National

The U.S. faces a range of health care flashpoints — unaffordable drugs, opioids, vaping — as we debate whether to adopt universal care. For now, the Affordable Care Act is the law of the land, but Republicans want to issue it a final death blow.

Health

The biggest U.S. insulin manufacturers have each committed to lower the cost of their products — a move that will save them money by lowering the amount they'd otherwise have to rebate Medicaid.

Driving the news: Sanofi yesterday said it plans to cap out-of-pocket costs for its most prescribed insulin, Lantus, at $35 per month for people with private insurance, following similar steps from Eli Lilly and Novo Nordisk.

Eli Lilly earlier this month also committed to $35 per month. Novo Nordisk, on the other hand, said it would lower prices by 75%, with its lowest price at $48.20.

The big picture: The companies were facing pressure from President Biden and some in Congress to cap out-of-pocket insulin costs, after the Inflation Reduction Act limited monthly costs of the medicine for Medicare beneficiaries.

Over 1 million adults in the U.S. say they ration insulin due to the high costs of the drug.

Be smart: The companies said they decided to lower costs to ensure that patients could afford their medications. But Novo Nordisk and Sanofi's changes kick in on Jan. 1 and coincide with the elimination of a cap that limits how much manufacturers have to rebate Medicaid.

What this means: Federal law tries to ensure that Medicaid pays the lowest possible price for prescription drugs, and manufacturers who want their product covered have to agree to pay a rebate.

If a drug manufacturer raises its prices faster than inflation, then the rebate they pay also increases.

Insulin prices had risen so much that the rebate owed was higher than the price of the drug. But the law limited what drugmakers to the insulin's price. 

That will end on Jan. 1, when a requirement from the American Rescue Plan takes hold. Then, Eli Lilly, Sanofi and Novo Nordisk's new low costs will save them from owing the government millions.

Additionally, with the price drop, Medicaid will likely end up paying the companies more in order to purchase and cover their drugs, per Ars Technica.

By the numbers: Eli Lily is avoiding paying around $430 million per year in new Medicaid rebates and Novo Nordisk would save $350 million, Spencer Perlman, the director of health care research at Veda Partners, told Bloomberg.

Pharma lowers insulin costs to save money

Illustration of a syringe pulling from a vial with a hundred dollar bill as a label.  

Medicaid

Questions still swirl over Paxlovid as FDA full approval nears

Illustration of a gavel hovering over a block with an image of a red cross.

COVID-19 treatments

Three hospital workers have been charged with second-degree murder in the death of Irvo Otieno, bringing the total to 10 people charged in the case, the Dinwiddie County Commonwealth's Attorney said Thursday.

Driving the news: The three, who worked at Central State Hospital at the time of Otieno's death, were arrested Thursday after seven Sheriff's deputies arrested and charged earlier this week.

Details: The cases of Darian M. Blackwell, 23, Wavie L. Jones, 34, and Sadarius D. Williams, 27, will be presented to a Dinwiddie County grand jury next week for a final determination of charges, per the prosecutor's office. They are being held without bail.

"A key element" of the evidence is the surveillance video from Central State Hospital that captured the intake process, said Dinwiddie County Commonwealth’s Attorney Ann Cabell Baskervill in an emailed statement. 

The prosecutor added that she would not publicly release the video at this time "to maintain the integrity of the criminal justice process."

The video shows the seven deputies pushing a handcuffed Otieno down, Mark Krudys, an attorney for Otieno's family, said at a news conference Thursday.

"You can see that they’re putting their back into it. Every part of his body is being pushed down with absolute brutality," he added.

Of note: Civil rights attorney Ben Crump, who represented George Floyd's family, announced Thursday that he's joined Otieno's family's legal team.

"It is truly shocking that nearly three years after the brutal killing of George Floyd by police, another family is grieving a loved one who allegedly died in nearly the exact same manner — being pinned down by police for 12 agonizing minutes," Crump said in a statement.

 Background: Otieno, 28, died on March 6 during the intake process at the mental health facility where he was being transferred to from county jail. 

He was physically restrained at the time of his death, according to the prosecutor.

The Richmond medical examiner's office identified asphyxiation as a cause of death.

3 Virginia hospital workers charged in death of Irvo Otieno

Civil rights attorney Ben Crump, who's joined the Otieno family's legal team, called the case "shocking."

Attorney Ben Crump during a news conference in Houston, Texas, last May. Photo: Brandon Bell/Getty Images

Virginia

President Biden has made the COVID-19 crisis and a post-Trump return to national unity and traditional democratic ideals his top priorities. From vaccinations to stimulus to schools, Biden is seeking bipartisan compromise while showing a willingness to use executive authority and bare Democratic majorities in the U.S. House and Senate to implement his policies. Republican leaders are navigating deep party divisions over if and how to move beyond former President Trump.

Politics & Policy

Exposure to air pollution and psychological stresses among low-income Hispanic pregnant women can have an outsized effect on fetal growth, according to a study linking it to hampered growth.

The big picture: Latino populations in the U.S. are among the groups most consistently exposed to smog, lead poisoning, unsafe water, and toxic waste.

Recent studies, including an analysis by The Guardian published last week, have found that Latinos and Black people live in U.S. cities and neighborhoods with some of the worst pollution, including Houston and parts of Los Angeles.

Such exposure can lead to higher risks of premature death or chronic diseases such as asthma and heart conditions, according to the EPA. Those risks may be worse for babies with low birth weight.

Details: The fetal growth study, published in JAMA Network, looked at 628 Latinas who were pregnant and had clinic visits in California between 2015 and 2021.

It found a slightly higher level of PM2.5 exposure (particles that result from burning oil, diesel fuel, or gas) at the halfway point of pregnancy meant 9.5 grams/0.33 oz lower birth weight.

If the women faced additional psychological stress, measured on a self-reported scale, the birth weight could drop from 34 grams (1 oz.) when PM2.5 levels were high, to 117 grams (4 oz.) when nitrogen oxide exposure from fossil fuel burning was also high.

What they're saying: "The most vulnerable women are those who are hit with multiple types of stressors… reducing individual and neighborhood stressors should be a priority, particularly at the policy level," co-author Carrie Breton, from USC's Keck School of Medicine, said in a press releaseabout the study.

State of play: The EPA on Wednesday announced a rule as part of its Good Neighbor Plan, which the agency says will cut down on smog and nitrogen oxide pollution in 23 states for communities living downwind of power plants.

What to watch: The Biden administration's proposed budget for FY2024, unveiled last week, seeks $52.2 billion for environmental investments such as lower-emission public transportation.

The EPA announced in January that it would distribute $100 million in grants to community nonprofits and local governments to address environmental issues.

NGOs have been working to tackle toxicity levels that Hispanic U.S. populations are exposed to, such as a pilot program for clean water in Texas communities.

Subscribe to Axios Latino to get vital news about Latinos and Latin America, delivered to your inbox on Tuesdays and Thursdays.

Study: Air pollution, stress exposure for pregnant Latinas linked to lower birth rate

Latino populations in the U.S. are among the groups most consistently exposed to smog, unsafe water and toxic waste.

Illustration of a crib sitting beneath a mobile with a hanging medical cross 

Pregnancy

Latin America and Latinos

China is becoming the most formidable rival America has faced, and the risk of confrontation with Russia, North Korea or Iran still looms. Authoritarians are rising, the chaotic Afghanistan exit revealed the limits of U.S. power, and the pandemic, climate change and other critical challenges continue to pose grave threats.

World

The maternal mortality rate in the U.S. spiked in 2021, with deaths disproportionately impacting Black women.

Driving the news: More than 1,200 women died during pregnancy or shortly after giving birth in 2021, a 40% increase from 2020, according to data out Thursday from the National Center for Health Statistics.

In 2020, 861 women died during pregnancy or shortly after, compared to 754 women in 2019.

The big picture: Maternal mortality rates climbed during the pandemic, likely due to COVID-19 itself and the pandemic's impact on delaying care for other conditions, Axios' Arielle Dreher previously reported.

Between the lines: There are stark racial disparities in the maternal death rate, per the data.

In 2021, the maternal mortality rate for Black women was 69.9 deaths per 100,000 live births, compared to a rate of 26.6 per 100,000 for white women.

For the first time, the mortality rate for Hispanic women was higher than that of white women in 2021, the Wall Street Journal notes.

The maternal mortality rate was much higher among mothers above 40 compared to younger mothers.

Zoom out: Declines in maternal mortality rates around the world have stalled in recent years, according to a report released last month by the World Health Organization.

An estimated 287,000 women died from pregnancy-related complications in 2020, which is approximately 800 deaths every day — or one every two minutes, according to the report.

Go deeper... CDC: Maternal mortality disparities have worsened

CDC: Maternal mortality disparities have worsened

U.S. maternal death rate spiked during pandemic, CDC data shows

There are stark racial disparities in the maternal death rate in the U.S.

An empty bed in the ICU Covid-19 ward at NEA Baptist Memorial Hospital in Jonesboro, Arkansas, U.S., on Wednesday, Aug. 4, 2021. 

An empty bed at NEA Baptist Memorial Hospital in Jonesboro, Arkansas on Aug. 4, 2021. Photo: Houston Cofield/Bloomberg via Getty Images

Maternal deaths

Public health

From New Mexico to Maine, a handful of states have pending waiver requests to tap Medicaid funds for food in pilot programs. 

Why it matters: This signals growing support for "food is medicine" and food-based health interventions that are being echoed at both federal and state levels, despite mixed pilot reviews. 

The latest: New Mexico, Washington, New York, New Jersey, Delaware and Maine have pending Section 1115 waiver requests that would tap funds for nutrition support, according to the Kaiser Family Foundation's (KFF) waiver tracker. 

KFF senior policy analyst Madeline Guth tells Axios that these waiver requests were submitted before the Centers for Medicare and Medicaid Services put out a recommended framework in December for providing health-related social needs through the waivers.

This indicates that states "were already thinking about Section 1115 waivers as a mechanism through which they could address food insecurity and nutrition," according to Guth, whose research focuses on Medicaid and includes the Section 1115 waivers.

If approved, they'll join the ranks of Arkansas, Oregon and Massachusetts, which were already green-lit by the Biden administration to roll out Medicaid-for-groceries pilots. 

Between the lines: While Guth notes it's difficult to predict precisely what actions CMS will take on pending waivers, she says that the prior approvals indicate that the agency under the Biden administration is "very likely" to grant future states' Section 1115 requests to provide nutrition supports to targeted populations.

Plus, the White House national strategy on hunger, nutrition, and health issued in September references Section 1115 demonstrations to expand coverage of nutrition services and supports.

Of note: The waivers are not the only funding vehicle state lawmakers are pursuing to advance "food is medicine" treatments and better mitigate food insecurity.

In 2022, California implemented a similar practice to the pilots, incorporating coverage of medically tailored meals through Medi-Cal health plans, per the Hunter College New York City Food Policy Center.

And in Pennsylvania, legislation is expected to be introduced in the House of Representatives that would establish a "medically tailored meals pilot program," per the Pennsylvania Legislative Black Caucus.

What they're saying: "I know what it's like to be hungry. I know what it's like to live in a rural food desert," says Ashley Tyrner, CEO of food delivery company FarmboxRx.

Tyrner was once a single mother living on food stamps struggling to access fresh produce, which eventually led her to start her own "food is medicine" service. 

"You've got to pick if you can pay rent, or do you buy food? Do you buy food, or do you buy your heart medication, or your insulin?" 

Tyrner tells Axios that these kind of choices are a "stark reality for a lot of people in this country," with the "detrimental" end of SNAP emergency allotments benefits resulting in a "trickle-down effect" that's going to make things worse for food-insecure families.  

Meanwhile: Devon Klatell, vice president of the food initiative at The Rockefeller Foundation, tells Axios that "food is medicine" programs have largely operated at a local, community-based scale and, as a result, while promising, studies on their effectiveness have been "pretty fragmented." 

"We are really in a position where we need more robust and definitive evidence," says Klatell. 

Yes, but: Sue Daugherty, CEO of Philadelphia-based MANNA, which provides nutrition education and medically tailored meals to people with chronic illnesses, tells Axios that while she'd argue enough evidence exists backing such interventions, there hasn't been enough funding made available to examine national impact. 

"This wasn't being looked at or talked about a year ago, two years ago," says Daugherty. 

The bottom line: "People get prescribed insulin, they get prescribed high-blood pressure medicine, nobody thinks twice that they may be on that forever," Daugherty tells Axios. 

"But when we talk about nutritious food or medically tailored food, people are like 'Well, they can't get that forever.' Well, what if they need that forever?" 

Medicaid isn't out of the woods in debt limit talks 

Medicaid for food's next destination

New Mexico, Washington, New York, New Jersey, Delaware and Maine are trying to start their own pilot programs.

Food security

About 15 million people may drop off Medicaid rolls in the coming year as states redetermine program eligibility with the end of the COVID-19 public health emergency, a Kaiser Family Foundation survey of state officials found.

The big picture: States that were able to report projected coverage losses estimate that about 18% of Medicaid recipients will be disenrolled after program rolls surged during the pandemic.

More than 91 million adults and children were covered by Medicaid or CHIP as of November. Eligibility redeterminations will start next month, prompted by the end of policies that guaranteed continuous coverage during the health emergency.

What they found: States can use Social Security or wage data to verify if a person still meets the safety net program's eligibility criteria and renew them. KFF found some states, like Arizona and Oregon, expect to use the process to renew 75% of beneficiaries while others including California, New Jersey and Georgia will use that process less than 25% of the time.

About half of the states (27) have been flagging individuals who may no longer be eligible or who did not respond to renewal requests.

Sixteen states reported having a greater than 10% shortage of workers for redeterminations.

Alaska, Minnesota and Missouri offer no way for people to renew Medicaid coverage online, per the KFF survey.

About 15M could fall off Medicaid rolls with end of COVID emergency: KFF survey

Starting April 1, states will have to process through all people on their Medicaid rolls.

Illustration of a line of people waiting at a red cross-shaped door.

The Biden administration on Wednesday began fleshing out how it will implement drug-pricing provisions in the Inflation Reduction Act, including a multi-step negotiation process for selected Medicare drugs starting next year.

Why it matters: The law gave the administration discretion to work out many details of the first-ever drug price talks, which will initially cover 10 Part D drugs for which there's no generic competition.

Details: The guidance envisions the Centers for Medicare and Medicaid Services accepting one counteroffer from the manufacturer and holding one to three in-person or virtual meetings with the company before settling on a "final maximum fair price offer." Negotiations would end by Aug. 1, 2024.

The negotiated price would become effective in 2026. Companies that don't comply will be hit by an excise tax.

What they're saying: "By considering factors such as clinical benefit and unmet medical need, drug price negotiation intends to increase access to innovative treatments for people with Medicare," CMS administrator Chiquita Brooks-LaSure said in a statement.

The administration earlier on Wednesday identified 27 drugs that will trigger penalties on their manufacturers under a separate part of the IRA for having prices that rose faster than inflation. Those inflation rebates on will take effect in April.

The medicines included AbbVie's blockbuster anti-inflammatory drug Humira and the CAR-T cancer treatment Yescarta from Gilead.

CMS said Medicare recipients with Part B coverage who take the drugs could save between $2 and $390 per average dose starting April 1, depending on their circumstances.

The other side: "Despite the rhetoric we always hear, the administration’s own report shows that prices for the vast majority of Part B medicines are not skyrocketing," said Brian Newell, spokesperson for the big drug industry trade group PhRMA.

Biden admin lays out Medicare drug negotiation process

The Biden administration on Wednesday began fleshing out how it will implement drug-pricing provisions in the Inflation Reduction Act, including a multi-step negotiation process for selected Medicare drugs starting in 2024.

Illustration of medical pills with half of the capsule created from paper money.

Drug prices

Health Care Policy

Health Care Policy Thought Bubble

First, it was passing the Affordable Care Act. Then, it was defending it. Then it was allowing Medicare to negotiate drug prices. But with those big boxes checked, it's not clear what congressional Democrats' next big health care goal is. 

Why it matters: Taking too long to agree on the next big thing could create a policy vacuum heading into a presidential election cycle — and deprive lawmakers and outside groups of a target to aim for. 

It could even cede some important health issues to Republicans, though the GOP has struggled to find major health targets after the failure of Obamacare repeal. 

Most Democrats asked about their agenda favor wonkier, incremental initiatives over crafting new landmark laws. 

What they're saying: "There's a lot of good ideas out there, but this often happens, once you get a big victory you often need a little time to form consensus on what's next," Sen. Chris Murphy (D-Conn.) told Axios.

Between the lines: Senate Finance Chairman Ron Wyden (D-Ore.) pointed to President Biden's call to expand drug price negotiations, as well as work on mental health issues, including targeting insurers for inadequate provider networks, when asked about the next big thing. "Mental health is really big," he told Axios.

Two outside groups that advise Democrats — the Center for American Progress and Families USA — pointed to health care costs, and in particular focusing on hospital costs, not just drug prices.

That could mean dusting off some of the ideas that got left behind in a bipartisan Senate health committee bill from 2019, such as measures on competition and price transparency, said Emily Gee, senior vice president for inclusive growth at the Center for American Progress.

Jen Taylor, senior director of federal relations at Families USA, added: "Talking about site neutral payment feels really obscure until you are like, 'Wait a minute, I'm now charged more because the hospital bought up my old doctor's office. I'm getting the same thing and now I pay twice as much' ... that connects with people."

Remember the public option? On a larger scale, there was a time (2019, not all that long ago) when it seemed like all Democrats could do was argue about full-on Medicare for All versus variations of the public option.

That focus on coverage, as opposed to costs, faded even before Republicans won the House, making the ideas even more dead for the moment.

"There's a lot more people with coverage today," Murphy said. "We have been successful in bending the cost curve; it's not spiraling upwards out of control like it was a decade ago. So I think there is some level of decreased angst about health care."

Of course, Sen. Bernie Sanders (I-Vt.) is now the chairman of the HELP Committee. But even he isn't putting a ton of emphasis on Medicare for All these days. "We don't have the votes," he told the New York Times last month.

Instead, he's been using his bully pulpit on issues like the price of the Moderna vaccine and insulin.

Another of Sanders' big ideas — adding dental, vision and hearing benefits to Medicare — came a bit closer during the Build Back Better debate, but still faces hurdles, including the cost. 

Hospitals could receive growing scrutiny after pharma took its beating in the Inflation Reduction Act. But the politics of taking them on are tough. 

"People love their local hospital," Taylor said. "But they also don't love getting home and opening a $35,000 bill for something that they have no idea why that happened."

A version of this story was published first on Axios Pro. Get news like this by subscribing. Use code POLICY100 which gives you $100 off.

Hill Democrats search for the next big health care target

With their big boxes checked, it's not clear what congressional Democrats' next big health care goal is.

Congress

A federal judge in Texas is poised to rule "as soon as possible" on whether to suspend the FDA's approval of a widely-used abortion pill and potentially reverse the agency's authority on drug regulation for the first time.

Why it matters: Legal experts fear that if District Judge Matthew Kacsmaryk orders the FDA to temporarily withdraw its approval of mifepristone, others will challenge FDA-approved treatments that they disagree with.

Kacsmaryk, a Trump appointee who openly opposed Roe v. Wade, heard arguments on Wednesday from the parties involved in the case and said he would issue a ruling "as soon as possible."

The case was brought by a coalition of anti-abortion groups challenging the FDA's 2000 approval on the grounds that the agency did not properly authorize the pill for terminating pregnancies.

State of play: A ruling "will have very significant implications for the drug approval process in this country as we know it," Lorie Chaiten, a senior staff attorney with the ACLU, told Axios last month. "It would say that a single judge sitting in Amarillo, Texas, gets to define drug approval policy and abortion policy for the entire country."

Additionally, "[m]anufacturers may be reluctant to bring to market certain new drugs or treatments if they are concerned that a court ruling could block the approval of the drug in the future," according to the Kaiser Family Foundation.

Driving the news: Kacsmaryk asked the anti-abortion group's attorney, Erik Baptist, if he could cite any other instances in which a court has removed an FDA-approved drug from the market. Baptist said there were none.

The judge also asked Baptist how to write a decision ordering the FDA to suspend its approval. The attorney said the court can order the FDA withdrawal “on its own accord," per The Washington Post.

Details: The FDA has a process for removing drugs from the market, so it is unclear precisely how a ruling for the plaintiffs could disrupt or supersede that process.

When the FDA requests a drug recall, it notifies manufacturers, who then have the opportunity to request a hearing, grant the request or argue against it. The process can take up to a year.

What they're saying: "There’s no precedent or basis for the judge to simply 'undo' an approval from the bench," said Susan Lee, a partner at the law firm Goodwin who specializes in the FDA's regulation of drugs and biologics.

"A judge’s appropriate role can be to consider whether the FDA appropriately exercised its legal authorities and followed its own regulations when making decisions, but it would be concerning if Judge Kacsmaryk were to come to a decision suggesting that his ruling can supersede the authorities that have been granted to FDA by law."

"This type of activity would fundamentally de-stabilize the FDA regulatory system," Lee added.

What we're watching: "It is the federal government's practice to follow a court order in these circumstances," said David Donatti, an attorney with the ACLU of Texas.

However, Donatti said, he expects that if the FDA gets any "adverse order," the agency would seek an emergency order from an appeals court.

"I think that there would be a good argument for that, which is that this is a drug that is distributed nationwide ... with a sterling safety rating that is relied upon by millions of people for their health care," Donatti added.

Any decision from this case would likely be appealed to the 5th U.S. Circuit Court of Appeals, widely regarded as one of the most conservative appeallate courts, and could eventually reach the Supreme Court.

Zoom in: The hearing today focused on looking at mifepristone's initial 2000 approval that the FDA granted under rules known as "Subpart H," which were used at the time to expedite approval or drugs that treated "serious or life-threatening illnesses," such as HIV/AIDS.

The plaintiffs in the Texas case argue that the FDA violated its own rules when it approved mifepristone because pregnancy, they say, it not a disease. However, some health experts say that this argument lacks standing because mifepristone is now approved under an agency process for drugs with safety concerns. 

"The issue is kind of moot," said Alina Salganicoff, KFF's senior vice president and director of women’s health policy. "REMS basically replaced Subpart H."

Don't forget: There is another lawsuit brought by state Democratic attorneys general challenging the FDA's REMS restrictions on mifepristone in an effort to make the drug more easily accessible.

Two other lawsuits have been brought in North Carolina and West Virginia that are looking to answer the question on whether states can regulate or restrict FDA-approved drugs.

Kacsmaryk's ruling could impact the outcome of these other lawsuits.

Go deeper: How abortion pills work and why they're in the spotlight

How abortion pills work and why they're in the spotlight

Abortion pill ruling looms over FDA's drug approval process

"This type of activity would fundamentally de-stabilize the FDA regulatory system," a legal expert said.

Picture of a pill bottle whose label says "mifepristone"

Photo: James Leynse/Corbis via Getty Images

Friday's health stories