Last year's Inflation Reduction Act included what on its face seems a modest proposal: The federal government would for the first time be empowered to negotiate prices Medicare pays for drugs — but only for 10 very expensive medicines beginning in 2026 (an additional 15 in 2027 and 2028, with more added in later years). Another provision would require manufacturers to pay rebates to Medicare for drug prices that increased faster than inflation.
Those provisions alone could reduce the federal deficit by $237 billion over 10 years, the Congressional Budget Office has calculated. That enormous savings would come from tamping down drug prices, which are costing an average of 3.44 times — sometimes 10 times — what the same brand-name drugs cost in other developed countries, where governments already negotiate prices.
These small steps were an attempt to rein in the only significant type of Medicare health spending — the cost of prescription drugs — that has not been controlled or limited by the government. But they were a call to arms for the pharmaceutical industry in a battle it assumed it had won: When Congress passed the Medicare prescription drug coverage benefit (Part D) in 2003, intense industry lobbying resulted in a last-minute insertion prohibiting Medicare from negotiating those prices.
Without any guardrails, prices for some existing drugs have soared, even as they have fallen sharply in other countries. New drugs — some with minimal benefit — have enormous price tags, buttressed by lobbying and marketing.
AZT, the first drug to successfully treat HIV/AIDS, was labeled "the most expensive drug in history" in the late 1980s. Its $8,000-a-year cost was derided as "inhuman" in a New York Times op-ed. Now, scores of drugs, many with much less benefit, cost more than $50,000 a year. Ten drugs, mostly used to treat rare diseases, cost over $700,000 annually.
Pharmaceutical manufacturers say high U.S. prices support research and development and point out that Americans tend to get new treatments first. But recent research has shown that the price of a drug is related neither to the amount of research and development required to bring it to market nor its therapeutic value.
And selling drugs first in the U.S. is a good business strategy. By introducing a drug in a developed country with limited scrutiny on price, manufacturers can set the bar high for negotiating with other nations.
Here are just a few of the many examples of drug pricing practices that have driven consumers to demand change.
Exhibit A is Humira, the best-selling drug in history, earning AbbVie $200 billion over two decades. Effective in the treatment of various autoimmune diseases, its core patent — the one on the biologic itself — expired in 2016. But for business purposes, the "controlling patent," the last to expire, is far more important since it allows an ongoing monopoly.
AbbVie blanketed Humira with 165 peripheral patents, covering things like a manufacturing step or slightly new formulation, creating a so-called patent thicket, making it challenging for generics makers to make lower-cost copycats. (When they threatened to do so, AbbVie often offered them valuable deals not to enter the market.) Meanwhile, it continued to raise the price of the drug, most recently to $88,000 a year. This year, Humira-like generics (called biosimilars for its type of molecule) are entering the U.S. market; they have been available for a fraction of the price in Europe for five years.
Or take Revlimid, a drug by Celgene (now part of Bristol Myers Squibb), which treats multiple myeloma. It won FDA approval to treat that previously deadly disease in 2006 at about $4,500 a month; today it retails at triple that. Why? The company's CEO explained price hikes were simply a "legitimate opportunity" to improve financial "performance."
Since it must be taken for life to keep that cancer in check, patients who want to live (or their insurers) have had no choice but to pay. Though Revlimid's patent protection ran out in 2022, Celgene avoided meaningful price-cutting competition by offering generic competitors "volume-limited licenses" to its patents so long as they agreed to initially produce a small share of the drug's $12 billion monopoly market.
Par Pharmaceutical, another drugmaker, maneuvered to create a blockbuster market out of a centuries-old drug, isoproterenol, through a well-meaning FDA program that gave companies a three-year monopoly in exchange for performing formal testing on drugs in use before the agency was formed.
During those three years, Par wrapped its branded product, Vasostrict, used to maintain blood pressure in critically ill patients, with patents — including one on the compound's pH level — extending its monopoly eight additional years. Par raised the price by 5,400% between 2010 and 2020. When the covid-19 pandemic filled intensive care units with severely ill patients, that hike cost Americans $600 million to $900 million in the first year.
And then there is AZT and its successors, which offer a full life to HIV-positive people. Pills today contain a combination of two or three medicines, the vast majority including one similar to AZT, tenofovir, made by Gilead Sciences. The individual medicines are old, off-patent. Why then do these combination pills, taken for life, sometimes cost $4,000 monthly?
It's partly because many manufacturers of the combination pills have agreements with Gilead that they will use its expensive branded version of tenofovir in exchange for various business favors. Peter Staley, an activist with HIV, has been spearheading a class-action suit against Gilead, alleging "collusion." The negotiated price for these pills is hundreds of dollars a month in the United Kingdom, not the thousands charged in the U.S.
Faced with such tactics, 8 in 10 Americans now support drug price negotiation, giving Congress and the Biden administration the impetus to act and to resist Big Pharma's legal challenges, which many legal experts view as a desperate attempt to stave off the inevitable.
"I don't think they have a good legal case," said Aaron Kesselheim, who studies drug pricing at Harvard Medical School. "But it can delay things if they can find a judge to issue an injunction." And even a year's delay could translate into big money.
Yes, American patients are lucky to have first access to innovative drugs. And, sadly, patients in countries that refuse to pay up once in a while go without the latest treatment. But more sadly, polling shows, large numbers of Americans are forgoing prescribed medicines because they can't afford them.
PUEBLO, Colo. — As 41% of American adults face medical debt, residents of this southern Colorado city contend their local nonprofit hospitals aren't providing enough charity care to justify the millions in tax breaks they receive.
The two hospitals in Pueblo, Parkview Medical Center and Centura St. Mary-Corwin, do not pay most federal or state taxes. In exchange for the tax break, they are required to spend money to improve the health of their communities, including providing free care to those who can't afford their medical bills. Although the hospitals report tens of millions in annual community benefit spending, the vast majority of that is not spent on the types of things advocates and researchers contend actually create community benefits, such as charity care.
And this month, four U.S. senators called on the Treasury's inspector general for tax administration and the Internal Revenue Service to evaluate nonprofit hospitals' compliance with tax-exempt requirements and provide information on oversight efforts.
The average hospital in the U.S. spends 1.9% of its operating expenses on charity care, according to an analysis of 2021 data by Johns Hopkins University health policy professor Ge Bai. Last year, Parkview provided 0.75% of its operating expenses, about $4.2 million, in free care.
Centura Health, a chain of 20 tax-exempt hospitals, reports its community benefit spending to the federal government in aggregate and does not break out specific numbers for individual hospitals. But St. Mary-Corwin reported $2.3 million in charity care in fiscal year 2022, according to its state filing. The filing does not specify the hospital's operating expenses.
The low levels of charity care have translated into more debt for low-income residents. About 15% of people in Pueblo County have medical debt in collections, compared with 11% statewide and 13% nationwide, according to 2022 data from the Urban Institute. Those Puebloans have median medical debt of $975, about 40% higher than in Colorado and the U.S. as a whole. And all of those numbers are worse for people of color.
"How far into debt do people have to go to get any kind of relief?" said Theresa Trujillo, co-executive director at the Center for Health Progress' Pueblo office. "Once you understand that there are tens of millions of dollars every single year that hospitals are extracting from our communities that are meant to be reinvested in our communities, you can't go back from that without saying, ‘Oh my gosh, that is a thread we need to pull on.'"
Trujillo is organizing a group of fed-up residents to engage both hospitals on their community benefit spending. The group of at least a dozen residents believe the hospitals are ignoring the needs identified by the community — things like housing, addiction treatment, behavioral health care, and youth activities — and instead spending those dollars on things that mainly benefit the hospitals and their staffs.
For the fiscal year ending June 2022, with total revenue of $593 million, Parkview reported $100 million in community benefit spending. But most of that — more than $77 million — represented the difference between the hospital's cost of providing care and what Medicaid paid for it.
IRS guidelines allow hospitals to claim Medicaid shortfall as a community benefit, but many academics and health policy experts argue such balance sheet shifts aren't the same as providing charity care to patients.
Parkview also reported $4.7 million for educating its medical staff and $143,000 in incentives to recruit health professionals as community benefit. The hospital spent only $44,000 on community health improvement projects, which appear to have consisted mainly of launching a new mobile app to streamline appointments and referrals.
Meanwhile, the hospital recently spent $58 million on a new orthopedic facility and $43 million on a new cancer center. Parkview also wrote off $39 million in bad debt in fiscal 2022, although that is different from charity care. The bad debt is money the hospitals tried to collect from patients and ultimately decided they'd never get. But by that time, those patients would likely have been sent to collections and potentially had their credit damaged. And outstanding debt often keeps patients from seeking other needed care.
There is a disconnect between what the community said its biggest health needs were and where Parkview directed its spending. The hospital's community needs assessment pegged access to care as the top concern, and the hospital said it launched the phone app in response.
The second-largest perceived health need was addressing alcohol and drug use. Yet, the only initiative Parkview cited in response was posting preventive health videos online, including some on alcohol and drug use. Meanwhile, the hospital shut down its inpatient psychiatric unit.
Parkview declined to answer questions about its charity care spending, but hospital spokesperson Todd Seip emailed a statement saying the hospital system "has been committed to providing extensive charity care to our community."
Seip noted that 80% of Parkview's patients are covered by Medicare or Medicaid, which pay lower rates than commercial insurance. The hospital posted a net loss of $6.7 million in the 2022 fiscal year, although its charity care wasn't appreciably higher in previous years in which it posted a net gain.
Centura St. Mary-Corwin reported $16 million in Medicaid shortfall and $2 million in medical staff education in 2022, according to its state filing. The hospital spent about $38,000 for its community health improvement projects, primarily on emergency medical services outreach programs in rural areas. The hospital provided another $96,000 in services, mainly to promote covid-19 vaccination.
Centura also declined to answer questions about its charity care spending. Hospital spokesperson Lindsay Radford emailed a statement saying St. Mary-Corwin was aligning its community health needs assessment process with the Pueblo Department of Public Health and Environment "to develop shared implementation strategies for our community benefit funds, ensuring the resources are targeting the highest needs."
Trujillo questioned how the hospital has conducted its community health assessments, relying on a social media poll to identify needs. After community members identified 12 concerns, she said, hospital leaders chose their priorities from the list.
"They talk about a community garden like they're feeding the whole south side of the community," Trujillo said. The hospital established a community garden in 2021, with 20 beds that could be adopted by residents to grow vegetables. Trujillo did praise the hospital for converting part of its building into dorms for a community college nursing program.
Trujillo's group has spent much of the summer researching hospital charity spending and showing up at public meetings to have their views heard. They are working to gain seats on hospital and other state boards that influence how community benefit dollars are spent, and are urging hospitals to reconfigure their boards to better represent the demographics of their communities.
"We've made folks now aware that we want to be a part of those processes," Trujillo said. "We're willing to help them reach deeper into the community."
Tax-exempt hospitals have been under increased state scrutiny for their charitable spending, especially after the Affordable Care Act and Medicaid expansion drove down the uninsured rate. That in turn cut the amount of care hospitals had to provide without being paid, potentially freeing up money to help more people without insurance or with high-deductible plans.
In Colorado, hospitals' charity care spending and bad debt write-offs dropped from an average of $680 million a year in the five years prior to the ACA being fully implemented in 2014 to an average of $337 million in the years after, according to the Colorado Healthcare Affordability and Sustainability Enterprise Board, a state advisory group.
In states like Colorado, which used federal funding to expand the number of people covered by Medicaid, hospitals shifted more of their community benefit spending to cover Medicaid reimbursement shortfalls.
A January report from Colorado's Department of Health Care Policy & Financing concluded that payments from public and private health plans help the state's hospitals make more than enough money to offset lower Medicaid rates and still turn a profit while providing more true charity care.
Colorado has enacted two bills in the past five years to increase the transparency of hospitals' charitable efforts with new reporting requirements.
"I think overall, we're pleased with the amount of money that hospitals are reporting they spent," said Kim Bimestefer, the executive director of the Department of Health Care Policy & Financing. "Is that money being expended in meaningful ways, ways that improve health and well-being of the community? Our reports right now can't determine that."
TULSA, Okla. — When Lou Ellen Horwitz first learned that a gas station company was going to open a chain of urgent care clinics, she was skeptical.
As CEO of the Urgent Care Association, Horwitz knows the industry is booming. Its market size has doubled in 10 years, as patients, particularly younger ones, are drawn to the convenience of the same-day appointments and extended hours offered by the walk-in clinics.
"Urgent care is harder than it looks," Horwitz recalled thinking when the Tulsa-based gas station and convenience store company QuikTrip announced an urgent care venture called MedWise in late 2020. "And that's a whole different ballgame than selling Funyuns."
But Horwitz said the more she thought about it, the more she saw an overlap between the business models of QuikTrip and of successful urgent care clinics: setting up in easy-to-find locations, catering to walk-ins, and accepting multiple payment methods, for example. QuikTrip opening health clinics might just make sense, she thought, provided they could deliver quality medical care.
In fact, QuikTrip had been providing primary care services to its own employees for years, through third parties and eventually at its own clinics. Five years ago, longtime "QuikTripper" Brice Habeck was tasked with leading a team to figure out how the company could offer such medical services to the general public, too. His team quickly realized that urgent care had a lot in common with their retail spaces.
"It's about access. It's about convenience," said Habeck, who started his career as a clerk at a QT, as the stores are often branded, and is now the executive director of MedWise.
MedWise has opened 12 clinics so far, all in the Tulsa area, and now belongs to Horwitz's trade group. The company is owned by QuikTrip, but the two businesses don't share buildings or a name. As much as people love the gas station, Habeck said, company leaders didn't want patients to think the person checking their vitals had just wiped down a gas pump.
QuikTrip is not the first company to see potential in the urgent care industry. Private equity firms have been investing in urgent care's consumer-friendly niche for over a decade. And nearly half of urgent cares are affiliated with hospital systems — which often see urgent care as a front door for bringing in new patients while also taking some burden off their busy emergency rooms.
Other retailers have also seen opportunities in expanding into patient care. Walmart, Target, CVS, and Walgreens have all opened what are called "retail clinics" in recent years, often in their existing stores and often partnering with local health systems to provide the actual medical care. Generally, the scope of services available at urgent care centers, such as MedWise clinics, is more robust than what's offered at those retail clinics, according to Horwitz.
But urgent care and retail clinics may not be a panacea for rising health care costs. A study co-authored by Harvard Medical School health policy professor Ateev Mehrotra shows urgent care clinics reduce less serious visits to the emergency room, yet 37 urgent care visits are needed to prevent a single trip to the ER, increasing total health care spending with all those trips.
And ongoing research by Vanderbilt University assistant professor Kevin Griffith suggests that newly constructed urgent care or retail clinics can decrease wait times at nearby private and public sector health centers initially. Eventually, however, the increased access provided by the new clinics increases demand as well, he is finding, and wait times creep back up.
"It's kind of like the 'build it and they will come' of health care," said Griffith, adding that even though the clinics may not decrease wait times long-term or reduce costs, they are getting patients seen. "There is a huge problem with unmet care in the United States. And so ostensibly, these clinics are making a dent into that problem as well."
The experience of some retail clinics is a cautionary tale for companies like MedWise, according to Mehrotra: Disrupting the health care industry is easier said than done, even for businesses with a successful track record of good customer service in a low-margin business such as gas stations.
"Generally people have been happy with the convenience," Mehrotra said, but the clinics have not been very profitable, promptingmanyclosures over the years.
Gas stations are accustomed to competing over customers by offering something special. QuikTrip, for example, was recently ranked ninth on a list of best gas station brands in America that noted QT's "beloved" made-to-order food, such as breakfast tacos. Habeck said he thinks patients today are open to a more transactional approach in health care as well.
That doesn't mean offering roller-grill hot dogs and taquitos in urgent care waiting rooms, although Habeck joked that MedWise might have tried that if it hadn't launched during the pandemic. Rather, he said, the chain is banking on winning customer loyalty by offering patients consistent service without necessarily offering a consistent clinician.
And, Habeck said, even though MedWise and QTs are not in the same buildings, the parent company's experience finding prominent locations for gas stations is useful for placing urgent cares as well.
On a recent Friday afternoon, Billy Rohling and Amy Shaver stood waiting for their ride home in the mostly empty parking lot of a MedWise at the same exit as a QT off Interstate Highway 244 in Tulsa. Rohling, 56, remembers when this corner of Admiral Place and Sheridan Road was a shopping center with tenants like J.C. Penney Co. and a five-and-dime called TG&Y.
Those stores are long gone now, though. The couple came to MedWise because Shaver, 37, was having breathing problems. It was her second time visiting the clinic.
"They aren't busy at all," Rohling said. "It took 15 minutes to get an EKG."
Indeed, MedWise's patient visits have slowed since the unexpected "windfall volume" that came as a result of opening during the pandemic, Habeck said. At one point, MedWise clinics administered curbside covid-19 tests to hundreds of patients a day, many of whom paid cash. The momentum from all those visits helped propel the clinics through abnormally low flu seasons in 2020 and 2021 — typically urgent care's bread and butter.
But Habeck said MedWise is still on track to expand. Four more locations are slated to open in northeastern Oklahoma this year, and the future should bring even more MedWise locations in QuikTrip's 17-state, 1,000-location footprint, in places such as Kansas City, Missouri, and Wichita, Kansas.
State health care rules, public insurance payment rates, and existing health system locations will all factor into where the new clinics are located, Habeck said, although expansion out of state is probably a couple of years away.
Horwitz said scaling up in the industry requires a degree of standardization — everything from clinic layouts to staffing levels, and even where various supplies are stored — that can be hard to attain. But she said it's a trend, with more urgent care chains having a triple-digit number of locations than ever before.
"Nobody's at 1,000, but some are closing in on it," Horwitz said.
This article was produced by KFF Health News, formerly known as Kaiser Health News (KHN), a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
Kaiser Permanente is looking to dramatically expand its national presence. It's committed $5 billion to a new unit called Risant Health and has agreed to acquire Pennsylvania-based Geisinger, but skeptics wonder how it will export its unique model to other states.
This article was published on Tuesday, August 15, 2023 in KFF Health News.
As regulators review Kaiser Permanente's proposed acquisition of a respected health system based in Pennsylvania, health care experts are still puzzling over how the surprise deal, announced in April, could fulfill the managed care giant's promise of improving care and reducing costs for patients, including in its home state of California.
KP said it would acquire Danville, Pennsylvania-based Geisinger — which has 10 hospitals, 1,700 employed physicians, and a 600,000-member health plan in three states — as the first step in the creation of a new national health care organization called Risant Health. Oakland-based Kaiser Permanente said it expects to invest $5 billion in Risant over the next five years, and to add as many as six more nonprofit health systems during that period.
Industry experts believe KP's aim is to build a big enough presence across the country to effectively compete with players like Amazon, Aetna CVS Health, Walmart Health, and UnitedHealth Group in providing health care for large corporate customers. Kaiser Permanente executives touted the potential for spreading the group's vaunted brand of quality, lower-cost care around the country.
But it's not clear how KP will be able to bring its model, in which facilities and doctors receive a monthly per-member fee for all care, to markets where it doesn't own an integrated system of physicians, hospitals, and health plans, as it does in California. Critics note that KP's efforts to expand failed in a number of states in the 1980s and 1990s.
In addition, the physician-led Permanente Medical Groups, which lead KP's patient care, were not involved in the Risant deal, raising questions about how their expertise would be shared.
"I don't know how Kaiser will bring its knowledge and best practices to improve health care delivery without the involvement of the medical group, which does all the care delivery," said Robert Pearl, a former CEO of the Permanente Medical Group who's now a lecturer at the Stanford Graduate School of Business.
There are also questions about how the expansion will benefit current KP customers. The tax-exempt, nonprofit organization has 39 hospitals, 24,000 physicians, and 12.7 million health plan members in eight states and Washington, D.C., though about three-quarters of its members are in California, where it controls nearly half of the private insurance market. KP reported $95 billion in revenue last year.
"We've asked Kaiser Permanente management questions about the deal's advantages to employees and customers, but we haven't heard back," said Caroline Lucas, the executive director of the Coalition of Kaiser Permanente Unions, several of which are in contentious contract talks with the company. "Where is the money coming from? Are the citizens of California and other states subsidizing this expansion? How are they benefiting?"
Kaiser Permanente CEO Greg Adams declined to comment. A KP spokesperson, Steve Shivinsky, said the group's physicians would be involved in developing a "platform" to offer other health systems its value-based care expertise, including in design of care models, pharmacy practices, consumer digital engagement, development of health insurance products, and best practices for supply chains. Shivinsky said work on the platform was just beginning.
"Risant Health's success will firmly establish value-based care as a better model for health care in this country," said Shivinsky, KP's director of national media relations.
"If there is a commitment to truly delivering higher-quality and lower-cost care, it will take time and hard work," said John Toussaint, chair of Catalysis, a nonprofit that trains executives in health care and other industries in quality improvement. "But frankly I'm skeptical that's the reason for these types of mergers. Bigger may be better for increasing prices, but not necessarily for improving care."
The deal may be a sign that KP, founded in 1945, is hearing the alluring call of lucrative fee-for-service medicine. "This gets Kaiser into the much bigger part of the market — commercial insurance — and expands beyond their traditional model of owning all the pieces and selling their own insurance," said Glenn Melnick, a health economics professor at the University of Southern California.
The Geisinger acquisition is being reviewed by the Pennsylvania Insurance Department, with a 30-day public comment period ending Aug. 7, 2023. The Federal Trade Commission and the California attorney general's office declined to say whether they were reviewing the deal. KP expects the deal to close sometime in 2024. There was no purchase price, but KP said Risant would make a minimum of $2 billion available to Geisinger through 2028, including income that Geisinger generates itself.
Federal and state antitrust regulators have expressed growing concern about consolidation of hospitals and physician groups into ever-larger organizations with the power to drive up prices. But antitrust experts say it's unlikely regulators will challenge the deal since KP does not currently have a presence in Pennsylvania, Delaware, or Maine, where Geisinger operates.
Indeed, the deal could boost competition if KP's investment enables Geisinger to expand beyond central and eastern Pennsylvania and take on the University of Pittsburgh Medical Center and Highmark, the state's two dominant integrated health systems.
Around the country, Risant could be appealing to businesses that offer health plans to their employees. "If Kaiser can become an effective player in more markets through Risant and that leads to greater price competition, that will be very attractive to large employers," said Bill Kramer, senior adviser for health policy at the Purchaser Business Group on Health, which represents large employer health plans.
Smaller health systems and physician groups that are struggling financially may also see joining Risant as a more palatable option than being acquired by more profit-hungry entities, such as private equity firms, Melnick noted.
Through tight coordination between its physicians, hospitals, and health plans, KP has a strong track record of producing good health outcomes, particularly for plan members with chronic conditions such as high blood pressure and diabetes. KP hospitals and doctors are paid a monthly per-member fee for all care — called capitated payment. That gives KP a powerful financial incentive to keep members healthy and prevent costly hospital admissions and emergency room visits.
In contrast, Geisinger and most other health systems across the country generally are paid for each separate procedure — known as fee-for-service payment — giving them less incentive to keep patients healthy and reduce overall costs. Because of that, it's not clear how KP's value-based care model will work at Geisinger and other health systems acquired through Risant.
Adams has said Risant won't try to fully replicate Kaiser Permanente's model. Instead, Risant will help other health systems achieve the same kind of outcomes and cost savings while working with multiple insurers and providers.
KP also could potentially learn lessons from Geisinger and other health systems about producing better health outcomes at lower cost for members. Geisinger has won acclaim for its ProvenCare model, in which it accepts a fixed fee for providing an entire episode of care, such as heart bypass surgery, with no extra charge if the outcome isn't satisfactory and the patient needs additional care.
But Kramer, a former KP executive, is skeptical. "It's hard if not impossible to transform a medical group that's reliant on fee-for-service payment into something like the Kaiser Permanente Medical Group," he said.
Critics of the deal, citing KP's failed expansion moves in the 1980s and 1990s, also worry that building Risant Health could distract KP executives from cost-control and quality improvement efforts in their home state and draw down the organization's financial reserves, potentially leading to premium hikes.
In 1999, for example, KP sold a money-losing medical group it had established in North Carolina in the mid-'80s. It faced opposition from the local medical community and challenges with employer health plans, among other factors. Kramer also pointed to its withdrawal from other markets including Connecticut, Missouri, Ohio, and Texas.
Still, KP did succeed in establishing a significant presence in the mid-Atlantic states, Washington, D.C., and Georgia, though it doesn't own hospitals in those markets. It also has long-standing operations in Hawaii, Colorado, and Oregon.
With Risant, KP will be up against very large, sophisticated managed care competitors including UnitedHealth's Optum, which employs about 70,000 physicians across the country.
"Hopefully Kaiser's senior leadership will be smarter this time around and avoid the kinds of problems they had when they expanded in the past," Kramer said.
California's largest public hospital plans to start notifying 43,000 former patients Monday that they may be eligible for refunds or billing corrections, part of what advocates called a major legal settlement that will help force the hospital to fulfill its charity care obligations.
Santa Clara Valley Medical Center, along with other units of county-owned Santa Clara Valley Healthcare, will also adopt procedures to ensure patients are informed of their eligibility for charity care, which nonprofit and public hospitals must provide.
"This is huge," said Helen Tran, a senior attorney with Western Center on Law & Poverty, which joined another California-based legal group, the Consumer Law Center, in a lawsuit against the hospital. "It's so important that the hospital is stepping up to take corrective action. That's something we haven't seen many hospitals do."
Filed in 2019 and settled in June, the lawsuit alleged that Santa Clara Valley Medical Center billed patients and sent them to collections for charges they should not have been required to pay. Emily Hepner, one of the plaintiffs, was a full-time student, raising two children alone,and uninsured in 2014 when she needed urgent surgery, according to the lawsuit. The hospital never followed up after telling her she might be eligible for charity care and, nearly a year later, she received a $34,884 bill. The hospital later sued her for that amount plus attorney fees.
The Santa Clara settlement comes at a time of mounting scrutiny of charity care around the country. A number of nonprofit hospitals have been found skimping on their obligations to provide free and discounted care, and failing to inform patients about their eligibility as more Americans struggle with medical debt.
"Santa Clara Valley Healthcare prides itself on delivering quality healthcare for individuals and communities that face significant socioeconomic hurdles to receiving this basic benefit," said Paul Lorenz, the system's chief executive, in a press release. "These newly implemented outreach efforts, combined with our current programs, multilingual approaches, and recent state-initiated efforts, will allow us to better serve those most in need." The health system and the county declined further comment.
The federal Affordable Care Act requires nonprofit hospitals to provide charity care, known officially as "financial assistance policies," to maintain their tax-exempt status. California requires it of all acute care hospitals. California patients whose income is below 400% of the federal poverty level can be eligible, meaning a single person earning less than $58,320 can qualify for financial assistance. A family of three, like Hepner's, could qualify today if the household makes less than $99,440. Factors such as a person's assets and the amount of medical expenses can also be considered.
In 2020, Santa Clara County raised the eligibility threshold for discounts from 350% of the federal poverty guidelines to 650%, and patients can qualify for free care if they make below 400%.
Under the settlement, the county agreed to give former patients at SCVMC the opportunity to apply for financial assistance retroactively, seek refunds, and have court judgments corrected. The entire Santa Clara Valley Healthcare system, which includes SCVMC and two other hospitals, also now must inform patients in eight languages about its charity care program and discount payment options in a timely manner.
A 2019 KFF Health News investigation found that St. Joseph Medical Center in Takoma, Washington, for example, settled a similar lawsuit in 2019 and agreed to pay more than $22 million in refunds and debt forgiveness. Tax-exempt hospitals around the country sent $2.7 billion in bills over the course of a year to patients who probably qualified for free or discounted care, the investigation found.
Tran said it's the first charity care settlement in California that provides restitution for a large group of patients since the Hospital Fair Pricing Act, which aims to protect patients from unaffordable hospital costs, took effect in 2007.
Emma Dinkelspiel, a senior attorney at Bay Area Legal Aid, said many hospitals obfuscate, making it difficult for patients to access financial aid.
"When you call in, they'll tell you that charity care doesn't exist and instead suggest payment plans," Dinkelspiel said. "There are some hospital systems who maybe advertise with posters but don't include information when they send out their debt collection letters."
According to a December report by KFF Health News, 1 in 5 hospitals that were scrutinized didn't post aid policies online.
In California, more than 4 million families could be income-eligible for free or discounted care, according to the 2022 American Community Survey.
Tran credits the county for addressing the issue and said private hospitals should follow their example.
"It's really setting the bar for what hospitals are able to do," Tran said. "We're hoping that other hospitals throughout California will too."
"How much is the ice cream?" A simple enough question, featured on a new TV and online advertisement, posed by a man who just wants something cold. A woman behind the counter responds with a smile: "Prices? No, we don't have those anymore. We have estimates."
The satirical ad pretends to be a news report highlighting a "trend" in which more retail outlets take up "the hospital pricing method": substituting estimates for actual prices for the cost of meals, merchandise on store shelves, and clothing. The scene ends with a partially deleted expletive from the ice cream-seeking man.
While the use of estimates in retail settings is imaginary and preposterous, the advertisement is part of an ongoing campaign by the advocacy group Patient Rights Advocate, which contends that some hospitals are still falling short of a law that went into effect in 2021 requiring them to publicly post their prices. Even then, said Cynthia Fisher, the group's founder and chairperson, too many post estimates rather than exact dollar-and-cent figures.
"People need price certainty," said Fisher. "Estimates are a way of gaming the people who pay for health care."
Although government data shows that hospitals' compliance with price transparency rules has improved, updating the requirements of that law is the focus of a new proposal by the Biden administration, which aims to further standardize the required data, increase its usefulness for consumers, and boost enforcement. Even with all that, however, the goal of exact price tags in every situation is likely to remain elusive.
"We're closer to that, but we're not there," said Gerard Anderson, a professor at the Johns Hopkins Bloomberg School of Public Health, who studies hospital pricing using the data that hospitals have already posted.
The proposed rule is designed to make it easier for consumers to learn in advance exactly what they might owe for nonemergency hospital care — though that was what the original price transparency rules were supposed to do.
Requiring hospitals to post their prices is part of a larger effort to make medical costs less opaque, which could help individual consumers predict their expenses and possibly slow health cost inflation, if it leads employers and insurers to contract with less expensive providers.
But the data files themselves are massive, often hard to find, and complex to decipher.
"Even for us, it's really hard to use," said Anderson.
Under current regulations, hospitals must publicly post prices for every service they offer, from drugs to stitches to time a patient spends in an operating room, as well as show all the bundled costs associated with 300 "shoppable" services, which are things people can plan for, such as a hip replacement or having a baby. Several different prices are required, including those they've negotiated with insurers and what they charge cash-paying customers.
Similar regulations, but with more prescriptive details and tougher penalties for noncompliance, went into effect for insurance companies in 2022, requiring them to post prices not only for hospital care, but also for outpatient centers and physician services.
The new hospital requirements proposed by the Centers for Medicare & Medicaid Services help "catch up to what they did with health plans," said Hal Andrews, CEO and president of Trilliant Health, a market research and analysis company.
"It's a step down the path to making the data more accessible" to data analysis firms that create online price comparison tools, said Jeff Leibach, a partner at the consulting firm Guidehouse. "And, ultimately, consumers who want to shop will then find this data more easily." Many hospitals, insurers, and third-party data firms have made such cost comparison tools available.
Even the new requirements may not resolve the demand that is central to the dystopian ad's ice cream-seeking man: getting exact prices, in dollars and cents. Such specificity may remain elusive for some consumers, if only because of the nature of medical care.
"Each patient is unique and uses a slightly different bundle of services," said Anderson of Johns Hopkins. "You might be in the operating room for 30 minutes, or it might be 45. You might need this lab test and not that one."
The proposed rule would, for one thing, further standardize the data required so that reporting is more comparable between facilities. It also mandates hospitals make their data sets easier to find on their websites, which could help data aggregators and consumers alike, and puts administrators in the hot seat to attest that their hospitals have posted all the required information accurately.
Individual hospitals that fail to post properly would face additional publicity by federal regulators: "Consider it a public naughty list," said Marcus Dorstel, vice president of operations at data analysis firm Turquoise Health, which provides an online tool consumers can use to check prices across hospitals.
In addition, the proposal adds a data category awkwardly called "consumer-friendly expected allowed charges," aimed at giving more information tied to the varied ways hospitals set prices. In plainer language, those allowed amounts are what hospitals expect to be reimbursed by insurance companies.
Some experts say that will be helpful.
For example, Dorstel said, currently a service might not be listed as a particular dollar amount, but the hospital will show the price is based on "70% of charges."
"Without the expected allowed amount, that doesn't tell you anything," Dorstel said.
Still, critics — such as Patient Rights Advocate, the group behind the new ad campaign — say that nodding to such allowed amounts will lead to even more estimates, rather than what they prefer: dollar-and-cent assessments.
"You and I would not buy a blouse at an average estimated amount," said Fisher.
Health care isn't like blouses or ice cream, responded executives from the American Hospital Association when asked about the advertisement and Fisher's concerns about exact, upfront amounts. In many situations, for example, it may be hard to know ahead of time exactly what kind of care a patient will need.
"Very few health services are so straightforward where you can expect no variation in the course of care," which could then result in a different cost than the original assessment," said Molly Smith, AHA's group vice president for public policy. "Organizations are doing the best they can to provide the closest estimate. If something changes in the course of your care, that estimate might adjust."
While hospitals' compliance with posting price information has improved, it still falls short, said Fisher, whose group in a July report said only 36% of 2,000 hospitals it reviewed complied with all aspects of the current law, marking as deficient those that had incomplete data fields or used formulas instead of dollar prices.
But the American Hospital Association says Fisher's group "misconstrues" hospital compliance, in part because hospitals are allowed to leave spaces blank, if, for example, they don't have a cash-only price. And formulas are allowed if that is how the prices are set.
The hospital group points instead to a CMS report from earlier this year that showed compliance was increasing year over year. It said 70% of hospitals were compliant with the current requirements of the law.
It took some doing to get that far. Since 2021, the federal government has sent more than 900 warning letters to hospitals about their posted data, with most resolving those concerns, according to the proposed rule. Four hospitals have been fined for failing to comply with the transparency law.
Pharmaceutical giant Novo Nordisk has turned to influential Black Americans in pursuit of what would be a lucrative victory: having Medicare cover a new class of weight loss drugs, including the company's highly sought Wegovy, which can cost patients more than $1,000 a month.
During a conference of the Congressional Black Caucus Foundation last fall — a jampacked gathering featuring prominent Black lawmakers and President Joe Biden — Novo Nordisk sponsored a panel discussion on obesity for which it selected the moderator and panelists, company spokesperson Nicole Ferreira said. The foundation is a nonprofit affiliated with the Congressional Black Caucus, a powerful group of lawmakers on Capitol Hill.
Former CNN political commentator Roland Martin moderated. Black health experts who support Medicare coverage of drugs used to treat obesity served on the panel. They included Fatima Cody Stanford, an associate professor of medicine at Harvard Medical School. Stanford is a specialist in obesity who has received consulting fees from Novo Nordisk.
During the panel discussion, Stanford told the audience that obesity "is a real disease that people struggle with," she recounted in an interview with KFF Health News. "We've denied people care for obesity when we haven't for other chronic diseases."
Novo Nordisk, the leading maker of so-called obesity drugs, followed up on the September panel by sponsoring a streaming show in March hosted by Martin, during which guests advocated for Medicare to cover drugs for weight loss. Ferreira said the company suggested experts for the segment, but she did not name them.
Those activities are part of a broader Novo Nordisk campaign to shift the public narrative about obesity. They open a new window on drugmakers' efforts to influence consumers and public policy.
Novo Nordisk is trying to reverse a 20-year-old ban on coverage of drugs used for weight loss under Medicare, the federal health insurance program primarily for people 65 and older. Congress excluded such medications when it established Medicare's Part D prescription drug benefit in 2003. The ban effectively deprives drugmakers of millions of potential customers.
Expanding the Patient Pool
Medicare coverage would put obesity drugs within reach of many people who could not otherwise afford them. It could have a multiplier effect because private insurers often follow Medicare's lead.
It would be a financial boon to Novo Nordisk and other drugmakers, including Eli Lilly, which is seeking FDA approval for a weight loss drug.
Adding to the cost, and the potential upside for the industry: To keep weight off, patients may have to take the drugs indefinitely.
Wegovy's list price is about $1,350 for roughly a month's supply. Eli Lilly's Mounjaro, a drug for people with Type 2 diabetes that doctors prescribe off-label for obesity, is priced at about $1,023 for roughly a month's supply.
Wegovy is FDA-approved for weight loss in adults who have a body mass index of 30 or greater — the definition of adult obesity, according to the Centers for Disease Control and Prevention — or a BMI of at least 27 plus at least one weight-related medical condition, such as hypertension. It's also approved for patients as young as 12 who are deemed obese.
In a statement, Novo Nordisk spokesperson Allison Schneider said, "We advocate for patients and policies that support access to all obesity treatments, including coverage for anti-obesity medications in Medicare Part D."
The company supports the Treat and Reduce Obesity Act, legislation introduced in 2013 that would overturn the Medicare coverage ban. In July, a bipartisan group of lawmakers in the House and Senate reintroduced the bill — something lawmakers have done repeatedly over the decade.
Drug companies have long used a variety of strategies to advance corporate interests, such as funding so-called patient advocacy groups focused on specific diseases and airing direct-to-consumer ads that spur patients to ask their doctors about brand-name drugs.
Novo Nordisk is the biggest corporate donor to the Obesity Action Coalition, which says its mission is "to elevate and empower those affected by obesity."
Novo Nordisk contributes more than $500,000 annually to the group, according to its website. The group's legislative objectives include reversing Medicare's coverage ban on weight loss drugs.
The Obesity Action Coalition "is not influenced in any way by our vast array of supporters," said Kendall Griffey, a spokesperson for the group.
Novo Nordisk has advertised Wegovy, which the FDA approved for weight loss in 2021, and Ozempic, which is approved for diabetes and prescribed off-label to treat obesity.
Like many large corporations, Novo Nordisk has contributed thousands of dollars annually to nonprofits tied to different groups of lawmakers while seeking support in Congress for its causes.
In 2021, Novo Nordisk gave between $100,000 and $399,999 to the Congressional Black Caucus Foundation and between $25,000 and $49,999 to the Asian Pacific American Institute for Congressional Studies, according to each nonprofit's annual report.
The latter nonprofit, known as APAICS, is affiliated with the Congressional Asian Pacific American Caucus. APAICS lists Novo Nordisk as a partner on webpages for events in March and May where panel discussions touched on the treatment of obesity.
The Congressional Hispanic Caucus Institute also lists Novo Nordisk as a donor but doesn't state how much the company contributed.
The Congressional Black Caucus, Congressional Hispanic Caucus, and Congressional Asian Pacific American Caucus back a bill on health disparities that in 2022 was revised to scrap Medicare's prohibition on covering prescriptions for weight loss.
The Congressional Black Caucus Foundation, the Congressional Hispanic Caucus Institute, and the Asian Pacific American Institute for Congressional Studies did not respond to questions for this article. Novo Nordisk declined to say how much it contributed to the Congressional Black Caucus Foundation's 2022 legislative conference and whether it sponsored the panel to influence Congressional Black Caucus members' positions; it similarly declined to specify its most recent annual contribution to the Congressional Hispanic Caucus Institute and its financial contributions for various APAICS events this year. "We support multiple organizations to help educate on and highlight issues important to their communities," company spokesperson Natalia Salomao said of Novo Nordisk's relationship with the nonprofits.
High-Profile Promoters
Martin's streaming daily news show in March featured an hourlong segment "powered by Novo Nordisk" on obesity among Black Americans. Ferreira, of Novo Nordisk, said Martin and Novo Nordisk "agreed that a segment on his show was a good opportunity to reach his audience to help further inform them about obesity as a chronic disease and the importance of good nutrition and health care."
Martin did not respond to requests for comment. During the episode, he cited Novo Nordisk's role. "I certainly want to thank them for partnering with us," he said.
Guests pushed for Medicare to cover patients' anti-obesity prescriptions, with an eye toward what coverage could mean for seniors and other adults. The federal government is "supposed to be leading the way on this," Nelson Dunlap, vice president of public policy and external affairs for Meharry Medical College, a historically Black institution, said during the segment.
"Commercial insurances tend to follow what Medicare does," Tiffani Bell Washington, a psychiatrist specializing in obesity medicine, said on the show. Obesity is "a health issue. So it really does need to be covered, and if Medicare covers it, usually other people follow."
Dunlap declined to comment for this article, and Bell Washington did not answer questions sent by email.
Novo Nordisk enlisted Black music and entertainment stars Queen Latifah and Yvette Nicole Brown to be paid spokespeople for an educational campaign that began in 2021 communicating that obesity is a chronic disease and should be treated like other ailments. Both celebrities have openly talked about living with obesity.
Stanford, one of the participants in the September panel, in 2022 received $23,188 from Novo Nordisk, nearly double what she received from the company in 2021, federal records show. The 2022 payments include consulting fees and expenses for meals and travel.
"I wouldn't want someone that has no knowledge informing them on how this actually works in real life," Stanford said, explaining her relationship with the companies. "The people they learn from are people like me, the people that actually do this work on the ground every day with patients."
Another panelist was Eric Griggs, an assistant vice president at Access Health Louisiana, a network of federally qualified health centers. In an interview, Griggs said Medicare coverage of obesity drugs "would help the solution. If you can help one group, you can help them all."
According to the Centers for Disease Control and Prevention, based on BMI, 50% of non-Hispanic Black adults in the U.S. are classified as obese, the highest rate for any race or ethnicity.
Since 2014, Novo Nordisk has spent more than $30 million lobbying members of Congress and other federal officials, according to a KFF Health News review of lobbying disclosures. A consistent subject is the Treat and Reduce Obesity Act.
"We have enormous health care challenges that flow from obesity," said Sen. Tom Carper (D-Del.), a lead sponsor of that legislation. He argued that spending money on weight loss drugs would reduce spending on chronic diseases that drive up the federal government's health care tab.
Carper is a longtime recipient of campaign cash from drug companies, including makers of weight loss drugs. However, some researchers express caution about lifting Medicare's coverage ban. For seniors, the side effects of such drugs could be more dangerous, according to a paper by scholars at Vanderbilt University and the University of Chicago.
Side effects for Wegovy and Ozempic may include kidney problems, gallbladder disease, inflammation of the pancreas, and thyroid cancer, according to the product labels. Suicidal thoughts are listed as a potentially serious side effect of Wegovy, its label says.
The Vanderbilt and Chicago researchers found that, even with modest uptake of the medications, annual Medicare Part D expenses could increase by $13.6 billion. That could leave policymakers "in the position of making broad cuts to other types of care," said Khrysta Baig, one of the paper's authors.
But people who want Medicare and other insurance programs to cover the drugs emphasize potential advantages.
Coverage would save "the lives that we're losing at early ages, especially in the Black community," Bell Washington said on Martin's show in March, before calling on viewers to take action. "You need to write to your legislators, make sure you're choosing people who are in support of health care for all," she said.
Many Americans really want to lose weight — and a new poll shows nearly half of adults would be interested in taking a prescription drug to help them do so.
At the same time, enthusiasm dims sharply if the treatment comes as an injection, if it is not covered by insurance, or if the weight is likely to return after discontinuing treatment, a new nationwide KFF poll found.
Those findings display the enthusiasm for a new generation of pricey weight loss drugs hitting the market and illustrate possible stumbling blocks, as users potentially must deal with weekly self-injections, lack of insurance coverage, and the need to continue the medications indefinitely.
For example, interest dropped to 14% when respondents were asked if they would still consider taking prescription medications if they knew they could regain weight after stopping the drugs.
One way to interpret that finding is "people want to lose a few pounds but don't want to be on a drug for the rest of their life," said Ashley Kirzinger, KFF's director of survey methodology. The monthly poll reached out to 1,327 U.S. adults.
The U.S. represents a large market for drugmakers who want to sell weight loss prescriptions: An estimated 42% of the population is classified as obese, according to a controversial metric known as BMI, or body mass index. In the KFF poll, 61% said they were currently trying to lose weight, although only 4% were taking a prescription medication to do so.
That gap between the 4% taking any kind of prescription weight loss treatment and the number of Americans deemed overweight or obese is the sweet spot drugmakers are targeting for the new drugs, which include several diabetes treatments repurposed as weight loss drugs.
The drugs have attracted much attention, both in mainstream publications and broadcasts and on social media, where they are often touted by celebrities and other influencers. Demand jumped and supplies have become limited. About 7 in 10 adults had heard at least "a little" about the new drugs, according to the survey.
The newer treatments include Wegovy, a slightly higher dose of Novo Nordisk's diabetes drug Ozempic, and Mounjaro, an Eli Lilly diabetes treatment for which the company is currently seeking FDA approval as a weight loss drug.
Weight loss with these injectable drugs surpasses those of earlier generations of weight loss medications. But they are also costlier than previous drugs. The monthly costs of the drugs set by the drugmakers can range from $900 to more than $1,300.
The drugs appear to work by mimicking a hormone that helps decrease appetite.
Still, like all drugs, they come with side effects, which can include nausea, diarrhea, vomiting, and constipation. More serious side effects include the risk of a type of thyroid cancer, inflammation of the pancreas, or low blood sugar. Health officials in Europe are investigating reports that the drugs may result in other side effects like suicidal thoughts.
The KFF survey found that 80% of adults thought insurers should cover the new weight loss drugs for those diagnosed as overweight or obese. Just over half wanted it covered for anyone who wanted to take it. Half would still support insurance coverage even if doing so could increase everyone's monthly premiums. Still, 16% of those surveyed said they would be interested in a weight loss prescription even if their insurance did not cover it.
In practice, coverage for the new treatments varies, and private insurers often peg coverage to patients' BMI, a ratio of height to weight. Medicare specifically bars coverage for drugs for "anorexia, weight loss, or weight gain," although it pays for bariatric surgery.
"Unfortunately, a lot of insurers have not caught up to the idea of recognizing obesity as a disease," said Fatima Cody Stanford, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School.
Employers and insurers must consider the potential costs of covering the drugs for enrollees — perhaps for them to use indefinitely — against the potential savings associated with losing weight, such as a lower chance of diabetes or joint problems.
Stanford said the drugs are not a miracle cure and do not work for everyone. But for those who benefit, "it can be significantly life-altering in a positive way," she said.
It's not surprising, she added, that the drugs may need to be taken long term, as "the idea that there is a quick fix" doesn't reflect the complexity of obesity as a disease.
While the drugs currently on the market are injectables, some drugmakers are developing oral weight loss drugs, although it is unclear whether the prices will be the same or less than the injectable products.
Still, many experts predict that a lot of money will be spent on weight loss products in the coming years. In a recent report, Morgan Stanley analysts called obesity "the new hypertension" and predicted industry revenue from U.S. sales of obesity drugs could rise from a current $1.6 billion annually to $31.5 billion by 2030.
Hospital toxicologist Ryan Marino has seen up close the violent reactions of children poisoned by liquid nicotine from electronic cigarettes. One young boy who came to his emergency room experienced intense nausea, diarrhea, and vomiting, and needed intravenous fluids to treat his dehydration.
Kids can also become dizzy, lose consciousness, and suffer dangerous drops in blood pressure. In the most severe case he's seen, doctors put another boy on a ventilator in the intensive care unit because he couldn't breathe, said Marino, of Case Western Reserve University School of Medicine.
Thousands of kids a year are exposed to the liquid nicotine in e-cigarettes, also known as vapes. For a toddler, even a few drops can be fatal.
Cases of vaping-related nicotine exposure reported to poison centers hit an all-time high in 2022 — despite a 2016 law, the Child Nicotine Poisoning Prevention Act, that requires child-resistant packaging on bottles of vaping liquid. In what doctors call a major oversight, the law doesn't require protective packaging on devices themselves.
Refillable vapes are designed to hold liquid nicotine in a central reservoir, making them dangerous to kids, Marino said. Even vapes that appear more child-resistant — because their nicotine is sealed inside a removable cartridge — present a risk, because the cartridges can be pried open. And some disposable e-cigarettes, now the top-selling type on the market, allow users to take thousands of "puffs" and contain as much nicotine as multiple packs of cigarettes.
Many e-cigarettes and liquids seem designed to appeal to kids, with pastel packages, names such as "Candy King," and flavors such as bubble gum and blue raspberry. That makes vapes far more tempting — and hazardous — than traditional cigarettes, which have lower doses of nicotine and a bitter taste that often prompts children to quickly spit them out, said Diane Calello, the executive and medical director of the New Jersey Poison Information and Education System.
"Nicotine liquid is an accident waiting to happen," Calello said. "It smells good and it's highly concentrated."
Sen. Richard Blumenthal (D-Conn.), who co-sponsored the 2016 legislation, said he would push to expand the childproof packaging requirement to disposable and pod-based e-cigarettes.
"Every day that FDA allows flavored e-cigarette products to remain on the market is another day that children can be enticed by these dangerous, and sometimes deadly, products," he said.
Although the FDA declined to comment for this article, on Aug. 2 the agency included a special feature about nicotine poisoning in children in its "CTP Connect" newsletter.
The number of reports to poison control centers about e-cigarettes has more than doubled since 2018, according to an FDA analysis. Poison control centers reported more than 7,000 vaping-related exposures in people of all ages from April 1, 2022, to March 31, 2023.
According to the FDA, 43 of those exposures resulted in hospitalization and an additional 582 in other medical treatment. About half of poison center reports had no information about whether patients needed medical care.
Nearly 90% of exposures involved children under 5. Authors of the report say their numbers likely underestimate the problem, given that poison control centers aren't contacted in every case.
A 1-year-old died from vaping-related nicotine poisoning in 2014. The new FDA report also mentions the apparent suicide of an adult via e-cigarette poisoning.
A spokesperson for the vaping industry said companies take safety seriously.
"All e-liquid bottles manufactured in the United States conform to U.S. law," said April Meyers, the president of the board of directors and CEO of the Smoke-Free Alternatives Trade Association, which represents the vaping industry. "Not only are the caps child-resistant, but the flow of liquid is restricted so that only small amounts can be dispensed."
Yet many vaping products are made outside the U.S., which has recently been flooded with illegal e-cigarettes, mostly from China.
The increasing number of nicotine exposures among kids — especially curious toddlers who put virtually everything they can grab into their mouths — likely reflects the sheer volume of e-cigarette sales, said Natalie Rine, the director of the Central Ohio Poison Center at Nationwide Children's Hospital.
E-cigarette unit sales grew 47% from January 2020 to December 2022, rising from 15.5 million every four weeks to 22.7 million, according to a report published by the Centers for Disease Control and Prevention.
"This isn't something that parents see as a really big risk," Marino said. "But with the popularity of e-cigarettes, the risk isn't going away anytime soon."
One effective strategy to reduce e-cigarette sales has been to ban flavored products. California, Massachusetts, New Jersey, New York, Rhode Island, and Washington, D.C., have banned all flavored e-cigarettes, while Utah and Maryland have banned some flavors. A study showed overall e-cigarette sales dropped 25% to 31% in states after flavor bans, compared with states that didn't ban them.
Some doctors say the country needs to do more to protect children.
"If the numbers are rising, then the law ain't working," said Carl Baum, a professor of pediatrics and emergency medicine at Yale School of Medicine.
Pediatrician Gary Smith said the lack of child safety requirements for e-cigarette devices is a major problem. Refillable e-cigarettes are relatively easy for kids to open.
Although most poison control center reports don't include brand information, disposable e-cigarettes — including Elfbar, Puff Bar, and Pop Vape — were some of the most common products mentioned in the FDA analysis. Elfbar is now known as EB Design.
Expanding the federal law to include devices would be "an important step," said Smith, president of the Child Injury Prevention Alliance, an Ohio-based advocacy group that works to prevent injuries in children.
In addition, federal officials should limit the nicotine concentration in vape juices to make them less toxic, as well as ban candy-like flavors and colors on packaging, Smith said.
"The public health response should be comprehensive," Smith said.
Kids have been known to pick up a vape and begin puffing, in imitation of their parents, Calello said.
Even if children don't inhale the aerosol, sucking on a vape exposes their skin to nicotine, which can be absorbed into the bloodstream, said Robert Glatter, an assistant professor of emergency medicine at Lenox Hill Hospital in New York City. Glatter noted that e-cigarette liquids also contain numerous harmful chemicals, including arsenic and lead, which is toxic at any dose; carcinogens such as acetaldehyde and formaldehyde; and benzene, a volatile organic compound found in auto exhaust.
Fortunately, children who inhale nicotine get a much lower dose than those who ingest it, reducing the risk of serious harm, said Marc Auerbach, a professor of pediatric emergency medicine at Yale School of Medicine.
Only about 2% of exposures in the FDA study were recorded as having a moderate or major effect.
That may be because little kids who get into dangerous liquids — from vape juice to household cleaning products or gasoline — usually spill most of it, Baum said. "They often end up wearing it rather than swallowing it," Baum said.
Although Stephen Thornton has seen a lot of children with nicotine exposure, he said, the human body has ways of protecting itself from toxic substances. "Fortunately, when kids do ingest these e-cig nicotine products, they self-decontaminate. They vomit — a lot — and this keeps the mortality rate very low, but these kids still often end up in emergency departments due to all the nausea and vomiting," said Thornton, an emergency medicine physician and medical director of the Kansas Poison Control Center.
The FDA urges parents and guardians of young children to keep e-cigarettes and vaping liquid out of reach and in its original container.
For emergency assistance, call Poison Help at 800-222-1222 to speak with a poison expert, or visit poisonhelp.org for support and resources.
A new Montana law will provide sweeping legal protections to health care practitioners who refuse to prescribe marijuana or participate in procedures and treatments such as abortion, medically assisted death, gender-affirming care, or others that run afoul of their ethical, moral, or religious beliefs or principles.
The law, which goes into effect in October, will gut patients' ability to take legal action if they believe they didn't receive proper care due to a conscientious objection by a provider or an institution, such as a hospital.
So-called medical conscience objection laws have existed at the state and federal levels for years, with most protecting providers who refuse to perform an abortion or sterilization procedure. But the new Montana law, and others like it that have passed or been introduced in statehouses across the U.S., goes further, to the point of undermining patient care and threatening the right of people to receive lifesaving and essential care, according to critics.
"I tend to call them ‘medical refusal bills,'" said Liz Reiner Platt, the director of Columbia Law School's Law, Rights, and Religion Project. "Patients are being denied the standard of care, being denied adequate medical care, because objections to certain routine medical practices are being prioritized over patient health."
This year, 21 bills instituting or expanding conscience clauses have been introduced in statehouses, and two have become law, according to the nonprofit Guttmacher Institute. Florida lawmakers passed legislation that allows providers and insurers to refuse any health service that violates ethical beliefs. Montana's law goes further, prohibiting the assignment of health workers to provide, facilitate, or refer patients for abortions unless the providers have consented in writing. South Carolina, Ohio, and Arkansas previously passed bills.
Supporters of the Montana law, called the Implement Medical Ethics and Diversity Act, say it fills gaps in federal law, empowering more medical professionals to practice medicine based on their conscience in circumstances beyond abortion and sterilization.
The bill applies to a wide range of practitioners, institutions, and insurers, encompassing just about any type of health care and anyone who could be providing it. The exception is emergency rooms, where the federal Emergency Medical Treatment and Labor Act takes precedence.
"We have technology that is pushing the limits of what is maybe ethical, and that is different in everybody's minds," said Republican state Rep. Amy Regier, who sponsored the Montana bill. "Having extra protections for people to practice according to their conscience as we continue down that path of innovation is important."
Claims the bill discriminates against patients frustrate Regier, who said it's about protecting health care providers. "Because someone has a conscientious objection to a specific service, they should be able to practice that way," she said.
In 1973, federal regulations known as the Church Amendments were implemented after the Supreme Court's Roe v. Wade decision made abortion legal nationwide. Under the Church Amendments, any institution that receives funding from the federal Department of Health and Human Services may not require health care providers to perform abortion or sterilization procedures if doing so would violate their religious or moral principles. Additionally, providers who refuse to perform these services may not be discriminated against for their decision.
Since then, at least 45 states have enacted their own abortion conscience clauses, according to the Guttmacher Institute. Of those, only 17 mandate that patients be notified of the refusal or limit the clause's use in the case of miscarriage or emergency.
A March 2020 article in the American Medical Association's Journal of Ethics said, "Clinicians who object to providing care on the basis of ‘conscience' have never been more robustly protected than today." Legal remedies for patients who receive inadequate care as a result have shrunk significantly, the article said.
But the wave of medical conscience bills introduced in statehouses since that article was published go beyond abortion to include contraception, sterilization, gender-affirming care, and other services. Opponents such as the American Civil Liberties Union, Planned Parenthood, and the Human Rights Campaign have been vocal opponents of this trend, criticizing it as a backdoor way to restrict the rights of women, LGBTQ+ community members, and other individuals.
Still, lawmakers across the country insist the right of doctors, nurses, pharmacists, and other medical providers to practice medicine in alignment with their beliefs is being infringed.
Some health care practitioners would "just be done" practicing medicine if forced to perform certain procedures such as abortion, Regier said. "That, to me, is what limits patient care."
Many of the most sweeping bills are backed by organizations that have made it their business to promote this "conscience" agenda nationwide, such as the Christian Medical Association, Catholic Medical Association, and National Association of Pro-Life Nurses. Other groups launched a joint effort in 2020 with the explicit purpose of advancing state legislation that makes it easier for health care providers to refuse to perform a wide range of procedures, including abortion and types of gender-affirming care.
The organizations that started the initiative are the Religious Freedom Institute in Washington D.C., an Arizona-based nonprofit called the Alliance Defending Freedom, and the Christ Medicus Foundation in Michigan. According to its website, the coalition bolsters efforts to pass more sweeping medical conscience legislation, using methods including print and digital media campaign strategy, grassroots organizing, and advocacy. After successes in Arkansas, Ohio, and South Carolina in 2021 and 2022, it turned to Montana and Florida. Regier said there are a "number of different organizations" pushing this type of legislation, including the Alliance Defending Freedom.
Most of these conscience laws are part of an "arsenal" to further social conservatism, and they are often religiously motivated, said Lori Freedman, a researcher and associate professor at the Bixby Center for Global Reproductive Health at the University of California-San Francisco.
Although federal law is meant to ensure people receive lifesaving care in an emergency, Freedman said, there are cases in which patients don't receive the care they should simply because they don't clear the bar of what a facility considers emergent.
While experts warn of the potential patient health consequences of these medical conscience bills, academics say placing a provider's choice over their patient's rights is itself a threat.
"These bills do not protect religious liberty because they make it impossible for people to follow their own religious and moral values in making major decisions," Reiner Platt said.
About 1 in 6 patients in the U.S. are treated in Catholic health care facilities, according to Freedman. Many of those venues strictly regulate or prohibit certain procedures, such as abortion, but do not necessarily disclose that to patients. As of 2016, more than 25% of hospital beds in Montana were in such facilities, according to the ACLU. Freedman determined through her research that about one-third of people whose primary hospital was Catholic didn't know of its religious affiliation and therefore were unaware of those limitations on their care.
The problem can extend to secular medical institutions, too. According to the AMA Journal of Ethics article, there are no rules requiring a patient be informed a provider is practicing conscientious objection, which means the patient might "unknowingly receive substandard care" and "even be harmed by" the provider's refusals.
"As much as we like to think about these providers and their opinions, so much is determined at a larger, structural level," Freedman said. "Abortion has been stigmatized, marginalized, and constrained," and plenty of hospitals and physician groups have made great efforts to "make a very safe service somehow illegal to provide within their context."