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Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Lauren Gardner | | | With help from Megan R. Wilson and Katherine Ellen Foley Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro. | | | — Medicare proposes covering a controversial Alzheimer’s drug only if patients are in a clinical trial. — Democrats and Biden administration allies are pushing the White House to reset its Covid strategy amid a hypercontagious variant and confusing public messaging. — The CDC will let its conditional sail order expire this weekend despite an explosion of Covid cases on cruise ships. WELCOME TO WEDNESDAY PULSE — I’m Lauren Gardner, an FDA reporter on the health team rotating in for Adam and Sarah for the next two days. You can find me over at Prescription Pulse on Tuesdays and Fridays. I regret to inform readers that Hulk Hogan is once again raining on ’90s kids’ nostalgia parade, this time over Covid vaccines. Got tips or feedback? Send them to lgardner@politico.com or on Twitter @Gardner_LM. | | | | A message from PhRMA: Did you know more than half of every dollar spent on medicines goes to someone who doesn’t make them? There’s a long line of middlemen, like PBMs and insurers, collecting a significant portion of what you pay for medicine. The share of total spending for brand medicines received by the supply chain and other stakeholders increased from 33% in 2013 to 50.5% in 2020. Learn more. | | | | | | MEDICARE LIMITS ADUHELM COVERAGE TO TRIAL PARTICIPANTS — The Centers for Medicare and Medicaid Services announced Tuesday it plans to cover Aduhelm, a monoclonal antibody treatment for Alzheimer’s disease, only if patients are enrolled in ongoing clinical trials cleared by CMS. The draft coverage determination effectively shuts off access to the drug, made by Biogen to target amyloid plaque in the brain that’s thought to cause the disease, for many older Americans in the illnesses’ early stages. It also applies to similar Alzheimer’s drugs already in development. The decision riled Biogen and the drug’s supporters, who said it limits the therapy’s availability to those with access to research institutions. The lack of diversity in clinical trials is a longstanding issue in the medical research world. “It will not reach people of color. These kinds of studies do not enroll people of color,” said John Dwyer, president of the Global Alzheimer’s Platform Foundation. “Underrepresented populations don’t get into studies, generally.” But others, including insurance groups like the Blue Cross Blue Shield Association and drug price negotiation stalwart Bernie Sanders (I-Vt.), applauded CMS’ proposal. “Biogen’s outrageous original price for Aduhelm, $56,000 per year, is the poster child for how dysfunctional our drug pricing system has become, and it is the perfect example of why Medicare should be negotiating drug prices with the pharmaceutical industry,” Sanders said. | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | DEMS URGE BIDEN COVID TEAM TO SHIFT MESSAGING STRATEGY — Congressional Democrats and former advisers to Biden-world on pandemic response are aligning on the administration’s need to reset its Covid-19 strategy to head off more distrust in public health authorities, POLITICO’s Sarah Ferris, Alice Miranda Ollstein and Nicholas Wu report. The party’s concerns played out during a Senate hearing Tuesday featuring President Joe Biden’s top health officials, but even Democratic leaders are entering the fray. “We need to make it very clear: This is not easy. We understand it’s not easy, but we’ve got to follow the rules,” House Majority Leader Steny Hoyer (D-Md.) said. “But the rules need to be clear, and the CDC needs to be clearer than it has been.” Stay tuned: The president is slated to give a speech on the state of the pandemic Thursday, when he might offer more guidance to the public in light of the Omicron variant’s spread and address criticism of the CDC’s reluctance to formally recommend high-quality masks like N95s and KN95s. Zeke Emanuel, an adviser to the Biden transition who’s joined others in urging a new strategy, said the administration has been too reactive to the virus’ mutations into the Delta and Omicron strains and should construct systems for where the country needs to be over the next year. “If you don’t do today what will help six months from now, you’re going to be in trouble,” he said. Need help interpreting what health officials said at the hearing? Alice decoded their jargon-filled answers. CDC TO LIFT CRUISE RESTRICTIONS DESPITE CASE SURGE — The CDC plans to let its conditional sail order for cruise ships lapse on Saturday, Director Rochelle Walensky said Tuesday, despite a dramatic spike in Covid cases on those vessels in recent weeks, POLITICO’s Alex Daughtry writes. Walensky told senators at the HELP hearing there’s been a “30-fold increase in cases on ships” amid Omicron’s rise. Still, she said the industry has “stepped up” and is largely adhering to CDC guidelines on its own, rendering additional regulations unnecessary. Flashback: The CDC on Dec. 30 increased its travel health notice for cruise ships to Level 4, its highest tier, because of case increases since Omicron was first identified. “Avoid cruise travel, regardless of vaccination status,” the agency currently warns. BE TRUE TO YOUR SCHOOL — The White House announced measures this morning to increase Covid testing in schools, including sending 5 million free rapid tests a month and 5 million free lab-based PCR tests a month to schools nationwide. The CDC will issue guidance later this week for schools to implement its “test-to-stay” approach to keeping kids in school after Covid exposures, with materials that include a school checklist and frequently asked questions. ICYMI, AUDIO EDITION — Check out POLITICO’s Rachael Levy on Tuesday’s POLITICO Dispatch podcast discussing her story about Covid-positive health care workers being compelled to return to work as caseloads and hospitalizations soar. | | | | A message from PhRMA:   | | | | | Inside the Humphrey Building | | BABY-MONITORING COMPANY TURNS TO K STREET AMID FDA FLAP — Owlet Baby Care, the maker of sleep-tracking socks for babies, has hired its first two K Street lobbying firms amid scrutiny from federal regulators over one of its products, Megan reports. Disclosure forms say that lobbyists from Akin Gump Strauss Hauer & Feld and Thorn Run Partners are working on issues “related to the FDA and digital health” and the “regulation of digital health products; consumer access to health data.” An Owlet spokesperson said the company is “working to educate around the opportunities and needs in digital health.” Akin Gump declined to comment, and a lobbyist for Thorn Run echoed the company’s statement. The FDA sent a warning letter to the company last fall about a line of sleep socks that claim to track a baby’s heart rate and oxygen levels, saying they qualify as a medical device and need to be cleared or authorized by the FDA. Owlet has stopped selling them in the U.S. — though they’ve debuted a new line of sleep-monitoring socks — and said in a statement that it plans to apply for marketing authorization from regulators. | | | FLORIDA GOP PLANS TIGHTER ABORTION LIMITS — Republican state lawmakers plan to pass legislation this year to restrict how and when people can access abortions, POLITICO’s Arek Sarkissian reports from Tallahassee , building on efforts in other states to limit abortion access. The measure, unveiled Tuesday, would prohibit abortions after 15 weeks unless two doctors agree a fetus suffers from a fatal abnormality. There would be no exceptions for rape or incest. | | | | BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now. | | | | | | | | Protect Our Care has tapped Nicole Haley to run the group’s Coronavirus War Room through 2022. She previously worked as research director for Vote Yes for Fairness, an Illinois ballot initiative, and is an alum of Priorities USA, American Bridge and Hillary for America. | | | Pfizer will cut its U.S. sales staff by a few hundred positions as it anticipates more virtual meetings with health care providers post-pandemic, Reuters reports. California Gov. Gavin Newsom plans to extend health care coverage to all undocumented immigrants in the state, the San Francisco Chronicle writes. Some Atlanta restaurants are adding surcharges to customers’ bills to help cover health insurance for their employees, The Atlanta Journal-Constitution writes. | | | | A message from PhRMA: Did you know that PBMs, hospitals, the government, insurers, and others received a larger share of total spending on medicines than biopharmaceutical companies? That’s right, more than half of spending on brand medicines goes to someone who doesn’t make them. Let’s fix the system the right way and ensure more of the savings go to patients, not middlemen. Read the new report. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
