| | | | |  | | By Chelsea Cirruzzo and Ben Leonard | | | | | 
The right to IVF has been a recurring topic in Gov. Tim Walz's first rallies with Vice President Kamala Harris. | Carlos Osorio/AP | WALZ’S IVF STORY IS PERSONAL — Gov. Tim Walz has cemented the story of his and his wife’s struggles with infertility and use of IVF as part of his stump speech — a cue of how central reproductive health care has become in American politics and how much the electoral landscape has shifted in the two years since Roe v. Wade was overturned, POLITICO’s Megan Messerly reports. The Minnesota governor shared his story Tuesday night when Vice President Kamala Harris introduced him as her running mate. And he repeated it Wednesday in Wisconsin. “This is very personal for my wife and I,” Walz told a crowd of 12,000 in Eau Claire, Wisconsin. “When Gwen and I decided to have children, we went through years of fertility treatments. I remember each night praying that the call was going to come, and it was going to be good news. The phone would ring, tenseness in my stomach, and then the agony when you heard the treatments hadn’t worked.” Walz isn’t talking about IVF as a women’s issue that men should care about on behalf of their wives and daughters. He’s framing its importance as a man and a father, underscoring Democrats’ argument that men should care about reproductive health care because it affects them, too. Why it matters: Walz’s story offers the Harris presidential campaign a vehicle to drive home the point that former President Donald Trump is responsible for the fall of Roe and its ripple effects, from the near-total abortion bans in more than a third of the country to the Alabama Supreme Court’s February ruling on IVF. It also opens a window for the campaign to needle Trump’s running mate, Sen. JD Vance of Ohio, over his vote against advancing a Democratic-sponsored bill to establish a nationwide right to IVF and other fertility treatments. “That we are here in 2024 and this may be an issue that helps to swing an election shows what a problem Republicans have in the family planning realm,” said Barrett Marson, a GOP strategist in Arizona. WELCOME TO THURSDAY PULSE. A study in JAMA found that a tailored text messaging intervention program aimed at youth using e-cigarettes was successful in getting more than a third of users to quit, according to self-reported results at a seven-month follow-up. Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.
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The CDC is helping some airports monitor wastewater for the mpox virus. | AP Photo/Mel Evans | MONITORING WASTEWATER FOR MPOX — The CDC is working with communities — including select airports — to help them monitor for mpox virus, according to an alert released by the agency on Monday, POLITICO’s Sophie Gardner reports. The move comes as the mpox outbreak is increasingly spreading outside of the Democratic Republic of the Congo, the epicenter of the virus, to other surrounding countries where mpox is not endemic. The CDC is looking for a deadlier version of the virus, called Clade I, which is responsible for the current outbreak in the DRC. The version that caused the 2022 outbreak in the U.S. was Clade II, a milder form of the virus. The CDC still considers the risk of Clade I mpox reaching the U.S. to be “very low” due to the limited commercial flights and travelers between the U.S. and the DRC. The outbreak overseas: Since January 2023, the DRC has reported more than 22,000 suspected cases and over 1,200 deaths. The Clade I mpox is endemic to the DRC, but it has started to spread to other countries where it’s not endemic, including Rwanda and Uganda, according to the CDC’s alert. The agency also noted that some cases in those countries are linked to the DRC. The virus spreads from person to person through physical contact, though some cases have also come from contact with infected wild animals. Vaccines: The mpox vaccine isn’t yet available to the DRC public despite an April pledge from the Administration for Strategic Preparedness and Response to provide the country with 50,000 doses. “The country is actively working on a plan to vaccinate,” the CDC wrote in the alert. Growing international concern: WHO Director-General Tedros Adhanom Ghebreyesus said Wednesday he plans to convene an emergency committee of independent experts to advise him on whether to declare a public health emergency of international concern. That designation is the second-highest the WHO can issue.
| | DEVICE RULE FINALIZED — A long-awaited rule finalized Wednesday by the Biden administration creates a pathway for Medicare to cover some FDA-designed breakthrough medical devices after the White House rescinded a Trump-era regulation, Chelsea and Ben report. Why it matters: Medical device makers have said such coverage for FDA-designated breakthrough devices can make them more accessible and improve quality of life for Medicare patients. CMS said the rule also reduces manufacturer burden. Details: The rule, first proposed in June 2023, covers devices on a case-by-case basis that are “highly relevant” to the Medicare population. The program is voluntary for device manufacturers. CMS says it aims to decide whether a device is eligible for transitional coverage within six months of FDA authorization of a breakthrough device. Manufacturers will develop a plan to address any “evidence gaps” for how the device might benefit Medicare patients. CMS said it will increase the annual number of so-called national coverage determinations, which decide whether Medicare should pay for a medical item or service. It expects to accept up to five Transitional Coverage for Emerging Technologies candidates each year. How we got here: The Biden administration repealed a Trump-era policy granting four years of Medicare coverage to FDA-approved breakthrough devices in 2021, saying it was too lenient. FIRST IN PULSE: FAMILY PLANNING GUIDANCE — CMS is reminding states of their obligations to offer family planning services in Medicaid in a new notice today and encouraging them to further strengthen access, Ben reports. In an informational bulletin first obtained by Pulse, the agency said state plans must cover family planning services and supplies, including education and counseling for desired contraception methods. States can’t use prior authorization approval processes, other than to determine whether it’s appropriate for the individual, and they should avoid delaying the provision of a beneficiary’s preferred method. CMS noted that enhanced federal payment rates are available for state expenditures for family planning and supplies and that states and managed care plans must follow confidentiality regulations. Zooming out: The move comes in the wake of the Dobbs decision sending abortion access back to the states, which the agency said makes access to contraception “especially important.”
| | NOVO PULLS BACK HEART FAILURE LABEL — Novo Nordisk, the Danish company behind blockbuster weight-loss drugs Wegovy and Ozempic, said Wednesday it had rescinded its filing with the FDA to expand the label of Wegovy to include heart failure. On an earnings call Wednesday, Dr. Martin Holst Lange, the company’s executive vice president of development, said the company has withdrawn the results of its studies on Wegovy for regulatory review “based on interactions with the FDA.” He later told people on the call that conversations with the FDA made it clear that if the company conducted further research to substantiate earlier findings of reduced risk of heart failure, “the likelihood of getting hard endpoints into the U.S. label would increase.” “We now expect to resubmit the file in the beginning of 2025 with additional relevant data,” he added. The company also reported lower-than-expected profits in the second quarter of 2024 amid increased competition in the weight-loss drug space. Novo Nordisk slimmed its profit growth outlook to between 20 and 28 percent, down from 22 to 30 percent in earlier forecasts. Despite lower-than-expected sales, the company reported a 25 percent sales increase in the first six months of 2024 compared with last year, driven largely by U.S. sales of GLP-1 drugs like Wegovy and Ozempic. What’s next? Eli Lilly, maker of weight-loss drug Zepbound, will release its quarter-two earnings today.
| | Tim Coetzee is now president and CEO of the National Multiple Sclerosis Society. He previously was the group’s chief advocacy, sciences and services officer. Susanna Quinn is now host of the podcast The Cancer SIGNAL, which covers early cancer detection. She previously was CEO and founder of Veluxe, a beauty and wellness app for influencers.
| | The New York Times explores whether a psychiatrist crossed ethical lines in livestreamed calls with a troubled gamer. Reuters reports that the World Health Organization says its polio vaccine campaign is being disrupted by the lack of a Gaza ceasefire. KFF Health News reports on how social media bans could deny teens mental health help.
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