| | | | |  | | By Daniel Payne and Krista Mahr | | | With Megan Messerly Programming Note: We’ll be off this Monday for Presidents Day but will be back in your inboxes on Tuesday.
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The Biden administration wants the uninsured to still be able to get free Covid tests, vaccines and treatment post-PHE. | Justin Sullivan/Getty Images | A PROPOSED PHE BACKSTOP — As the government’s Covid-19 response winds down, the Biden administration is mulling a plan to keep vaccines, tests and treatments free for the uninsured into 2024, POLITICO’s Adam Cancryn and David Lim report. The initiative, shared by four people with knowledge of the matter, represents a bid to allay fears that the most vulnerable Americans could be left without access to Covid care once the government exhausts its ability to purchase vaccines and treatments and shifts responsibility for distributing them to the private market. The issue has come to the fore as provider and patient groups look for last-minute changes to the government’s plans for addressing the pandemic after the public health emergency, set to end in May. “We know that the end of the [Covid public health emergency] is not the end of our work on Covid,” said one senior administration official, who was granted anonymity to discuss the ongoing deliberations. “It remains a public health priority, and a lot of people will still need these treatments.” The administration doesn’t plan to shift responsibility for vaccines and treatments to the private market until late summer at the earliest, giving it time beyond the PHE’s May expiration to navigate the handover. Even then, most people would still be able to get shots and treatments through private health insurers or federal programs like Medicare and Medicaid, which would be newly responsible for negotiating their own supply deals with Covid drugmakers. A separate preexisting federal program would continue providing free vaccinations for uninsured children. But for the roughly 30 million adults without coverage, the changeover means they could be forced to pay out of pocket for drugs that can cost hundreds of dollars per dose — raising concerns among health experts that those most in need of pandemic care will soon be least able to afford it. WELCOME TO THURSDAY PULSE. Chick-fil-A is testing the limits of cauliflower: breading, frying and making a sandwich out of it. Are you in a test market and gotten a taste? Send us your thoughts — and health tips — to dpayne@politico.com and kmahr@politico.com. TODAY ON OUR PULSE CHECK PODCAST, host Ruth Reader talks with Erin Schumaker about the prospect of developing next-generation non-hallucinogenic versions of drugs like psilocybin to treat brain disorders, such as depression, post-traumatic stress disorder and addiction, and the regulatory barriers researchers who want to study psychedelics are up against.
| | | | | | | A message from PhRMA: In 2021, Insurers and their pharmacy benefit managers (PBMs) subjected patients to six times the out-of-pocket costs for brand medicines through the use of deductibles or coinsurance compared to patients with only copays — even when these middlemen received a discounted price. That’s not fair. Learn more. | | | | | | | 
FDA advisers say the agency should allow Narcan to be sold over the counter. | Scott Olson/Getty Images |
FDA ADVISERS RECOMMEND OTC NALOXONE — Expert advisers to the FDA voted unanimously Wednesday that the agency should approve a nonprescription version of naloxone, an opioid overdose antidote, POLITICO’s Katherine Ellen Foley reports.
If the recommendation is adopted, the drug could be sold to consumers in venues such as gas stations, grocery stores and convenience stores — a major win for the Biden administration, which has prioritized taking action against the ongoing opioid epidemic. The injectable form of the drug, as well as the inhalable version, Narcan, require a prescription from a health care provider, though all 50 states and the District of Columbia have laws that make it possible to obtain naloxone through other means, such as from a pharmacist or safe syringe programs. The agency has until March 29 to decide and usually follows the advice of its expert advisers. OVERDOSE DEATHS HIGH BUT DECLINING — The number of drug overdose deaths in the U.S., though still painting a bleak picture, has been steadily declining since the middle of last year, Krista reports. According to provisional data released Wednesday by the CDC, a predicted 106,840 drug overdose deaths occurred from September 2021 to September 2022, down from 107,937 in the 12-month period ending in August. Most deaths were caused by illegal synthetic drugs, including fentanyl and methamphetamine, which are increasingly being sold in combination with other drugs.
| | | | DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOS– DOWNLOAD FOR ANDROID. | | | | | | | | MODERNA-BERNIE BRAWL — HELP Committee Chair Bernie Sanders (I-Vt.) is set to grill Moderna CEO Stéphane Bancel at a hearing next month on the company’s planned vaccine price hikes. “After the company received billions of dollars from the federal government to research, develop and distribute the Covid vaccine, guess what happened? It turns out the CEO of Moderna, Stéphane Bancel, became a billionaire overnight and is now worth $5.7 billion,” Sanders said on the Senate floor Wednesday, signaling what may be in store at the hearing. Moderna released a statement Wednesday saying it would continue to ensure access to the vaccine at no cost to consumers. “Moderna remains committed to ensuring that people in the United States will have access to our COVID-19 vaccines regardless of ability to pay,” the company said, adding that people with or without insurance would still have access to free Covid vaccines, partly because of its patient assistance program.
| | | | A message from PhRMA:   | | | | | | U.S. BACKS MODERNA IN LAWSUIT — The Justice Department said the U.S. should be liable in any patent infringement charges leveled against Moderna, according to a Tuesday court filing. The company faces a lawsuit from Genevant Sciences and Arbutus Biopharma, which argue the Covid vaccine uses technology they own. The DOJ said in its filing that the government’s role in creating the vaccines should relieve Moderna of liability in the case, instead moving that liability to the U.S.
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CHOLERA OUTBREAKS SPAN CONTINENTS — Climate change and conflict are supercharging cholera, a diarrheal disease caused by ingesting contaminated water and food, killing thousands of people from Haiti to Malawi, POLITICO’s Carmen Paun reports.
More people died of cholera last year globally than in the previous five years combined, Tedros Adhanom Ghebreyesus, the World Health Organization’s director-general, said. Nearly 20 countries are battling outbreaks, and not enough vaccines are available to immunize all those at risk. One billion people — that’s 1 in 8 — are at direct risk, according to the WHO. COVID ORIGIN INVESTIGATION ‘STYMIED’ — The WHO’s effort to better understand Covid’s origins has stalled, with China refusing to provide access and data, POLITICO’s Ashleigh Furlong reports. The scientific advisory group tasked with investigating evidence around the coronavirus’ origins had called in June 2022 for new studies, including audits of labs close to Wuhan, China, where the original outbreak was first reported. On Tuesday, the journal Nature reported that the investigation’s second phase had been shelved, quoting the WHO’s technical lead for Covid-19, Maria Van Kerkhove, as saying “there is no phase two.” But a WHO spokesperson told POLITICO the investigation had not been abandoned but needs access and data from China for knowledge to advance.
| | | | 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. | | | | | | ARKANSAS RENEWS WORK REQUIREMENTS FIGHT — Arkansas Gov. Sarah Huckabee Sanders announced a new plan Wednesday that would require 300,000 Arkansans to work, attend school or volunteer to remain eligible for Medicaid coverage. If they don’t, they could be kicked off the state program known as the Arkansas Health and Opportunity for Me program, or ARHOME — which covers people under qualified health plans purchased by the state — and into traditional fee-for-service Medicaid, Megan reports. Arkansas plans to publish its proposed Section 1115 demonstration waiver amendment on April 23 for a 30-day public comment period and formally submit it to CMS by June 1. Sanders said the state’s new proposal — which would downgrade instead of stripping coverage from Arkansans — is “fully compliant” with previous court rulings. “By making this innovation, we are … ensuring our plan can actually go into effect while still maintaining the same goal, which is moving Arkansans from government dependency to prosperity,” Sanders said. A CMS spokesperson said the agency doesn’t speculate on Section 1115 applications but added that “CMS determined in March 2021 that the previously approved authorities that permitted Arkansas to require work and community engagement as a condition of eligibility are not likely to promote the objectives of the Medicaid statute.” A NEW HEALTH WORKER WAGE — California health care workers could have a $25 minimum wage under a new bill, POLITICO’s Alexander Nieves reports. The bill, introduced by state Sen. María Elena Durazo (D-Los Angeles), would largely apply to low-wage workers in nursing and those who don’t work directly with patients, such as housekeepers, security guards, food staff and laundry providers. The bill would apply to health facilities and in-home agencies. | | | Drew Hanchett is now chief health information officer for the NYS Department of Health. He most recently was acting executive director of the environment, energy and transportation portfolio of the NYS Office of IT Services. Darian Burrell-Clay joined the Children’s Hospital Association as the federal affairs manager. He previously worked for Sen. Gary Peters (D-Mich.) The Vogel Group has poached health care lobbyist Meg Gilley from McDermott+Consulting, where she was a director and advised clients in the industry, including hospitals, biomedical companies, coalitions and vaccine manufacturers, our POLITICO Influence colleagues first reported.
| | | State and local governments are using Covid funds to eliminate their residents’ medical debt, The Associated Press reports. Steven Petrow writes in an essay in The Washington Post that ketamine, a new depression treatment, can also be terrifying.
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