Let’s talk about XBB.1.5

Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.

Jan 04, 2023 View in browser   By Krista Mahr and Daniel Payne Presented by Driving the Day Only about 15 percent of Americans have gotten their bivalent booster shots, which provides some protection against new Omicron variants. | Scott Olson/Getty Images THE VARIANT NO ONE CAN NAME — It's not catchy, but it's here and moving quickly across the country. The Centers for Disease Control and Prevention now reports that the Omicron variant XBB.1.5 — or "ex-bee-bee-one-point-five" — is now the dominant SARS-CoV-2 strain in the nation, comprising more than 40 percent of cases. The new variant doesn't appear to be causing more severe disease, the agency has said; while hospitalizations are ticking up across the country, they don't appear to be connected to areas hit hardest by the new variant. But it's worrying public health experts who point to studies that indicate XBB.1.5 appears to be very adept at evading antibodies generated by infection and vaccination. Research of related variants show the updated bivalent booster provides some level of protection against the newer Omicron mutations. But only about 15 percent of Americans have received it. All that — plus the weeks of frenetic travel we're just coming out of — adds up to an imminent winter surge, they say. "We're going to see another surge going forward. We can be pretty confident of that," Ezekiel Emanuel, a physician and vice provost of the University of Pennsylvania, told MSNBC on Wednesday. The China factor: The impact that the massive Covid-19 outbreak in China will have on its own population — and the rest of the world — remains unclear. After abruptly ending its three years of "zero-Covid" strategy, Beijing has downplayed the number of current infections and deaths, observers say, and lambasted foreign governments, including the U.S., that have put restrictions on people traveling from China into their countries. The emergence of new variants in the Chinese outbreak is part of other governments' concern, and there's little visibility into what's circulating there. But many public health experts agree that the new testing requirements — or anything more stringent that governments are considering — won't do much. WELCOME TO WEDNESDAY PULSE — Congrats on hitting the midway mark of the first work week of 2023. A vast new study finds that women — of any age and anywhere in the world — are more empathetic than men. We understand how that might make you feel. Send news and tips to kmahr@politico.com and dpayne@politico.com. TODAY ON OUR PULSE CHECK PODCAST, Katherine Ellen Foley talks with Alice Miranda Ollstein about the actions anti-abortion groups want the new GOP House majority to take. Listen to today's Pulse Check podcast   A message from PhRMA: Costly out-of-pocket expenses tied to deductible and coinsurance requirements are a leading concern for patients with commercial insurance. These harmful practices put in place by insurers and pharmacy benefit managers (PBMs) are even causing patients to abandon their medicines. New IQVIA data break down how insurers and their PBMs are impacting how patients access and afford their medicines.   Global Health Some countries have begun testing travelers from China for Covid. | Mark Schiefelbein/AP Photo MEANWHILE IN EUROPE … EU countries are inching toward coordinated travel measures in response to China's Covid surge, including pre-departure testing, masks on flights and wastewater testing for possible new variants, POLITICO's Helen Collis reports. Several EU countries have already introduced measures to curb Covid coming from China, despite vows to improve collaboration during the pandemic's first wave. Belgium was the first country this week to announce it was testing wastewater samples from two flights a week from China and sequencing for variants. Meanwhile, Italy, France, Spain and other countries introduced their own testing measures for travelers from China last week, as did the U.K. At the Agencies DOJ CLEARS USPS TO DELIVER ABORTION DRUGS — The Justice Department has cleared the U.S. Postal Service to deliver abortion drugs to states that have strict limits on terminating a pregnancy, POLITICO's Josh Gerstein and Alice Miranda Ollstein report. A legal opinion, from the department's Office of Legal Counsel, concludes that a nearly 150-year-old statute aimed at fighting "vice" through the mail isn't enforceable against mailings of abortion drugs as long as the sender doesn't know that the drugs will be used illegally. Backstory: A week after the Supreme Court overturned Roe v. Wade last June, the Postal Service asked the Justice Department for legal guidance on how to respond to growing efforts to circumvent state abortion restrictions by sending the drugs to people seeking them in those states. FDA UPDATES NEW RULE ON ABORTION PILL — On Tuesday, the Food and Drug Administration updated a rule allowing brick-and-mortar pharmacies to dispense the medication abortion pill mifepristone, Alice and Lauren Gardner report. What's in the rule: The policy will allow chain and independent pharmacies to stock and dispense the drug to patients with a prescription. It's unclear, however, how many pharmacies will agree to do so, considering it requires a special certification process. Pharmacies in more than a dozen states that have near-total bans on abortion won't be able to participate. Why it matters: The abortion pill recently became the most common method of terminating a pregnancy in the United States. What's next: The Biden administration already took a major step to open up access to the pill in 2021, making permanent pandemic-era rules allowing people to access it within the first 10 weeks of pregnancy via telemedicine and mail delivery. But the FDA's move opens a new legal and regulatory front in the ongoing battle over the procedure following the fall of Roe v. Wade and is likely to draw lawsuits from anti-abortion groups and state officials. PARENTS SLAM FDA ON FORMULA INACTION — Dozens of parents across the country are convinced that the infant formula crisis was more extensive than industry leaders and federal health officials have determined, Helena Bottemiller Evich writes for POLITICO. Their babies suffered illnesses they suspect were caused by contaminated formula, but their cases aren't included in the government's official count, leaving them feeling as if their children's illnesses have been dismissed by federal officials. They're alarmed by what they see as a lack of urgency by the FDA to address weaknesses in the oversight of formula manufacturing plants. No single official is clearly in charge of food at the FDA, and the agency suffers from serious organizational and cultural problems that make it painfully slow to get just about anything done, as a POLITICO investigation found earlier this year. The findings were confirmed this month in an external review of the FDA's foods program conducted by the Reagan-Udall Foundation, a nonprofit that supports the FDA. HEALTH TECH WHAT MUSK'S SUPER APP COULD MEAN FOR HEALTH — Elon Musk's vision for a "super-app" that could be the West's answer to China's WeChat social media app could have implications for the health care sector, POLITICO's Rebecca Kern, Sam Sutton, Ruth Reader and Tanya Snyder write. While a 1996 patient data-protection law sets strict rules around how health care providers share and store data, Musk could try to push the envelope with respect to building an app where users could perform tasks like accessing medical records and attending telehealth appointments. Musk also has his own medical venture in Neuralink, an interface that allows a person to navigate a computer directly from their brain with an implantable device. He still needs FDA signoff on a clinical trial that could allow the product to come to market.   A message from PhRMA:   Names in the News Alston & Bird has elected 23 new partners, including Brad Smyer on the health care litigation team and Jane Lucas on the health care and legislative and public policy group. The Alliance for Regenerative Medicine announced Mark Battaglini as its first chief strategy officer. He joins the advocacy organization after seven years at bluebird bio. What We're Reading Stat reports on the pile-up of health priorities in federal agencies as the new year kicks off. Reuters reports that state media outlets in China are playing down the nation's Covid-19 outbreak, while the WHO is trying to learn more about the variants in circulation. A new study found that the number of kids who accidentally ate cannabis edibles has jumped more than 1,300 percent in five years, CNN reports.   A message from PhRMA: Every day, patients at the pharmacy counter discover their commercial insurance coverage does not provide the level of access and affordability they need. New data from a study by IQVIA reveal the harmful practices of insurers and their pharmacy benefit managers (PBMs) can lead to significantly higher out-of-pocket costs for medicines — causing some patients to abandon their medicines completely. Learn more.     Follow us on Twitter Dan Goldberg @dancgoldberg Katherine Ellen Foley @katherineefoley Lauren Gardner @Gardner_LM Ben Leonard @_BenLeonard_ David Lim @davidalim Krista Mahr @kristamahr Megan Messerly @meganmesserly Alice Miranda Ollstein @aliceollstein Carmen Paun @carmenpaun Megan R. Wilson @misswilson Daniel Payne @_daniel_payne Ruth Reader @RuthReader   Follow us

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