1 big thing: Boosting U.S. drug manufacturing

2. Trump's Obamacare gift to Dems

3. Ransomware halts ERs across the U.S.

4. The effort to limit abortion exceptions

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5. Catch up quick 

Happy Tuesday. Today's newsletter is 1,095 words or a 4-minute read.

Thanks for reading Axios Vitals, and to health care editor Jason Millman and copy editor Matt Piper. Please ask your friends and colleagues to sign up.

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1 big thing: SCOTUS weighs Purdue payout plan

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2. Obesity startups jockey for position

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3. Panel probes FDA's handling of decongestant

4. A new needle-free vaccine makes waves

5. While you were weekending

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Good morning, Vitals crew. Today's newsletter is 1,052 words or a 4-minute read.

1 big thing: What ChatGPT has changed

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2. HHS sending COVID tests to schools

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3. FDA probes CAR-T safety

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4. Quote du jour: Global health success

5. Soaring health costs may level a bit: Survey

6. Catch up quick

Good morning, Vitals crew. Today's newsletter is 997 words or a 4-minute read.

1 big thing: GOP's repeal caution

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2. PBM business could trip up Cigna-Humana deal

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3. Suicides reached record levels last year

4. COVID vax update in the states

5. Catch up quick

Happy Thursday, Vitals gang. Today's newsletter is 956 words or a 3.5-minute read.

Situational awareness: Mandy Cohen, in her first Hill hearing as CDC director, will testify this morning about rebuilding trust in the agency.

1 big thing: Bulked-up health care

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2.  New docs aren't interested in geriatrics

3. GOP floats potential CDC changes

4. Walgreens' big plans for digital tools

5. A warning about AIDS progress

7. Dog of the week

Somehow, it's December again, Vitals crew. Today's newsletter is 1,191 words or a 4.5-minute read.

Situational awareness: Medicaid expansion begins in North Carolina today, with about half of the 600,000-plus eligible low-income adults being automatically enrolled, the AP notes.

FetchError

National

The Biden administration for the first time will allow all schools to order free COVID-19 tests from the federal government ahead of the holidays, officials told Axios first. 

Why it matters: Uptake of updated COVID vaccines has been sluggish, making other precautions like timely testing all the more critical as respiratory virus season heats up.

What they're saying: "Our schools are so important in our communities. They reach both children, their families, parents, teachers and staff and we think they're an important avenue to make sure that free tests are available," Dawn O'Connell, assistant secretary for preparedness and response, told Axios.

Details: The Administration for Strategic Preparedness and Response (ASPR), an agency within HHS, has a stockpile of hundreds of millions of COVID tests. It is teaming up with the Department of Education to allow school districts to order tests directly to distribute to families.

HHS officials said schools could order tests at a rate they could expect to distribute them, but they did not specify a limit.

"I could imagine a situation where perhaps a fifth grade classroom, it has a COVID-positive student and then they send everyone home with a COVID test in the backpack from that fifth grade class," O'Connell said.

The administration this fall also restarted a program allowing households to order free at-home tests through the U.S. Postal Service. 

It has also been sending free tests to long-term care facilities, food banks and other organizations working with vulnerable populations. A small number of schools that serve socially vulnerable students were previously able to order tests from the federal stockpile.

Between the lines: Most of the tests provided by ASPR have expiration dates that have been extended for at least several months. Health officials are encouraging people who receive the tests to check with the Food and Drug Administration to verify that the expiration date has been extended.

Scoop: Biden administration sending free COVID tests to schools

Uptake of updated COVID vaccines has been sluggish, making other precautions like timely testing all the more important.

COVID-19

Coronavirus

The Biden administration for the first time will allow all schools to order free <a class="gtmContentClick" data-vars-link-text="COVID-19 tests" data-vars-click-url="https://www.axios.com/2023/09/20/covid-test-program-mail" data-vars-content-id="57215c2d-2e00-4f4d-b776-36af5f3553c9" data-vars-headline="Scoop: Biden administration sending free COVID tests to schools" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/09/20/covid-test-program-mail" target="_self">COVID-19 tests</a> from the federal government ahead of the holidays, officials told Axios first. Why it matters: Uptake of updated COVID vaccines has been sluggish, making other precautions like timely testing all the more critical as respiratory virus season <a class="gtmContentClick" data-vars-link-text="heats up" data-vars-click-url="https://www.axios.com/2023/11/22/covid-rsv-flu-cases-up-holidays-family-gathering" data-vars-content-id="57215c2d-2e00-4f4d-b776-36af5f3553c9" data-vars-headline="Scoop: Biden administration sending free COVID tests to schools" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/11/22/covid-rsv-flu-cases-up-holidays-family-gathering" target="_self">heats up</a>.

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

Despite reported spikes of pneumonia cases among kids in two states, the Centers for Disease Control and Prevention says U.S. transmission rates are still considered "typical" for this time of year.

Driving the news: Health officials in Massachusetts and Ohio have reported a sharp uptick in pediatric pneumonia caused by the bacteria Mycoplasma pneumonia, often the cause of what's known as "walking pneumonia" because of its typically mild symptoms. 

It comes amid reports that hospitals in China, as well as some European nations like Denmark, have been overwhelmed by a surge in childhood pneumonia and other respiratory illnesses. 

What they're saying: "As of today, we are not seeing anything that is atypical in terms of pneumonia-related emergency department visits," CDC director Mandy Cohen told reporters Friday.

Cohen said she's been in contact with the CDC's Chinese public health counterparts and partners in Europe. So far, evidence suggests an uptick in illnesses in China appears to be from the spread of RSV, COVID-19, the flu and pneumonia, she said. Other health authorities and public health experts have offered a similar assessment. 

"Based on what we know today, the illnesses are not due to a new or novel virus or illness," Cohen said. 

Between the lines: CDC officials say they've been in touch with health officials in Massachusetts and Ohio and that there is enough hospital capacity to handle a surge in cases.

The majority of patients are being treated with antibiotics or antivirals and are recovering at home, Cohen said. 

Pneumonia rates in U.S. "typical," despite reported spikes: CDC

Reported upticks in Massachusetts and Ohio come as China and some European countries have reported a rise in pneumonia and other respiratory illnesses.

Photo: Nathan Posner/Anadolu Agency via Getty Images

Children's health

Public health

Despite reported spikes of pneumonia cases among kids in two states, the Centers for Disease Control and Prevention says U.S. transmission rates are still considered &quot;typical&quot; for <a class="gtmContentClick" data-vars-link-text="this time of year" data-vars-click-url="https://www.axios.com/2023/11/22/covid-rsv-flu-cases-up-holidays-family-gathering" data-vars-content-id="73562ef7-0ea9-4f41-9b99-f33064273bc8" data-vars-headline="Pneumonia rates in U.S. &quot;typical,&quot; despite reported spikes: CDC" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/11/22/covid-rsv-flu-cases-up-holidays-family-gathering" target="_self">this time of year</a>.Driving the news: Health officials in <a class="gtmContentClick" data-vars-link-text="Massachusetts" data-vars-click-url="https://www.westernmassnews.com/2023/11/29/doctors-seeing-increase-walking-pneumonia-rsv-cases-kids/" data-vars-content-id="73562ef7-0ea9-4f41-9b99-f33064273bc8" data-vars-headline="Pneumonia rates in U.S. &quot;typical,&quot; despite reported spikes: CDC" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.westernmassnews.com/2023/11/29/doctors-seeing-increase-walking-pneumonia-rsv-cases-kids/" target="_blank">Massachusetts</a> and <a class="gtmContentClick" data-vars-link-text="Ohio" data-vars-click-url="https://www.nbcnews.com/now/video/ohio-officials-report-rising-number-of-pediatric-pneumonia-cases-199155781939" data-vars-content-id="73562ef7-0ea9-4f41-9b99-f33064273bc8" data-vars-headline="Pneumonia rates in U.S. &quot;typical,&quot; despite reported spikes: CDC" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.nbcnews.com/now/video/ohio-officials-report-rising-number-of-pediatric-pneumonia-cases-199155781939" target="_blank">Ohio</a> have reported a sharp uptick in pediatric pneumonia caused by the bacteria Mycoplasma pneumonia, often the cause of what&#x27;s known as &quot;walking pneumonia&quot; because of its typically mild symptoms.

Republicans on a House oversight panel will investigate the Food and Drug Administration's handling of a common decongestant ingredient that the agency recently concluded was ineffective, the committee told Axios first.

Why it matters: The inquiry, the latest in an aggressive investigative agenda by House Republicans, seeks to understand why the FDA didn't take earlier action against a wide range of over-the-counter cough and cold drugs that accounted for nearly $1.8 billion in sales last year. 

Driving the news: Rep. Lisa McClain (R-Mich.), chairwoman of the House Oversight subcommittee on health care and financial services, in a letter being sent today will request a briefing with FDA commissioner Robert Califf. 

The FDA "relied upon outdated and insufficient evidence regarding phenylephrine's use as a decongestant for so many years, despite numerous appeals by the scientific community," she wrote.

"Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs."

Catch up quick: In September, an FDA advisory panel found that oral formulations of phenylephrine, which is in drugs like Sudafed PE and some versions of NyQuil, were ineffective.

There had been questions about the ingredient's effectiveness for years, and the FDA previously reviewed it about 15 years ago. Since then, there were several large studies that confirmed oral formulations were ineffective, agency scientists said in September. 

CVS Health voluntarily removed common decongestants that contain phenylephrine as the only active ingredient from store shelves in October. 

Doctors and other health experts have since raised skepticism about the efficacy of a large number of over-the-counter cold medications, NPR reported.

What we're watching: The FDA is expected to decide whether it will order products with oral phenylephrine be pulled from shelves. 

Scoop: House panel investigating FDA's handling of decongestants

Republicans want to know why the FDA didn't take earlier action against a drug ingredient recently deemed ineffective.

Food and Drug Administration (FDA)

Republicans on a House oversight panel will investigate the Food and Drug Administration&#x27;s handling of a common decongestant ingredient that the agency recently concluded was <a class="gtmContentClick" data-vars-link-text="ineffective" data-vars-click-url="https://www.axios.com/2023/09/12/fda-cold-medication-sudafed-nyquil-inneffective" data-vars-content-id="a43c4fdf-68a9-4177-9279-7913603f4840" data-vars-headline="Scoop: House panel investigating FDA&#x27;s handling of decongestants" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/09/12/fda-cold-medication-sudafed-nyquil-inneffective" target="_self">ineffective</a>, the committee told Axios first.Why it matters: The inquiry, the latest in an <a class="gtmContentClick" data-vars-link-text="aggressive investigative agenda" data-vars-click-url="https://www.axios.com/2023/02/28/oversight-committee-plots-sweeping-scope-investigations" data-vars-content-id="a43c4fdf-68a9-4177-9279-7913603f4840" data-vars-headline="Scoop: House panel investigating FDA&#x27;s handling of decongestants" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/02/28/oversight-committee-plots-sweeping-scope-investigations" target="_self">aggressive investigative agenda</a> by House Republicans, seeks to understand why the FDA didn&#x27;t take earlier action against a wide range of over-the-counter cough and cold drugs that accounted for nearly $1.8 billion in sales last year.

A deal reportedly brewing between health insurance giants Cigna and Humana will likely face antitrust challenges over their respective pharmacy benefit management businesses, experts tell Axios.

Details: The combination would be huge. Cigna is now valued at $78 billion and Humana is at roughly $60 billion.

With 35 million members between them, the combined company would have the scale to rival UnitedHealth Group and CVS Health.

What they're saying: The companies' respective insurance businesses may not trigger antitrust concerns, since Cigna is more focused on the private market while Humana is centered on government business, including Medicare Advantage.

Cigna is reportedly exploring a sale of its Medicare Advantage business, which investors see as preparation for a possible Humana bid, wrote TD Cowen analyst Gary Taylor.

"We actually think antitrust concerns could be alleviated in the medical insurance part of this deal since there would be very little overlap that couldn't be solved by divestitures," Julie Utterback, a senior equity analyst for Morningstar, wrote in an email to Axios.

Yes, but: That "leaves an elephant in the room," Taylor wrote — PBMs.

"Given the extraordinary regulatory scrutiny of PBMs, this aspect of the deal seems certain to be challenged," he said.

Utterback said it was hard to imagine Cigna giving up Express Scripts, the country's second-largest PBM, which it acquired for $54 billion in 2018. At the same time, it would be hard for Humana to divest of its PBM, which largely serves its own customers.

"It gets trickier on the PBM side of things where we are unsure of how a deal could be structured to satisfy regulators," Utterback wrote.

Flashback: Humana and Cigna flirted with the idea of merging in 2017 after regulators struck down their deals to combine with Aetna and Anthem, respectively.

Yes, but: Insurance behemoth UnitedHealth Group, the largest in the U.S with more than 47 million enrollees, would still eclipse a combined company.

The antitrust tripwire for health insurers Cigna and Humana

Pharmacy benefit managers are the "elephant in the room."

Photo: Joe Buglewicz/Bloomberg via Getty Images.

Dealmaking

A deal <a class="gtmContentClick" data-vars-link-text="reportedly brewing" data-vars-click-url="https://www.wsj.com/business/deals/cigna-humana-in-talks-for-blockbuster-merger-c5c7f1b0" data-vars-content-id="e32573bd-080c-470e-9eb4-034659c097d4" data-vars-headline="The antitrust tripwire for health insurers Cigna and Humana" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.wsj.com/business/deals/cigna-humana-in-talks-for-blockbuster-merger-c5c7f1b0" target="_blank">reportedly brewing</a> between health insurance giants Cigna and Humana will likely face antitrust challenges over their respective pharmacy benefit management businesses, experts tell Axios.Details: The combination would be huge. Cigna is now valued at $78 billion and Humana is at roughly $60 billion.

Latest news on Wall Street, Corporate America and financial regulation.

Business

It's passed medical licensing exams. It's advanced how researchers develop new medicines and cut down on doctors' hefty paperwork. And it's nudged health care closer to a world where AI can offer diagnoses. 

Why it matters: One year after OpenAI's ChatGPT exploded onto the scene, the generative AI model is already upending health care — an industry not exactly known for its speedy adoption of tech — while accelerating questions about AI's promises and limitations.

The big picture: While AI and algorithms have been used in health care for decades, ChatGPT and other generative AI models that quickly followed have supercharged their use across research and the delivery of care.

"All these things that are happening now [are] because the race to get to AI faster, quicker and to create the market share began with ChatGPT," said Shafiq Rab, system CIO and chief digital officer at Tufts Medicine.

"We're in the 'wow' period,"  Stanford's School of Medicine dean Lloyd Minor told Axios at a health tech event earlier this fall.

He and other experts predicted that the unprecedented hype around how AI may change health care will begin to quiet down over the next few months as the industry races to get a better handle on what the technology can and can't do.

Catch up quick: Early in 2023, experts were holding "conversations" with ChatGPT on subjects like stem cell research or the future of surgery.

They quickly graduated to testing how well ChatGPT performed on the U.S. Medical Licensing Exam. (It passed.)

Soon, clinicians started wondering if it could lighten their workloads, with studies examining how well ChatGPT wrote discharge summaries or radiology reports. In some cases, it was even found to be more empathetic in answering patient questions.

With the rollout of other large language models from competitors such as Google and Amazon, tech companies started looking at how to help doctors more efficiently sift through the latest research or listen in on patient visits to give doctors a hand with documentation.

The pharma industry is already using generative AI models to make drug discovery more efficient. Tech giants have been finding ways to use the algorithms to better target cancer.

"What we did in the last 100 years, we'll achieve in the next 10 years, or even five years," Rab predicted. 

Yes, but: There's also been quite a bit of hand-wringing about AI chatbots' potential to churn out harmful misinformation, amplify bias and undermine medical education.

The medical community has emphatically dismissed the idea that AI could replace doctors' role in diagnosing patients — but research is already raising questions about its potential.

While the evolution of generative AI has been hailed for its potential ability to develop biodefense tools, there have also been warnings about its ability to create new biological threats. 

Our thought bubble: At a recent health tech conference, it seemed every other company and health system there touted their use of AI. 

It was a clear sign health care was in the throes of the generative AI hype cycle, something several folks I interviewed there also observed.

"It's powerful. But I think you know, the hype right now is, is probably a little more than reality," Headspace CEO Russ Glass said about the number of companies boasting about AI since ChatGPT's launch. His company uses AI to assist behavioral health clinicians with their notes and responses to patients. 

"We don't see a time in the near future that it's going to supplant human intervention. But it is important," he told Axios.

accurately sift through the latest research

A year after launching, ChatGPT is already changing medicine

The use of ChatGPT has exploded across health care.

ChatGPT

It&#x27;s <a class="gtmContentClick" data-vars-link-text="passed" data-vars-click-url="https://www.axios.com/2023/01/18/chatgpt-ai-health-care-doctors" data-vars-content-id="e751ef8d-eee9-4c80-bf3a-a3f751f713d4" data-vars-headline="A year after launching, ChatGPT is already changing medicine" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/01/18/chatgpt-ai-health-care-doctors" target="_self">passed</a> medical licensing exams. It&#x27;s advanced how researchers develop new medicines and cut down on doctors&#x27; hefty paperwork. And it&#x27;s nudged health care closer to a world where AI can offer diagnoses. Why it matters: One year after <a class="gtmContentClick" data-vars-link-text="OpenAI&#x27;s ChatGPT" data-vars-click-url="https://www.axios.com/2023/11/28/chatgpt-big-tech-microsoft-google-apple-meta-amazon" data-vars-content-id="e751ef8d-eee9-4c80-bf3a-a3f751f713d4" data-vars-headline="A year after launching, ChatGPT is already changing medicine" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/11/28/chatgpt-big-tech-microsoft-google-apple-meta-amazon" target="_self">OpenAI&#x27;s ChatGPT</a> exploded onto the scene, the generative AI model is already upending health care — an industry not exactly known for its speedy adoption of tech — while accelerating questions about AI&#x27;s promises and limitations.

Tina Reed

Stories

Scoop: House panel investigating FDA's handling of decongestants

Pneumonia rates in U.S. "typical," despite reported spikes: CDC

The antitrust tripwire for health insurers Cigna and Humana

Scoop: Biden administration sending free COVID tests to schools

A year after launching, ChatGPT is already changing medicine

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ChatGPT's mark on medicine

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