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Presented by Blue Cross Blue Shield Association: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Adam Cancryn and Sarah Owermohle | | | With Carmen Paun 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.
| | | — Democrats' social spending proposal represents a sweeping expansion of the health safety net — as well as a reminder that they could have gone even bigger. — Trump-era health officials knew Novavax faced serious issues making its Covid-19 vaccine as early as fall 2020, but decided to stick with the company anyway. — An early decision to exclude pregnant people from Covid-19 vaccine trials ended up clearing the way for one of the pandemic's most entrenched avenues of misinformation. WELCOME TO FRIDAY PULSE — where more than a year-and-a-half into our remote work existence, Rep. Katie Porter is still finding new ways to liven up Congress’ Zoom-style hearings. Tips to acancryn@politico.com and sowermohle@politico.com. | | | | A message from Blue Cross Blue Shield Association: Millions more Americans could gain access to high-quality health insurance coverage by expanding Medicaid. Let’s close the low-income coverage gap and create a more equitable health care system that works better for everyone. Learn how. | | | | | | THE TWO TRUTHS ABOUT DEMS’ SPENDING BILL — Even in a deeply divided Washington where progress is increasingly measured in absolutes, there are times when two things can be true about a single piece of legislation. Democrats’ $1.75 trillion spending bill is one of them. Truth one: Democrats are on the verge of the most significant strengthening of the health safety net since Obamacare. From Medicare to Medicaid, the Affordable Care Act to care at home, the health elements of the package are as sweeping as they are consequential . The legislation would mean extending access to hearing aids to millions of older Americans, and coverage for the roughly 4 million in red states who are too poor to afford private insurance – but not poor enough to qualify for base-level Medicaid. Obamacare would be further entrenched under the proposal, with a greater proportion of enrollees given access to subsidized plans. In-home care for older people and those with disabilities would get a $150 billion boost – an infusion likely to put a dent in waiting lists and raise worker pay. And those are just the headline provisions. Tucked into the bill are long-sought priorities like the permanent reauthorization of the Children’s Health Insurance Program, permanent Medicaid funding for U.S. territories and a host of investments aimed at combating maternal mortality and addiction, as well as building out the nation’s public health infrastructure. “Some people look at the donut and just see the hole. I see the donut. This donut is substantial,” Sen. Dick Durbin said Thursday . Truth two: The donut sure could’ve been a whole lot bigger. Perhaps the only health provisions as significant as the ones in the proposal are those that were left on the cutting room floor. That includes any sort of drug pricing overhaul, which Democrats pledged for years to tackle once they had full control of Washington – only to abandon it in the face of massive industry pushback and staunch opposition from Sen. Kyrsten Sinema and others. Two-thirds of a proposed Medicare expansion is also out for now, meaning no new glasses or dental work to go along with beneficiaries’ hearing aids. Paid family and medical leave – another broadly popular idea – is also on the outs after Sen. Joe Manchin refused to back it. The upshot is that the framework – in its current form – could end up as the biggest win of President Joe Biden’s first year, and also one of his most notable disappointments. Democrats’ months of negotiations resulted in a potentially transformational bill that could benefit millions of voters. But in the process, they also sold those voters on the importance of lowering drug prices and expanding Medicare benefits – only to pare those elements back not because Americans didn’t support them, but because too many of their elected officials do not.
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WHY WARP SPEED STUCK WITH TROUBLED NOVAVAX — U.S. officials knew as early as fall 2020 that Novavax faced serious difficulties mass producing its Covid-19 vaccine, even as the company publicly projected confidence and promised to supply billions of doses to the world, POLITICO’s Erin Banco and your PULSE authors report.
The manufacturing issues were so bad at points that some officials urged Operation Warp Speed to abandon its federal support of Novavax, expressing frustration with the company’s inexperience and apparent inability to make progress. But those concerns were rebuffed by senior Trump health officials including Moncef Slaoui and White House Covid-19 Task Force Coordinator Deborah Birx, who argued that Novavax’s candidate offered a critical alternative to the mRNA vaccines developed by Pfizer and Moderna – and would be essential to helping combat the pandemic worldwide. Fast forward a year, and Novavax has yet to deliver a single dose. The company’s manufacturing setbacks have persisted into the Biden administration, delaying the shipment of hundreds of millions of doses that were supposed to go to low and middle-income countries – and leaving the global vaccine campaign severely shorthanded. U.S. officials are now skeptical that the company can meet the FDA’s high standards any time soon, putting Novavax’s pledge of 100 million doses for the U.S. in doubt. The company has also yet to file for regulatory authorization in several other key regions, delaying its ability to begin sending doses to COVAX. Novavax executives contend those filings are on their way. And there is one bright spot: Earlier this week, Novavax submitted its regulatory application to the U.K. Still, it’s unclear when the U.K. will grant authorization – or even if it’s on track to do so. Asked whether Britain’s regulators had accepted the company’s submission, a Novavax spokesperson would say only that it “acknowledged receipt” of the application. As for the U.S.’s global role: Progressive activists spent the night outside Covid-19 Coordinator Jeff Zients’ house demanding more action from the administration to combat the pandemic abroad, POLITICO’s Carmen Paun reports. The protest followed a rally earlier in the day, where activists under the umbrella of the group Justice is Global called for lowering the barriers to vaccine production, the sharing of vaccine recipes and more funding of manufacturing hubs around the world. | | | | A message from Blue Cross Blue Shield Association:   | | | | | | HOW EARLY COVID TRIALS FUELED PREGNANCY MISINFO — When scientists began the first Covid-19 vaccine trials, they excluded pregnant people from participating – and inadvertently set the stage for a wave of misinformation, POLITICO’s Lauren Gardner reports. The absence of early data on the vaccines’ safety for pregnant and lactating people meant the CDC and other health organizations hesitated initially to recommend them for those groups. That seeded doubts about the shots that have persisted to this day, long after officials concluded that they pose no risk. “I think it hurt us to be able to not strongly come out of the gate and recommend these vaccines,” said Linda Eckert, the liaison to the CDC for the American College of Obstetricians and Gynecologists. Biden officials and maternal health experts are now redoubling outreach to pregnant Americans, in a bid to combat unfounded rumors that the vaccines could harm fetuses or reduce fertility. Just 34 percent of pregnant adults are fully vaccinated so far, according to the CDC – well below the broader national pace. But the effort is also fueling a separate campaign to rethink clinical trial procedures by including pregnant people much earlier in the process. That would involve more quickly starting the non-clinical research required for trials in pregnant people, or allowing them to enroll in vaccine studies during epidemics if the potential benefits outweigh the risk. “Our mantra is: We need to protect pregnant women through research instead of from research,” Diana Bianchi, director of NIH’s National Institute for Child Health and Human Development, said. | | | DEMS’ DRUG PRICE DREAM EVAPORATES — The social spending bill is on course to be Democrats’ latest defeat at the hands of the pharmaceutical lobby – but perhaps its most painful one, POLITICO’s Alice Miranda Ollstein, Megan R. Wilson and Hailey Fuchs report. In particular, a long-sought proposal allowing the government to negotiate drug prices fell short despite Democrats controlling Congress and the White House and enjoying the support of more than 80 percent of the public. That could still change. But the setback comes after the drug lobby spent millions on lobbying and advertising campaigns, and at the hands of a small group of centrist Democrats who receive outsized support from the industry. “Pharma is everywhere,” Senate Finance Chair Ron Wyden said after the party’s framework excluded any meaningful drug price reform. Progressives are still attempting to get the provision back in the bill. But the reality is the party had to bend several of its health provisions to the industry’s specifications to secure enough support for them on Capitol Hill. That included scuttling new Medicare dental benefits in the face of opposition from dentists’ groups, and extending coverage to low-income people through private insurance rather than a new federal program. | | | COUNTRIES INCH TOWARD PANDEMIC TREATY — World Health Organization member countries are warming to the idea of establishing an international pandemic treaty to deal with the equity challenges complicating the global Covid-19 response, Carmen writes. A group of countries tasked with discussing the treaty, led by the U.S. and Indonesia, recommended Thursday that talks continue after a special WHO general assembly on the issue at the end of November. That meeting is supposed to decide whether to open negotiations – but the group has asked instead for a mandate to identify what a potential treaty would cover and how to negotiate it. The U.S. had previously been tepid on the idea of a treaty, but appears to have warmed to it of late. The report issued by the countries also calls for amendments to the International Health Regulations that govern the world’s response to health emergencies and countries’ reporting obligations.
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| | | HHS Press Secretary Sean Higgins has left the administration after roughly eight months on the health department’s comms team. Higgins will join Precision Strategies – the consulting firm co-founded by Obama alums – beginning on Monday, he told PULSE. Health technology firm Healthy.io has added former VA Secretary David Shulkin to its advisory board, as well as Stanford University Professor of Surgery Geoffrey Gurtner. The company also appointed Cove Hill Partners co-founder Yvonne Hao and former FDA official and current Greenleaf Health exec Kalah Auchincloss to its board. | | | State regulators have reprimanded Boston Medical Center’s head of spine surgery for leaving an operating room before the start of a surgery to eat in his car, then falling asleep and missing the procedure, The Boston Globe’s Jonathan Saltzman reports. After Sen. Richard Burr sold $1.6 million in stock ahead of a Covid-driven market crash, he called his brother-in-law, who began the process of dumping stock within a minute of getting off the phone, ProPublica’s Robert Faturechi writes. | | | | A message from Blue Cross Blue Shield Association: The racial health disparity crisis in the U.S. is unconscionable and unacceptable. That’s why Blue Cross and Blue Shield companies are working to reduce disparities in maternal health by 50% in 5 years – part of our multi-year commitment to promote health equity. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
