| Good morning. Emmanuel, possibly the world's most famous emu, refused to comment in an interview with The Post. Make it up to us, and send us your best tips to rachel.roubein@washpost.com. Today's edition: Amid controversies, the FDA is asking outside experts to conduct an evaluation of its food and tobacco programs. Overdose deaths increased during the first year of the pandemic with racial disparities widening. But first … | Democrats are full speed ahead on drug pricing bill, but big questions remain |  Senate Majority Leader Chuck Schumer (D-N.Y.) reads over notes during a news conference following a closed-door caucus lunch yesterday. (J. Scott Applewhite/AP) | | | It's official. Democrats' Manchin-ified health-care reconciliation bill is moving forward. But there are still major questions hanging over the effort. For one, the structure of a two-year extension of enhanced Affordable Care Act subsidies is still under discussion, according to multiple people familiar with the negotiations. And the drug pricing effort is set this week to go before the arbiter of the Senate's rules — and must pass inspection before Democrats can approve the measure with a simple majority. Last week, Sen. Joe Manchin III (D-W.Va.) demanded Democrats whittle down their ambitions for an economic package, saying he wouldn't support new spending on climate change or tax increases. On Tuesday, the news didn't appear to deter his party, as lawmakers seem all but resigned to passing a scaled-back health-care deal. Doing so would still have some political payoff. It would allow Democrats to say they've fulfilled a years-long campaign pledge to allow Medicare to negotiate drug prices. And it would prevent roughly 13 million Americans from learning just weeks before the midterms that their health-care costs will rise. | - "Democrats are moving ahead with the provision to lower prescription drug prices," Senate Majority Leader Chuck Schumer (D-N.Y.) said yesterday after Democrats' private lunch. He later added: "We are proud of this. And that's what we are doing on reconciliation in addition to the ACA provisions."
| | The Post's Leigh Ann Caldwell: |  | | | | PLUGGING OBAMACARE'S GAPS | | This is a big priority for Democrats. The coronavirus package that passed last year boosted financial help for low-income Americans and extended it to middle-income earners for the first time. | | | | | | | | Optum Rx's Genoa Healthcare is embedded in community health centers & offers customized pharmacy services for people with behavioral health & other complex, chronic health conditions. Learn more. | | | |  | | | | | But those beefed-up subsidies are set to expire at the end of the year. Our colleagues Tony Romm and Jeff Stein reported last week that Manchin has endorsed a two-year extension. Over the past few weeks, Manchin has aimed to further limit the enhanced subsidies by income level, believing they should be means-tested. The final contours of what an extension may look like are still getting worked out. Meanwhile, a dozen Republican states have refused to take up Obamacare's Medicaid expansion. Closing the Medicaid coverage gap is a huge priority for the three Democratic senators hailing from non-expansion states: Sens. Tammy Baldwin (Wis.), Raphael Warnock (Ga.) and Jon Ossoff (Ga.). Though including such a policy is an uphill battle at this point, all three senators told The Health 202 that they plan to continue to push for its inclusion. | | Democrats are attempting to pass the package through a fast-track budget maneuver called reconciliation. That lets the party circumvent Republican votes, but it comes with a catch. Each provision must impact government spending or revenue — and if not, it can be stripped from the bill. The Senate parliamentarian is the arbiter of those rules. And on Thursday, the two parties will plead their case on whether the drug provisions comply with the rules of reconciliation before the parliamentarian. | - The Democratic side: "We have been working on these issues for well over a year to be ready for the parliamentarian, and I feel we're in a strong position," said Sen. Ron Wyden (D-Ore.), the chair of the Senate Finance Committee.
- The Republican side: "We're literally in the process today of engaging in our final analysis of what our case may be on various provisions," Sen. Mike Crapo (R-Idaho), the panel's ranking member, said yesterday.
| | All eyes are on a policy aimed at capping inflation. Democrats' legislation requires drugmakers to pay rebates when they increase prices faster than inflation in Medicare and the commercial market. But some experts have questioned whether the parliamentarian could nix extending the penalty to the commercial market. Those in favor of keeping it contend the measure is crucial to ensuring drugmakers don't hike prices for millions of people with private insurance to make up for lost revenue. Chris Condeluci, a health policy consultant, said there could be an argument made for keeping the provision. That's because drugmakers are required to pay the rebates to a key Medicare trust fund, so the provision could impact government spending. | | "I think both arguments are reasonable," said Condeluci, a former Republican aide. "I think it's reasonable to say based on precedent — you, parliamentarian — have indicated that if a provision is impacting private-based insurance, that that doesn't pass muster." Meanwhile … the pharmaceutical industry is waging a long-shot lobbying campaign to kill the drug pricing bill. Read more on that fight from our pals at The Early 202. | | |  | Agency alert | | Amid controversies, FDA seeks advice on food and tobacco operations |  The announcement follows a series of controversies that have plagued FDA Commissioner Robert Califf's second stint leading the agency. (Manuel Balce Ceneta/AP) | | | The head of the Food and Drug Administration is asking outside experts to conduct an independent review of the agency's food and tobacco programs, which in recent months have endured sharp criticism over its handling of the infant formula shortage and e-cigarette reviews, our colleague Laurie McGinley reports. FDA Commissioner Robert Califf didn't pin the need for review solely on the recent controversies. But he said a "series of challenges" have tested the agency's procedures and operations, prompting him to reevaluate the way it does business. The statement is a significant concession from Califf, who has defended the agency during congressional hearings and public appearances. The Reagan-Udall Foundation, a nonprofit created by Congress that works closely with the FDA, will work with an external group of experts on the evaluation. The outside experts will scrutinize … | - The Center for Food Safety and Applied Nutrition, which Califf said has been "stressed by the increasing diversity and complexity of the nation's food systems and supply chain."
- The Center for Tobacco Products, for which Califf said "challenges lie ahead" as it handles an increasing number of novel products that could affect public health — including the review of applications by vaping companies to stay on the U.S. market.
| | FDA Commissioner Robert Califf: |  | | | | Overdose deaths climbed in 2020 as the nation's racial disparities widened | | Overdose deaths among Black Americans and American Indian and Alaska Natives outpaced that of White people in the first year of the pandemic, according to a report released yesterday by the Centers for Disease Control and Prevention. | | Overdose fatalities have been rising across the United States for decades. Officials said disruptions in access to treatments, recovery resources and harm reduction services because of the pandemic contributed to the spike in drug-related deaths that widened the country's existing racial disparities. The recent deaths were overwhelmingly driven by illicit fentanyl, though deaths attributed to stimulants have also increased in recent years, the agency noted. Key takeaways from the report: | - Overdose deaths increased by 30 percent overall from 2019 to 2020, with nearly 92,000 deaths.
- Fatalities rose 44 percent among Black people; 39 percent among American Indian and Alaska Natives; and 24 percent among White people.
- Hispanic people and Asian or Pacific Islanders reported the lowest increases, 21 percent and 22 percent respectively.
| | CDC Director Rochelle Walensky: |  | | | | | |  | White House prescriptions | | White House debates limited abortion health emergency directive |  Some officials for President Biden remain skeptical that the option would survive inevitable legal challenges. (Samuel Corum/Bloomberg News) | | | White House officials are considering a narrow public health directive aimed at safeguarding nationwide access to abortion pills, Politico reports. The Biden team is zeroing in on that directive, believing it could have the most immediate on-the-ground impact of the limited options available to the White House to shore up abortion rights, while also appeasing Democrats' calls for more aggressive action. Even still, some senior aides remain skeptical such a move would survive the inevitable legal challenges, which they worry could also potentially open the door for conservative justices to further limit the president's executive powers, Adam Cancryn writes. The details: The proposal would rely on authorities granted under the Public Readiness and Emergency Preparedness Act reserved for public health emergencies to protect providers and pharmacies from liability for providing abortion pills to patients nationwide — even in states that have restricted or banned the procedure. | | |  | Reproductive wars | | Doctor in 10-year-old's abortion case takes legal step against Indiana attorney general |  Indiana Attorney General Todd Rokita (R) could face a defamation lawsuit over comments he made about an abortion provider at the heart of a case that has garnered international attention. (Photo/Darron Cummings/AP) | | | An Indianapolis doctor who helped a 10-year-old Ohio rape victim obtain an abortion took the first legal step yesterday in a possible defamation lawsuit against Indiana Attorney General Todd Rokita (R), The Post's Timothy Bella reports. Attorneys for Caitlin Bernard filed a notice of tort claim against Rokita for "false and misleading statements" he made about the OB/GYN in media appearances in the days after Bernard shared how she helped the child. A spokesperson for Rokita said he would fight any potential lawsuit. Catch up quick: Rokita claimed last week on Fox News that Bernard had a "history of failing to report" abortions in child-abuse cases and announced that his office would launch an investigation into her licensure. Documents obtained by The Post show that Bernard had informed the relevant state agencies about the procedure before the legally mandated deadline to do so. | | More from Rokita: |  | | | | | More abortion coverage across the nation: | - The Mississippi provider at the center of the Supreme Court decision that overturned the constitutional right to an abortion dropped a lawsuit yesterday that sought to block the state from enforcing its near-total ban on the procedure, the Associated Press reports.
- Seventeen members of Congress were among dozens of abortion rights protesters arrested outside the Supreme Court yesterday in a rally demanding immediate action to protect access to the procedure, The Post's Ellie Silverman writes.
| | |  | In other health news | | - Tennessee is proposing to strip some of the controversial elements of a Trump-approved Medicaid waiver after Biden officials demanded the change.
- CDC Director Rochelle Walensky recommended the use of Novavax's coronavirus shot following a unanimous vote from the agency's advisers, opening the door to a fourth vaccine option for adults.
- An investigation by the Markup found that Facebook has allowed ads and posts for the "abortion pill reversal" procedure, a medically unapproved and potentially dangerous process chastised by a major provider group, to circulate on its site for months.
| | |  | Health reads | | | By Liz Szabo and Lauren Weber | Kaiser Health News ● Read more » | | | | | |  | Sugar rush | | | Thanks for reading! See y'all tomorrow. | |
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