are illustrative. Because it has the potential for serious side effects, it falls under the FDA’s Risk Evaluation and Mitigation Strategies program, which puts extra requirements in place, said Robinson. Spravato’s REMS requires two hours of monitoring after each dose and prohibits patients from driving on treatment days.

Generic ketamine, by contrast, has no REMS requirements. And because it is generic and cheap, drugmakers have little financial incentive to undertake the costly clinical trials that would be required for FDA approval.

That leaves it to the patient to assess ketamine providers. Clinics dedicated to intravenous infusions, rather than offering the treatment as an add-on, may be more familiar with the nuances of administering the drug. Ideally, practitioners should have mental health and anesthesia expertise, or have multiple specialties under one roof, and clinics should be equipped with hospital-grade monitoring equipment, Mandel said.

Siegel, who has researched ketamine since 2003, said the drug is especially useful as an emergency intervention, abating suicidal thoughts for long enough to give traditional treatments, like talk therapy and SSRI antidepressants, time to take effect. “The solutions that we have and have had up until now have failed us,” Mandel said.

The drug is now popular enough as a mental health treatment that the name of Mandel’s clinic is a daily sight for thousands of Angelenos as it appears on 26 Adopt-A-Highway signs along the 405 and 10 freeways.

And the psychedelic renaissance in mental health is accelerating. A drug containing MDMA, known as ecstasy or molly, is expected to receive FDA approval in 2024. A drug with psilocybin, the active ingredient in “magic mushrooms,” could launch as early as 2027, the same year a stroke medicine with the active ingredient of DMT, a hallucinogen, is expected to debut.

Robinson said many ketamine clinics have opened in anticipation of the expanded psychedelic market. Since these new drugs will likely be covered by insurance, Robinson advises clinics to offer FDA-approved treatments such as Spravato so they’ll have the proper insurance infrastructure and staff in place.

For now, Sarah Gutilla will pay out-of-pocket for ketamine treatments. One year after her first round of infusions, she and her husband are saving for her second. In the meantime, she spends her days on her ranch in Llano where she rescues dogs and horses, and relies on telehealth therapy and psychiatric medications.

While the infusions aren’t “a magic fix,” they are a tool to help her move in the right direction.

“There used to be no light at the end of the tunnel,” she said. “Ketamine literally saved my life.”

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A Legal Battle Over Herring Fishing Has Big Implications for Health Care

What do herring fishing and health policy have in common? Quite a bit, it turns out, owing to a case now before the Supreme Court.

If the justices rule as expected, based on this month’s oral arguments, they could dramatically change the way federal health agencies operate. “The upheaval caused … would be immense,” argues a friend of the court brief filed on behalf of the American Cancer Society and a dozen other health groups.

On its face, Relentless Inc. v. Department of Commerce and Loper Bright Enterprises v. Raimondo (the two cases were heard together) are about whether commercial herring fishermen should pay for government observers assigned to their boats. But those who brought the case are trolling for much bigger fish: overturning a 40 year-old Supreme Court precedent that undergirds modern federal regulation.

Under the “Chevron doctrine” — named after the 1984 case Chevron U.S.A. Inc. v. Natural Resources Defense Council — in cases where statutes are ambiguous, federal courts are supposed to defer to the interpretation of laws by the agencies implementing them, as long as that interpretation is “reasonable.”

The fishing groups (backed in part by a group funded by anti-regulatory crusader Charles Koch) want the court to overturn Chevron, thereby transferring much of the power to interpret federal law from the executive bureaucracy to Congress and federal judges.

That could lead to real turmoil for the health-care system, according to the groups that filed the friend of the court brief. It would suddenly put long-standing regulations that govern drug safety, public health and Medicare and Medicaid — insurance programs that together cover more than a third of all Americans — in jeopardy of fresh legal challenges.

“It’s just a matter of stability and certainty,” said Sarah Somers, legal director of the National Health Law Program and an author of the brief, in an interview on the KFF Health News podcast “What the Health?”

For example, the Centers for Medicare & Medicaid Services, said Somers, “has the expertise, has the time, has the resources, and has the duty to figure out what these particular terms and statutes mean, and how the programs should work.”

While federal bureaucrats are often treated as punching bags by politicians and voters, many are hired because of their expertise in fields that most Americans would probably agree demand regulation — like drug safety.

“The idea of courts, every single drug that’s challenged in every single forum, having to delve into what that means without deference to the agency would be just a recipe for chaos, really,” Somers said.

Cases challenging federal health care policy can arise all across the country. In the absence of Chevron, “if you have hundreds of district courts and courts of appeals coming up with different interpretations of these terms, you’re going to have a lot of problems,” Somers said.

There is also the possibility of reopening cases that have already been decided. Without the rule requiring lower courts to defer to agency interpretations, “litigants will come out of the woodwork seeking to open those decisions and contending that they didn’t actually address what they now say is the relevant question,” Solicitor General Elizabeth B. Prelogar told the court during oral arguments on Jan. 17.

That ability to look back, particularly by “big interests that have a lot of time and resources to devote to litigation,” said Somers, could result in “a great deal of uncertainty, a lot of disruption, and a lot of problems for the courts and for all the entities that function under these systems.”

A decision in the case is expected later this year.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

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An Arm and a Leg: Self-Defense 101: Keeping Your Cool While You Fight

Navigating the U.S. health care system can feel like a “battle royale.” From challenging unfair medical bills to wrestling with insurance companies over pre-authorizations, patients have to be ready to stick up for themselves.

So, how can you stay cool and confident in these fights? In this rebroadcast of “An Arm and a Leg” from 2020, host Dan Weissmann hits up self-defense coach Lauren Taylor about strategies for standing up for yourself and hears how she applied her approach in her own fight for health care coverage.

Dan Weissmann @danweissmann Host and producer of "An Arm and a Leg." Previously, Dan was a staff reporter for Marketplace and Chicago's WBEZ. His work also appears on All Things Considered, Marketplace, the BBC, 99 Percent Invisible, and Reveal, from the Center for Investigative Reporting.

Credits

Emily Pisacreta Producer Adam Raymonda Audio Wizard Ellen Weiss Editor Marian Wang Editor Click to open the Transcript Transcript: Self-Defense 101: Keeping Your Cool While You Fight

Note: “An Arm and a Leg” uses speech-recognition software to generate transcripts, which may contain errors. Please use the transcript as a tool but check the corresponding audio before quoting the podcast.

Dan: Hey there – Before we start, I just want to say THANK YOU for supporting our work here. Thanks to you, we beat all of our goals for the end of 2023.

That means we collected every dollar of matching funds that were on offer — and because so many folks became donors for the first time, we earned a bonus from the Institute for Nonprofit News.

So we are starting this year in good shape, which is great, because we’ve got some big projects planned.

Thank you so much.

Now, in less delightful news, I’m fighting a little bit with my insurance company right now. Or … is it the hospital billing office I’m fighting with? Each one keeps sending me back to the other. It’s … a good time.

There’s a First Aid Kit newsletter in all this, but for now I’m struggling to find the hours for all the phone calls, and to keep my composure.

On that last note– keeping my composure — this seems like a good time to bring back what may be the most useful episode we’ve ever done, from late 2020.

You ready? Here we go.

I got a voicemail from a listener named Amanda Jaffe. She’s been listening to our episodes about folks who fight back against insurance companies and outrageous bills. And she says she’s kind of a bulldog herself on this stuff. BUT she says there’s a snag. Maybe you can relate — I definitely can.

Amanda Jaffe: When I call the insurance companies, I start to get angry to a point where maybe it’s unproductive. So I need some guidance on how to remain cool when calling insurance companies. Thanks. I’d really need the help.

Dan: YES. I have been thinking about this for months and months. We’ve been hearing from people who fight and fight, and sometimes win, and a couple of things keep getting clearer:

ONE: You’re probably gonna spend a LOT of time on the phone, a lot of it on hold, and a lot of it with people who, for one reason or another, are not gonna seem that helpful.

And TWO, I keep hearing over and over again: You’ve gotta keep your cool. OK, sure.

But I keep wondering again and again: OK, HOW?

And today, I think I’ve got exactly the person I’ve been looking for.

Lauren Taylor: My name is Lauren Taylor. I run Defend Yourself in Washington, DC, and we teach people skills for stopping harassment, abuse, and assault.

Dan: So for like a YEAR I’ve been describing this show as being focused on self-defense against the cost of health care. And Lauren is an actual self-defense teacher. Has been one for thirty-five years.

And it turns out self-defense — the way Lauren and her colleagues teach it — is NOT just the hitting and the kicking. It’s defending yourself against all kinds of … encroachment. Street harassment. Creepy co-workers. Just standing up for yourself. You might’ve noticed, Lauren said her group teaches people skills for stopping harassment, abuse, and assault.

And abuse … I’m not sure that’s too strong a word for how the health-care industrial complex treats people.

So, Lauren herself is just wrapping up an EPIC fight with her health insurance. And she has been using self-defense skills all along the way. I’m not going into all the details.

Lauren Taylor: There’s been so many things. I honestly can’t remember them all.

Dan: But we talked through them– because she’s got ’em written down.

Lauren Taylor: This is also a self-defense thing, which is document, right?

Just like you would with a stalker or a workplace harasser or, uh, even uh, An abusive partner, is document everything because, you might need it

Dan: You teach this in the class.

Lauren Taylor: Oh yeah.

Dan: I walk in, think I’m gonna learn how to need somebody in the nuts. And you’re like, “get a notebook.” I’m like, wow.

Lauren Taylor: People, people do walk in thinking they’re going to learn how to, , knee someone in the groin, and we do teach that. but I can’t tell you how often in evaluations people tell us that they were completely blown away by all the other stuff that they learn, which is really about empowerment.

Dan: Yes. Yes, please. Let’s have some of that.

This is An Arm and a Leg — a show about the cost of health care. I’m Dan Weissmann. I’m a reporter, and I like a challenge. So my job here is to take one of the most enraging, terrifying, depressing issues in American life– and YES, there’s a bunch of those, but I’m sticking with this one– and produce a show that’s entertaining, empowering, and useful.

And here we are.

Here’s Lauren’s deal: It starts the early 1980s,

Lauren Taylor: I had saved up money and I was gonna take some time and travel by myself. And a friend of mine told me about a self-defense class that she had taken. And I thought, “Oh, that’s a really good idea. I should probably do that if I’m going to travel by myself.”

Dan: She says it changed her life. Like, as a teenager, she’d dealt with a LOT of street harassment. She figured, man, that’s just how it goes.

Lauren Taylor: And I had always thought that if anybody tried to rape me, there would be nothing I could do because by definition they would be bigger and stronger than me.

And the real life-changing piece of the self-defense class was realizing that that was wrong. It was realizing that I had power and that I could hurt somebody who was trying to hurt me.

Dan: How did that feel?

Lauren Taylor: It’s, it’s totally life changing. I mean, even now, like, just tell it to you. I still feel like a rush of energy through my body saying it.

Dan: It’s thrilling. It’s like, holy shit! I’m not helpless

Lauren Taylor: Yeah. I can protect myself. Yeah. And I have power and, and . A big piece of it also is I have permission to do this and I deserve to be protected.I deserve to be able to defend myself.

And all of those are not messages that, you know, most of us get growing up still. And certainly not when I was growing up. So, it’s kind of like, caught the fever and then wanted to spread the gospel of self-defense.

Dan: So, she’s been teaching self-defense since 1985.

I asked her: So, how did it change your life– beyond the fact that you started teaching it? Like, what did you do differently?

She says for starters, she did take that trip, and there was a night or two that didn’t go according to plan: Her place to crash fell through, she was out late, lost, a little scared. And she took out a pen, so in case she needed to hurt somebody, she’d have a pen to hurt them with. She did NOT have to use it, but having a plan helped her keep cool.

But that wasn’t the big stuff. The big stuff was standing up for herself in other ways. Like when her boss in a full-time volunteer gig started sexually harassing her.

Lauren Taylor: Whereas before I would have liked, you know, suffered and wrung my hands and journaled about it and called 12 friends and, thought maybe there was something wrong with me and you know, all of those things I didn’t do, I was just like, Really no, don’t do this.

Dan: And then what happened?

Lauren Taylor: Ge pretty much cut it out.

Dan: YEAH. And then there was her mom. Who did NOT deal well with Lauren being gay. It was painful. And then there was the final straw:

Lauren Taylor: We had a large family reunion and She didn’t invite my partner and she invited my siblings partners.

Jesus, ouch. They’d had a lot of conversations. Now Lauren set a hard boundary. She put it in writing to her mom:

Lauren Taylor: There are some basic things I need from you, or I’m not going to be able to stay in contact with you. Right. So, if there’s a family event, My partner gets invited , that’s self-defense

Dan: That first self-defense class Lauren took had not covered Dealing With Difficult Family Members, but Lauren says she’d gotten the message:

Lauren Taylor: It was okay. to require certain kinds of respect from people. it was okay to be who I was, that wasn’t my fault that people treated me as less than all of that kind of stuff.

Dan: And by the way, Lauren says the classes she leads now, they DO cover all that kind of stuff.

In other words, self-defense covers a LOT of territory. The big idea: If you’re in a tough spot, you want some options.

Lauren says she gives students a five-part framework– five kinds of options.

They are: Run, yell, hit, tell, and go along.

And they’re not all literal. Like, RUN is …

Lauren Taylor: Leave walk away. Don’t show up for the appointment, break up with the person, anything that makes you not there.

Dan: And she says by YELL, she means: Use your voice.

Lauren Taylor: Assertiveness or deescalation or negotiation, or, you know, that’s not okay with me or don’t come any closer or, you know, I won’t come to family events if you don’t invite my partner. Right.

Dan: “Yell” covers a lot of territory there.

Lauren Taylor: Everything with your words pretty much.

Dan: Everything with words you use with the other person. Because there’s also TELL. Which she says mean — also really broadly — get help.

Lauren Taylor: It can be getting help in the moment. uh, this person is bothering me. Can I stand with you? And then there’s, longer-term getting help going to HR, going to a hotline, , talking to a lawyer,

Dan: Posting to social media.

Lauren Taylor: Posting it. Right. exactly.

Dan: Hit is — well, it’s actually hitting. They practice that too.

And then there’s the last one: Go along.

Lauren Taylor: We want people to know that that’s an option, right? We’re not saying. Always resist. We’re saying resistance is successful way more than you’ve been told and way more than you believe.

But there are times when, going along, is the smartest and safest thing for you to do. And for example, if someone’s trying to take your property, right, if it’s a mugging, And you want to get out of there, unharmed, the smartest and safest thing to do is to give them your property.

Dan: Yeah. I think you can probably see the broad outlines of how this could apply to wrangling with your insurance company or fighting unfair medical bills. I mean, talk about a mugging.

It definitely reminds me of something I said when we started this self-defense series: We’re not gonna win ’em all. We just don’t have to lose them all either.

So, that’s Lauren’s framework.

Next: Let’s learn some SPECIFIC techniques and how we can start applying them. That’s right after this.

This episode of An Arm and a Leg is produced in partnership with KFF Health News. That’s a non-profit newsroom covering health care in America. Their work is terrific, wins all kinds of awards every year. I am so proud to work with them.

OK. How to actually USE self-defense techniques with medical bills and insurance BS.

We’ll start with an example from Lauren’s epic health-insurance fight this year. We’re not gonna get into the story– it’s too long, too weird, and it’s not even really over. BUT we will zoom in on a moment when Lauren’s on the phone and the other person opens by throwing up a roadblock, saying, YOU probably did something wrong.

I’m like, Argh, I’m already angry. What do you do now? And Lauren’s like, “I stayed on my agenda.”

STAYING ON YOUR AGENDA. This is a whole self-defense thing. Lauren walks me through it:

Lauren Taylor: Here’s the process. Okay. Something’s happening. You know, like somebody is harassing you on the street or whatever …

Dan: Or you’re calling your insurance, and the other person is being REALLY unhelpful.

She says you ask yourself three questions, in this order: First, how am I feeling? It’s probably not pleasant.

Lauren Taylor: I’m terrified. I’m angry, I’m upset. I want to cry. I feel humiliated.

Dan: Good times. That’s the first question: How am I feeling?

Second: What do I need? Which is more big-picture: Need to get a safe distance, need respect.

Third, what do I WANT? This is more specific– what do you want from the other person:

Lauren Taylor: I want you to take your hands off me. I want you to take three steps back. I want you to knock before you come in my office. I want you to stop making racist jokes. whatever it is, you turn it into what I want you to sentence, and that is your agenda. What you want to happen is your agenda.

So. Then when they do whatever people who are misusing power do, which is often. Guilt trip you or trying to manipulate you or blame you like, well, why were you there? Why were you wearing that? Why did you get drunk? Um, it’s just a joke. Um, why wouldn’t have said it, if you hadn’t blah, blah, blah, or why you being such a bitch?

Um, you know, all of those things are to get you into their web of conversation and off of your agenda and you stay on your agenda. So if I say to you, don’t ask me about my personal life while we’re at work. And you’re like, Oh Lauren, you’re so sensitive.

Dan: Yeah, I’m changing the subject. Suddenly, we’re not talking about what you want. We’re talking about my perception of you. And you may have a pretty strong impulse to address that– Like, “Oh, geez, am I?” Or, “I AM NOT”

Lauren Taylor: But instead I’m just going to say again, “Listen, Dan, I asked you. I only want to talk about work at work. And I really don’t like answering personal questions at work. So please stop asking me.” That’s staying on your agenda.

Dan: And so how did that happen in these phone calls?

Lauren Taylor: I just kept saying what I needed or. I would keep saying so what’s the next step? What can we do from here?

So for instance, Lauren played out a long, long set of calls with her health insurance company AND the state office that administers the Obamacare exchange in Maryland, where she lives.

Whenever they hit an impasse, she asked, “What is the next step?” Eventually, the next step was: file an appeal through the state attorney general’s office. Lauren called, and the first person to pick up the phone did not have a super-encouraging opening line.

Lauren Taylor: She was like, well, I’m sure you missed a deadline. And, um, instead of saying, I didn’t miss any deadlines because then we’re into her conversation.

I said, so please tell me more about how to appeal. Right? Because you know, she probably talks to a hundred people a day and, you know, people make all kinds of mistakes and you know, it’s a big headache to her, I’m sure.

Dan: So Lauren didn’t take the bait. She stayed on her agenda… AND AFTER A WHILE, ONCE THE APPEAL WAS REALLY IN MOTION, Lauren noticed the same woman– who was now calling LAUREN with updates, sometimes more than once a day– was singing a different tune. Well, definitely some new words.

Lauren Taylor: She was using we language.

Dan: That’s what we like. Yeah,

Lauren Taylor: right. So I was like, Oh, this is going very well. she was like, “we just need to figure this thing out and then we’ll let them know.”

“WE” language.

OK, this is great.

AND it’s like: Wait, how do I actually do this? Like, in the moment? Like, here’s Amanda’s question again:

Amanda Jaffe: I start to get angry to a point where maybe it’s unproductive. So I need some guidance how to remain cool when calling insurance companies.

Dan: YEAH. Me too! Me too.

And Lauren reframed it. She was like: OK, getting angry, that’s not a problem, not a mistake. It’s a feeling that you’re having. And it’s a really reasonable feeling to have.

And she says Amanda’s nailing it in saying: those feelings probably aren’t gonna be super-helpful IN this conversation.

So, you want a strategy. An agenda. A plan.

Lauren Taylor: If you can ground yourself in the fact that you’re strategy is to remain calm and confident while still being very assertive and persistent. that is a strategy, it doesn’t mean that you have to feel great about what’s happening. or that you aren’t upset the way that people are treating you. it just means that as a strategy, you are choosing to use this persona, this common, confident, assertive, persistent persona to try and get what you need.

Dan: So, yeah: You’re gonna be mad. That’s gonna happen. You just don’t wanna act out those feelings in the conversation. So here’s the actual ADVICE part: You take those feelings and…

Lauren Taylor: Do them somewhere else. You, you know, go for a walk and pound the pavement. You vent to a friend. Um, if you have a car, you roll up the windows and drive on a highway and scream. Um, you find, you know, you find a place that’s probably not alcohol or ice cream too.

Um, To process those feelings because you don’t want them just hanging out in you either. That’s not good for you either.

Dan: Which is to say: It may be smart to have a plan GOING INTO the conversation about how you’re deal with those feelings afterwards. Maybe even make a plan with somebody else. You know…

Lauren Taylor: Call a friend or a family member who’s in your house and say, I’m going to get on the phone with the health insurance company, and we’re going to call you afterwards and vent. Right. And then, you know, I have a place for these feelings. It’s not that I’m squashing

Dan: Right.

Lauren Taylor: There’s a time for that too.

Dan: I love that. But meanwhile, here I am IN the conversation, and things are getting hairy, and I’m HAVING A LOT OF FEELINGS ABOUT IT.

Not so calm, not so confident, NOT SO CALM.

Lauren’s like: Right. Got you covered. You want to find a technique that helps you quickly get calm and grounded in the moment. She says paying attention to her breathing is her go-to, but

Lauren Taylor: My way of doing it may not work for you or her or somebody else. People have to find what works for them to stay calm and grounded. So just a few ideas. It can be, um, breathing. It can be feeling your feet on the floor. Those are my top two, but it also can be, you know, some people saying a quick prayer helps them.

Dan: She’s got more:

Lauren Taylor: It can be, orienting yourself to the room. Like, what are five things I can see or can I find three blue things? And then what’s one thing I can hear. What’s the one thing I can feel, those orienting things that keep you very much in the present moment and also let you know, like, this may be incredibly upsetting, but right now I’m actually okay. Right now in this moment, I’m actually okay. You know, I’m maybe scared about losing my health insurance. I may be scared about where the money’s going to come from. But if you can say to yourself, like, Oh right now, I’m sitting in a room in my apartment and, um, you know, My loved ones are around me or my pets are around me, or I have a plan for dinner or I’m going to call a friend right now I’m okay. So there’s lots of ways to get present. and I think that getting present is what can help this woman and everybody else.

Dan: What I hear you talking about … Like when you say: “get into the present,” it’s like, I’m moving my attention. I’m moving my attention from this feeling that I’m having that wants to take up my entire field of attention. And I’m kind of like reminding myself that there are other things to give my attention to. And now that I know that I can give my attention to my strategy

I think one thing that really strikes me about what you’re saying is … it’s kind of reframing the question. I start to get angry to a point where maybe it’s unproductive and I think the way that’s framed, is how do I not have the feeling? That’s how I’m reading the questions. The problem is I get angry. And what I’m hearing you say is like, not a problem.

Lauren Taylor: Not a problem

Dan: You’re getting angry.

Lauren Taylor: There are really good reasons to be angry

Dan: YES! For sure. So what you want isn’t to avoid getting angry– it’s just to avoid getting out of control. You probably ARE going to get mad. So you want to plan for it.

And to review, Lauren’s top two tips are:

One: Have a plan for what you’re gonna do with that anger AFTER the call. How are you going to deal with it?

And two: Have a couple of favorite hacks for quickly re-focusing your attention. To your breath, some other sensation, whatever clicks for you.

You’re probably gonna want to WRITE down those tricks, practice them, before you get on the phone.

I really love this. And talking to Lauren, I realized: Being on the phone with the insurance company– or the medical-billing office or whoever else in the medical-industrial complex you’re talking with– we’ve got advantages we don’t have in some other self-defense situations:

One: You’re not in the same physical space with that other person. They can’t see you scrunch up your face, or gently rub your heart, or pet the cat, or silently count to ten while they’re talking.

Which is different from being face-to-face with somebody who could hurt you– physically or emotionally.

And two: You don’t have an ongoing relationship with this particular person. It’s not like telling your mom that you need her to invite your partner to family gatherings. Or telling your colleague to stop making racist jokes. Those are relationships that are going to keep affecting you. And probably keep affecting other relationships.

Here, you’re like, WHATEVER, anonymous insurance-company person. Which doesn’t mean you can act like a jerk to them– that’s not going to help you. But you do have an escape hatch. If you really can’t take it any more without losing your cool… you can hang up and call back later, when you’re ready, and tell the next person, GEE, I got disconnected before.

I tell Lauren this, and she’s like

Lauren Taylor: Yeah, I was definitely thinking, you know, you can, if you have, if you’re too filled up with feeling to be doing something that feels useful, you can absolutely say, you know, I can talk about this anymore. I’ll call, call back another time.

Dan: Oh yeah. Right. You don’t have to like fake, dropping the call. You can just say like, wow. I think I need to, I need some time to digest this. , I’d like to call

Lauren Taylor: I’ll call back later.

Dan: YES. I’ll call back later. That’s where we left things with Lauren Taylor in the fall of 2020, and it’s all still super-relevant — as I can attest right now, with my back-and-forth calls to the hospital and the insurance company.

One update: Since we talked, Lauren Taylor has published a book!

Get Empowered: A Practical Guide to Thrive, Heal, and Embrace Your Confidence in a Sexist World was published in October 2023, and — although the title suggests that the book targets folks with one X chromosome more than I happen to have — I am looking forward to reading it.

We condensed some of Lauren’s advice into a First Aid Kit newsletter last year — along with related tips from other superstars. We’ll put a link in the show notes — you should be able to find it wherever you’re listening, and you can sign up for any of our newsletters at arm and a leg show dot com, slash, newsletter.

We will be back in three weeks.

Till then, take care of yourself.

This episode of An Arm and a Leg was produced by me, Dan Weissmann, edited in 2020 by Marian Wang, and for this re-release by Ellen Weiss.

Emily Pisacreta is our senior producer. Adam Raymonda is our audio wizard.

Gabrielle Healy is our managing editor for audience — she edits the First Aid Kit newsletter.

Sarah Ballema is our operations manager. Bea Bosco is our consulting director of operations.

An Arm and a Leg is produced in partnership with KFF Health News.

That’s a national newsroom producing in-depth journalism about health care in America, and a core program at KFF — an independent source of health policy research, polling, and journalism.

You can learn more about KFF Health News at arm and a leg show dot com, slash KFF.

Zach Dyer is senior audio producer at KFF Health News. He is editorial liaison to this show.

Thanks to the INSTITUTE FOR NONPROFIT NEWS for serving as our fiscal sponsor, allowing us to accept tax-exempt donations. You can learn more about INN at I-N-N dot org.

And thanks to everybody who supports this show financially. I am about to shout out FIFTY people who donated in the last dozen days of 2023. You ready?

Thanks this time to… [names redacted].

Thank you so much!

“An Arm and a Leg” is a co-production of KFF Health News and Public Road Productions.

To keep in touch with “An Arm and a Leg,” subscribe to the newsletter. You can also follow the show on Facebook and X, formerly known as Twitter. And if you’ve got stories to tell about the health care system, the producers would love to hear from you.

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from Health Industry Archives - KFF Health News

Records Show Publix Opioid Sales Grew Even as Addiction Crisis Prompted Other Chains’ Pullback

An executive at Teva Pharmaceuticals flagged Publix Super Markets in October 2015 after detecting what he called in an email “serious red flags” with the grocery chain’s orders of powerful opioids.

The share of high-strength oxycodone orders was well above normal for a chain of grocery store pharmacies, and the total number of pills sent to Publix stores was “significantly above their peers,” Teva’s head of federal compliance wrote in the email to his supervisors, according to court records in a federal lawsuit pending in Ohio against Publix and other companies.

“This is high-strength oxycodone ultimately going to Florida, a well-established hot spot for oxycodone abuse in the U.S.,” wrote the compliance officer, Joseph Tomkiewicz, in the email explaining why he halted Teva-manufactured prescription opioids to Florida’s Publix pharmacies.

The volume of prescription opioids dispensed in Florida fell 56% from 2011 to 2019 as the pharmaceutical industry was hit by lawsuits for its role in the national opioid crisis, according to a Tampa Bay Times analysis of Drug Enforcement Administration data recently released by a federal court. But while national pharmacy chains like CVS and Walgreens were dispensing fewer of the highly addictive drugs, Publix’s sales were soaring.

The Lakeland-based grocer’s sales of oxycodone climbed from 26 million pills per year in 2011 to 43.5 million in 2019, the data shows. The increase in sales, which far outpaced the chain’s addition of stores in Florida, saw its market share rise to 14%, enough to overtake CVS to become Florida's second-largest dispenser of all opioid medications, behind only Walgreens, which dispensed 28% of opioids in the state in 2019. The analysis excludes drugs like methadone prescribed for addiction treatment. Opioid sales at Publix dipped slightly in 2018 and 2019, the last two years of available data.

Even as its market share grew, however, Publix was not among the 15 national manufacturers, distributors, and pharmacies that Florida sued in 2018. That lawsuit claimed other pharmacies had flooded America with painkillers such as OxyContin, fueling debilitating addictions that strained communities’ first responders and medical providers.

The state’s lawsuit was a boon for Florida. While admitting to no wrongdoing, the companies agreed to settlement payments to the state, including $177 million from Teva, $440 million from CVS, and $620 million from Walgreens. The state didn’t sue Walmart but in 2022 negotiated a $215 million settlement from the retail giant, which also denied any wrongdoing.

However, there is no mention of Publix’s role on a state webpage touting the 10 opioid settlements reached during Ashley Moody’s tenure as attorney general.

That’s despite Publix being the third-biggest dispenser of opioids in the state, selling nearly twice the amount of the drugs as Walmart from 2006 to 2012, according to earlier DEA data made public in July 2019, more than two years before Florida prosecutors reached settlements with other pharmacy chains.

Moody, a Republican, took over as the state’s top legal official in January 2019. Her office declined to specifically address why Florida has not included Publix in any of its legal actions over opioids.

“We are proud of the more than $3 billion recovered through the historic opioid litigation, and since the filing of the amended complaint, the Department of Legal Affairs has and will continue to take action when merited by the evidence — as we did in the more recent actions with Walmart and McKinsey,” said Moody’s communications director, Kylie Mason, in an email.

The grocery chain made $10.6 million in political donations in Florida from 2016 to 2022 when the state was preparing and pursuing its litigation, state election data shows. Most of the donations were for Republican committees and candidates, including $125,000 donated to the Friends of Ashley Moody political action committee.

In Florida, Walgreens made $637,000 in political donations, including $8,000 to Moody, over the same period. CVS made $208,500 in donations, none of which went to Moody.

Other local communities in Florida and beyond did sue Publix. The federal suit naming Publix that prompted the release of the federal data was filed by Georgia's Cobb County. It has been earmarked as a test case for dozens of other lawsuits brought by cities and counties in the Southeast. Those include more than 20 Florida communities, among them St. Petersburg and Pinellas and Pasco counties.

While Walgreens and other national companies paid billions to settle their lawsuits and agreed to stricter drug controls, Publix is still contesting the cases.

Those communities claim that the grocery chain failed to operate an “effective suspicious ordering monitoring program” and that when Publix did limit orders to its own pharmacies, those pharmacies could bypass the check by going to a third-party distributor such as AmerisourceBergen.

Publix also should have known that its pharmacies in Georgia, Florida, Alabama, Tennessee, and South Carolina, were filling multiple prescriptions written for the same patient by the same doctor or by multiple doctors, the federal lawsuit alleges. As part of the national opioid settlement, other pharmacy chains were required to be more compliant with laws regulating opioids, including checks on suspicious orders and prescriptions from “blocked and potentially problematic” doctors.

“It’s a heck of a lot cheaper to distribute and dispense controlled substances without all these checks,” said Jayne Conroy, an attorney with New York law firm Simmons Hanly Conroy who is representing the Florida communities and has served as co-lead counsel in the national opioid litigation that has secured more than $50 billion in settlements and verdicts.

Publix did not respond to three emails and three phone calls to its communications office seeking comment.

In its responses to the lawsuits, it has repeatedly denied allegations of wrongdoing.

In seeking to get the Ohio case dismissed, Publix attorneys argued that it can’t be considered “a public nuisance” to legally distribute and dispense opioids. The judge in the case denied the company’s motion and another legal brief that sought to prevent the release of the more recent DEA data.

In November 2022, Publix sued more than a dozen of its insurers in federal court in Tampa, claiming they had not honored policies that would protect it from opioid litigation claims.

It also countersued Cobb County in 2023, saying the Georgia community’s lawsuit was “motivated by promises of a windfall.” The case is still pending.

“Publix takes great pride in its relationship with its valued customers and the communities it serves,” that lawsuit states. “These novel and unprecedented claims are baseless, false, and belied by Publix’s decades of service.”

DEA officials declined to comment on Publix’s opioid record. No enforcement actions against Publix are listed in the federal registry.

A Growing Player

Since its 1930 start as a food store in Winter Haven, Florida, Publix has grown into a massive company with more than 250,000 employees and nearly 900 stores in Florida alone. Revered for its free cookies for kids, chicken tender subs, fresh produce, birthday cakes, and BOGO deals, the grocery chain has become one-stop shopping for customers.

And, increasingly, “Where Shopping Is a Pleasure” — Publix’s slogan since 1954 — includes powerful prescription drugs.

Publix was a smaller player in Florida’s opioid market before 2011, responsible for fewer than 5% of all opioid medications distributed to pharmacies across the state, according to the Times analysis of federal opioid data.

That year marked a turning point for opioid sales in Florida. As the scale of the opioid epidemic came to public attention, and litigation followed, most chain pharmacies began to back off their orders for pills, the data shows.

Many companies ultimately agreed to pay billions of dollars to settle lawsuits filed across the country by state and local governments. That included a $683 million settlement between Florida and Walgreens in May stating the pharmacy, which denied any wrongdoing, must pay for community treatment, education, and prevention programs, plus litigation costs.

In addition to hefty payouts, some settlement agreements required companies to adopt stricter controls to bring operations into fuller compliance with the Controlled Substances Act, a federal law that governs the manufacture, distribution, and use of drugs considered to have a high risk of being abused.

Distributors were required to adopt automated software that would flag suspicious orders from pharmacies such as quantities well above a store’s average. Pharmacy companies were required to conduct checks on doctors to ensure the prescribers are registered with the Drug Enforcement Administration.

Those measures and others put the brakes on opioid distribution nationwide. Meanwhile, the distribution in Florida’s Publix stores went in the opposite direction: From 2011 to 2019, the grocery chain increased its dispensing of all opioid medication by 35%, according to the Times’ analysis of the data.

That growth far exceeded any increase in sales that would correspond to the grocer’s net addition of 146 pharmacies from 2011 to 2019.

As Publix’s distribution increased, so too did the number of orders that should have been flagged as suspicious, according to plaintiffs in multiple lawsuits. Drug distributor McKesson instructed its employees to investigate any pharmacy ordering more than 8,000 oxycodone pills in a single month as part of the company’s “Lifestyle Drug Monitoring Program,” according to 2018 congressional testimony.

Publix pharmacies’ orders surpassed that threshold almost 1,500 times in 2019, the Times analysis found, more than triple the number in 2011. The benchmark has been repeatedly used in opioid litigation as evidence of inadequate monitoring of drug distribution.

‘Red Flags’ Missed

As Tomkiewicz faced pressure from Teva management to fulfill Publix’s orders, he mined the data to back up his concerns, court records show. During a heated phone call, one Teva executive stressed that Publix was an increasingly important player in the opioid distribution market, Tomkiewicz said at his deposition, and an important client for the world’s largest generic drug manufacturer.

Tomkiewicz requested data from Publix’s 10 largest pharmacies by opioid sales, all located in Florida.

By law, Publix was required to keep tabs on the physicians whose prescriptions it filled. But it took Tomkiewicz just one day of searching the internet to find problems, according to time stamps on emails submitted in the court records.

Among the top prescribers at two Publix locations in Melbourne was Thomas Velleff, according to Tomkiewicz’s email. Public records and a newspaper report showed “significant anecdotal evidence of pill mill activity,” Tomkiewicz wrote. He said he found a 2010 article in the Treasure Coast Palm, in which a city employee claimed Velleff’s prior pain clinic in Palm City attracted “carloads” of patients, often with out-of-state license plates.

Complaints filed with the state Department of Health dating to 2010 allege that Velleff overprescribed opioids and failed to monitor his patients’ usage for signs of abuse. One 2017 complaint alleges that Velleff pressured one patient into loaning him money. The state Board of Medicine revoked Velleff’s medical license in December 2020. Velleff did not appear at his medical board hearing, according to the final order revoking his license. He did not respond to emails seeking comment.

A top prescriber at one Ocala store had been disciplined in 2011 for injecting herself with a sedative while leaving an anesthetized patient unsupervised. Other pharmacies repeatedly filled prescriptions from “cash-only” pain clinics or written by physicians located hundreds of miles away with no license to practice in Florida, Tomkiewicz wrote in the email. It is legal to do so, but drug diversion experts consider out-of-state prescriptions a red flag that should prompt additional checks for possible drug abuse.

Tomkiewicz had amassed a list of nine doctors among Publix’s top prescribers who made him wonder: “Why the hell do they still have a license and are still registered with the DEA?” according to his deposition.

Tomkiewicz also said in his deposition he was troubled by not just the volume of opioids Publix was selling, but that they were handing out a disproportionate share of 30-milligram instant-release oxycodone pills — another red flag for abuse. In an email to Teva’s director of compliance, he compared that with the Moffitt Cancer Center in Tampa, where cancer patients were mostly being prescribed 5 mg instant-release pills, court records show.

As the strongest dose on the market, the 30 mg pills have limited use in retail pharmacies and are highly sought-after among abusers, Tomkiewicz wrote in the email. Stronger doses of oxycodone are available, but only in long-release capsules such as OxyContin, according to the U.S. National Institutes of Health.

Publix sold 4.8 million of the highly addictive high-dose pills in 2019 — roughly 1 in 10 of all oxycodone pills dispensed by the pharmacy chain that year, according to the Times analysis of the federal data.

Eventually, Tomkiewicz relented, he said in his deposition. As long as Publix promised not to send Teva products to nine locations that he’d picked out, he would let the shipment go ahead. Teva did not notify federal authorities, according to his deposition.

A Times review of court documents found no written record indicating that Publix responded to Tomkiewicz’s concerns at the time. An expert report submitted in the lawsuit came to the same conclusion.

Tampa Bay Times staff writer Ian Hodgson previously worked for a research company, Cornerstone Research, that had a client relationship with Teva Pharmaceuticals. This article was produced in partnership with the Tampa Bay Times.

Methodology

For comparison and dosing purposes, it is standard practice to convert opioid medications to an equivalent dose of morphine. Every shipment of opioids in the federal database is reported as both the number of pills and its morphine milligram equivalent, or “MME.” This story uses that standard to calculate increases in the number of pills dispensed and compare the volume of pills prescribed by different pharmacy chains.

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from Health Industry Archives - KFF Health News

Ouch. That ‘Free’ Annual Checkup Might Cost You. Here’s Why.

When Kristy Uddin, 49, went in for her annual mammogram in Washington state last year, she assumed she would not incur a bill because the test is one of the many preventive measures guaranteed to be free to patients under the 2010 Affordable Care Act. The ACA’s provision made medical and economic sense, encouraging Americans to use screening tools that could nip medical problems in the bud and keep patients healthy.

So when a bill for $236 arrived, Uddin — an occupational therapist familiar with the health care industry’s workings — complained to her insurer and the hospital. She even requested an independent review.

“I’m like, ‘Tell me why am I getting this bill?’” Uddin recalled in an interview. The unsatisfying explanation: The mammogram itself was covered, per the ACA’s rules, but the fee for the equipment and the facility was not.

That answer was particularly galling, she said, because, a year earlier, her “free” mammogram at the same health system had generated a bill of about $1,000 for the radiologist’s reading. Though she fought that charge (and won), this time she threw in the towel and wrote the $236 check. But then she dashed off a submission to the KFF Health News-NPR “Bill of the Month” project:

“I was really mad — it’s ridiculous,” she later recalled. “This is not how the law is supposed to work.”

The ACA’s designers might have assumed that they had spelled out with sufficient clarity that millions of Americans would no longer have to pay for certain types of preventive care, including mammograms, colonoscopies, and recommended vaccines, in addition to doctor visits to screen for disease. But the law’s authors didn’t reckon with America’s ever-creative medical billing juggernaut.

Over the past several years, the medical industry has eroded the ACA’s guarantees, finding ways to bill patients in gray zones of the law. Patients going in for preventive care, expecting that it will be fully covered by insurance, are being blindsided by bills, big and small.

The problem comes down to deciding exactly what components of a medical encounter are covered by the ACA guarantee. For example, when do conversations between doctor and patient during an annual visit for preventive services veer into the treatment sphere? What screenings are needed for a patient’s annual visit?

A healthy 30-year-old visiting a primary care provider might get a few basic blood tests, while a 50-year-old who is overweight would merit additional screening for Type 2 diabetes.

Making matters more confusing, the annual checkup itself is guaranteed to be “no cost” for women and people age 65 and older, but the guarantee doesn’t apply for men in the 18-64 age range — though many preventive services that require a medical visit (such as checks of blood pressure or cholesterol and screens for substance abuse) are covered.

No wonder what’s covered under the umbrella of prevention can look very different to medical providers (trying to be thorough) and billers (intent on squeezing more dollars out of every medical encounter) than it does to insurers (who profit from narrower definitions).

For patients, the gray zone has become a billing minefield. Here are a few more examples, gleaned from the Bill of the Month project in just the past six months:

Peter Opaskar, 46, of Texas, went to his primary care doctor last year for his preventive care visit — as he’d done before, at no cost. This time, his insurer paid $130.81 for the visit, but he also received a perplexing bill for $111.81. Opaskar learned that he had incurred the additional charge because when his doctor asked if he had any health concerns, he mentioned that he was having digestive problems but had already made an appointment with his gastroenterologist. So, the office explained, his visit was billed as both a preventive physical and a consultation. “Next year,” Opasker said in an interview, if he’s asked about health concerns, “I’ll say ‘no,’ even if I have a gunshot wound.”

Kevin Lin, a technology specialist in Virginia in his 30s, went to a new primary care provider to take advantage of the preventive care benefit when he got insurance; he had no physical complaints. He said he was assured at check-in that he wouldn’t be charged. His insurer paid $174 for the checkup, but he was billed an additional $132.29 for a “new patient visit.” He said he has made many calls to fight the bill, so far with no luck.

Finally, there’s Yoori Lee, 46, of Minnesota, herself a colorectal surgeon, who was shocked when her first screening colonoscopy yielded a bill for $450 for a biopsy of a polyp — a bill she knew was illegal. Federal regulations issued in 2022 to clarify the matter are very clear that biopsies during screening colonoscopies are included in the no-cost promise. “I mean, the whole point of screening is to find things,” she said, stating, perhaps, the obvious.

Though these patient bills defy common sense, room for creative exploitation has been provided by the complex regulatory language surrounding the ACA. Consider this from Ellen Montz, deputy administrator and director of the Center for Consumer Information and Insurance Oversight at the Centers for Medicare & Medicaid Services, in an emailed response to queries and an interview request on this subject: “If a preventive service is not billed separately or is not tracked as individual encounter data separately from an office visit and the primary purpose of the office visit is not the delivery of the preventive item or service, then the plan issuer may impose cost sharing for the office visit.”

So, if the doctor decides that a patient’s mention of stomach pain does not fall under the umbrella of preventive care, then that aspect of the visit can be billed separately, and the patient must pay?

And then there’s this, also from Montz: “Whether a facility fee is permitted to be charged to a consumer would depend on whether the facility usage is an integral part of performing the mammogram or an integral part of any other preventive service that is required to be covered without cost sharing under federal law.”

But wait, how can you do a mammogram or colonoscopy without a facility?

Unfortunately, there is no federal enforcement mechanism to catch individual billing abuses. And agencies’ remedies are weak — simply directing insurers to reprocess claims or notifying patients they can resubmit them.

In the absence of stronger enforcement or remedies, CMS could likely curtail these practices and give patients the tools to fight back by offering the sort of clarity the agency provided a few years ago regarding polyp biopsies — spelling out more clearly what comes under the rubric of preventive care, what can be billed, and what cannot.

The stories KFF Health News and NPR receive are likely just the tip of an iceberg. And while each bill might be relatively small compared with the stunning $10,000 hospital bills that have become all too familiar in the United States, the sorry consequences are manifold. Patients pay bills they do not owe, depriving them of cash they could use elsewhere. If they can’t pay, those bills might end up with debt-collection agencies and, ultimately, harm their credit score.

Perhaps most disturbing: These unexpected bills might discourage people from seeking preventive screenings that could be lifesaving, which is why the ACA deemed them “essential health benefits” that should be free.

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from Health Industry Archives - KFF Health News

Senate Probes the Cost of Assisted Living and Its Burden on American Families

A U.S. Senate committee on Thursday launched an examination of assisted living, holding its first hearing in two decades on the industry as leaders of both parties expressed concern about the high cost and mixed quality of the long-term care facilities.

The federal government has minimal oversight of assisted living, which is regulated by states, unlike skilled nursing homes. Both the Democratic and Republican leaders of the Senate Special Committee on Aging said their inquiry aimed to detail the financial practices and quality levels in the industry so that consumers would be better able to choose facilities. Lawmakers expressed little appetite for Congress to take a more direct role in regulating the sector, such as by setting federal standards for staffing levels and how workers are trained.

Prompted by a New York Times-KFF Health News series, Sen. Bob Casey, the Pennsylvania Democrat who chairs the panel, put out a call for residents and their families to submit their bills so the panel could assess the industry’s business practices.

“I want to know more about what people are paying for assisted living and to have people tell their stories,” Casey said. “We want to hear from you about the true cost of assisted living and understand whether families have the information — the information that they need — to make this difficult financial and health care decision for a family member and for the family.”

Sen. Mike Braun of Indiana, the ranking Republican on the committee, endorsed the inquiry while cautioning against actions that would lead to new financial burdens on the federal budget. “When you’re promoting transparency, it can bring odd partners together,” Braun said.

More than 800,000 older Americans reside in assisted living facilities, which cater to people who have dementia or trouble walking, eating, or doing other daily activities. Most residents have to pay out-of-pocket because Medicare doesn’t cover long-term care and only a fifth of facilities accept Medicaid, the federal-state insurance for people with low incomes or disabilities. The industry is quite profitable, running median operating margins around 20% and often charging residents with extensive needs $10,000 or more a month. The national median cost of assisted living is $54,000 a year, according to a survey by the insurer Genworth.

The New York Times-KFF Health News series detailed industry’s pursuit of maximum profits by charging residents extra at every opportunity. Facilities have billed residents $50 for each injection, $12 for a single blood pressure check, and $93 a month to order medications from a pharmacy.

The quality problems in assisted living have been widely exposed by national and state news organizations. At the Jan. 25 hearing, Patricia Vessenmeyer, a Virginia woman, described the poor care and overwhelmed workers she observed at a dementia care facility where her late husband, John Whitney, lived.

“I once believe I saved a man’s life,” she said, describing how she helped stop a resident who was beating another resident using the victim’s cane. “It took several minutes before a staff member finally heard me and came to help,” she testified. Vessenmeyer said the facility, which she did not name, charged her husband around $13,000 a month.

Jennifer Craft Morgan, director of the Gerontology Institute at Georgia State University, testified that state governments have inconsistent and nontransparent monitoring and enforcement of quality at facilities. She said fewer than 10 states shared information about these procedures in a manner easily accessible to the public.

She said the crux of the problem is that assisted living “is marketed to those who can afford it with a hospitality mindset. They advertise and compete on the basis of amenities, beautiful campuses, luxury food and furnishings, and concierge service.”

Richard Mollot, executive director of the Long Term Care Community Coalition, a nonprofit advocacy group, testified there is “an escalating demand for federal involvement,” which he said is justified by the fact that a large amount of federal Medicaid funds are going to facility operators, some of which also get loans from the U.S. Department of Housing and Urban Development.

“While some assisted living can be wonderful places to live and to work, too many take in or retain residents for whom they are unable to provide safe care and dignified living conditions,” Mollot said. “Too many residents and families are at risk for financial exploitation and even fraud.”

Casey and other Democratic senators on Jan. 24, citing the Times-KFF Health News series, sent a letter to the Government Accountability Office requesting it study how much Medicaid and other federal agencies pay for assisted living.

A GAO report in 2018 called for improved federal oversight and found that state Medicaid agencies spent $10 billion to provide care in assisted living for 330,000 people in 2014.

In a news release, the National Center for Assisted Living, an industry trade group, said the overall quality of facilities is strong and best overseen by states. It acknowledged that the U.S.’ method of funding long-term care is “broken” and that assisted living is “out of reach for too many seniors.”

Julie Simpkins, co-president of Gardant Management Solutions, which operates senior living facilities in Illinois, Indiana, Ohio, Maryland, and West Virginia, testified that a national standard for all assisted living facilities would be “both unworkable and irresponsible for resident care,” and that injuries, neglect, and deaths are rare. She called for government and private entities to work to develop more affordable options and address the shortage of caregivers.

“These efforts could make a real difference,” she testified.

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The FTC Escalates Biden’s Fight Against Drug Prices

It’s daggers out at the Federal Trade Commission in its fight against anticompetitive practices in health care.

This past year, it has issued more stringent guidelines to block and discourage hospital mergers, and it investigated practices by middlemen in the drug supply chain.

Now drug manufacturers themselves are in the agency’s crosshairs. In November, the FTC challenged the validity of more than 100 drug patents in the Food and Drug Administration’s “Orange Book.” It’s a novel attack on drug prices.

The Orange Book is where drug companies list patents, which they argue protect their products from competition.

Generic drugmakers seeking to make a copycat version of a branded drug generally have to first challenge its patents in court. But listing a patent in the Orange Book can trigger a 2½-year delay of FDA approval for a generic competitor.

Though there has long been a procedure to dispute the validity of Orange Book-listed patents, it’s seldom used. November’s action marks the first time the FTC has deployed this weapon, said Hannah Garden-Monheit, director of the FTC’s Office of Policy Planning.

“We are using all the tools we have to bring down drug prices and reduce barriers to generic competition,” she said in an interview.

In what Garden-Monheit described as “a first salvo,” the agency sent letters to 10 drugmakers challenging patents that covered delivery devices for certain drugs. The FTC argues that patent law protects active ingredients in medicines, not delivery methods.

Inhalers for asthma and chronic obstructive pulmonary disease as well as EpiPens were among the targeted products.

“We thought, ‘How are these products still hundreds of dollars after all these years?’” Garden-Monheit said.

After an Orange Book challenge, companies have 30 days to withdraw or amend the patent, or prove it is valid.

The move is critically important because drugmakers frequently extend the 20-year patent protection for a drug by changing its delivery device or method. Instead of a pill, they develop a capsule. Instead of a dose every six hours, they create a longer-acting version. Sometimes they alter the process by which the drug is made — a “process patent.”

Each tweak gets a new patent in the Orange Book.

While a single patent once would cover a single active medicine, many drugs are now protected by over half a dozen patents or more — “patent thickets” — which pose obstacles to cheaper generics seeking to enter the market.

The pharmaceutical industry, naturally, is chafing at the FTC’s decision, saying drug companies are acting legally in listing these patents in the Orange Book, according to their interpretation of law. (It is already battling the Biden administration’s plan to negotiate prices of some drugs for Medicare patients.)

“The underlying statute is not clear about listing certain types of drug-delivery device patents, and the industry has long asked for the FDA to provide guidance,” Megan Van Etten, a spokesperson for PhRMA, the industry trade group, said in an email. “We’re disappointed that the FTC has characterized companies as acting inappropriately rather than help seek the clarity industry needs to ensure compliance.”

The agency’s letters have already produced some wins. After an FTC challenge, drugmaker GSK withdrew all patents on two popular inhalers for asthma, Advair and Flovent. Both delivered old off-patent medicines, yet nonetheless cost hundreds of dollars.

About 30 percent of the first round of warning letters resulted in companies voluntarily delisting patents from the FDA’s book, according to an FTC spokesperson. The FTC is considering how to go after those that ignored the letters and said in a November statement that it could “take any further action as needed in the public interest, which includes investigating the manufacturers’ conduct as a violation of FTC laws.”

But it’s a big job clearing out patent thickets. The Orange Book contains tens of thousands of listings. While the FTC has targeted delivery patents, it may next go after other types of patents that it feels are unjustified.

“We are taking a close and active look at this,” Garden-Monheit said. “Companies who haven’t received a letter from us challenging a patent shouldn’t think they’re off the hook.”

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The Colonoscopies Were Free. But the ‘Surgical Trays’ Came With $600 Price Tags.

Chantal Panozzo and her husband followed their primary care doctors’ orders last year after they both turned 45, now the recommended age to start screening for colorectal cancer. They scheduled their first routine colonoscopies a few months apart.

Panozzo said she was excited to get a colonoscopy, of all things, because it meant free care. The couple run a business out of their suburban home near Chicago and purchase coverage costing more than $1,400 each month for their family of four on the exchange, which was created by the Affordable Care Act.

By law, preventive services — including routine colonoscopies — are available at zero cost to patients. So Panozzo said she expected their screenings would be fully covered.

“This was our chance to get our free preventative care,” she said.

Their results came back normal, she said.

Then the bills came.

The Patients: Chantal Panozzo, who uses her maiden name professionally, now 46, and Brian Opyd, 45, are covered by Blue Cross and Blue Shield of Illinois.

Medical Services: Two routine colonoscopies (one for him, one for her), as recommended by the U.S. Preventive Services Task Force for patients beginning at age 45.

Service Provider: Illinois Gastroenterology Group in Hinsdale. The practice is part of the private equity-backed GI Alliance, which has more than 800 gastroenterologists working in 15 states, including Florida, Missouri, and Texas.

Total Bill: For each colonoscopy, the gastroenterology group charged $2,034 before any insurance discounts or reductions. After discounts, Blue Cross and Blue Shield of Illinois said it was responsible for paying $395.18 for Brian’s screening and $389.24 for Chantal’s.

But apart from the screening costs, the total included a $600 charge for each patient — though insurance documents did not identify what the charge was for. This left Chantal and Brian each with a $250 bill, the amount allowed by BCBS of Illinois, which was applied to their deductibles.

What Gives: Panozzo and her husband’s experience exposes a loophole in the law meant to guarantee zero-cost preventive services: Health care providers may bill how they choose as long as they abide by their contracts with insurance — including for whatever goods or services they choose to list, and in ways that could leave patients with unexpected bills for “free” care.

After their screenings, Panozzo said she and her husband each saw the same strange $600 charge from the Illinois Gastroenterology Group on their insurance explanation of benefits statements. Bills from the gastroenterology group explained these charges were for “surgical supplies.” Her insurer eventually told her the codes were for “surgical trays.”

At first, she was confused, Panozzo said: Why were they receiving any bills at all?

The Affordable Care Act requires preventive care services to be fully covered without any cost sharing imposed on patients — procedures such as colonoscopies, mammograms, and cervical cancer checks.

Policymakers included this hallmark protection because, for many patients, cost can deter them from seeking care. A KFF poll in 2022 found that roughly 4 in 10 adults skipped or postponed care they needed due to cost concerns.

Under the law, though, it is the insurer’s responsibility to make preventive care available at zero-cost to patients. Providers may exploit this loophole, said Sabrina Corlette, a research professor and co-director of the Center on Health Insurance Reforms at Georgetown University.

“The insurance company is supposed to pay the full claim, but there is no requirement on the provider to code the claim correctly,” Corlette said.

In this case, BCBS of Illinois covered the full cost of the screenings the couple received, according to its own documents. But those documents also showed that each patient was on the hook for a portion of their separate, $600 charges.

Panozzo thought a phone call with her insurer, BCBS of Illinois, would quickly fix the mistake. But she said she spent most of her time on hold and could not get an answer as to why the colonoscopy came with a separate charge for supplies. She said she learned in later communications with her insurer that the $600 was specifically for “surgical trays.”

BCBS of Illinois declined to comment despite receiving a waiver authorizing the insurer to discuss the case.

Panozzo said that she called the gastroenterology practice and was told by a billing representative that the extra charge was part of an arrangement the practice has with BCBS: She recalled being told that the practice was accustomed to keying in a billing code for “surgical trays” in lieu of a separate fee, which was described to Panozzo as a “use cost” for the doctor’s office.

“I was getting a different story from any person I talked to,” Panozzo said.

She said she was stuck in “no man’s land,” with each side telling her the other was responsible for removing the charge.

The Resolution: Panozzo went wide with her objections, contesting the total $500 they owed by filing appeals with her insurer; lodging a complaint with the Illinois Department of Insurance; and writing to her elected officials, warning that Illinois consumers were being “taken advantage of” and “ripped off.”

Ultimately, BCBS approved both appeals, saying neither Panozzo nor her husband was expected to pay the charges.

An administrative employee reached by phone at the Illinois Gastroenterology Group location where the couple was treated said they could not comment and directed KFF Health News to contact an executive with GI Alliance, the national group that manages the practice. Neither the executive nor media relations representatives responded to multiple requests for comment.

Panozzo said that, in the past, she would have paid the bill to avoid wasting time haggling with the doctor, insurer, or both. But getting hit with the same bill twice? That was too much for her to accept, she said.

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“If change is ever going to happen, I need to stop accepting some of these bills that I knew were potentially incorrect,” Panozzo said.

The Takeaway: Medical providers have broad leeway to determine how they bill for care, including by deciding how to identify what goods or services are provided. This means patients may get stuck with charges for unfamiliar or downright bizarre things.

And because the law doesn’t address how providers bill patients for preventive services, odd charges can crop up even for care that should be fully covered.

Research also shows private equity ownership, which has been increasing in specialties like gastroenterology, can lead to higher costs for patients, as well as lower quality care.

For patients, “under federal law, there is no recourse,” Corlette said. State regulatory bodies may go after these providers for billing patients for covered services, but that can be a mixed bag, Corlette said.

Insurers should crack down on this kind of practice with the providers participating in their networks, Corlette said. Otherwise, patients are stuck in the middle, left to contest what should be “free” care — and at the mercy of the insurance appeals process.

Health plans may not catch billing oddities — after all, for a major insurer, a charge of $600 may not be worth investigating. That leaves patients ultimately responsible for keeping track of what they’re being asked to pay — and speaking up if something seems suspicious.

Panozzo said the experience left her feeling defeated, exhausted, and distrustful of America’s health care system.

Having lived abroad with her family for almost 10 years, she said, “I could function in a health care system in German better than I could here in English.”

KFF Health News senior producer Zach Dyer reported the audio story.

Bill of the Month is a crowdsourced investigation by KFF Health News and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

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