| | | | |  | | By Krista Mahr and Daniel Payne | | | With Daniel Lippman
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Flu hospitalizations have doubled over the past week. | Robert Ray/AP Photo | A PERFECT STORM — CDC Director Rochelle Walensky warned on Monday that flu hospitalizations have hit their highest levels for this time of year in a decade, Krista reports. Pair that with rising Covid-19 cases and hospitalizations and respiratory syncytial virus rates that continue to creep up in some parts of the country, and you've got what Sandra Fryhofer of the American Medical Association called "a perfect storm for a terrible holiday season" during a briefing with Walenksy. The outlook: The CDC estimates there have been 8.7 million cases of flu this season, 78,000 hospitalizations and 4,500 deaths, including 14 pediatric deaths. Flu-related hospitalizations doubled over the past week. Officials cautioned the picture could get worse as Americans head indoors during the coldest part of the year and gather for the holidays. Covid-19 hospitalizations, meanwhile, are up 17 percent between last week and the week leading into Thanksgiving, according to CDC data. The agency's published data suggests weekly case numbers have risen by more than 40,000 over the last month. The fatigue factor: Flu vaccine uptake and Covid-19 booster uptake have been underwhelming this fall — and the coldest parts of the year, which drive people inside, have yet to come. Fryhofer warned against the complacency that's set in after two long years of being told to get one vaccine after another. During the last two years, when less flu was circulating, "we had forgotten how bad flu can be," said Fryhofer. "But this year's season is a shoutout that it can get really bad and it's here. People need to get vaccinated." WELCOME TO TUESDAY PULSE — Researchers at the University of Waterloo are using seaweed molecules in bypass surgery , with promising results. Send other good news (OK, and bad news) and tips to kmahr@politico.com and dpayne@politico.com . TODAY ON OUR PULSE CHECK PODCAST , Ben Leonard talks with POLITICO's Erin Banco about her investigation into why the FDA team overseeing licensed vaccines is overwhelmed by high turnover and a backlog of inspections. Plus, Shawn Zeller has a preview of the Milken Institute's Future of Health Summit, which starts today.
| | | | | A message from Humana: More than 28 million people choose Medicare Advantage. With Medicare Advantage, members can see better health outcomes at lower costs. That's one of the reasons why nearly half of the total Medicare population chooses Medicare Advantage. Learn more. | | | | | | | 
The FDA's Team Biologics office is short-staffed and undertrained, say three former FDA inspectors. | AP Photo | FORMER FDA INSPECTORS RAISE CONCERNS — Training in the Food and Drug Administration's office that oversees licensed vaccines has decreased dramatically in recent years, raising concerns that the team isn't equipped to identify quality control issues in manufacturing, POLITICO's Erin Banco reports. Three former inspectors told Banco that an agencywide reorganization and an influx of inexperienced inspectors led to an increased workload, particularly during the pandemic. In the last several years, multiple inspectors have left the team, citing internal frustrations over the lack of training and concern that supervisors had little knowledge of the complexities associated with the inspections they oversee. All three former inspectors worked in one of the FDA's most critical offices, Team Biologics, which is responsible for inspecting licensed vaccine products, as well as cord blood, allergenic, gene and cell-therapy products. What the FDA says: Audra Harrison, a spokesperson for the FDA, said the inspectors on Team Biologics are "highly trained professionals" who produce thorough assessments of each facility during inspection.
| | | | GO INSIDE THE MILKEN INSTITUTE FUTURE OF HEALTH SUMMIT: POLITICO is featuring a special edition of our "Future Pulse" newsletter at the 2022 Milken Institute Future of Health Summit from Dec. 6 to 8. The newsletter takes readers inside one of the most influential gatherings of health industry leaders and innovators solving the biggest global health issues to ensure a healthier, more resilient future for all. SUBSCRIBE TODAY TO RECEIVE EXCLUSIVE COVERAGE . | | | | | | | | FIRST IN PULSE — Dozens of healthcare and patient advocacy groups wrote to congressional leaders on Monday, calling for lawmakers to pass the NOPAIN Act as part of its end-of-year package. The 53 signatories, part of the Voices for Non-Opioid Choices coalition, say the passage of the bill would remove "reimbursement barriers that limit patient and provider access to non-opioid pain management approaches, increasing access to and use of medically appropriate, safe, and effective non-opioid approaches to pain management for five years," among other measures. The campaign follows new CDC guidance issued in November stating that non-opioid pain management options are as effective as opioids for acute pain and preferred for subacute and chronic pain. HEALTH GROUPS PUSH TO STOP MEDICARE CUTS — Efforts to persuade Congress to dial back Medicare payment cuts to doctors intensified this week with more than 100 health care groups coordinating an all-out push, Daniel reports. The groups, including the American Medical Association, the Surgical Care Coalition and the American College of Physicians, want billions in scheduled cuts to be postponed or eliminated in Congress' year-end spending package. Doctors oppose a 4.5 percent reduction in the Medicare physician fee schedule, which the Centers for Medicare and Medicaid Services announced last month. Separately, providers are arguing against a 4 percent pay-as-you-go, or PAYGO, cut worth $38 billion, according to a calculation by the American Hospital Association. FLYING IN — More than 70 representatives from children's hospitals across the country are in Washington, D.C., today to meet with lawmakers on both sides of the aisle. They'll advocate for more congressional investment in children's mental health and the pediatric workforce; protection of children's health coverage; and support for the Medicaid Reentry Act, the Children's Health Insurance Program, a 12-month postpartum coverage for Medicaid and a declaration of a public health emergency to help hospitals battle the ongoing surges of flu and RSV.
| | | SUMMITS, SUMMITS, SUMMITS — The Milken Institute's Future of Health Summit kicks off today in Washington, D.C., offering insights on where health care is headed. The summit will feature top administration health officials, including FDA Commissioner Robert Califf and his deputy, Janet Woodcock; CDC Director Rochelle Walensky; CMS Administrator Chiquita Brooks-LaSure; Office of National Drug Control Policy Director Rahul Gupta; and National Coordinator for Health IT Micky Tripathi. Several lawmakers will also speak, including Sen. Tim Kaine (D-Va.), Rep. Anna Eshoo (D-Calif.), Sen. Bill Cassidy (R-La.) and retiring Rep. Fred Upton (R-Mich.). Follow POLITICO's Future Pulse newsletter for ongoing analysis from the conference this week. But that's not all: The Annual Bloomberg American Health Summit also starts in Philadelphia tomorrow , where issues from the overdose epidemic, adolescent mental health and gun violence will be covered. Speakers include Mike Bloomberg, Walenksy and Pennsylvania Gov.-elect Josh Shapiro. AMERICAN HEALTH, RANKED — United Health Foundation's annual ranking of Americans' health is out today , offering a look into how the pandemic impacted a range of health factors. What got worse for everyone: Premature deaths, drug deaths, firearm deaths, nonmedical drug use and fourth-grade reading proficiency, among other things. What got better: Suicide rates decreased, per capita income rose, food insecurity dropped and mental health care providers increased in number. The healthiest states to live in: New Hampshire, Massachusetts, Vermont, Connecticut and Hawaii The unhealthiest: Louisiana, Mississippi, Arkansas, West Virginia and Alabama A TOOLKIT FOR CLINICS IN THE CLIMATE FIGHT — A new toolkit, launched today by the Center for Climate, Health, and the Global Environment at Harvard T.H. Chan School of Public Health and Americares, a disaster relief and global health organization, is designed to help community health centers and free clinics better protect patients from climate risks. The Climate Resilience for Frontline Clinics toolkit is set up to help the clinics that care for millions of uninsured and underinsured patients and are susceptible to climate shocks, like heat waves and storms.
| | | | A message from Humana:   | | | | | | BIDEN BACKS VAX MANDATE FOR TROOPS — The White House said Monday that President Joe Biden and his Pentagon chief oppose any effort to repeal the vaccine mandate for troops, writes POLITICO's Lara Seligman . The move sets the White House up for a fight with lawmakers who want to roll back the controversial policy as part of the defense policy bill set to be unveiled this week. NEW BOOSTERS FOR THE UNDER 5 SET — Pfizer and BioNTech asked the FDA to authorize their updated Covid-19 vaccine for emergency use in children under 5 on Monday, POLITICO's Lauren Gardner reports. The shot, which would be the third in a three-dose series, targets the original strain and two Omicron subvariants. The bivalent vaccine is authorized as a booster dose for individuals ages 5 and up in the U.S.
| | | | POLITICO APP USERS: UPGRADE YOUR APP BY DECEMBER 19! We recently upgraded the POLITICO app with a fresh look and improved features for easier access to POLITICO's scoops and groundbreaking reporting. Starting December 19, users will no longer have access to the previous version of the app. Update your app today to stay on top of essential political news, insights, and analysis from the best journalists in the business. UPDATE iOS APP – UPDATE ANDROID APP . | | | | | | | | Elana Ross is now director of strategic comms at the Health Resources and Services Administration at HHS. She previously was deputy comms director for Assistant Speaker Katherine Clark (D-Mass.). Josselin Castillo is now manager of government relations at the National Federation of Independent Business. She previously led health care federal affairs for Americans for Prosperity.
| | | Nina Schwalbe and Elliot Hannon argue in The Washington Post why the world needs a global pandemic treaty that holds governments to account for compliance. A new analysis from KFF found that, contrary to the popular narrative, some large hospital systems not only survived the pandemic — they thrived. The New York Times reports on the case of a couple in New Zealand refusing to allow their infant to undergo heart surgery unless the blood donated does not contain mRNA Covid-19 vaccine.
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