How a Medical Recoding May Limit Cancer Patients’ Options for Breast Reconstruction

The federal government is reconsidering a decision that breast cancer patients, plastic surgeons, and members of Congress have protested would limit women’s options for reconstructive surgery.

On June 1, the Centers for Medicare & Medicaid Services plans to reexamine how doctors are paid for a type of breast reconstruction known as DIEP flap, in which skin, fat, and blood vessels are harvested from a woman’s abdomen to create a new breast.

The procedure offers potential advantages over implants and operations that take muscle from the abdomen. But it’s also more expensive. If patients go outside an insurance network for the operation, it can cost more than $50,000. And, if insurers pay significantly less for the surgery as a result of the government’s decision, some in-network surgeons would stop offering it, a plastic surgeons group has argued.

The DIEP flap controversy, spotlighted by CBS News in January, illustrates arcane and indirect ways the federal government can influence which medical options are available — even to people with private insurance. Often, the answers come down to billing codes — which identify specific medical services on forms doctors submit for reimbursement — and the competing pleas of groups whose interests are riding on them.

Medical coding is the backbone for “how business gets done in medicine,” said Karen Joynt Maddox, a physician at Washington University School of Medicine in St. Louis who researches health economics and policy.

CMS, the agency overseeing Medicare and Medicaid, maintains a list of codes representing thousands of medical services and products. It regularly evaluates whether to add codes or revise or remove existing ones. Last year, it decided to eliminate a code that has enabled doctors to collect much more money for DIEP flap operations than for simpler types of breast reconstruction.

In 2006, CMS established an “S” code — S2068 — for what was then a relatively new procedure: breast reconstructions with deep inferior epigastric perforator flap, or DIEP flap. S codes temporarily fill gaps in a parallel system of billing codes known as CPT codes, which are maintained by the American Medical Association, a physician group.

Codes don’t dictate the amounts private insurers pay for medical services; those reimbursements are generally worked out between insurance companies and medical providers. However, using the narrowly targeted S code, doctors and hospitals have been able to distinguish DIEP flap surgeries, which require complex microsurgical skills, from other forms of breast reconstruction that take less time to perform and generally yield lower insurance reimbursements.

CMS announced in 2022 that it planned to eliminate the S code at the end of 2024 — a move some doctors say would slash the amount surgeons are paid. (To be precise, CMS announced it would eliminate a series of three S codes for similar procedures, but some of the more outspoken critics have focused on one of them, S2068.) The agency’s decision is already changing the landscape of reconstructive surgery and creating anxiety for breast cancer patients.

Kate Getz, a single mother in Morton, Illinois, learned she had cancer in January at age 30. As she grappled with her diagnosis, she said, it was overwhelming to think about what her body would look like over the long term. She pictured herself getting married one day and wondered “how on earth I would be able to wear a wedding dress with only having one breast left,” she said.

She thought a DIEP flap was her best option and worried about having to undergo repeated surgeries if she got implants instead. Implants generally need to be replaced every 10 years or so. But after she spent more than a month trying to get answers about how her DIEP flap surgery would be covered, Getz’s insurer, Cigna, informed her it would use a lower-paying CPT code to reimburse her physician, Getz said. As far as she could see, that would have made it impossible for Getz to obtain the surgery.

Paying out-of-pocket was “not even an option.”

“I’m a single mom. We get by, right? But I’m not, not wealthy by any means,” she said.

Cost is not necessarily the only hurdle patients seeking DIEP flaps must overcome. Citing the complexity of the procedure, Getz said, a local plastic surgeon told her it would be difficult for him to perform. She ended up traveling from Illinois to Texas for the surgery.

The government’s plan to eliminate the three S codes was driven by the Blue Cross Blue Shield Association, a major lobbying organization for health insurance companies. In 2021, the group asked CMS to discontinue the codes, arguing that they were no longer needed because the American Medical Association had updated a CPT code to explicitly include DIEP flap surgery and the related operations, according to a CMS document.

For years, the American Medical Association advised doctors that the CPT code was appropriate for DIEP flap procedures. But after the government’s decision, at least two major insurance companies told doctors they would no longer reimburse them under the higher-paying codes, prompting a backlash.

Physicians and advocacy groups for breast cancer patients, such as the nonprofit organization Susan G. Komen, have argued that many plastic surgeons would stop providing DIEP flap procedures for women with private insurance because they wouldn’t get paid enough.

Lawmakers from both parties have asked the agency to keep the S code, including Rep. Debbie Wasserman Schultz (D-Fla.) and Sen. Amy Klobuchar (D-Minn.), who have had breast cancer, and Sen. Marsha Blackburn (R-Tenn.).

CMS at its June 1 meeting will consider whether to keep the three S codes or delay their expiration.

In a May 30 statement, Blue Cross Blue Shield Association spokesperson Kelly Parsons reiterated the organization’s view that “there is no longer a need to keep the S codes.”

In a profit-driven health care system, there’s a tug of war over reimbursements between providers and insurance companies, often at the expense of patients, said Joynt Maddox, the Washington University physician.

“We’re in this sort of constant battle” between hospital chains and insurance companies “about who’s going to wield more power at the bargaining table,” Joynt Maddox said. “And the clinical piece of that often gets lost, because it’s not often the clinical benefit and the clinical priority and the patient centeredness that’s at the middle of these conversations.”

Elisabeth Potter, a plastic surgeon who specializes in DIEP flap surgeries, decided to perform Getz’s surgery at whatever price Cigna would pay.

According to Fair Health, a nonprofit that provides information on health care costs, in Austin, Texas — where Potter is based — an insurer might pay an in-network doctor $9,323 for the surgery when it’s billed using the CPT code and $18,037 under the S code. Those amounts are not averages; rather, Fair Health estimated that 80% of payment rates are lower than or equal to those amounts.

Potter said her Cigna reimbursement “is significantly lower.”

Weeks before her May surgery, Getz received big news — Cigna had reversed itself and would cover her surgery under the S code. It “felt like a real victory,” she said.

But she still fears for other patients.

“I’m still asking these companies to do right by women,” Getz said. “I’m still asking them to provide the procedures we need to reimburse them at rates where women have access to them regardless of their wealth.”

In a statement for this article, Cigna spokesperson Justine Sessions said the insurer remains “committed to ensuring that our customers have affordable coverage and access to the full range of breast reconstruction procedures and to quality surgeons who perform these complex surgeries.”

Medical costs that health insurers cover generally are passed along to consumers in the form of premiums, deductibles, and other out-of-pocket expenses.

For any type of breast reconstruction, there are benefits, risks, and trade-offs. A 2018 paper published in JAMA Surgery found that women who underwent DIEP flap surgery had higher odds of developing “reoperative complications” within two years than those who received artificial implants. However, DIEP flaps had lower odds of infection than implants.

Implants carry risks of additional surgery, pain, rupture, and even an uncommon type of immune system cancer.

Other flap procedures that take muscle from the abdomen can leave women with weakened abdominal walls and increase their risk of developing a hernia.

Academic research shows that insurance reimbursement affects which women can access DIEP flap breast reconstruction, creating a two-tiered system for private health insurance versus government programs like Medicare and Medicaid. Private insurance generally pays physicians more than government coverage, and Medicare doesn’t use S codes.

Lynn Damitz, a physician and board vice president of health policy and advocacy for the American Society of Plastic Surgeons, said the group supports continuing the S code temporarily or indefinitely. If reimbursements drop, some doctors won’t perform DIEP flaps anymore, she said.

A study published in February found that, of patients who used their own tissue for breast reconstruction, privately insured patients were more likely than publicly insured patients to receive DIEP flap reconstruction.

To Potter, that shows what will happen if private insurance payments plummet. “If you’re a Medicare provider and you’re not paid to do DIEP flaps, you never tell a patient that it’s an option. You won’t perform it,” Potter said. “If you take private insurance and all of a sudden your reimbursement rate is cut from $15,000 down to $3,500, you’re not going to do that surgery. And I’m not saying that that’s the right thing to do, but that’s what happens.”

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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A Catch-22 for Clinics: State Bans Limit Abortion Counseling. Federal Title X Rules Require It.

State abortion bans in Tennessee and beyond, which constrain women’s health care, have put family planning clinics at risk of losing their federal funding.

The conflict involves the Title X family planning program, which provides services to low-income people, including minors. As of 2021, more than 3,200 clinics used federal grants to supply free or low-cost contraception, testing for sexually transmitted infections, screening for breast and cervical cancer, and pregnancy-related counseling.

Federal regulations for the program, which was established more than 50 years ago to reduce unintended pregnancies, say participating clinics must offer pregnant women information about terminating pregnancies and abortion referrals on request. But following those rules puts medical providers at odds with state laws banning abortion, some of which threaten jail time, fines, or the loss of medical licenses if they help someone end a pregnancy.

President Joe Biden’s administration at the end of March cut off Tennessee’s Title X funds after determining the state health department — which oversees its clinics and was awarded $7.1 million last year — violated federal rules by not counseling patients about abortion. “Continued funding is not in the best interest of the government,” two U.S. Department of Health and Human Services officials wrote to Tennessee officials on March 20. The state had more than 100 Title X clinics as of March, according to an HHS directory.

In 2022, the federal government awarded Title X grants to roughly 90 entities, a mix of state and local governments and private organizations. Those grantees distribute funds to public or private clinics.

Federal law prohibits clinics from using Title X money to pay for abortions. However, HHS requires clinics to offer pregnant women information about prenatal care and delivery, infant care, foster care, adoption, and pregnancy termination.

In states where abortion is generally illegal, that could mean directing patients to providers in other states. But Tennessee told family planning clinics they could discuss only services that were legal in the state — effectively cutting off any talk about abortion.

Tennessee allows abortions only under limited circumstances, including to save a pregnant person’s life. State health department policies for family planning “are consistent with state law,” said Jade Byers, a spokesperson for Republican Gov. Bill Lee. Tennessee allocated state funds to replace the federal money.

Whitney Rice, director of Emory University’s Center for Reproductive Health Research in the Southeast, said failing to provide timely information and referrals for abortion “could contribute to further delays in people’s ability to access that care,” especially because women may need to travel long distances for it.

The clash over the federally funded clinics is part of the widening fallout from the Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization ending the constitutional right to an abortion.

In Idaho, which has a near-total abortion ban, two Planned Parenthood clinics with Title X funding recently stopped giving patients abortion information and halted out-of-state referrals, according to a lawsuit Planned Parenthood and the American Civil Liberties Union filed in April against Idaho’s attorney general.

State law prohibits providers from assisting in performing or attempting to perform an abortion, and violators risk having their medical license suspended.

The clinics’ decision came after Idaho Attorney General Raúl Labrador, in a March 27 letter, said Idaho law prohibits providers from “referring a woman across state lines to access abortion services.”

That interpretation is “preventing medical professionals from providing full information to their patients,” said Mack Smith, spokesperson for Planned Parenthood Great Northwest, Hawaii, Alaska, Indiana, Kentucky.

Though Labrador later withdrew the letter, Planned Parenthood clinics there still are not referring patients out of state for abortions, Smith said.

Before Labrador’s letter, the lawsuit states, Planned Parenthood staff would furnish general information about pregnancy options, a list of abortion providers in other states and organizations that help defray patients’ abortion and related costs, and a flyer about Idaho’s abortion law. Staff would also occasionally help patients schedule care outside of Idaho. Now, “Planned Parenthood providers no longer do so.”

“When my patients require abortions, I am now forced to tell them that I am unable to help them and that I cannot say anything about their abortion options in other states,” Caitlin Gustafson, a physician who had practiced at an Idaho Planned Parenthood clinic, said in a legal declaration.

Kimberley Harris, a visiting assistant professor at Texas Tech University School of Law, said clinicians in states with strict bans worry about referring patients to other states because a prosecutor could interpret that as “aiding and abetting an abortion.”

Facilitating medication abortion in particular could “pose potential risk to health care providers,” Harris said, because a patient they refer to obtain pills out of state might then take them in a state where abortion is illegal. Medication abortion accounts for most abortions in the U.S. and involves taking a series of pills during the first 10 weeks of pregnancy.

“The federal regulation might require me to provide counseling and provide information,” Harris said of clinicians. “But if you’re telling providers that they may lose their license, or they might go to jail, or they might face a huge fine? Rightfully, they’re going to be concerned.”

As senior HHS officials travel the country, they are getting an earful about the issue.

HHS spokesperson Tara Broido said that, increasingly, “providers and patients have raised concerns about the impact that the Dobbs decision has had on access” to pregnancy counseling and referrals.

KFF Health News asked Broido which grantees have not been following the counseling and referral requirements. She declined to say.

People who use Title X’s services are disproportionately women. A report from HHS’ Office of Population Affairs said roughly two-thirds of 1.7 million patients in 2021 had family incomes at or below the poverty line. Thirty-six percent were uninsured, more than two times the national uninsured rate for adults.

The Office of Population Affairs and the Centers for Disease Control and Prevention jointly recommend family planning services that clinics are expected to follow. They include pregnancy testing and counseling.

The Title X program has been whipsawed before.

In 2019, the Trump administration barred Title X clinics from making abortion referrals. And the administration said abortion providers couldn’t share physical space with Title X clinics. The number of participating clinics subsequently dropped sharply — from 3,825 sites in 2019 to 3,031 the following year. With fewer clinics, the number of people receiving free or low-cost family planning services through the program plummeted from 3.1 million in 2019 to 1.5 million in 2020.

The Biden administration in 2021 overturned many of the Trump policies. The Biden rules remain in effect, but several states sued to block them. That litigation is ongoing.

Sarah Parshall Perry, a senior legal fellow at the conservative Heritage Foundation think tank, anticipates additional challenges to Title X rules because “states have an interest in defending their own laws and their ability to enforce their own laws.”

In Texas, which prohibits abortion with few exceptions, the nonprofit Every Body Texas oversees 154 Title X family planning clinics.

Its providers are still counseling pregnant women about options, but “that’s not to say it hasn’t been made very, very difficult,” said Stephanie LeBleu, the group’s acting Title X director.

LeBleu said the approach to counseling “can look different” from clinic to clinic. For example, clinics in rural Texas “have to be a lot more cautious about how they share information with their clients,” LeBleu said. Sometimes that means making a “referral to the referral” — such as directing patients to organizations like All-Options, which operates a national pregnancy options hotline.

ask for information on pregnancy options, “our clinics refer clients to other resources,” Karen M. Landers, chief medical officer for the Alabama Department of Public Health, said in a statement. The department declined to say what those resources are and whether clinicians worry about being prosecuted under Alabama law for providing abortion counseling or referrals.

“Clients are additionally informed of the legality of pregnancy termination in the state,” Landers wrote.

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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California Hospitals Seek a Broad Bailout, but They Don’t All Need It

SACRAMENTO, Calif. — One of the country’s richest hospitals, which caters to Hollywood elites, accepted nearly $28 million last year from an unusual source: a charity that siphons money from other California hospitals, many of which serve the state’s poorest residents.

Cedars-Sinai Health System in Los Angeles secured the grant under California’s recession-era financing scheme that allows wealthy hospitals to take valuable health care tax money from poorer ones. Hospitals across the state agreed in 2009 to the arrangement in order to tap billions more per year in taxpayer dollars to support the state’s Medicaid program, called Medi-Cal.

Now, some of those hospitals serving a greater share of Medi-Cal patients are in dire financial need and face cutbacks and potential closures. But instead of asking for help for only those at greatest risk, California’s powerful hospital industry is putting the squeeze on Gov. Gavin Newsom and fellow Democratic lawmakers for an unprecedented bailout. And they are doing it even as the state faces a nearly $32 billion budget deficit.

Hospitals argue that to avert a crisis, they need an emergency infusion of $1.5 billion. They also want a steady annual stream of new health care tax money despite already having their own dedicated tax intended to support struggling facilities that serve a large percentage of the state’s low-income people, such as Madera Community Hospital in the Central Valley, which closed earlier this year.

Ads by the California Hospital Association paint a scary picture: “1 in 5 Hospitals are at risk of closure.” Yet another warns, “Health care that millions rely on is at risk.” Those claims are being repeated by state lawmakers as they debate financial rescue for hospitals.

But a KFF Health News analysis of state data revealed that despite increased labor costs and inflation, many California hospitals have been profitable in recent years. The industry earned roughly $131 billion last year in patient revenue, a key indicator of profitability — $7.3 billion more than the previous year. After factoring in rising costs, the industry still turned a profit of about $207 million last year. State figures show the industry reaped $9.2 billion in patient revenue in 2021, partly a reflection of big swings in the stock market.

Leading health care finance experts and former state officials are urging Newsom and lawmakers to resist the industry’s fear tactics, saying that, even though hospitals are still reeling from the covid-19 pandemic, many have plush financial reserves.

“They are big fans of these giant bailouts, where the relatively rich hospitals benefit as well as the ones who really need it,” said Glenn Melnick, a health economist at the University of Southern California. “A big chunk of the hospitals, even if they’re losing money, don’t need taxpayer money to help them through this crisis.”

Melnick and others who have analyzed the financial state of California hospitals say a sliver of California’s 368 general hospitals are in crisis and that relief should be given only to those that can show they are in immediate peril. Many hospitals in underserved and rural communities are struggling financially, in part because they have failed to attract enough patients with private insurance. And the cost of providing care to lower-income patients who rely on Medi-Cal hasn’t kept pace with government reimbursement rates.

But low Medi-Cal rates aren’t necessarily a predictor of financial disaster, according to a report released Thursday by the California Health Care Foundation. (KFF Health News publishes California Healthline, which is an editorially independent service of the California Health Care Foundation.)

Health economists found that hospitals “with the lowest margins were no more dependent on Medi-Cal or Medicare than the average California hospital.” And many cash-strapped hospitals may be sitting on enormous wealth, an indication they don’t necessarily need more taxpayer money.

“Most of the facilities that have negative margins are a part of larger systems, which suggests that they have the underlying wealth of those systems to stabilize them,” said Kristof Stremikis, director of market analysis and insight for the foundation.

Carmela Coyle, the influential leader of the state hospital lobby, said California’s hospitals are in the worst crisis they’ve faced in recent history, largely because the state reimburses providers just 74 cents on the dollar to care for Medi-Cal patients.

“You have these underserved communities in the Central Valley, where a hospital comes in, they’re doing their best, and those underserved individuals are not reimbursed the same as everybody else,” Coyle told KFF Health News. “The real underlying issue here is government underfunding.”

But Coyle isn’t disclosing the full picture. Experts agree that reimbursement rates in Medi-Cal — money provided to doctors, clinics, and hospitals for taking care of low-income patients — are too low to cover the actual cost of care. Yet the state and federal government give billions in bonus and incentive payments that can actually result in higher reimbursements and even profits.

After Madera Community Hospital cut off services and shuttered, Coyle warned that it was a “canary in the coal mine” for other hospitals unable to make ends meet because of its high proportion of low-income patients and reliance on government payments. But the hospital actually made nearly $15 million from Medi-Cal in 2021, KFF Health News has gleaned from state hospital financial records.

The overarching problem, according to emails obtained by KFF Health News, was an inability to demand higher payments from commercial health insurance companies, as well as attract their patients — 70% of whom sought care outside Madera County.

The hospital “does not have the ability to negotiate competitive rates on its own,” according to an email last June to the California attorney general’s office from representatives of Trinity Health, a national Catholic health system, which backed off from acquiring the hospital.

The Madera hospital’s CEO, Karen Paolinelli, and other hospital leaders made another last-ditch effort to keep its doors open: They asked for an advance payment of their hospital tax revenue — money distributed through health insurance plans and the state. The payment they sought was from the Hospital Quality Assurance Fee, which allows hospitals to tax themselves to draw in federal money for Medi-Cal. Adopted in California in 2009 and later approved by voters through a ballot initiative, the tax brought in $8.4 billion last year.

“We did ask before we closed to get paid some of the provider money owed to us,” Paolinelli said. “But we were not successful.”

She said the hospital needed $5 million to remain open and couldn’t secure funding in time.

Under the hospital tax revenue, the money is spread across California hospitals, but the system is designed to protect the rich hospitals and essentially help them avoid industry taxes.

Hospitals with a greater share of low-income patients pay a higher tax than wealthier systems that don’t serve as many poor people. However, they benefit handsomely, ultimately increasing how much they are paid to care for Medi-Cal patients. Then those hospitals give up a portion of their tax money to a charity that funnels it to better-performing hospitals in exchange for their political support for the hospital tax.

“The winner hospitals contribute money to a fund that is used to distribute money to the loser hospitals,” said Elaine Batchlor, CEO of MLK Community Health, which is asking for financial help because roughly 70% of its patients are on Medi-Cal. “No hospital loses by being a part of it. If you were going to lose money, you’d be against it.”

The transactions are routed through the California Health Foundation and Trust, the charity operated by the leadership of the California Hospital Association.

For example, Cedars-Sinai paid nearly $172 million in taxes in 2022, eclipsing the $151 million it got back in additional Medi-Cal dollars. To make up for the loss, it secured the nearly $28 million in grant revenue — earning nearly $6.9 million from the program, its commissioned tax audit shows.

Cedars-Sinai spokesperson Duke Helfand acknowledged the benefit from the taxing scheme but said the health system effectively subsidizes Medi-Cal enrollees and incurs losses of more than $180 million annually serving those low-income patients. “Over the years, our teams at Cedars-Sinai have effectively managed our financial resources, enabling us to provide exceptional patient care,” Helfand said.

By comparison, the faith-based Adventist Health, which serves more poor people and operates roughly two dozen hospitals in California, Oregon, and Hawaii, paid $148 million in taxes in 2022 and reaped $401 million in additional Medi-Cal dollars through the program, according to its independent tax audit. It then contributed $3 million of that money to the charity.

These sorts of financing arrangements are under federal scrutiny. Officials with the Centers for Medicare & Medicaid Services have blasted “hold harmless” deals that can result in wealthier hospitals receiving enough money back that they ultimately wind up paying little or no tax at all.

“A health care-related tax cannot have a hold harmless provision that guarantees to return all or a portion of the tax back to the taxpayer,” Daniel Tsai, deputy administrator and director for the federal Medicaid agency, wrote in February.

Dave Regan, president of Service Employees International Union-United Healthcare Workers West, which represents hospital workers, has long lambasted California’s scheme as a ploy that lets wealthy hospitals siphon valuable health care dollars from smaller, rural hospitals that need more support for Medi-Cal patients.

“We believe the policies and practices of the hospital industry, in large part, contribute to the problems that Madera faced,” Regan said. “The hospital industry is richer than it’s ever been — and it’s being disingenuous, trying to get the public to fork over more money at a time when they have more money than they’ve ever had.”

California Hospital Association spokesperson David Simon defended the charity, saying it helps “hospitals provide health care services despite losses” from the tax.

Hospital leaders say exorbitant costs and inflation have created extreme financial woes. Last year, California’s hospitals paid at least $10 billion more for labor, supplies, and other expenses than the year before, according to state hospital finance data. And overall, they saw substantially smaller investment gains, reporting nearly $119 million in non-operating revenue compared with $6 billion the year before — a big blow to their financial cushion to ensure patient care.

The industry points out 200 hospitals had negative operating margins last year, yet KFF Health News found that, even before the pandemic, about 160 hospitals reported losing money in their operating budgets. Experts say the finding underscores the reality that hospitals operate on slim margins.

And, credit ratings agencies have recently upgraded the bonds of a number of hospitals and health systems, including Sutter Health in Northern California and Loma Linda University Medical Center in San Bernardino County.

“We just upgraded Sutter like two weeks ago, so it would be very hard-pressed, for me, to look at California and say California is looking bad,” said Kevin Holloran, a senior director at Fitch Ratings.

Some Democratic lawmakers agree that not all hospitals need a bailout. Instead, they favor targeted relief such as a $150 million loan program that Newsom signed into law earlier this month to help struggling hospitals.

“I’m not a big fan of writing everybody a check,” said Democratic Assemblymember Jim Wood, chair of the Health Committee, who says hospitals ought to be more transparent about their finances before state taxpayers give them any more money. “If you’re a hospital system that’s doing well, I don’t believe you should be getting any additional resources from the state.”

KFF Health News senior correspondent Bernard J. Wolfson contributed to this report.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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

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 health care for more than 30 years.

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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Una FTC más agresiva persigue las fusiones en la industria farmacéutica y a los intermediarios del sector

Bajo la dirección de una agresiva opositora al comportamiento empresarial que menoscaba la competencia, la Comisión Federal de Comercio (FTC) está actuando contra las empresas farmacéuticas y los intermediarios del sector, como parte de la campaña de la administración Biden para reducir los precios de los medicamentos en las farmacias.

El 16 de mayo, la FTC interpuso una demanda para bloquear la fusión de las farmacéuticas Amgen y Horizon Therapeutics, alegando que la enmarañada red de acuerdos de la industria  permitiría a Amgen aprovechar el poder monopolístico de dos de los principales medicamentos de Horizon que no tienen rivales.

En su demanda, la FTC alegó que si se permitía la compra que pretende Amgen por $27,800 millones, Amgen podría presionar a las empresas que gestionan el acceso a los medicamentos con receta —los gestores de beneficios de farmacia, o PBM— para que impongan los dos productos extremadamente caros de Horizon de una manera que eliminaría cualquier competencia.

Es la primera vez desde 2009 que la FTC intenta bloquear una fusión de empresas farmacéuticas, y esta demanda refleja el gran interés de la presidenta Lina Khan por las medidas antimonopolio. Al anunciar la demanda, la agencia declaró que al luchar contra los poderes monopolísticos pretendía controlar los precios y mejorar el acceso de los pacientes a productos más baratos.

Para Robin Feldman, profesor y experto en la industria farmacéutica de la Facultad de Derecho de la Universidad de California en San Francisco, la actuación de la FTC es “un golpe frontal a la industria farmacéutica”. David Balto, ex funcionario de la FTC y abogado que luchó contra las fusiones Bristol-Myers Squibb-Celgene en 2019 y AbbVie-Allergan en 2020, dijo que la acción de la FTC era necesaria desde hace mucho tiempo.

La fusión Horizon-Amgen “costaría a los consumidores precios más altos, menos opciones e innovación”, señaló. “La fusión habría dado a Amgen aún más herramientas para explotar a los consumidores y dañar la competencia”.

La FTC también anunció la ampliación de una investigación de un año sobre los PBM, indicando que se investigaban dos gigantescas empresas de compra de medicamentos, Ascent Health Services y Zinc Health Services. Los críticos afirman que los PBM crearon estas empresas para ocultar beneficios.

Cuando Amgen anunció la compra de Horizon en diciembre —la mayor operación biofarmacéutica de 2022— mostró especial interés por los medicamentos de Horizon para la enfermedad tiroidea ocular (Tepezza) y la gota grave (Krystexxa), por los que la empresa cobraba hasta $350,000 y $650,000, respectivamente, por un año de tratamiento. Según la demanda, la fusión perjudicaría a rivales biotecnológicos que tienen productos similares en fase avanzada de pruebas clínicas.

Según la FTC, Amgen podría promocionar los fármacos de Horizon a través de la “venta cruzada”. Esto significa exigir a los PBM que promocionen algunos de los medicamentos menos populares de Amgen —los productos Horizon, en este caso— a cambio de que Amgen ofrezca a los PBM grandes descuentos por sus superventas. Según la denuncia, Amgen tiene nueve medicamentos que el año pasado generaron más de $1,000 millones cada uno. El más popular es Enbrel, que trata la artritis reumatoide y otras enfermedades.

Los tres mayores PBM negocian los precios y el acceso al 80% de los medicamentos recetados en Estados Unidos, lo que les confiere un enorme poder de negociación. Su capacidad para influir en los medicamentos a los que tienen acceso los estadounidenses, y a qué precio, les permite obtener miles de millones en descuentos de los fabricantes.

“La posibilidad de que Amgen pudiera aprovechar su cartera de medicamentos superventas para obtener ventajas sobre sus rivales potenciales no es hipotética”, afirma la denuncia de la FTC. “Amgen ha desplegado esta misma estrategia para conseguir condiciones favorables de los pagadores y proteger así las ventas de los medicamentos de Amgen en dificultades”.

La denuncia señaló que la biotecnológica Regeneron demandó el año pasado a Amgen, alegando que la estrategia de reembolso de esta última perjudicó la capacidad de Regeneron para vender su medicamento competidor contra el colesterol, Praluent. Repatha, de Amgen, generó unos ingresos mundiales de $1,300 millones en 2022.

Según la demanda, “puede resultar completamente imposible” para los rivales más pequeños “igualar el valor de los reembolsos agrupados que Amgen podría ofrecer”, ya que aprovecha la colocación de los medicamentos de Horizon en los formularios de los planes de salud.

Los analistas de la industria se mostraron escépticos sobre el éxito de la acción de la FTC. Hasta ahora, la Comisión y el Departamento de Justicia han evitado cuestionar las fusiones farmacéuticas, un precedente difícil de superar.

Las investigaciones sobre el impacto de las fusiones han demostrado que a menudo benefician a los accionistas al aumentar el precio de las acciones; pero perjudican la innovación en el desarrollo de fármacos al recortar los proyectos de investigación y el personal.

Las olas de consolidación redujeron el número de empresas farmacéuticas líderes de 60 a 10 entre 1995 y 2015. Según Feldman, la mayoría de las fusiones de los últimos años se han producido entre “peces gordos que adquieren muchos peces pequeños”, como empresas de biotecnología con fármacos prometedores.

La gigantesca fusión Amgen-Horizon es una excepción obvia y, por tanto, una buena oportunidad para que la FTC demuestre la “teoría del daño” en las maniobras de consolidación de la industria farmacéutica con los PBM, dijo Aaron Glick, analista de fusiones de Cowen & Co.

Pero eso no significa que la FTC vaya a ganar.

Amgen puede incurrir o no en prácticas anticompetitivas, pero “otra cuestión es cómo encaja esta demanda en las leyes antimonopolio y los precedentes actuales”, señaló Glick. “Tal y como está configurada la ley hoy, parece poco probable que se sostenga en los tribunales”.

El argumento de la FTC sobre el comportamiento de Amgen con los productos Horizon es hipotético. La demanda pendiente de Regeneron contra Amgen, así como otras demandas que han prosperado, sugiere que existen normas para suprimir este tipo de comportamiento anticompetitivo cuando se produce, añadió Glick.

El juez que preside el caso en el Tribunal de Distrito de Estados Unidos en Illinois es John Kness, quien fue nombrado por el entonces presidente Donald Trump y es un ex miembro de la Federalist Society, cuyos miembros tienden a ser escépticos sobre los esfuerzos antimonopolio.

Es probable que el caso se resuelva antes del 12 de diciembre, fecha límite para que la fusión se lleve a cabo en los términos actuales.

Amgen trató de socavar los argumentos del Gobierno comprometiéndose a no agrupar los productos de Horizon en futuras negociaciones con los gestores de beneficios farmacéuticos (PBM). Esta promesa, aunque difícil de hacer cumplir, podría obtener una audiencia favorable en corte, apuntó Glick.

Sin embargo, incluso una derrota permitiría a la FTC arrojar luz sobre un problema en la industria y lo que considera una deficiencia en las leyes antimonopolio que quiere que el Congreso corrija, explicó.

Al día siguiente de ir a corte para detener la fusión, la FTC anunció que profundizaba en una investigación sobre los gestores de beneficios farmacéuticos que inició el pasado mes de junio. La agencia solicitó información a Ascent y Zinc, los dos llamados agregadores de reembolsos, organizaciones de compra de medicamentos creadas por los PBM Express Scripts y CVS Caremark.

En una audiencia celebrada el 10 de mayo, el CEO de Eli Lilly & Co., Dave Ricks, afirmó que la mayor parte de los $8,000 millones en cheques de reembolso que su empresa pagó el año pasado fueron a parar a los agregadores de reembolsos, en lugar de directamente a los PBM. Una “gran parte” de los $8,000 millones fue a parar al extranjero, indicó Ricks. Ascent tiene su sede en Suiza, mientras que Emisar Pharma Services, un agregador establecido por PBM OptumRx, tiene su sede en Irlanda. Zinc Health Services está registrada en Estados Unidos.

Los críticos afirman que los agregadores permiten a los PBM ocultar la cuantía y el destino de los reembolsos y otras comisiones que cobran como intermediarios en el negocio de los medicamentos.

Por su parte, los PBM aseguran que sus esfuerzos reducen los precios en el mostrador de la farmacia. Los testimonios en el Congreso y en las audiencias de la FTC del año pasado indican que, al menos en algunos casos, en realidad los aumentan.

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

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.

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), 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.

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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The Abortion Pill Goes Back to Court

The Host

Julie Rovner KFF Health News @jrovner Read Julie's stories. Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

The fate of the abortion pill mifepristone remains in jeopardy, as an appellate court panel during a hearing this week sounded sympathetic to a lower court’s ruling that the FDA should not have approved the drug more than two decades ago. No matter how the appeals court rules, the case seems headed for the Supreme Court.

Meanwhile, in the partisan standoff over raising the nation’s debt ceiling, a key sticking point has emerged: whether to add a work requirement to the state-federal Medicaid program. Republicans are adamant about adding one; Democrats point out that, in the few states that have tried them, red tape has resulted in eligible people wrongly losing their health coverage.

This week’s panelists are Julie Rovner of KFF Health News, Sandhya Raman of CQ Roll Call, Rachel Roubein of The Washington Post, and Victoria Knight of Axios.

Panelists

Sandhya Raman CQ Roll Call @SandhyaWrites Read Sandhya's stories Rachel Roubein The Washington Post @rachel_roubein Read Rachel's stories Victoria Knight Axios @victoriaregisk Read Victoria's stories

Among the takeaways from this week’s episode:

  • Hopes among abortion rights advocates for continued access to mifepristone dimmed as the three judges on the 5th Circuit Court of Appeals signaled they are skeptical of the FDA’s decades-old approval of the drug and of the Biden administration’s arguments defending it. Lawyers debated whether the Texas doctors challenging the drug had been harmed by it and thus had standing to sue. If the original ruling effectively revoking the drug’s approval is allowed to stand, the case could open the door to future legal challenges to the approval of controversial drugs.
  • Two more states in the South are moving to restrict abortion, further cutting access to the procedure in the region. In North Carolina, a new Republican supermajority in the state legislature enabled the passage this week of a new, 12-week ban, as lawmakers in South Carolina consider a six-week ban.
  • In Congress, the top Senate Republican said he will not back one senator’s months-long effort to hold up Pentagon nominations over a policy that supports troops and their dependents who must travel to other states to obtain an abortion.
  • Envision Healthcare — which spent big in 2019 to fight legislation prohibiting some surprise medical bills — has filed for bankruptcy protection more than a year after the law took effect and cut into its bottom line. But a federal lawsuit from a group of emergency room physicians against Envision may move forward. The lawsuit claims the private equity-backed company is in violation of a California law banning corporate control of medical practices, and it could carry major consequences for the growing number of practices backed by private equity firms across the country.
  • Monica Bertagnolli has been nominated to lead the National Institutes of Health. Currently the director of the National Cancer Institute, she will need to be confirmed by the Senate, which hasn’t confirmed an NIH chief since before the passage of the Affordable Care Act in 2010. Meanwhile, Sen. Bernie Sanders’ stewardship of a key health committee is causing delays on even bipartisan efforts.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The Washington Post’s “A 150-Year-Old Law Could Help Determine the Fate of U.S. Abortion Access,” by Dan Diamond and Ann E. Marimow.

Victoria Knight: The New York Times’ “World Health Organization Warns Against Using Artificial Sweeteners,” by April Rubin.

Rachel Roubein: CBS News’ “Thousands Face Medicaid Whiplash in South Dakota and North Carolina,” by Arielle Zionts of KFF Health News.

Sandhya Raman: CQ Roll Call’s “A Year After Dobbs Leak, Democrats Still See Abortion Driving 2024 Voters,” by Mary Ellen McIntire and Daniela Altimari.

Also mentioned in this week’s episode:

KFF Health News’ “ER Doctors Vow to Pursue Case Against Envision Despite Bankruptcy,” by Bernard J. Wolfson.

Credits

Francis Ying Audio producer Emmarie Huetteman Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News’ ‘What the Health? on SpotifyApple PodcastsStitcherPocket Casts, or wherever you listen to podcasts.

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An AI Chatbot May Be Your Next Therapist. Will It Actually Help Your Mental Health?

In the past few years, 10,000 to 20,000 apps have stampeded into the mental health space, offering to “disrupt” traditional therapy. With the frenzy around AI innovations like ChatGPT, the claim that chatbots can provide mental health care is on the horizon.

The numbers explain why: Pandemic stresses led to millions more Americans seeking treatment. At the same time, there has long been a shortage of mental health professionals in the United States; more than half of all counties lack psychiatrists. Given the Affordable Care Act’s mandate that insurers offer parity between mental and physical health coverage, there is a gaping chasm between demand and supply.

For entrepreneurs, that presents a market bonanza. At the South by Southwest conference in March, where health startups displayed their products, there was a near-religious conviction that AI could rebuild health care, offering apps and machines that could diagnose and treat all kinds of illnesses, replacing doctors and nurses.

Unfortunately, in the mental health space, evidence of effectiveness is lacking. Few of the many apps on the market have independent outcomes research showing they help; most haven’t been scrutinized at all by the FDA. Though marketed to treat conditions such as anxiety, attention-deficit/hyperactivity disorder, and depression, or to predict suicidal tendencies, many warn users (in small print) that they are “not intended to be medical, behavioral health or other healthcare service” or “not an FDA cleared product.”

There are good reasons to be cautious in the face of this marketing juggernaut.

Decades ago, Joseph Weizenbaum, a professor at the Massachusetts Institute of Technology and considered one of the fathers of artificial intelligence, predicted AI would never make a good therapist, though it could be made to sound like one. In fact, his original AI program, created in the 1960s, was a psychotherapist named ELIZA, which used word and pattern recognition combined with natural language programming to sound like a therapist:

Woman: Well, my boyfriend made me come here.ELIZA: Your boyfriend made you come here?Woman: He says I’m depressed much of the time.ELIZA: I am sorry to hear that you are depressed.Woman: It’s true. I am unhappy.ELIZA: Do you think coming here will help you not to be unhappy?

Though hailed as an AI triumph, ELIZA’s “success” terrified Weizenbaum, whom I once interviewed. He said students would interact with the machine as if Eliza were an actual therapist, when what he’d created was “a party trick,” he said.

He foresaw the evolution of far more sophisticated programs like ChatGPT. But “the experiences a computer might gain under such circumstances are not human experiences,” he told me. “The computer will not, for example, experience loneliness in any sense that we understand it.”

The same goes for anxiety or ecstasy, emotions so neurologically complex that scientists have not been able pinpoint their neural origins. Can a chatbot achieve transference, the empathic flow between patient and doctor that is central to many types of therapy?

“The core tenet of medicine is that it’s a relationship between human and human — and AI can’t love,” said Bon Ku, director of the Health Design Lab at Thomas Jefferson University and a pioneer in medical innovation. “I have a human therapist, and that will never be replaced by AI.”

Ku said he’d like to see AI used instead to reduce practitioners’ tasks like record-keeping and data entry to “free up more time for humans to connect.”

While some mental health apps may ultimately prove worthy, there is evidence that some can do harm. One researcher noted that some users faulted these apps for their “scripted nature and lack of adaptability beyond textbook cases of mild anxiety and depression.”

It may prove tempting for insurers to offer up apps and chatbots to meet the mental health parity requirement. After all, that would be a cheap and simple solution, compared with the difficulty of offering a panel of human therapists, especially since many take no insurance because they consider insurers’ payments too low.

Perhaps seeing the flood of AI hitting the market, the Department of Labor announced last year it was ramping up efforts to ensure better insurer compliance with the mental health parity requirement.

The FDA likewise said late last year it “intends to exercise enforcement discretion” over a range of mental health apps, which it will vet as medical devices. So far, not one has been approved. And only a very few have gotten the agency’s breakthrough device designation, which fast-tracks reviews and studies on devices that show potential.

These apps mostly offer what therapists call structured therapy — in which patients have specific problems and the app can respond with a workbook-like approach. For example, Woebot combines exercises for mindfulness and self-care (with answers written by teams of therapists) for postpartum depression. Wysa, another app that has received a breakthrough device designation, delivers cognitive behavioral therapy for anxiety, depression, and chronic pain.

But gathering reliable scientific data about how well app-based treatments function will take time. “The problem is that there is very little evidence now for the agency to reach any conclusions,” said Kedar Mate, head of the Boston-based Institute for Healthcare Improvement.

Until we have that research, we don’t know whether app-based mental health care does better than Weizenbaum’s ELIZA. AI may certainly improve as the years go by, but at this point, for insurers to claim that providing access to an app is anything close to meeting the mental health parity requirement is woefully premature.

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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Study Reveals Staggering Toll of Being Black in America: 1.6M Excess Deaths Over 22 Years

Research has long shown that Black people live sicker lives and die younger than white people.

Now a new study, published Tuesday in JAMA, casts the nation’s racial inequities in stark relief, finding that the higher mortality rate among Black Americans resulted in 1.63 million excess deaths relative to white Americans over more than two decades.

Because so many Black people die young — with many years of life ahead of them — their higher mortality rate from 1999 to 2020 resulted in a cumulative loss of more than 80 million years of life compared with the white population, the study showed.

Although the nation made progress in closing the gap between white and Black mortality rates from 1999 to 2011, that advance stalled from 2011 to 2019. In 2020, the enormous number of deaths from covid-19 — which hit Black Americans particularly hard — erased two decades of progress.

Authors of the study describe it as a call to action to improve the health of Black Americans, whose early deaths are fueled by higher rates of heart disease, cancer, and infant mortality.

“The study is hugely important for about 1.63 million reasons,” said Herman Taylor, an author of the study and director of the cardiovascular research institute at the Morehouse School of Medicine.

“Real lives are being lost. Real families are missing parents and grandparents,” Taylor said. “Babies and their mothers are dying. We have been screaming this message for decades.”

High mortality rates among Black people have less to do with genetics than with the country’s long history of discrimination, which has undermined educational, housing, and job opportunities for generations of Black people, said Clyde Yancy, an author of the study and chief of cardiology at Northwestern University’s Feinberg School of Medicine.

Black neighborhoods that were redlined in the 1930s — designated too “high risk” for mortgages and other investments — remain poorer and sicker today, Yancy said. Formerly redlined ZIP codes also had higher rates of covid infection and death. “It’s very clear that we have an uneven distribution of health,” Yancy said. “We’re talking about the freedom to be healthy.”

A companion study estimates that racial and ethnic inequities cost the U.S. at least $421 billion in 2018, based on medical expenses, lost productivity, and premature death.

In 2021, non-Hispanic white Americans had a life expectancy at birth of 76 years, while non-Hispanic Black Americans could expect to live only to 71. Much of that disparity is explained by the fact that non-Hispanic Black newborns are 2½ times as likely to die before their 1st birthdays as non-Hispanic whites. Non-Hispanic Black mothers are more than 3 times as likely as non-Hispanic white mothers to die from a pregnancy-related complication. (Hispanic people can be of any race or combination of races.)

Racial disparities in health are so entrenched that even education and wealth don’t fully erase them, said Tonia Branche, a neonatal-perinatal medicine fellow at Lurie Children’s Hospital of Chicago who was not involved in the JAMA study.

Black women with a college degree are more likely to die from pregnancy complications than white women without a high school diploma. Although researchers can’t fully explain this disparity, Branche said it’s possible that stress, including from systemic racism, takes a greater toll on the health of Black mothers than previously recognized.

Death creates ripples of grief throughout communities. Research has found that every death leaves an average of nine people in mourning.

Black people shoulder a great burden of grief, which can undermine their mental and physical health, said Khaliah Johnson, chief of pediatric palliative care at Children’s Healthcare of Atlanta. Given the high mortality rates throughout the life span, Black people are more likely than white people to be grieving the death of a close family member at any point in their lives.

“We as Black people all have some legacy of unjust, unwarranted loss and death that compounds with each new loss,” said Johnson, who was not involved with the new study. “It affects not only how we move through the world, but how we live in relationship with others and how we endure future losses.”

Johnson’s parents lost two sons — one who died a few days after birth and another who died as a toddler. In an essay published last year, Johnson recalled, “My parents asked themselves on numerous occasions, ‘Would the outcomes for our sons have been different, might they have received different care and lived, had they not been Black?’”

Johnson said she hopes the new study gives people greater understanding of all that’s lost when Black people die prematurely. “When we lose these lives young, when we lose that potential, that has an impact on all of society,” she said.

And in the Black community, “our pain is real and deep and profound, and it deserves attention and validation,” Johnson said. “It often feels like people just pass it over, telling you to stop complaining. But the expectation can’t be that we just endure these things and bounce back.”

Teleah Scott-Moore said she struggles with the death of her 16-year-old son, Timothy, an athlete who hoped to attend Boston College and study sports medicine. He died of sudden cardiac arrest in 2011, a rare condition that kills about 100 young athletes a year. Research shows that an underlying heart condition that can lead to sudden cardiac death, hypertrophic cardiomyopathy, often goes unrecognized in Black patients.

Scott-Moore still wonders if she should have recognized warning signs. She also has blamed herself for failing to protect her two younger sons, who found Timothy’s body after he collapsed.

At times, Scott-Moore said, she wanted to give up.

Instead, she said, the family created a foundation to promote education and health screenings to prevent such deaths. She hears from families all over the world, and supporting them has helped heal her pain.

“My grief comes back in waves, it comes back when I least expect it,” said Scott-Moore, of Baltimore County, Maryland. “Life goes on, but it’s a pain that never goes away.”

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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Michael Milken Wants to Speed Up Cures

Years ago, a top chemical biologist pondered ditching his cancer research to take a more lucrative commission growing healthier apples. Michael Milken stopped him.

“I told him we could probably eat the same apples for the next 20 years and be OK, but we wouldn’t be OK if he didn’t continue his potential groundbreaking work,” Milken, 76, said. “Then we funded him.”

Driven by a family history of disease and his own experience with prostate cancer, Milken, the onetime junk-bond wizard whose spectacular downfall on securities charges led to a 22-month prison term in the 1990s, has spent the last three decades trying to advance medical science so that people “can find cures to life-threatening diseases within their own lifetimes.”

In “Faster Cures,” a book that is part memoir and part medical history, the financier-turned-philanthropist argues for applying business principles to foster quicker medical breakthroughs: more collaboration and information-sharing among researchers, a more streamlined path through government regulations, and more public and private funding to keep the best and brightest working in the field. The book was written with Geoffrey Evans Moore, a longtime associate of Milken’s.

Milken, whose net worth is estimated at $6 billion, has donated $1.2 billion to medical research and public health causes and raised another $1 billion for them from donors, according to a spokesperson. Much of that money is distributed through the Santa Monica-based Milken Institute, which funds organizations around the world that support research and education.

This interview has been edited for length and clarity.

Q: Was it difficult to write about your father’s death from cancer and your own diagnosis of advanced prostate cancer in 1993, which was thought at the time to be terminal?

Life-threatening diseases are not separated by wealth or anything else. One in 2 men are going to get diagnosed with cancer in their lifetime; for women, it’s 1 in 3. In the hospital room or in surgery, we’re all equal. That’s why I wanted to personalize it because my family is no different. In the 1970s, science could not move fast enough to save my father’s life.

Q: Is the U.S. too slow in reaching cures?

A train today in Europe or Asia can travel at 200 miles an hour, but the average train in the U.S. travels at the same speed as 100 years ago because you can’t put faster trains on tracks that aren’t more modern. Science is this train that’s moving fast, but the tracks are 20th-century tracks. As science moves quickly — sequencing your genome and your microbiome, for example — many of the ways we deal with our health system still relate to what it was in the 1900s, not in this century.

Q: What are those outdated practices?

One is collaboration. Thirty years ago, after my diagnosis, I attended a prostate cancer conference at MD Anderson Cancer Center in Houston, and I noticed that no one from Memorial Sloan Kettering [in New York City] was presenting, and they were the other recognized top experts in the field. When I asked why, I was told by MD Anderson’s people that they felt Sloan Kettering was a competitor. I said, “They’re not a competitor to patients.” We’ve done a huge amount of work in that area to get researchers and scientists sharing information and working together.

Q: Are cancer patients getting into clinical trials at earlier stages?

Yes, but there’s another element here relating to health equity. The demographics of America have changed considerably. Sixty years ago, 75% of everyone living in the U.S. who was not born here came from Europe. Today, more than 70% of everybody living here who wasn’t born here came from Latin America or Asia, but our clinical trials are still largely Caucasian. We’re not including people who will someday make up the majority of people in this country.

Q: You also spend a lot of time writing about prevention, especially as it pertains to diet. Why?

If you went to medical school in China 30 or 40 years ago, you wouldn’t have even studied diabetes because it was so rare there. Today, because of changes in the food chain and what they’re eating — meat-based and fat-based diets — China has the most people with diabetes of any country in the world. That’s what thousands of McDonald’s and KFC and other franchises will do. We also know that eating certain foods can slow the growth of certain kinds of cancers, or that changing your diet can accelerate the growth. The CEO of one of the largest medical research companies in the world told me, “The next great drug is going to be prevention.”

Q: But isn’t the medical industry oriented toward selling treatment and not prevention?

When we proposed the idea to the medical community in the ’90s that you are what you eat, they said, “Prove it.” And we didn’t sequence the genome until 2003, so prior to that the evidence was mostly anecdotal, but there was plenty of it. The notion is mainstream today, but teaching doctors that nutrition makes a difference is still a minor, minor part of medical school. It should be at the forefront. We often refer to the produce section of the grocery store as the pharmacy of the 21st century.

Q: Your financial theories revolved around finding lower-graded bonds that produced great returns — essentially, identifying an undervalued segment of the market. Is there an undervalued equivalent in medicine or science?

It’s about the democratization of capital. In medicine and science, access to financial capital serves as a multiplier effect, but the largest asset is human capital. I’ve spent considerable time trying to identify the future Ted Turners or [telecommunications giant] John Malones of the world of medicine, then convincing them to go into research and funding them.

Q: How do you provide financing to the most talented people in the field?

That includes private and public funding. In 1998, we organized a march on Washington, and a few months later President Clinton signed into law a massive increase in the NIH [National Institutes of Health] budget. Since then, there’s been an incremental half a trillion dollars invested into the NIH, and that has made all the difference for so many organizations working on specific diseases or types of cancer.

Q: Why do you fund medical research?

My interest in medicine and science started when I was 8 years old. It accelerated in the ’70s when my wife’s mother was diagnosed with breast cancer and my father’s melanoma returned. That began a search for medical solutions that I brought into my existing philanthropy in 1982. Who a person is and what they believe in — there has always been a lot of misinformation out there, and it’s only going to get worse with artificial intelligence chat. It’s not just related to me. But I think the thousands of companies that we financed, and the millions of jobs created, are evidence that the ideas I put forth are today in the mainstream. All of the facts are there for one to see.

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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.

USE OUR CONTENT

This story can be republished for free (details).



from Health Industry – KFF Health News

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