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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 Susannah Luthi | Presented by |  | | | With help from Rachel Roubein, Alice Miranda Ollstein and Adam Cancryn 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.
| | | — The FDA has approved Moderna’s plan to increase doses in its vaccine vials. — A Johnson & Johnson contractor admitted it ruined 15 million vaccine doses. — The vaccine rollout has hit another snag: not enough data loggers at inoculation sites. WELCOME TO FRIDAY PULSE, where we’re thrilled that SARAH OWERMOHLE will be the new permanent co-author of PULSE. Sarah makes her debut on Monday, joining Adam Cancryn in bringing you an even deeper look at the health policy and politics shaping the White House, Congress and the rest of official Washington. Tips to Sarah at sowermohle@politico.com and Adam at acancryn@politico.com. | | A message from Blue Cross Blue Shield Association: Reluctance about vaccines is higher in communities of color due to a long history of inequitable health treatment. Learn how we are using Blue Cross and Blue Shield data to identify social vulnerabilities and replace hesitancy with hope. | | | | | | FIRST, THE GOOD NEWS — The FDA has given Moderna the OK to increase the number of doses in its vaccine vials from 10 to 15, POLITICO’s David Lim reports. The company late Thursday night said it can start shipping the 15-dose vials in the “coming weeks.” The agency also said the vaccine providers can extract 11 doses from the existing 10-dose vials already in circulation at vaccine sites, provided they have the appropriate syringes and needles. Some pharmacies have already said they’ve been able to eke out these extra doses, but now it’s official. As David and Sarah have previously reported, Moderna has been in discussions with the FDA since early February about wanting to increase the number of vaccine doses in each vial. Now that Moderna has gotten the all-clear, the company said it will take two to three months to make the dosage changes. AND NOW, THE BAD NEWS — Emergent BioSolutions, a contractor enlisted by Johnson & Johnson to produce the active ingredient in the vaccine, on Thursday confirmed earlier reports that a Baltimore facility had botched millions of vaccine doses, Sarah Owermohle writes. — Emergent has signed deals with both J&J and AstraZeneca, pledging to deliver 1 billion shots between the two by the end of this year. The company reportedly mixed up ingredients from the two different vaccines, resulting in the bad batch, which will be “disposed of properly.” “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” Emergent said in a statement. Still on track? White House press secretary Jen Psaki insisted Thursday that the administration still expects J&J will meet its delivery target of 100 million shots by the end of May. But it’s the latest hiccup for the two vaccine manufacturers, which for the past few weeks have both faced PR flak over their apparent vaccine difficulties. Meanwhile, AstraZeneca was hit with more bad press on Thursday when Germany’s vaccine commission advised that people under 60 who have already received their first AstraZeneca shot should get a different maker’s vaccine for their second jab, following reports of dangerous blood clots in vaccine recipients. WANTED: MORE PAPER PUSHERS — Some health systems are paying up to $45 per hour to workers who manually enter barcode numbers on vials and record billing information and the demographic profiles of the people getting vaccinated, Darius Tahir reports. Why the crunch? Failure to record all this data in real time can make it look like there’s a shortage of vaccines and could undercut efforts to make sure the shots are going out equitably. As Darius notes, it’s the latest manifestation of a basic problem that’s plagued health authorities throughout the pandemic: high-tech breakthroughs like the vaccine and disease tracking apps still require lots of manpower, in part because of historic underinvestment in public health IT. For an example, just look to the University of Texas at Austin, where officials are striving to meet a 24-hour state requirement to feed data into vaccine registries. Any lags in those reports will make it look like sites aren’t using up their vaccines — and that could cause the feds to cut their supply.
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| | | THE NEW OBAMACARE LAUNCH WAS DRAMA-FREE. NOW COMES THE HARD PART — New financial help for Obamacare shoppers rolled out Thursday seemingly without a hitch, a sharp contrast to the infamously glitchy rollout of HealthCare.gov in 2013, Rachel Roubein reports. Democrats’ most recent stimulus bill expanded federal Obamacare subsidies to the estimated tune of more than $34 billion. The provisions will largely benefit older, middle-income people previously priced out of the market, who can now get cheaper plans through the law for the first time. The bill also expanded aid for lower income brackets. But in the majority of states that sell Obamacare plans on the federal exchange, people have to go back to HealthCare.Gov in order to claim the new benefits right away. And it’s up to enrollment groups and insurance agents to help them do it. — HealthSherpa, a website helping people enroll in Healthcare.gov plans, received 32,000 application submissions as of Thursday evening, compared to 5,600 a month ago. Many of the submissions were done by insurance agents who are proactively trying to secure new financial aid for Obamacare enrollees, according to CEO George Kalogeropoulos. — HealthCare.gov will also contact those who already have coverage through the federal marketplace, so they can update their information and receive financial help immediately. | | | |   | | | | | | CDC HITS MESSAGING SNAFU — After CDC Director Rochelle Walensky told MSNBC’s Rachel Maddow this week that people inoculated against Covid-19 won’t spread the virus, her agency stepped in to clarify. “Our data from the CDC today suggests that vaccinated people do not carry the virus, don’t get sick,” Walensky said on Monday. Walensky’s interview with Maddow followed a new CDC study of nearly 4,000 health care workers and first responders showing that Pfizer and Moderna's vaccines were 90 percent effective in blocking transmission — building on trial data that showed the shots effectively ward off illness and death. Both Walensky’s comments and the CDC’s response to follow-up queries fueled confused Twitter exchanges — with some noting that the director overstated things but in practical terms spoke of the vaccines' effectiveness pretty accurately. The CDC hasn’t yet updated guidance saying that people should still mask up outside their households after they get their shots. The New York Times’ Apoorva Mandavilli reported Thursday night that the CDC walked back Walensky’s assertion on Maddow’s show, saying she had been speaking “broadly,” after health experts voiced concern that the CDC director had been too cavalier and could be misinterpreted. A CDC spokesperson reiterated to POLITICO in a statement that no vaccine is 100 percent effective for everyone, and the evidence isn’t clear yet whether the small percentage of immunized people who do get infected could spread the virus to others. The spokesperson also stressed the CDC's study was able to detect asymptomatic cases, and thus could show that the two vaccines can reduce the risk of both symptomatic and asymptomatic infections. | | | WHITE HOUSE GETS EXTENSIONS IN ABORTION-RELATED CASES — The Biden administration secured deadline delays for two key abortion-related cases on Thursday, as the new Justice Department works through the long list of lawsuits dockets from the Trump years. In a Supreme Court case against a Trump-era Title X family planning program overhaul, justices granted a DOJ request to push back its response deadline to May 6. The contested rule blocked federal funds from abortion clinics like Planned Parenthood and also prohibited abortion referrals. A group of red states has stepped in to defend it. The 4th Circuit Court of Appeals postponed deadlines in a case that will determine how abortion pills are dispensed nationwide, Alice Miranda Ollstein reports. The Biden administration said the FDA needs more time to review the rules for who can prescribe the pills and how — both during the pandemic and in general — and the DOJ said the agency’s final decision may moot the case. Anticipating the Biden administration will loosen the restrictions on the pills, many conservative states are currently moving bills to ban or restrict their distribution. | | A message from Blue Cross Blue Shield Association: The United States has the highest maternal death rate of any developed country, with 60% of deaths being preventable. See how Blue Cross and Blue Shield companies are supporting healthier pregnancies and making childbirth safer. | | | | | | John O’Brien will be the new president and CEO of the National Pharmaceutical Council, Adam Cancryn reports. O’Brien, who officially takes over on June 1, spent two-and-a-half years at the Trump health department, including as senior adviser for drug pricing reform to then-Secretary Alex Azar, before departing in 2019. And other Trump administration health officials are moving into new posts: former CMS Administrator SEEMA VERMA has joined the board of directors of Lumeris, a health care company that contracts with hospitals to lower costs. Former HHS Deputy Secretary Eric Hargan, meanwhile, is joining the boards of the Cleveland-based University Hospital health system and Alio Medical, a health tech company. | | | | TUNE IN TO GLOBAL TRANSLATIONS: Our Global Translations podcast, presented by Citi, examines the long-term costs of the short-term thinking that drives many political and business decisions. The world has long been beset by big problems that defy political boundaries, and these issues have exploded over the past year amid a global pandemic. This podcast helps to identify and understand the impediments to smart policymaking. Subscribe and start listening today. | | | | |
| | | Some 200 Texans died during the deep February freeze and power grid failure, according to a Houston Chronicle analysis that found the fatalities were double the state’s official number. The pandemic brought new pregnancy risks — more deaths and stillbirths than in previous year s, the New York Times’ Apoorva Mandavilli reports. Cheap, fast Covid tests are coming — even as demand wanes, reports Kaiser Health News’ Hannah Norman.
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