The DEA Relaxed Online Prescribing Rules During Covid. Now It Wants to Rein Them In.

KFF Health News, June 27, 2023

Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.

This article was published on Tuesday, June 27, 2023 in Kaiser Health News.

By Arielle Zionts

Federal regulators want most patients to see a healthcare provider in person before receiving prescriptions for potentially addictive medicines through telehealth — something that hasn't been required in more than three years.

During the COVID-19 public health emergency, the Drug Enforcement Administration allowed doctors and other healthcare providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.

Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.

Regulators said they decided to extend the current regulations — which don't require an in-person appointment — until November 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they've never met in person will have until November 11, 2024, to come into compliance with the agency's future rules.

The public comments discuss the potential effects on a variety of patients, including people being treated for mental health disorders, opioid addiction, or attention-deficit/hyperactivity disorder. Thousands of commenters also mentioned possible impacts on rural patients.

Opponents wrote that healthcare providers, not a law enforcement agency, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to receive care.

Other commenters called for exemptions for specific medications and conditions.

Supporters wrote that the proposal would balance the goals of increasing access to healthcare and helping prevent medication misuse.

Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 residents northeast of Portland. Coogan has volunteered with hospice patients and said it's important for very sick and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be hard to see a doctor in person if they lack transportation or are too debilitated to travel.

Coogan said she supports the DEA's proposed rules because of a provision that could help patients who can't travel to meet their telehealth prescriber. Instead, they could visit a local healthcare provider, who then could write a special referral to the telehealth prescriber. But she said accessing controlled medications would still be difficult for some rural residents.

"It could end up being a very sticky wicket" for some patients to access care, she said. "It's not going to be easy, but it sounds like it's doable."

Some healthcare providers may hesitate to offer those referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose expertise includes addiction treatment. Kertesz said the proposed referral process is confusing and would require burdensome record-keeping.

Ateev Mehrotra, a physician and Harvard professor who has studied telehealth in rural areas, said different controlled drugs come with different risks. But overall, he finds the proposed rules too restrictive. He's worried people who started receiving telehealth prescriptions during the pandemic would be cut off from medicine that helps them.

Mehrotra said he hasn't seen clear evidence that every patient needs an in-person appointment before receiving controlled medicine through telehealth. He said it's also not clear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth ones.

Mehrotra described the proposed rules as "a situation where there's not a clear benefit, but there are substantial harms for at least some patients," including many in rural areas.

Beverly Jordan, a family practice doctor in Alabama and a member of the state medical board, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients who receive controlled medications. Jordan prescribes such medications, including to rural patients who travel to her clinic in the small city of Enterprise.

"I think that once-a-year hurdle is probably not too big for anybody to be able to overcome, and is really a good part of patient safety," Jordan said.

Jordan said it's important for healthcare practitioners to physically examine patients to see if the exam matches how the patients describe their symptoms and whether they need any other kind of treatment.

Jordan said that, at the beginning of the pandemic, she couldn't even view most telehealth patients on her computer. Three-fourths of her appointments were over the phone, because many rural patients have poor internet service that doesn't support online video.

The proposed federal rules also have a special allowance for buprenorphine, which is used to treat opioid use disorder, and for most categories of non-narcotic controlled substances, such as testosterone, ketamine, and Xanax.

Providers could prescribe 30 days' worth of these medications after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal healthcare practitioners would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.

Many people who work in healthcare were surprised by the proposed rules, Kertesz said. He said they expected the DEA to let prescribers apply for special permission to provide controlled medicine without in-person appointments. Congress ordered the agency to create such a program in 2008, but it has not done so.

Agency officials said they considered creating a version of that program for rural patients but decided against it.

Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, used to experience postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn't think she should have to go see her telehealth provider in person to maintain her prescriptions.

"I would have to get on a plane to go to Florida. I'm not going to do that," she said. "If the government forces me to do that, that's wrong."

Holiman said her primary care doctor doesn't prescribe injectable hormones and that she shouldn't have to find another in-person prescriber to make a referral to her Florida provider.

Holiman is one of thousands of patients who shared their opinions with the DEA. The agency also received comments from advocacy, healthcare, and professional groups, such as the American Medical Association.

The physicians' organization said the in-person rule should be eliminated for most categories of controlled medication. Even telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should be exempt when medically necessary, the group said.

Some states already have laws that are stricter than the DEA's proposed rules. Amelia Burgess said Alabama's annual exam requirement, which went into effect last summer, burdened some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.

Burgess said hundreds of the company's patients in Alabama couldn't switch to in-state prescribers because many weren't taking new patients, were too far away, or were more expensive than the telehealth service. So Burgess and her co-workers flew to Alabama and set up a clinic at a hotel in Birmingham. About 250 patients showed up, with some rural patients driving from five hours away.

Critics of the federal proposal are lobbying for exemptions for medications that can be difficult to obtain due to a lack of specialists in rural areas.

Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including in jails and prisons.

Rural areas also have shortages of mental health providers who can prescribe controlled substances for anxiety, depression, and ADHD. Patients across the country who use opioids for chronic pain have trouble finding prescribers.

It also can be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men and people with various medical conditions, such as menopause. Controlled medications are also used to treat seizures, sleep disorders, and other conditions.

Arielle Zionts: azionts@kff.org, @Ajzionts

Dementia Can Take a Toll on Financial Health, as Some Families Learn the Hard Way

KFF Health News, June 21, 2023

A growing body of research shows money problems are a possible warning sign — rather than only a product — of certain neurological disorders.

This article was published on Tuesday, June 20, 2023 in Kaiser Health News.

By Sarah Boden, WESA

Angela Reynolds knew her mother's memory was slipping, but she didn't realize how bad things had gotten until she started to untangle her mom's finances: unpaid bills, unusual cash withdrawals, and the discovery that, oddly, the mortgage on the family home had been refinanced at a higher interest rate.

Looking back, Reynolds realizes her mother was in the early stages of Alzheimer's disease: "By the time we caught on, it was too late."

Reynolds and her mother are among a large group of Americans grappling with the financial consequences of cognitive decline.

A growing body of research shows money problems are a possible warning sign — rather than only a product — of certain neurological disorders. This includes a 2020 study from Johns Hopkins University of more than 81,000 Medicare beneficiaries that found people with Alzheimer's and related dementias became more likely to miss bill payments up to six years before a formal diagnosis.

The reach of these conditions is enormous. One recent study found nearly 10% of people over age 65 have dementia; more than twice as many are living with mild cognitive impairment.

Missing the Signs of Declining Cognition

One weekday in the spring of 2018, Reynolds sat next to her 77-year-old mother, Jonnie Lewis-Thorpe, in a courtroom in downtown New Haven, Connecticut. She listened in discomfort as strangers revealed intimate details of their own finances in a room full of people waiting their turn to come before the judge.

Then it hit her: "Wait a second. We're going to have to go up there, and someone's going to be listening to us."

That's because the family home was in foreclosure. The daughter hoped if she explained to the judge that her mother had Alzheimer's disease, which had caused a series of financial missteps, she could stop the seizure of the property.

Reynolds can't pinpoint when Alzheimer's crept into her mother's life. A widow, Lewis-Thorpe had lived alone for several years and had made arrangements for her aging, including naming Reynolds her power-of-attorney agent. But Reynolds lived a 450-mile drive away from New Haven, in Pittsburgh, and wasn't there to see her mom's incremental decline.

It wasn't until Reynolds began reviewing her mother's bank statements that she realized Lewis-Thorpe — once a hospital administrator — had long been in the grip of the disease.

Financial problems are a common reason family members bring their loved ones to the office of Robin Hilsabeck, a neuropsychologist at the University of Texas at Austin Dell Medical School who specializes in cognitive issues.

"The brain is really a network, and there are certain parts of the brain that are more involved with certain functions," said Hilsabeck. "You can have a failure in something like financial abilities for lots of reasons caused by different parts of the brain."

Some of the reasons are due to normal aging, as Reynolds had assumed about her mother. But when a person's cognition begins to decline, the problems can grow exponentially.

Dementia's Causes — And Sometimes Ruthless Impact

Dementia is a syndrome involving the loss of cognitive abilities: The cause can be one of several neurological illnesses, like Alzheimer's or Parkinson's, or brain damage from a stroke or head injury.

In most cases, an older adult's dementia is progressive. The first signs are often memory slips and changes in high-level cognitive skills related to organization, impulse control, and the ability to plan — all critical for money management. And because the causes of dementia vary, so do the financial woes it can create, said Hilsabeck.

For example, with Alzheimer's comes a progressive shrinking of the hippocampus. That's the catalyst for memory loss that, early in the course of the disease, can cause a person to forget to pay their bills.

Lewy body dementia is marked by fluctuating cognition: A person veers from very sharp to extremely confused, often within short passages of time. Those with frontotemporal dementia can struggle with impulse control and problem-solving, which can lead to large, spontaneous purchases.

And people with vascular dementia often run into issues with planning, processing, and judgment, making them easier to defraud. "They answer the phone, and they talk to the scammers," said Hilsabeck. "The alarm doesn't go off in their head that this doesn't make sense."

For many people older than 65, mild cognitive impairment, or MCI, can be a precursor to dementia. But even people with MCI who don't develop dementia are vulnerable.

"Financial decision-making is very challenging cognitively," said Jason Karlawish, a specialist in geriatrics and memory care at the University of Pennsylvania's Penn Memory Center. "If you have even mild cognitive impairment, you can make mistakes with finances, even though you're otherwise doing generally OK in your daily life."

Some mistakes are irreversible. Despite Reynolds' best efforts on behalf of her mother, the bank foreclosed on the family home in the fall of 2018.

Property records show that Lewis-Thorpe and her husband bought the two-bedroom Cape Cod for $20,000 in 1966. Theirs was one of the first Black families in their New Haven neighborhood. Lewis-Thorpe had planned to pass this piece of generational wealth on to her daughters.

Instead, U.S. Bank now owns the property. A 2021 tax assessment lists its value as $203,900.

Financial Protections Are Slow to Come

Though she can't prove it, Reynolds suspects someone had been financially exploiting her mom. At the same time, she feels guilty for what happened to Lewis-Thorpe, who now lives with her: "There's always that part of me that's going to say, ‘At what point did it turn, where I could have had a different outcome?'"

Karlawish often sees patients who are navigating financial disasters. What he doesn't see are changes in banking practices or regulations that would mitigate the risks that come with aging and dementia.

"A thoughtful country would begin to say we've got to come up with the regulatory structures and business models that can work for all," he said, "not just for the 30-year-old."

But the risk-averse financial industry is hesitant to act — partly out of fear of getting sued by clients.

2018's Senior Safe Act , the most recent major federal legislation to address elder wealth management, attempts to address this reticence. It gives immunity to financial institutions in civil and administrative proceedings stemming from employees reporting possible exploitation of a senior — provided the bank or investment firm has trained its staff to identify exploitative activity.

It's a lackluster law, said Naomi Karp, an expert on aging and elder finances who spent eight years as a senior analyst at the Consumer Financial Protection Bureau's Office for Older Americans. That's because the act makes training staff optional, and it lacks government oversight. "There's no federal agency that's charged with covering it or setting standards for what that training has to look like," Karp said. "There's nothing in the statute about that."

One corner of the financial industry that has made modest progress is the brokerage sector, which concerns the buying and selling of securities, such as stocks and bonds. Since 2018, the Financial Industry Regulatory Authority — a nongovernmental organization that writes and enforces rules for brokerage firms — has required agents to make a reasonable effort to get clients to name a "trusted contact."

A trusted contact is similar to the emergency contact health care providers request. They're notified by a financial institution of concerning activity on a client's account, then receive a basic explanation of the situation. Ron Long, a former head of Aging Client Services at Wells Fargo, gave the hypothetical of someone whose banking activity suddenly shows regular, unusual transfers to someone in Belarus. A trusted emergency contact could then be notified of that concerning activity.

But the trusted contact has no authority. The hope is that, once notified, the named relative or friend will talk to the account holder and prevent further harm. It's a start, but a small one. The low-stakes effort is limited to the brokerage side of operations at Wells Fargo and most other large institutions. The same protection is not extended to clients' credit card, checking, or savings accounts.

A Financial Industry Reluctant to Help

When she was at the Consumer Financial Protection Bureau, Karp and her colleagues put out a set of recommendations for companies to better protect the wealth of seniors. The 2016 report included proposals on employee training and changes to fraud detection systems to better detect warning signs, such as atypical ATM use and the addition of a new owner's name to an existing checking account. "We would have meetings repeatedly with some of the largest banks, and they gave a lot of lip service to these issues," Karp said. "Change is very, very slow."

Karp has seen some smaller community banks and credit unions take proactive steps to protect older customers — such as instituting comprehensive staff training and improvements to fraud detection software. But there's a hesitancy throughout the industry to act more decisively, which seems to stem in part from fears about liability, she said. Banks are concerned they might get sued — or at least lose business — if they intervene when no financial abuse has occurred, or a customer's transactions were benign.

Policy solutions that address financial vulnerability also present logistical challenges. Expanding something as straightforward as use of trusted contacts isn't like flipping a light switch, said Long, the former Wells Fargo executive: "You have to solve all the technology issues: Where do you house it? How do you house it? How do you engage the customer to even consider it?"

Still, a trusted contact might have alerted Reynolds much sooner that her mom was developing dementia and needed help.

"I fully believe that they noticed signs," Reynolds said of her mother's bank. "There are many withdrawals that came out of her account where we can't account for the money. … Like, I can see the withdrawals. I can see the bills not getting paid. So where did the money go?"

This article is from a partnership that includes WESA, NPR, and KFF Health News.

Sarah Boden, WESA: @Sarah_Boden

Drugmakers Are Abandoning Cheap Generics, and Now U.S. Cancer Patients Can't Get Meds

KFF Health News, June 21, 2023

Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit.

This article was published on Wednesday, June 21, 2023 in Kaiser Health News.

By Arthur Allen

On Nov. 22, three FDA inspectors arrived at the sprawling Intas Pharmaceuticals plant south of Ahmedabad, India, and found hundreds of trash bags full of shredded documents tossed into a garbage truck. Over the next 10 days, the inspectors assessed what looked like a systematic effort to conceal quality problems at the plant, which provided more than half of the U.S. supply of generic cisplatin and carboplatin, two cheap drugs used to treat as many as 500,000 new cancer cases every year.

Seven months later, doctors and their patients are facing the unimaginable: In California, Virginia, and everywhere in between, they are being forced into grim contemplation of untested rationing plans for breast, cervical, bladder, ovarian, lung, testicular, and other cancers. Their decisions are likely to result in preventable deaths.

Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, attention-deficit/hyperactivity disorder pills, blood thinners, and antibiotics. Covid-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry. Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.

The problem isn't new, and that's particularly infuriating to many clinicians. President Joe Biden, whose son Beau died of an aggressive brain cancer, has focused his Cancer Moonshot on discovering cures — undoubtedly expensive ones. Indeed, existing brand-name cancer drugs often cost tens of thousands of dollars a year.

But what about the thousands of patients today who can't get a drug like cisplatin, approved by the FDA in 1978 and costing as little as $6 a dose?

"It's just insane," said Mark Ratain, a cancer doctor and pharmacologist at the University of Chicago. "Your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys and you want them to be NBA stars when they grow up?"

"It's just a travesty that this is the level of health care in the United States of America right now," said Stephen Divers, an oncologist in Hot Springs, Arkansas, who in recent weeks has had to delay or change treatment for numerous bladder, breast, and ovarian cancer patients because his clinic cannot find enough cisplatin and carboplatin. Results from a survey of academic cancer centers released June 7 found 93% couldn't find enough carboplatin and 70% had cisplatin shortages.

"All day, in between patients, we hold staff meetings trying to figure this out," said Bonny Moore, an oncologist in Fredericksburg, Virginia. "It's the most nauseous I've ever felt. Our office stayed open during covid; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can't get them a $10 drug."

The 10 cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives — though sometimes less effective and often with more side effects — are available. But some doctors are even rationing doses intended to cure.

Isabella McDonald, then a junior at Utah Valley University, was diagnosed in April with a rare, often fatal bone cancer, whose sole treatment for young adults includes the drug methotrexate. When Isabella's second cycle of treatment began June 5, clinicians advised that she would be getting less than the full dose because of a methotrexate shortage, said her father, Brent.

"They don't think it will have a negative impact on her treatment, but as far as I am aware, there isn't any scientific basis to make that conclusion," he said. "As you can imagine, when they gave us such low odds of her beating this cancer, it feels like we want to give it everything we can and not something short of the standard."

Brent McDonald stressed that he didn't blame the staffers at Intermountain Health who take care of Isabella. The family — his other daughter, Cate, made a TikTok video about her sister's plight — were simply stunned at such a basic flaw in the health care system.

Cate McDonald used this TikTok video to let people know about her sister's osteosarcoma, a rare and dangerous bone cancer. She wanted to raise awareness of the critical shortages of generic drugs in the United States, including methotrexate, which her sister, Isabella, desperately needs. (Cate McDonald)

At Moore's practice, in Virginia, clinicians gave 60% of the optimal dose of carboplatin to some uterine cancer patients during the week of May 16, then shifted to 80% after a small shipment came in the following week. The doctors had to omit carboplatin from normal combination treatments for patients with recurrent disease, she said.

On June 2, Moore and her colleagues were glued to their drug distributor's website, anxious as teenagers waiting for Taylor Swift tickets to go on sale — only with mortal consequences at stake.

She later emailed KFF Health News: "Carboplatin did NOT come back in stock today. Neither did cisplatin."

Doses remained at 80%, she said. Things hadn't changed 10 days later.

Generics Manufacturers Are Pulling Out

The causes of shortages are well established. Everyone wants to pay less, and the middlemen who procure and distribute generics keep driving down wholesale prices. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.

As generics manufacturers compete to win sales contracts with the big buyers, including wholesale purchasers Vizient and Premier, their profits sink. Some are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February. Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and "high-value generics." Lannett Co., with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.

The generics industry used to lose money on about a third of the drugs it produced, but now it's more like half, Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said. Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage. On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn't immediately clear.

Cisplatin and carboplatin are made in special production lines under sterile conditions, and expanding or changing the lines requires FDA approval. Bargain-basement prices have pushed production overseas, where it's harder for the FDA to track quality standards. The Intas plant inspection was a relative rarity in India, where the FDA in 2022 reportedly inspected only 3% of sites that make drugs for the U.S. market. Sardella, the Washington University professor, testified last month that a quarter of all U.S. drug prescriptions are filled by companies that received FDA warning letters in the past 26 months. And pharmaceutical industry product recalls are at their highest level in 18 years, reflecting fragile supply conditions.

The FDA listed 137 drugs in shortage as of June 13, including many essential medicines made by few companies.

Intas voluntarily shut down its Ahmedabad plant after the FDA inspection, and the agency posted its shocking inspection report in January. Accord Healthcare, the U.S. subsidiary of Intas, said in mid-June it had no date for restarting production.

Asked why it waited two months after its inspection to announce the cisplatin shortage, given that Intas supplied more than half the U.S. market for the drug, the FDA said via email that it doesn't list a drug in shortage until it has "confirmed that overall market demand is not being met."

Prices for carboplatin, cisplatin, and other drugs have skyrocketed on the so-called gray market, where speculators sell medicines they snapped up in anticipation of shortages. A 600-milligram bottle of carboplatin, normally available for $30, was going for $185 in early May and $345 a week later, said Richard Scanlon, the pharmacist at Moore's clinic.

"It's hard to have these conversations with patients — ‘I have your dose for this cycle, but not sure about next cycle,'" said Mark Einstein, chair of the Department of Obstetrics, Gynecology and Reproductive Health at Rutgers New Jersey Medical School.

Should Government Step In?

Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.

As a result, neither Accord nor other cisplatin makers had a response plan in place when Intas' plant was shut down, said Soumi Saha, senior vice president of government affairs for Premier, which arranges wholesale drug purchases for more than 4,400 hospitals and health systems.

Premier understood in December that the shutdown endangered the U.S. supply of cisplatin and carboplatin, but it also didn't issue an immediate alarm, she said. "It's a fine balance," she said. "You don't want to create panic-buying or hoarding."

More lasting solutions are under discussion. Sardella and others have proposed government subsidies to get U.S. generics plants running full time. Their capacity is now half-idle. If federal agencies like the Centers for Medicare & Medicaid Services paid more for more safely and efficiently produced drugs, it would promote a more stable supply chain, he said.

"At a certain point the system needs to recognize there's a high cost to low-cost drugs," said Allan Coukell, senior vice president for public policy at Civica Rx, a nonprofit funded by health systems, foundations, and the federal government that provides about 80 drugs to hospitals in its network. Civica is building a $140 million factory near Petersburg, Virginia, that will produce dozens more, Coukell said.

Ratain and his University of Chicago colleague Satyajit Kosuri recently called for the creation of a strategic inventory buffer for generic medications, something like the Strategic Petroleum Reserve, set up in 1975 in response to the OPEC oil crisis.

In fact, Ratain reckons, selling a quarter-million barrels of oil would probably generate enough cash to make and store two years' worth of carboplatin and cisplatin.

"It would almost literally be a drop in the bucket."

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

International Rights Group Calls Out U.S. for Allowing Hospitals to Push Millions Into Debt

KFF Health News, June 15, 2023

Human Rights Watch calls for stronger government action to protect Americans from aggressive billing and collections by nonprofit hospitals.

This article was published on Thursday, June 15, 2023 in Kaiser Health News.

By Noam N. Levey

Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.

In a new report, published June 15, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients' human rights.

"Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working," concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.

The report continues: "The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abU.S.ive medical billing and debt collection practices and undermines human rights, including the right to health."

Nationwide, about 100 million people — or 41% of adults — have some form of healthcare debt, a KFF survey conducted for the KFF Health News-NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.

About a third of U.S. adults with healthcare debt owed money for hospitalization, KFF's polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.

The scale of this crisis — which is unparalleled among wealthy nations — compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. "Historically, Human Rights Watch has been an organization that has focused on international human rights issues," he said. "But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights."

Hospital industry officials defend their work, citing hospitals' broader work to help the communities they serve. "As a field, hospitals provide more benefit to their communities than any other sector in healthcare," Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.

Federal law requires private, tax-exempt hospitals — which make up more than half the nation's medical centers — to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.

At the same time, thousands of medical centers — including many tax-exempt ones — engage in aggressive debt collection tactics to pursue patients, including garnishing patients' wages, placing liens on their homes, or selling their debt to third-party debt collectors.

Overall, KFF Health News found that most of the nation's approximately 5,100 hospitals serving the general public have policies to U.S.e legal action or other aggressive tactics against patients. And 1 in 5 will deny nonemergency care to people with outstanding debt.

"Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax statU.S. as they pursue families for medical debt," said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients' homes.

Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.

The Human Rights Watch report — titled "In Sheep's Clothing: United States' Poorly Regulated Nonprofit Hospitals Undermine Healthcare Access" — lists more than a dozen recommendations. These include:

  • Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
     
  • The IRS should set uniform national standards on patients' eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
     
  • The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
     
  • CMS, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.

"Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices," McConnell said. "The reason this keeps happening is the absence of clear guidelines and the federal government's inadequate enforcement of existing regulations."

About This Project

"Diagnosis: Debt" is a reporting partnership between KFF Health News and NPR exploring the scale, impact, and causes of medical debt in America.

The series draws on original polling by KFF, court records, federal data on hospital finances, contracts obtained through public records requests, data on international health systems, and a yearlong investigation into the financial assistance and collection policies of more than 500 hospitals across the country. 

Additional research was conducted by the Urban Institute, which analyzed credit bureau and other demographic data on poverty, race, and health statU.S. for KFF Health News to explore where medical debt is concentrated in the U.S. and what factors are associated with high debt levels.

The JPMorgan Chase Institute analyzed records from a sampling of Chase credit card holders to look at how cU.S.tomers' balances may be affected by major medical expenses. And the CED Project, a Denver nonprofit, worked with KFF Health News on a survey of its clients to explore links between medical debt and housing instability.

KFF Health News journalists worked with KFF public opinion researchers to design and analyze the "KFF healthcare Debt Survey." The survey was conducted Feb. 25 through March 20, 2022, online and via telephone, in English and Spanish, among a nationally representative sample of 2,375 U.S. adults, including 1,292 adults with current healthcare debt and 382 adults who had healthcare debt in the past five years. The margin of sampling error is plus or minus 3 percentage points for the full sample and 3 percentage points for those with current debt. For results based on subgroups, the margin of sampling error may be higher.

Reporters from KFF Health News and NPR also conducted hundreds of interviews with patients across the country; spoke with physicians, health industry leaders, consumer advocates, debt lawyers, and researchers; and reviewed scores of studies and surveys about medical debt.

Noam N. Levey: nlevey@kff.org, @NoamLevey

Biden Admin Implores States to Slow Medicaid Cuts After More Than 1M Enrollees Dropped

KFF Health News, June 13, 2023

Too many Americans are losing Medicaid coverage because of red tape, and states should do more to make sure eligible people keep their health insurance, the Biden administration said Monday.

Hannah Recht June 13, 2023

More than a million Americans have lost coverage through the program for low-income and disabled Americans in the past several weeks, following the end of pandemic protections on April 1, according to the latest Medicaid renewal data from more than 20 states.

After a three-year pause, most states have now resumed checking which Medicaid recipients remain eligible and dropping those who no longer qualify or don’t complete required paperwork. About 4 in 5 people dropped so far either never returned the paperwork or omitted required documents, federal and state data show.

Xavier Becerra, secretary of the Department of Health and Human Services, decried those numbers in a letter sent to state governors on June 12.

“I am deeply concerned with the number of people unnecessarily losing coverage, especially those who appear to have lost coverage for avoidable reasons that State Medicaid offices have the power to prevent or mitigate,” he wrote.

The Biden administration outlined several optional steps states can take to ensure everyone who still qualifies for the safety-net health insurance program stays covered. For instance, states can pause the cancellations to allow more time to reach people who haven’t responded. Health insurance companies that manage Medicaid plans can help their enrollees fill out the paperwork.

Some states were already choosing to take extra time. Though Wyoming began renewals in May, the state is being “deliberately cautious” and won’t drop people for incomplete paperwork until July or August, state Health Department spokesperson Kim Deti said. Oregon won’t start those cancellations until October.

Officials in other states have demonstrated no eagerness to slow the cuts.

About 10 percent of Arkansas’ Medicaid and Children’s Health Insurance Program enrollees have already been dropped, nearly all because they didn’t complete paperwork. Arkansas is speeding through the redeterminations in just six months, while most other states are taking about a year, as HHS recommended. Despite outcry from some federal lawmakers and advocates, Medicaid officials in the state wrote on June 8 that they would continue to “swiftly disenroll” people who no longer qualify.

That could be disastrous, said Joan Alker, executive director of Georgetown University’s Center for Children and Families. “My big worry is that we could lose millions of families quickly. It’s going to be very hard to get them back.”

Becerra also wrote that he is “particularly concerned” about children losing coverage, although the administration doesn’t know exactly how many kids have been dropped. States don’t have to report numbers by age to federal authorities, said Dan Tsai, director of the Center for Medicaid and CHIP Services.

Tens of thousands of kids are losing coverage, according to data from states that shared it. In Indiana, of the 53,000 dropped in the first month, a third were kids. In South Dakota, more than half were kids. In Arkansas, nearly 55,000 kids were dropped in the first two months.

Becerra also urged governors to work more directly with families at risk of losing coverage. State agencies should team up with schools, faith-based groups, pharmacies, and other community organizations to help enrollees better understand how to stay on Medicaid, he wrote.

In most states, people who still qualify for Medicaid but lose coverage because of state errors or incomplete paperwork have 90 days to ask for their coverage back.

Some officials view the large number of paperwork-related cancellations as no big deal because people can reapply if they still qualify. But it’s not that simple, Alker said. Many people don’t know their appeal rights, and the grace period doesn’t apply to all adults in several of the hardest-hit states.

Alker said states will temporarily save money from not having to pay for enrollees’ care. But in the meantime, people won’t be able to afford their regular medications. Some will end up in the emergency room sicker than before, she said. “There’s really nothing good that comes out of these gaps in coverage.”

The Debt Ceiling Deal Takes a Bite Out of Health Programs. It Could Have Been Much Worse.

KFF Health News, June 7, 2023

Policy analysts, Democrats, and Republicans dissatisfied with the deal agree: Federal health programs have dodged a budgetary bullet in the Washington showdown over raising the nation’s debt ceiling.

Julie Rovner, KFF Health News

A compromise bill, approved late Thursday by the Senate, includes some trims and caps on health spending for the next two years.

But the deal spares health programs like Medicaid from the deep cuts approved in April by the Republican-led House. The bill suspends the debt ceiling — the federal government’s borrowing limit — until January 1, 2025, after the next presidential election.

The need for Congress to act to avoid an unprecedented debt default and its rippling economic consequences gave House Republicans leverage to extract spending concessions from Democrats. But in the end the compromise bill, negotiated primarily by House Speaker Kevin McCarthy and Biden administration officials, limits health spending only slightly.

The most conservative Republicans said they are outraged at what they see as a giveaway to Democrats. “It is a bad deal,” said Rep. Chip Roy (R-Texas), one of the bill’s most outspoken opponents, during a news conference at the Capitol. “No one sent us here to borrow an additional $4 trillion to get absolutely nothing in return.”

Besides the spending limits, the main health-related concession made by Democrats is the clawback of about $27 billion in money appropriated for covid-related programs but not yet spent.

Only a portion of the money being reclaimed from covid programs is specifically health-related; money is also being returned to the federal government from programs centered on housing and transportation, for example.

Of the unspent covid funds, according to the Congressional Budget Office, the biggest single rescission is nearly $10 billion from the Public Health and Social Services Emergency Fund. The CDC would have to give back $1.5 billion. But exempted from those health-related givebacks are “priority” efforts such as funding for research into next-generation covid vaccines; long covid research; and efforts to improve the pharmaceutical supply chain.

“The deal appears to have minimal effect on the health sector,” concluded Capital Alpha Partners, a Washington-based policy strategy firm.

That would not have been the case with the House Republicans’ “Limit, Save, Grow Act,” their first offer to raise the debt ceiling and slow — in some areas dramatically — the growth of federal spending. That bill would have reduced the federal deficit by nearly $5 trillion over the next decade, including through more than $3 trillion in cuts to domestic discretionary programs, which account for roughly 15 percent of federal spending. A part of that 15 percent goes to health programs, including the National Institutes of Health, the Centers for Disease Control and Prevention, and the FDA.

The Republican bill would also have imposed nationwide work requirements on the Medicaid health program, a proposal that was vehemently opposed by Democrats in Congress and the Biden administration.

Democrats argued that such requirements would not increase work but rather would separate eligible people from their health insurance for failing to complete required paperwork. That is already happening, according to a KFF Health News analysis, as states begin to trim rolls following the end of the covid public health emergency.

The compromise bill, however, leaves untouched the major federal health programs, Medicare and Medicaid — amounting to a political victory for Democrats, who prioritized protecting entitlement programs. The deal includes no new work requirements for Medicaid.

The bill also freezes other health spending at its current level for the coming fiscal year and allows for a 1% increase the following year. It will be up to the House and Senate Appropriations Committees to determine later exactly how to distribute the funds among the discretionary programs whose spending levels they oversee.

Advocacy groups have argued that even a funding freeze hurts programs that provide needed services to millions of Americans. The result, said Sharon Parrott, president of the liberal Center on Budget and Policy Priorities, “will still be cuts overall in key national priorities when the very real impact of inflation is taken into account.”

Even less happy, however, are conservatives who had hoped the debt ceiling fight would give them a chance to take a much bigger bite out of federal spending.

“Overall, this agreement would continue America’s trajectory towards economic destruction and expanded federal control,” Kevin Roberts, president of the conservative Heritage Foundation, said in a statement.

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Will a 'National Patient Safety Board,' Modeled After the NTSB, Actually Fly?

KFF Health News, June 5, 2023

Stakeholders warn that public reporting would compromise data integrity by leading hospitals to scrub records to hide bad events.

This article was published on Monday, June 5, 2023 in Kaiser Health News.

By Mary Chris Jaklevic

People concerned about the safety of patients often compare healthcare to aviation. Why, they ask, can't hospitals learn from medical errors the way airlines learn from plane crashes?

That's the rationale behind calls to create a "National Patient Safety Board," an independent federal agency that would be loosely modeled after the National Transportation Safety Board, which is credited with increasing the safety of skies, railways, and highways by investigating why accidents occur and recommending steps to avoid future mishaps.

But as worker shortages strain the U.S. healthcare system, heightening concerns about unsafe care, one proposal to create such a board has some patient safety advocates fearing that it wouldn't provide the transparency and accountability they believe is necessary to drive improvement. One major reason: the power of the hospital industry.

Two measures are underway to create a safety board: A bill filed in the U.S. House in December by Rep. Nanette Diaz Barragán (D-Calif.), which is expected to be refiled this session, calls for the creation of a board to help federal agencies monitor safety events, identify conditions under which problems occur, and suggest preventive measures.

However, the board would need permission from healthcare organizations to probe safety events and could not identify any healthcare provider or setting in its reports. That differs from the NTSB, which can subpoena both witnesses and evidence, and publish detailed accident reports that list locations and companies.

A related measure under review by a presidential advisory council would create such a board by executive order. Its details have not been made public.

The push comes as many patients continue to get hurt, according to recent reviews of medical records. The Department of Health and Human Services' inspector general found that 13% of hospitalized Medicare patients experienced a preventable harm during a hospital stay in October 2018. A New England Journal of Medicine study of patients hospitalized in Massachusetts in 2018 showed that 7% had a preventable adverse event with 1% suffering a preventable injury that was serious, life-threatening, or fatal.

Learning about safety concerns at specific facilities remains difficult. While transportation crashes are public spectacles that make news, creating demand for public accountability, medical errors often remain confidential, sometimes even ordered into silence by court settlements. Meaningful and timely information for consumers can be challenging to find. However, patient advocates said, unsafe providers should not be shielded from reputational consequences.

"People pay vast amounts of money for healthcare," said Helen Haskell, president of South Carolina-based Mothers Against Medical Error, an advocacy group she founded because her 15-year-old son died from septic shock following elective surgery in 2000. "Providers shouldn't be able to sweep things under the rug."

Barragán's bill follows a 2014 effort to create a national patient safety board to investigate incidents and make more providers' safety records publicly available. It stemmed from the Institute of Medicine's landmark 1999 report that called medical error in hospitals a leading cause of death and recommended a nationwide mandatory reporting system for serious adverse events. That campaign never got enough traction to become a congressional bill.

Patients and their families would still like to know the rate of harm in every hospital, said Lisa McGiffert, president of the Patient Safety Action Network, a group discontented with some aspects of the current bill. "We are so far away from that now," she added.

But Karen Wolk Feinstein, president and CEO of the Jewish Healthcare Foundation, a Pittsburgh-based philanthropy that leads more than 70 groups pushing the latest safety board campaign, said during an online forum in January that public reporting would compromise data integrity by leading hospitals to scrub records to hide bad events.

"You're going to have to protect data for a while — de-identify it," she said, "so that we can do what needs to be done."

She said that a patient safety board "will not happen" without broad support, including from hospitals and medical societies. Those groups have long opposed measures to publicly identify facilities where errors occur.

That industry influence is "the elephant in the room," said McGiffert. Hospitals, nursing homes, and medical professionals pour hundreds of millions of dollars into federal political campaigns each election cycle and spent $220 million lobbying Congress last year, according to OpenSecrets, a nonprofit that tracks money in U.S. politics.

Moreover, healthcare is the dominant employer in at least 47 states, according to Health Affairs, which means that, when legislation is in play, the industry "can always drum up local people to talk about how it affects them," McGiffert added.

Feinstein agreed that legislators always ask about the position of their local health systems. "That is the first question," she said during the January forum.

Although patient safety groups represent the interests of millions of people, they don't have the same financial firepower on hand as the healthcare industry does. McGiffert said her own organization's bank balance is $6,000. Feinstein said her foundation is using its endowment — created with proceeds from the sale of a tax-exempt hospital — to fund the patient safety board campaign, among other initiatives. The foundation reported assets of nearly $186 million in 2021.

The American Hospital Association declined to comment about the patient safety board proposal because it was still reviewing it, said spokesperson Colin Milligan. He provided a statement from the association's senior director of quality and patient safety policy, Akin Demehin, saying hospitals are "deeply committed" to safety and have urged that "publicly reported measures assess hospitals accurately and fairly while giving patients meaningful information."

The safety board campaign initially declared the NTSB as its model. However, Feinstein said, it now envisions it as "something of a hybrid" of the NTSB and the Commercial Aviation Safety Team, a lesser-known government-industry partnership that analyzes a massive amount of data to detect emerging risks.

Christopher Hart, a former NTSB chairperson who serves on the board of the Joint Commission, a healthcare accrediting body, likened the proposed patient safety board to the voluntary reporting of aviation errors and near misses, which are statutorily protected from public disclosure. Protecting such tips about non-public events has "enabled a flood of voluntarily provided information" that is "foundational to improving airline safety," Hart said.

But some consumer advocates argue that in healthcare, secrecy and voluntarism have fallen short. They point to the 2005 Patient Safety Act, which lets healthcare providers submit data confidentially to research groups called patient safety organizations. As of 2018, about 40% of hospitals reimbursed by Medicare didn't report to such organizations despite liability and public disclosure protections, and most of the organizations didn't submit data to national research databases, according to the HHS inspector general.

With safety indicators worsening during the pandemic, supporters of a patient safety board argue the current proposal would be a step forward. It could hasten adoption of surveillance technology, launch a national portal for anyone to report events, and coordinate efforts of states, federal agencies, and accrediting bodies.

Barragán will reintroduce the bill in the current term but declined to give a date, said spokesperson Kevin McGuire. "From our understanding, the stakeholders we are working with are discussing the concerns" raised by advocates, McGuire said.

Sue Sheridan, a co-founder of Patients For Patient Safety US, became a patient safety advocate after untreated jaundice left her son brain-damaged and her husband died of cancer that went untreated for months because a pathology result was not properly communicated. She now is a member of a working group for the presidential advisory council and said she expects consumer-friendly tweaks to the proposal, including putting patient representatives on the board itself — a step she said she would support. And she backs the overall effort, despite saying the plan needs to be somewhat refined.

"We will be safer with it than without it," Sheridan said.

Perspective: Denials of Health Insurance Claims Are Rising — And Getting Weirder

KFF Health News, May 30, 2023

Denials have become another predictable, miserable part of the patient experience.

This story was published on Friday, May 26, 2023 in Kaiser Health News.

By Elisabeth Rosenthal

Millions of Americans in the past few years have run into this experience: filing a healthcare insurance claim that once might have been paid immediately but instead is just as quickly denied. If the experience and the insurer's explanation often seem arbitrary and absurd, that might be because companies appear increasingly likely to employ computer algorithms or people with little relevant experience to issue rapid-fire denials of claims — sometimes bundles at a time — without reviewing the patient's medical chart. A job title at one company was "denial nurse."

It's a handy way for insurers to keep revenue high — and just the sort of thing that provisions of the Affordable Care Act were meant to prevent. Because the law prohibited insurers from deploying previously profit-protecting measures such as refusing to cover patients with preexisting conditions, the authors worried that insurers would compensate by increasing the number of denials.

And so, the law tasked the Department of Health and Human Services with monitoring denials both by health plans on the Obamacare marketplace and those offered through employers and insurers. It hasn't fulfilled that assignment. Thus, denials have become another predictable, miserable part of the patient experience, with countless Americans unjustly being forced to pay out-of-pocket or, faced with that prospect, forgoing needed medical help.

A recent KFF study of ACA plans found that even when patients received care from in-network physicians — doctors and hospitals approved by these same insurers — the companies in 2021 nonetheless denied, on average, 17% of claims. One insurer denied 49% of claims in 2021; another's turndowns hit an astonishing 80% in 2020. Despite the potentially dire impact that denials have on patients' health or finances, data shows that people appeal only once in every 500 cases.

Sometimes, the insurers' denials defy not just medical standards of care but also plain old human logic. Here is a sampling collected for the KFF Health News-NPR "Bill of the Month" joint project.

  • Dean Peterson of Los Angeles said he was "shocked" when payment was denied for a heart procedure to treat an arrhythmia, which had caused him to faint with a heart rate of 300 beats per minute. After all, he had the insurer's preapproval for the expensive ($143,206) intervention. More confusing still, the denial letter said the claim had been rejected because he had "asked for coverage for injections into nerves in your spine" (he hadn't) that were "not medically needed." Months later, after dozens of calls and a patient advocate's assistance, the situation is still not resolved.
     
  • An insurer's letter was sent directly to a newborn child denying coverage for his fourth day in a neonatal intensive care unit. "You are drinking from a bottle," the denial notification said, and "you are breathing on your own." If only the baby could read.
     
  • Deirdre O'Reilly's college-age son, suffering a life-threatening anaphylactic allergic reaction, was saved by epinephrine shots and steroids administered intravenously in a hospital emergency room. His mother, utterly relieved by that news, was less pleased to be informed by the family's insurer that the treatment was "not medically necessary."

As it happens, O'Reilly is an intensive-care physician at the University of Vermont. "The worst part was not the money we owed," she said of the $4,792 bill. "The worst part was that the denial letters made no sense — mostly pages of gobbledygook." She has filed two appeals, so far without success.

Some denials are, of course, well considered, and some insurers deny only 2% of claims, the KFF study found. But the increase in denials, and the often strange rationales offered, might be explained, in part, by a ProPublica investigation of Cigna — an insurance giant, with 170 million customers worldwide.

ProPublica's investigation, published in March, found that an automated system, called PXDX, allowed Cigna medical reviewers to sign off on 50 charts in 10 seconds, presumably without examining the patients' records.

Decades ago, insurers' reviews were reserved for a tiny fraction of expensive treatments to make sure providers were not ordering with an eye on profit instead of patient needs.

These reviews — and the denials — have now trickled down to the most mundane medical interventions and needs, including things such as asthma inhalers or the heart medicine that a patient has been on for months or years. What's approved or denied can be based on an insurer's shifting contracts with drug and device manufacturers rather than optimal patient treatment.

Automation makes reviews cheap and easy. A 2020 study estimated that the automated processing of claims saves U.S. insurers more than $11 billion annually.

But challenging a denial can take hours of patients' and doctors' time. Many people don't have the knowledge or stamina to take on the task, unless the bill is especially large or the treatment obviously lifesaving. And the process for larger claims is often fabulously complicated.

The Affordable Care Act clearly stated that HHS "shall" collect the data on denials from private health insurers and group health plans and is supposed to make that information publicly available. (Who would choose a plan that denied half of patients' claims?) The data is also supposed to be available to state insurance commissioners, who share with HHS the duties of oversight and trying to curb abuse.

To date, such information-gathering has been haphazard and limited to a small subset of plans, and the data isn't audited to ensure it is complete, according to Karen Pollitz, a senior fellow at KFF and one of the authors of the KFF study. Federal oversight and enforcement based on the data are, therefore, more or less nonexistent.

HHS did not respond to requests for comment for this article.

The government has the power and duty to end the fire hose of reckless denials harming patients financially and medically. Thirteen years after the passage of the ACA, perhaps it is time for the mandated investigation and enforcement to begin.

Elisabeth Rosenthal: erosenthal@kff.org, @rosenthalhealth

Abortion Bans Are Driving Off Doctors and Closing Clinics, Putting Basic Healthcare at Risk

KFF Health News, May 24, 2023

This article was published on Wednesday, May 24, 2023 in Kaiser Health News.

By Julie Rovner

The rush in conservative states to ban abortion after the overturn of Roe v. Wade is resulting in a startling consequence that abortion opponents may not have considered: fewer medical services available for all women living in those states. 

Doctors are showing — through their words and actions — that they are reluctant to practice in places where making the best decision for a patient could result in huge fines or even a prison sentence. And when clinics that provide abortions close their doors, all the other services offered there also shut down, including regular exams, breast cancer screenings, and contraception.

The concern about repercussions for women's health is being raised not just by abortion rights advocates. One recent warning comes from Jerome Adams, who served as surgeon general in the Trump administration.

In a tweet thread in April, Adams wrote that "the tradeoff of a restricted access (and criminalizing doctors) only approach to decreasing abortions could end up being that you actually make pregnancy less safe for everyone, and increase infant and maternal mortality."

An early indication of that impending medical "brain drain" came in February, when 76% of respondents in a survey of more than 2,000 current and future physicians said they would not even apply to work or train in states with abortion restrictions. "In other words," wrote the study's authors in an accompanying article, "many qualified candidates would no longer even consider working or training in more than half of U.S. states."

Indeed, states with abortion bans saw a larger decline in medical school seniors applying for residency in 2023 compared with states without bans, according to a study from the Association of American Medical Colleges. While applications for OB-GYN residencies were down nationwide, the decrease in states with complete abortion bans was more than twice as large as those with no restrictions (10.5% vs. 5.2%).

That means fewer doctors to perform critical preventive care like Pap smears and screenings for sexually transmitted infections, which can lead to infertility.

Care for pregnant women specifically is at risk, as hospitals in rural areas close maternity wards because they can't find enough professionals to staff them — a problem that predated the abortion ruling but has only gotten worse since.

In March, Bonner General Health, the only hospital in Sandpoint, Idaho, announced it would discontinue its labor and delivery services, in part because of "Idaho's legal and political climate" that includes state legislators continuing to "introduce and pass bills that criminalize physicians for medical care nationally recognized as the standard of care."

Heart-wrenching reporting from around the country shows that abortion bans are also imperiling the health of some patients who experience miscarriage and other nonviable pregnancies. Earlier this year, a pregnant woman with a nonviable fetus in Oklahoma was told to wait in the parking lot until she got sicker after being informed that doctors "can't touch you unless you are crashing in front of us."

A study by researchers from the State University of New York-Buffalo published in the Women's Health Issues journal found that doctors practicing in states with restrictive abortion policies are less likely than those in states with supportive abortion policies to have been trained to perform the same early abortion procedures that are used for women experiencing miscarriages early in pregnancy.

But it's more than a lack of doctors that could complicate pregnancies and births. States with the toughest abortion restrictions are also the least likely to offer support services for low-income mothers and babies. Even before the overturn of Roe, a report from the Commonwealth Fund, a nonpartisan research group, found that maternal death rates in states with abortion restrictions or bans were 62% higher than in states where abortion was more readily available.

Women who know their pregnancies could become high-risk are thinking twice about getting or being pregnant in states with abortion restrictions. Carmen Broesder, an Idaho woman who chronicled her difficulties getting care for a miscarriage in a series of viral videos on TikTok, told ABC News she does not plan to try to get pregnant again.

"Why would I want to go through my daughter almost losing her mom again to have another child?" she said. "That seems selfish and wrong."

The anti-abortion movement once appeared more sensitive to arguments that its policies neglect the needs of women and children, a charge made most famously by former Rep. Barney Frank (D-Mass.), who once said: "Conservatives believe that from the standpoint of the federal government, life begins at conception and ends at birth."

In fact, an icon of the anti-abortion movement — Rep. Henry Hyde (R-Ill.), who died in 2007 — made a point of partnering with liberal Rep. Henry Waxman (D-Calif.) on legislation to expand Medicaid coverage and provide more benefits to address infant mortality in the late 1980s.

Few anti-abortion groups are following that example by pushing policies to make it easier for people to get pregnant, give birth, and raise children. Most of those efforts are flying under the radar.

This year, Americans United for Life and Democrats for Life of America put out a joint position paper urging policymakers to "make birth free." Among their suggestions are automatic insurance coverage, without deductibles or copays, for pregnancy and childbirth; eliminating payment incentives for cesarean sections and in-hospital deliveries; and a "monthly maternal stipend" for the first two years of a child's life.

"Making birth free to American mothers can and should be a national unifier in a particularly divided time," says the paper. Such a policy could not only make it easier for women to start families, but it could address the nation's dismal record on maternal mortality.

In a year when the same Republican lawmakers who are supporting a national abortion ban are even more vehemently pushing for large federal budget cuts, however, a make-birth-free policy seems unlikely to advance very far or very quickly.

That leaves abortion opponents at something of a crossroads: Will they follow Hyde's example and champion policies that expand and protect access to care? Or will women's health suffer under the anti-abortion movement's victory?

HealthBent, a regular feature of KFF Health News, offers insight and analysis of policies and politics from KFF Health News chief Washington correspondent, Julie Rovner, who has covered healthcare for more than 30 years.

KFF Health News chief Washington correspondent Julie Rovner, who has covered healthcare for more than 30 years, offers insight and analysis of policies and politics in her regular HealthBent columns.

Send questions to: jrovner@kff.org, @jrovner

A More Aggressive FTC Is Starting to Target Drug Mergers and Industry Middlemen

KFF Health News, May 22, 2023

The suit marks the first time since 2009 that the FTC has tried to block a drug company merger.

This article was published on MOnday, May 22, 2023 in Kaiser Health News.

By Arthur Allen

Under the leadership of an aggressive opponent of anti-competitive business practices, the Federal Trade Commission is moving against drug companies and industry middlemen as part of the Biden administration's push for lower drug prices at the pharmacy counter.

On May 16, the FTC sued to block the merger of drugmakers Amgen and Horizon Therapeutics, saying the tangled web of drug industry deal-making would enable Amgen to leverage the monopoly power of two top Horizon drugs that have no rivals.

In its lawsuit, the FTC said that if it allowed Amgen's $27.8 billion purchase to go through, Amgen could pressure the companies that manage access to prescription drugs — pharmacy benefit managers, or PBMs — to boost the two extremely expensive Horizon products in a way that would inhibit any competition.

The suit, the first time since 2009 that the FTC has tried to block a drug company merger, reflects Chair Lina Khan's strong interest in antitrust action. In announcing the suit, the agency said that by fighting monopoly powers it aimed to tame prices and improve patients' access to cheaper products.

The FTC's action is a "shot across the bow for the pharmaceutical industry," said Robin Feldman, a professor and drug industry expert at the University of California College of the Law-San Francisco. David Balto, a former FTC official and attorney who fought the 2019 Bristol-Myers Squibb-Celgene and 2020 AbbVie-Allergan mergers, said FTC's action was long overdue.

The Horizon-Amgen merger would "cost consumers in higher prices, less choice, and innovation," he said. "The merger would have given Amgen even more tools to exploit consumers and harm competition."

The FTC also announced an expansion of a yearlong investigation of the PBMs, saying it was looking at two giant drug-purchasing companies, Ascent Health Services and Zinc Health Services. Critics claim the PBMs set up these companies to conceal profits.

When Amgen announced its purchase of Horizon in December — the biggest biopharma transaction in 2022 — it showed particular interest in Horizon's drugs for thyroid eye disease (Tepezza) and severe gout (Krystexxa), for which the company was charging up to $350,000 and $650,000, respectively, for a year of treatment. The complaint said the merger would disadvantage biotech rivals that have similar products in advanced clinical testing.

Amgen could promote the Horizon drugs through "cross-market bundling," the FTC said. That means requiring PBMs to promote some of Amgen's less popular drugs — the Horizon products, in this case — in exchange for Amgen offering the PBMs large rebates for its blockbusters. Amgen has nine drugs that each earned more than $1 billion last year, according to the complaint, the most popular being Enbrel, which treats rheumatoid arthritis and other diseases.

The three biggest PBMs negotiate prices and access to 80% of prescription drugs in the U.S., giving them enormous bargaining power. Their ability to influence which drugs Americans can get, and at what price, enables the PBMs to obtain billions in rebates from drug manufacturers.

"The prospect that Amgen could leverage its portfolio of blockbuster drugs to gain advantages over potential rivals is not hypothetical," the FTC complaint states. "Amgen has deployed this very strategy to extract favorable terms from payers to protect sales of Amgen's struggling drugs."

The complaint noted that biotech Regeneron last year sued Amgen, alleging that the latter's rebating strategy harmed Regeneron's ability to sell its competing cholesterol drug, Praluent. Amgen's Repatha generated $1.3 billion in global revenue in 2022.

It "may be effectively impossible" for smaller rivals to "match the value of bundled rebates that Amgen would be able to offer" as it leverages placement of the Horizon drugs on health plan formularies, the complaint states.

Business analysts were skeptical that the FTC action would succeed. Until now the commission and the Department of Justice have shied away from challenging pharmaceutical mergers, a precedent that will be hard to overcome.

Research on the impact of mergers has shown that they often benefit shareholders by increasing stock prices, but hurt innovation in drug development by trimming research projects and staffing.

Waves of consolidation shrank the field of leading pharma companies from 60 to 10 from 1995 to 2015. Most of the mergers in recent years have involved "big fish buying up lots of little fish," such as biotech companies with promising drugs, Feldman said.

The giant Amgen-Horizon merger is an obvious exception, and therefore a good opportunity for the FTC to demonstrate a "theory of harm" around drug industry bundling maneuvers with PBMs, said Aaron Glick, a mergers analyst with Cowen & Co.

But that doesn't mean the FTC will win.

Amgen may or may not engage in anti-competitive practices, but "a separate question is, how does this lawsuit fit under current antitrust laws and precedent?" Glick said. "The way the law is set up today, it seems unlikely it will hold up in court."

The FTC's argument about Amgen's behavior with Horizon products is hypothetical. The pending Regeneron suit against Amgen, as well as other, successful lawsuits, suggests that rules are in place to suppress this kind of anti-competitive behavior when it occurs, Glick said.

The judge presiding over the case in U.S. District Court in Illinois is John Kness, who was appointed by then-President Donald Trump and is a former member of the Federalist Society, whose membership tends to be skeptical of antitrust efforts. The case is likely to be settled by Dec. 12, the deadline for the merger to go through under current terms.

Amgen sought to undercut the government's case by agreeing not to bundle Horizon products in future negotiations with pharmacy benefit managers. That promise, while hard to enforce, might get a sympathetic hearing in court, Glick said.

Still, even a loss would enable the FTC to shed light on a problem in the industry and what it sees as a deficiency in antitrust laws that it wants Congress to correct, he said.

The day after suing to stop the merger, the FTC announced it was pushing further into an investigation of pharmacy benefit managers that it began last June. The agency demanded information from Ascent and Zinc, the two so-called rebate aggregators — drug purchasing organizations set up by PBMs Express Scripts and CVS Caremark.

At a May 10 hearing, Eli Lilly & Co. CEO Dave Ricks said that most of the $8 billion in rebate checks his company paid last year went to rebate aggregators, rather than to the PBMs directly. A "big chunk" of the $8 billion went overseas, he said. Ascent is based in Switzerland, while Emisar Pharma Services, an aggregator established by PBM OptumRx, is headquartered in Ireland. Zinc Health Services is registered in the U.S.

Critics say the aggregators enable PBMs to obscure the size and destination of rebates and other fees they charge as intermediaries in the drug business.

The PBMs say their efforts reduce prices at the pharmaceutical counter. Testimony in Congress and in FTC hearings over the past year indicate that, at least in some instances, they actually increase them.

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

 

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