1 big thing: Embryo "adoption": IVF off-shoot gains popularity

2. First look: A new Republican health care plan

3. PBM reform bill advances in Senate

Illustration of a prescription bottle surrounded by plus signs and circles

4. Rewarding the neighborhood drug store

Illustration taken from the video of medicine bottles filled with pills

5. Catch up quick

It's the Thursday before August recess, gang. Stay focused! Today's newsletter is 958 words or a 3½-minute read.

Thanks for reading Axios Vitals, and to senior copy editor Bryan McBournie. Please ask your friends and colleagues to sign up.

Plus, a new health care script for Republicans

Vitals

A briefcase with a red cross on the front.

mustard

Keep up with health care politics, policy and business

Axios Vitals

Standard

1 big thing: More Americans go abroad for fertility treatments

A fertility clinic in Barcelona. Photo: LLUIS GENE/AFP via Getty Images Delete image

2. AI lawsuits spread to health

3. Rural Americans pass on needed care

4. Biden admin moves to reinforce mental health parity

Illustration of a shadow about to sign off on the health symbol. 

5. A medical museum confronts its ghosts

6. Catch up quick

It's Tuesday, Vitals gang, and I'll be filling in the rest of this week. Today's newsletter is 1,038 words or a 4-minute read.

Situational awareness: Pfizer said more than 30 drugs, including injectable fentanyl and the anesthetic lidocaine, could see supply disruptions after a tornado demolished part of a North Carolina plant last week, per Reuters. 

1 big thing: Abortion, spending fights snag FDA bill

2. Congress dips into prior authorization fight

3. Biden launches precision cancer surgery effort

4. Data du jour: Alzheimer's prevalence, mapped

5. Antibody treatment targets fentanyl overdoses

Illustration of gloved hand holding tiny beaker

Break out the beach umbrellas, we made it to Friday, Vitals fam! Today's newsletter is 965 words or a 3½-minute read.

1 big thing: Lawmakers target hospital billing 

Illustration of a very long hospital bill pierced by fountain pens. 

2. "Poison pills" hang over congressional spending

3. Hospitals struggling to discharge patients

Illustration of an exit sign with a red cross replacing the "t"

4. Longer trips for gender-affirming care 

Happy Wednesday, Vitals readers. Today's newsletter is 937 words or a 3½-minute read.

Plus, health care "poison pills" disrupt congressional spending process

1 big thing: The potential downsides of obesity drugs 

2. Makers of obesity drugs build up patents

3. Extreme heat's toll on hungry Americans

4. CPR: Easier than you remember

5. Medicare payment roundup

6. While you were weekending

Illustration of a weekly calendar with an exclamation point shaped like a medical red cross drawn on with a red marker 

Happy Monday, Vitals readers. Today's newsletter is 950 words, or a 3½-minute read.

🍻 On tap this week: CVS Health, Tenet Health, Humana, Pfizer and Moderna all have Q2 earnings. CDC advisers on Aug. 3 will consider whether to recommend the new RSV antibody nirsevimab for infants and if it should be added to the Vaccines for Children program. And Biden Cabinet and senior White House officials will start crisscrossing the country touting legislative wins like the Inflation Reduction Act and its health provisions. 

And Biden Cabinet and senior White House officials will start crisscrossing the country touting legislative wins like the Inflation Reduction Act and its health provisions.

National

The Centers for Disease Control today recommended that updated COVID-19 vaccines from Pfizer and Moderna be given to anyone ages 6 months and older, clearing the way for reformulated shots to be available later this week.

Why it matters: Amid a months-long uptick in cases, the Biden administration is facing pressure to make the updated vaccines available to help head off a repeat of last year's "tripledemic" of respiratory disease. 

The new shots are expected to take aim at circulating strains, including the EG.5, or Eris, strain, which the CDC said accounted for 21.5% of cases as of Sept. 2, as well as a newer variant, FL.1.5.1, dubbed Fornax, which accounted for 14.5% of U.S. infections.

The FDA approved mRNA shots from Pfizer and Moderna on Monday, and it's still reviewing a shot from Novavax that uses more traditional protein-based technology.

CDC advisers earlier today recommended the updated Pfizer and Moderna vaccines in a 13-1 vote.

What they're saying: "Today's announcement ... means we now have immunizations for all three major seasonal respiratory viruses  COVID-19, flu and RSV," President Biden said in a statement. "As we head into fall and winter, we are in our strongest position yet with more tools and systems available than ever before."

CDC Director Mandy Cohen said: "We have more tools than ever to prevent the worst outcomes from COVID-19."

Details: The vaccine advisers recommended everyone ages 5 years and over receive one dose of an updated vaccine. 

Children 6 months to 4 years should complete a two-dose initial series with at least one dose of the updated vaccine.

Moderately or severely immunocompromised people should complete a three-dose initial series that includes at least one dose of the updated vaccine.

Some advisers questioned whether there was enough data to make a universal recommendation for the updated shots, or whether the recommendation should only apply to higher-risk individuals. But only one member, Ohio State University pediatrician Pablo Sanchez, voted against the recommendation on those grounds.

Go deeper: The bivalent vaccine that's been available for the past year targets the original coronavirus strain and earlier Omicron subvariants that are largely out of circulation. Those shots will no longer be recommended.

The unwinding of the COVID-19 public health emergency means the federal government is no longer covering the shots, but most people with private insurance and those enrolled in Medicare and Medicaid should be able to get them at no cost.

A temporary Bridge Access Program that runs through 2024 is supposed to provide COVID-19 vaccines at no cost for adults who can't access them through their insurance.

The list prices for the updated Pfizer and Moderna shots will be $120 and $129 per dose, respectively. Novavax would be $130 per dose. 

Officials expect boosters to be updated annually to account for circulating variants, much like flu shots. 

Uptake of boosters has lagged, with just 17% of the population receiving it, according to the CDC. 

Go deeper: The plan to dodge another tripledemic  

CDC recommends updated COVID vaccines for anyone 6 months and older

President Biden said the announcement means "we are in our strongest position yet" heading into winter.

Illustration of descending bar chart made of syringes gradually shrinking in size.

COVID-19 vaccines

The Centers for Disease Control today recommended that updated COVID-19 vaccines from Pfizer and Moderna be given to anyone ages 6 months and older, clearing the way for reformulated shots to be available later this week.Why it matters: Amid a <a class="gtmContentClick" data-vars-link-text="months-long uptick" data-vars-click-url="https://www.axios.com/2023/09/01/covid-cases-uptick-summer-2023-new-variant" data-vars-content-id="7ec74c1b-e562-49d3-a467-311763f53427" data-vars-headline="CDC recommends updated COVID vaccines for anyone 6 months and older" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/09/01/covid-cases-uptick-summer-2023-new-variant" target="_self">months-long uptick</a> in cases, the Biden administration is facing pressure to make the updated vaccines available to help head off a repeat of last year&#x27;s &quot;tripledemic&quot; of respiratory disease. <ul><li>The new shots are expected to take aim at circulating strains, including the EG.5, or Eris, strain, which the CDC said <a class="gtmContentClick" data-vars-link-text="accounted for 21.5% of cases" data-vars-click-url="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" data-vars-content-id="7ec74c1b-e562-49d3-a467-311763f53427" data-vars-headline="CDC recommends updated COVID vaccines for anyone 6 months and older" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank">accounted for 21.5% of cases</a> as of Sept. 2, as well as a newer variant, FL.1.5.1, dubbed Fornax, which accounted for 14.5% of U.S. infections.</li><li>The FDA <a class="gtmContentClick" data-vars-link-text="approved" data-vars-click-url="https://www.axios.com/2023/09/11/fda-approves-updated-covid-19-vaccines" data-vars-content-id="7ec74c1b-e562-49d3-a467-311763f53427" data-vars-headline="CDC recommends updated COVID vaccines for anyone 6 months and older" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/09/11/fda-approves-updated-covid-19-vaccines" target="_self">approved</a> mRNA shots from Pfizer and Moderna on Monday, and it&#x27;s still reviewing a shot from Novavax that uses more traditional protein-based technology.</li><li>CDC advisers earlier today recommended the updated Pfizer and Moderna vaccines in a 13-1 vote.</li></ul>What they&#x27;re saying: &quot;Today&#x27;s announcement ... means we now have immunizations for all three major seasonal respiratory viruses COVID-19, flu and RSV,&quot; President Biden said in a statement. &quot;As we head into fall and winter, we are in our strongest position yet with more tools and systems available than ever before.&quot;CDC Director Mandy Cohen said: &quot;We have more tools than ever to prevent the worst outcomes from COVID-19.&quot;Details: The vaccine advisers recommended everyone ages 5 years and over receive one dose of an updated vaccine. <ul><li>Children 6 months to 4 years should complete a two-dose initial series with at least one dose of the updated vaccine.</li><li>Moderately or severely immunocompromised people should complete a three-dose initial series that includes at least one dose of the updated vaccine.</li><li>Some advisers questioned whether there was enough data to make a universal recommendation for the updated shots, or whether the recommendation should only apply to higher-risk individuals. But only one member, Ohio State University pediatrician Pablo Sanchez, voted against the recommendation on those grounds.</li></ul>Go deeper: The bivalent vaccine that&#x27;s been available for the past year targets the original coronavirus strain and earlier Omicron subvariants that are largely out of circulation. Those shots will no longer be recommended.<ul><li>The unwinding of the COVID-19 public health emergency means the federal government is no longer covering the shots, but most people with private insurance and those enrolled in Medicare and Medicaid should be able to get them at no cost.</li><li>A temporary Bridge Access Program that runs through 2024 is supposed to provide COVID-19 vaccines at no cost for adults who can&#x27;t access them through their insurance.</li><li>The list prices for the updated Pfizer and Moderna shots will be $120 and $129 per dose, respectively. Novavax would be $130 per dose. </li><li>Officials expect boosters to be updated annually to account for circulating variants, much like flu shots. </li><li>Uptake of boosters has lagged, with just 17% of the population receiving it, according to <a class="gtmContentClick" data-vars-link-text="the CDC" data-vars-click-url="https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop5" data-vars-content-id="7ec74c1b-e562-49d3-a467-311763f53427" data-vars-headline="CDC recommends updated COVID vaccines for anyone 6 months and older" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-booster-percent-pop5" target="_blank">the CDC</a>. </li></ul>Go deeper: <a class="gtmContentClick" data-vars-link-text="The plan to dodge another tripledemic" data-vars-click-url="https://www.axios.com/2023/07/06/tripledemic-covid-vaccines" data-vars-content-id="7ec74c1b-e562-49d3-a467-311763f53427" data-vars-headline="CDC recommends updated COVID vaccines for anyone 6 months and older" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/07/06/tripledemic-covid-vaccines" target="_self">The plan to dodge another tripledemic</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

The maker of a widely used abortion drug today asked the Supreme Court to review an August appeals court decision that curtailed access to the pill.

Why it matters: The request gives justices an opportunity to rule on the availability of mifepristone for medication abortion less than two years after the high court struck down federal protection of the procedure.

Medication abortions account for more than half of the abortions in the U.S., and 98% of those used mifepristone.

Driving the news: Danco Laboratories, mifepristone's manufacturer, said the decision raises questions about whether a single federal court can limit abortion access in states that protect it.

"The risks and confusion that result from the Fifth Circuit's decision are not ones that women, teenage girls, and the public health system should be forced to bear without this court's review," the company wrote in its petition. 

The decision also "destabilizes the pharmaceutical and biotechnology industries" by challenging the Food and Drug Administration's authorization of the pill, Danco wrote.

The Department of Justice also asked for a Supreme Court review hours later, citing "destabilizing practical consequences" from the decision and "its serious legal errors."  

Catch up quick: A three-judge panel of the 5th U.S. Circuit Court of Appeals ruled in August that the FDA failed to take into account safety concerns when it made mifepristone more easily accessible in 2016.

The panel at the time partially blocked a lower court ruling that struck the FDA's approval of the drug, which was granted in 2000.

The pill remains widely available under an order the Supreme Court issued in April that maintained the status quo while legal challenges to the FDA's authority play out.

If the Supreme Court takes the case, it will likely hear it during the term that starts next month. 

Abortion pill maker and DOJ ask Supreme Court to review ruling that limited access

The request gives the high court an opportunity to rule on the availability of mifepristone for medication abortion less than two years after striking federal protection of the procedure.

Illustration of a pill bottle with a "no" symbol on the lid

Abortion

Abortions surged in states near those with new bans: study

States near those that banned abortion after Roe v. Wade fell saw sharp increases in the number of procedures performed.

A map of the United States showing the estimated change in the number of abortions provided by the formal health care system comparing 6-month period of 2020 to January to June, 2023. Four states have seen increases of more than 100%, including New Mexico with change of +220% and Wyoming with 202%.

States geographically near ones that banned abortion after Roe v. Wade <a class="gtmContentClick" data-vars-link-text="was overturned" data-vars-click-url="https://www.axios.com/2022/05/10/blue-states-abortion-protection-roe-supreme-court" data-vars-content-id="9d6b4928-801b-4774-a2cb-3c5bf5fa3c46" data-vars-headline="Abortions surged in states near those with new bans: study" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2022/05/10/blue-states-abortion-protection-roe-supreme-court" target="_self">was overturned</a> saw sharp increases in the number of procedures performed, likely due to an influx of border-hopping patients, according to a new analysis from the <a class="gtmContentClick" data-vars-link-text="Guttmacher Institute" data-vars-click-url="https://www.guttmacher.org/monthly-abortion-provision-study" data-vars-content-id="9d6b4928-801b-4774-a2cb-3c5bf5fa3c46" data-vars-headline="Abortions surged in states near those with new bans: study" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.guttmacher.org/monthly-abortion-provision-study" target="_blank">Guttmacher Institute</a>.Why it matters: Patients are proving highly motivated to travel to get the care they need in the face of state bans, according to Guttmacher, a research organization that supports abortion rights. But for some, that involves overcoming logistical and financial challenges.

Public health groups criticized the Food and Drug Administration on Thursday for missing a self-imposed August deadline to finalize a rule banning menthol in cigarettes.

Why it matters: Menthol products account for a significant portion of tobacco industry sales, and the ban was expected to be challenged in court and complicate prospects for an FDA funding bill in Congress.

Menthol cigarettes have been aggressively marketed to Black communities, contributing to health disparities and making it harder for African American people to quit smoking than other groups, per the Centers for Disease Control. 

Driving the news: In a joint statement, the African American Tobacco Leadership Council, About Action on Smoking & Health, the American Medical Association and National Medical Association accused the agency of dragging its feet and urged regulators to press forward with the plan.

"Further delays will only cause more harm by allowing tobacco companies to continue marketing menthol cigarettes to Black people and harming Black youth," said AMA president Jesse Ehrenfeld.

Catch up quick: The FDA proposed the ban on menthol cigarettes and flavored cigars in April 2022, saying it would reduce the appeal of smoking, particularly to youths. It arrived at that conclusion after a lengthy process. 

Menthol products were excluded from a 2009 law that took aim at other flavored tobacco products.

Public interest groups filed a citizen petition in 2013, asking the FDA to ban menthol. Groups sued the agency in 2020, saying it was delayed in responding to the petition.

FDA blasted over inaction on menthol ban

Public health groups criticized the Food and Drug Administration for missing a self-imposed August deadline to finalize a rule banning menthol in cigarettes.

Illustration of a pack of cigarettes as a downward trending bar chart.

Tobacco

Public health groups criticized the Food and Drug Administration on Thursday for missing a self-imposed August deadline to <a class="gtmContentClick" data-vars-link-text="finalize a rule" data-vars-click-url="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&amp;RIN=0910-AI60" data-vars-content-id="d26c28ae-6a84-451c-84c8-aade95e53e7d" data-vars-headline="FDA blasted over inaction on menthol ban" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&amp;RIN=0910-AI60" target="_blank">finalize a rule</a> banning menthol in cigarettes.Why it matters: Menthol products account for a significant portion of tobacco industry sales, and the ban was expected to be <a class="gtmContentClick" data-vars-link-text="challenged in court" data-vars-click-url="https://journalnow.com/business/technology/fda-still-plans-august-debut-of-menthol-cigarette-ban-rules/article_9f348fce-0c95-11ee-844c-ebce72352675.html" data-vars-content-id="d26c28ae-6a84-451c-84c8-aade95e53e7d" data-vars-headline="FDA blasted over inaction on menthol ban" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://journalnow.com/business/technology/fda-still-plans-august-debut-of-menthol-cigarette-ban-rules/article_9f348fce-0c95-11ee-844c-ebce72352675.html" target="_blank">challenged in court</a> and complicate prospects for an <a class="gtmContentClick" data-vars-link-text="FDA funding bill" data-vars-click-url="https://www.axios.com/2023/05/19/house-fda-funding-abortion-tobacco" data-vars-content-id="d26c28ae-6a84-451c-84c8-aade95e53e7d" data-vars-headline="FDA blasted over inaction on menthol ban" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/05/19/house-fda-funding-abortion-tobacco" target="_self">FDA funding bill</a> in Congress.

A late summer COVID surge is prompting some school districts to reinstate safety measures, as they try to protect student and teacher health without risking further disruptions to learning.

Why it matters: Widespread school closings are a non-starter, and officials in red and blue states also insist broad mask mandates won't return. But, in a flashback to the dark days of the pandemic, some districts in consultation with local health officials have reinstated limited masking and other precautions as COVID cases and hospitalizations rise.

Driving the news: Districts in Kentucky and Texas have canceled classes after a surge of respiratory illnesses, including COVID, led to widespread absences. 

Philadelphia schools imposed a safety plan that calls for students who test positive to isolate for five days, then wear masks for another five days on return. 

And rising cases counts have prompted two Alabama school districts to bring back masking requirements. 

Yes, but: Administrators and local health officials have much less available information about disease spread compared to during the height of the crisis since the Centers for Disease Control and Prevention scaled back how it reports COVID data and at-home testing has fallen off. 

With half of Americans believing the pandemic is over and memories of missed school years still fresh, any sweeping measures could face blowback.

The Biden administration is showcasing efforts to reverse declining student performance since the pandemic amid continued criticism from Republicans that the administration and its allies kept schools closed too long, Reuters reported.

But rebounding case counts and the prospect of another "tripledemic" of respiratory illness are causing concern and prompting districts to walk a tightrope as they reevaluate protocols.

Talladega city school officials took pains in a Facebook post to stress their policy wasn't a mask mandate, saying "masks are encouraged but not required."

Los Angeles schools, which had some of the strictest COVID measures in the country, are maintaining an optional masking policy, saying kids can come to school with mild illness, as long as they don't have a fever, to combat high absence rates, the L.A. Times reports.

What they're saying: There isn't consensus among public health experts around how schools should deal with COVID this fall. 

Some said it's time to start treating COVID like any other respiratory illness in schools, while saving greater caution for high-risk settings. 

"Maybe kids can still go to school with symptoms, as long as they don't have fevers or as long as they don't have severe coughing — but they should not be visiting their elderly grandparents who live in a nursing home," said Leana Wen, a public health professor at George Washington University who's advocated since the spring of 2022 for most people to return to pre-pandemic life.

Others disagreed. If your kid is feeling sick, they shouldn't go to in-person classes, said Georges Benjamin, executive director of the American Public Health Association. 

"You're not just protecting that individual child, but that child has classmates who may have chronic diseases," he said. "The problem with treating it like everything else is we should be telling parents — and we do — if your kid has the flu, they should stay home, too." 

Benjamin said any decisions about reinstating mask mandates should be made "on a case-by-case basis."

Between the lines: The late-summer surge of illness comes after a stretch when most Americans put the pandemic behind them. And acceptance of public health measures is often tied to perceptions of personal risk.

The percentage of people who wear a mask some or all of the time has dropped by half over the past six months, to 15%, according to the latest Axios-Ipsos American Health Index. 

69% say contracting COVID poses small or no risk to their health and well-being. And booster uptake has been low, with about 17% of the population receiving last year's updated COVID shot, per the CDC. 

The bottom line: While people now think their risk of contracting COVID is about on par with getting a mosquito bite, people still registered some concern about the current uptick when asked about it. And ultimately, they want to make sure their kids are safe.  

Clarification: This story has been updated with information on when Leana Wen advocated for a return to pre-pandemic life.

Schools grapple with COVID safety amid late summer surge

Some districts have reinstated limited masking and other precautions as COVID cases and hospitalizations rise.

Illustration of a chalkboard with a circular arrow and a coronavirus icon drawn in chalk.

COVID-19

A late <a class="gtmContentClick" data-vars-link-text="summer COVID surge" data-vars-click-url="https://www.axios.com/2023/09/01/covid-cases-uptick-summer-2023-new-variant" data-vars-content-id="f1c66fa3-0951-4e88-b825-4b027f6dbb2d" data-vars-headline="Schools grapple with COVID safety amid late summer surge" data-vars-event-category="story" data-vars-sub-category="story" data-vars-item="in_content_link" href="https://www.axios.com/2023/09/01/covid-cases-uptick-summer-2023-new-variant" target="_self">summer COVID surge</a> is prompting some school districts to reinstate safety measures, as they try to protect student and teacher health without risking further disruptions to learning.Why it matters: Widespread school closings are a non-starter, and officials in red and blue states also insist broad mask mandates won&#x27;t return. But, in a flashback to the dark days of the pandemic, some districts in consultation with local health officials have reinstated limited masking and other precautions as COVID cases and hospitalizations rise.

Adriel Bettelheim

Stories

CDC recommends updated COVID vaccines for anyone 6 months and older

Abortion pill maker and DOJ ask Supreme Court to review ruling that limited access

Abortions surged in states near those with new bans: study

Schools grapple with COVID safety amid late summer surge

FDA blasted over inaction on menthol ban

Newsletter editions

Axios Vitals: Obesity drug concerns

Axios Vitals: FDA bill delayed

Axios Vitals: Donor embryo boom

Axios Vitals: Hospital billing targeted

Axios Vitals: Fertility treatments abroad