| | | | | |  | | By Dan Diamond and Adam Cancryn | Presented by |  | | | With Susannah Luthi and Rachel Roubein Editor's Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our subscribers 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.
| | | — Covid-19 vaccines are rolling out across America today after a flurry of regulatory activity over the weekend. — A bipartisan, bicameral deal on surprise billing doesn't have the backing yet of Senate Majority Leader Mitch McConnell. — An industry panel is set to vote on President Donald Trump's promised drug-discount cards, potentially dealing a fatal blow to the plan. IT's MONDAY PULSE AGAIN IN AMERICA — Where shots are set to go into health care workers' arms today, including at an event at George Washington University Hospital featuring HHS Secretary Alex Azar. The vaccine can't come soon enough: The nation topped 15,000 Covid-19-related deaths in the past week. Tips to ddiamond@politico.com and acancryn@politico.com. | | | | A message from PhRMA: Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives. More. | | | | | | THE VACCINES ARE COMING — Federal health officials expect 145 sites across all states to receive Covid-19 vaccine shots today; 425 sites to get their shipments Tuesday; and then the remaining 66 to receive their doses on Wednesday, the administration said this weekend and POLITICO's Rachel Roubein reports. "We'll be working hard the next couple of days to ensure these first shipments go very well," said Gen. Gustave Perna, the chief operating officer of the Trump administration's vaccine accelerator, known as Operation Warp Speed, said Saturday at a press conference. "It is the foundation for all future deliveries." Federal health officials have said that roughly 2.9 million doses of the Pfizer vaccine will come in the first shipment, as the government holds back another 2.9 million shots so the first vaccine recipients will be able to get their second shots. The amount of shots reserved for a second dose will dwindle as the vaccination effort moves forward. — A flurry of regulatory activity occurred over the weekend, with FDA issuing an emergency-use authorization on Friday night, and CDC's vaccine advisory committee voting Saturday to recommend use of the Pfizer vaccine in people 16 and older. CDC Director Robert Redfield approved the recommendation on Sunday. — STEPHEN HAHN: Vaccine authorization based in 'science and data.' The FDA commissioner defended the process in a series of weekend appearances, seeking to reassure Americans wary about an expedited vaccine. "Our timeline, how we approached this was based upon our thorough review of the science and data," Hahn said on CNN's "State on the Union" on Sunday. At the same time, the FDA commissioner pushed back on suggestions that the vaccine could have been further rushed — a complaint made by Trump. "We do not feel that this could have been out a week earlier," Hahn said in an interview with ABC's Martha Raddatz. "We went through our process," Hahn added. "We promised, Martha, the American people that we would do a thorough review of the application, and that's what we did." — From 'America First' to America sixth. Mexico on Friday night also authorized Pfizer's vaccine, narrowly beating the FDA's announcement. That means that the United States ended up as the sixth nation in the world to permit the Pfizer vaccine — following the United Kingdom, Bahrain, Canada, Saudi Arabia and Mexico — despite playing a key role in its development. Pfizer held clinical trials for the vaccine across America, and the U.S. government put $1.95 billion toward a guaranteed purchase order. That delay had been a source of frustration in the White House, with officials putting pressure on FDA to move quicker up until Friday night's announcement. — White House staff were set to get the vaccine early. Staffers who have close proximity to Trump were told they would get Covid-19 injections soon, NYT's Annie Karni and Maggie Haberman report. But Trump tweeted Sunday night that he'd called for an "adjustment" to the plan . "People working in the White House should receive the vaccine somewhat later in the program, unless specifically necessary," Trump wrote. | | | | STAY UP TO SPEED ON THE PEOPLE AND POLITICS DRIVING GLOBAL HEALTH: The global pandemic has revealed just how critical it is to keep up with the politics, policy and people driving global health. Will America reclaim its leadership on the worldwide health stage as the Biden administration assumes power in 2021? What will the global distribution of a Covid-19 vaccine look like? Which counties and people will be prioritized? Our Global Pulse newsletter connects leaders, policymakers and advocates to the politics impacting our global health. Join the conversation and subscribe today. | | | | | BIDEN STARTS COUNTERING TRUMP'S VACCINE MESSAGE — President-elect Joe Biden's team is feverishly working to get a messaging plan in place to sell a skeptical public on the first FDA-backed coronavirus vaccine, believing the Trump administration has set the effort back significantly, Rachel and Dan Goldberg report. Biden implied on Friday that he's not going to wait until he takes office to start counteracting Trump's mixed messaging on the vaccine, which includes downplaying the public health threat of the coronavirus while hailing the unprecedented speed at which a shot was developed. Biden's team is already laying the groundwork for a public education campaign by placing scientists in top posts — and promising to defer to them — and by putting an intensive focus on getting the vaccine to underserved populations, according to public health experts who've spoken with the transition. According to a transition official, the Biden team is "planning on how to communicate in the most creative, transparent and effective ways to reach Americans where they are" with more details available in "the coming weeks." — The view from the administration: A White House spokesperson defended the administration's messaging, pointing to the administration's three-hour, live-streamed summit on the vaccines' development, review and distribution. "Any mixed messages or attacks from the president's opponents for political purposes are shameful," the spokesperson said in a statement. — Trump team finally moving forward with $250 million ad campaign on coronavirus. Contractor Fors Marsh Group is rushing out a campaign to try to boost vaccine uptake, the administration told the New York Times for a story that popped Sunday night. But the ads aren't ready yet: Focus groups to help tweak the ads will begin Tuesday, HHS told the NYT. — PULSE reminder on how we got here: HHS abruptly took $300 million from CDC this summer for its planned Covid ad campaigns, with the bulk awarded to Fors Marsh, in an eye-catching effort to "defeat despair" about coronavirus through pre-election ads. Despite considerable scrutiny and congressional probes, there's been no report of wrongdoing with the Fors Marsh contract. But a component of HHS' campaign — a separate $15 million contract with Atlas Research — raised multiple red flags , with congressional investigators asking why celebrities were being vetted for their political views. HHS also steered funds to the business partner of the department's spokesperson, despite no prior experience working on U.S. public health campaigns, and efforts to produce ads quickly ran aground. The Atlas contract was ultimately scrapped last month after an internal review. | | | | HAPPENING TUESDAY - CONFRONTING INEQUALITY IN AMERICA TOWN HALL : The pandemic-induced recession has put over 40 million Americans at risk of foreclosure and eviction and caused a steady decline in Black homeownership. What solutions need to happen to make housing more inclusive and fair? Join POLITICO for its fourth town hall in the series "Confronting Inequality in America." Our latest town hall explores "The Housing Gap" and will convene policymakers, lawmakers, advocates and mortgage industry leaders to discuss various approaches for eliminating housing inequality as we begin to recover from the Covid-19 recession. REGISTER HERE. | | | | | | | | A SURPRISE ON 'SURPRISE BILLING' — Key congressional committees on Friday clinched a last-minute deal to protect patients from receiving "surprise" medical bills, potentially putting an end to nearly two years of infighting, POLITICO's Susannah Luthi and Rachel Roubein report. Shielding insured patients from eye-popping medical bills for unexpected out-of-network and emergency care has been a bipartisan priority for lawmakers, but progress had been stalled for more than a year — largely because of resistance from House Ways and Means Chair Richard Neal (D-Mass.). In a last-ditch effort to clinch an agreement, Neal scored major structural changes to the leading legislation to make the policy more friendly to hospitals and doctors. The late-breaking deal surprised Washington, where the fight over what was supposed to be a simple policy fix had devolved over the past two years into a lobbying blood bath – with private equity-backed physician groups pouring millions of dollars to sink an earlier deal that could cut into their profits. — What's in the bill: All billing disputes are allowed to be appealed to an independent mediator, a key ask of physician groups. The nearly 375-page bill, which the four health committees released Friday night, also includes price transparency measures and a provision letting patients off the hook from paying if they get their bill more than 90 days after receiving care. — Who's on board: Senate Minority Leader Chuck Schumer, Speaker Nancy Pelosi and the White House all put out statements in support of the deal Friday night. — But Senate Majority Leader Mitch McConnell has not yet signed on. And the blame game is already starting. A senior Democratic aide alleged McConnell is "singlehandedly blocking" the protections from getting included in a year-end deal. A senior GOP aide countered that Republicans are reviewing the proposal. — The American Hospital Association says it has "significant concerns" with several provisions, arguing that arbiters shouldn't consider public payer reimbursement rates when determining the cost of care, given that public payer reimbursement is "well known to be below the cost of providing care." "We urge that the legislation include an explicit prohibition on considering Medicare, Medicaid and other public payer rates, especially as these programs are not implicated by the surprise medical billing provisions," AHA writes in a letter to congressional leaders. AHA also said that if the measure moves forward, its estimated $16 billion in savings — earmarked for key health programs, like community health centers — should go to hospitals and clinicians, citing the Covid-19 pandemic. (Congress has already set aside more than $175 billion in financial relief for hospitals and other providers.) A coalition that includes insurer and employer groups asked Congress not to pass the new policy, which it called "a gift to private equity." | | | |   | | | | | | TODAY: KEY VOTE ON TRUMP's DRUG CARDS — An industry panel is set to decide whether it will help advance Trump's promised drug-discount cards for seniors, two people with knowledge of the vote tell POLITICO's Dan Diamond. The Special Interest Group for Inventory Information Approval System Standards, or SIGIS, is planning to vote on whether to participate in the project. SIGIS' participation is necessary for mass-producing millions of cards that work at retail locations, officials tell PULSE. The group has emerged as a key roadblock to Trump's promised $200 drug-discount cards, because SIGIS helps govern electronic transitions at point-of-sale. But SIGIS has spent weeks rebuffing the administration, saying that Trump's one-time drug discount cards weren't consistent with its standards for other health-benefit cards. Trump promised Medicare beneficiaries on Sept. 24 that the cards would arrive in the "coming weeks." | | | HOSPITALS SUE TRUMP ADMINISTRATION OVER PHARMA 340B PLAY — The AHA, other hospital groups and individual facilities teamed up to sue HHS for not intervening when pharma companies quit extending generous discounts on certain medicines to hospitals' contract pharmacies, Susannah writes. — How we got here: Those discounts, enshrined through a federal drug discount program known as 340B, have been the source of considerable frustration and lobbying during Trump's term. Hospitals allege that the Trump administration has "refused to take action against the drug companies or even inform them that their conduct violates the 340B statute," despite frequent requests for intervention, instead determining that "they lack the authority" to force the drug companies to honor the 340B discounts when the medicines are dispensed through contract pharmacies. — The hospital-pharma standoff over the drug discount program intensified this summer when Eli Lilly, AstraZeneca and other manufacturers said they were ceasing some of their discounts, Susannah notes. The hospital complaint follows a related lawsuit filed in October by HIV/AIDS clinics in the program, naming Eli Lilly, AstraZeneca, Novartis and the U.S. division of Sanofi-Aventis. | | | | A message from PhRMA: America's biopharmaceutical companies are making great progress against a common enemy – COVID-19. They're learning from successful vaccines for other diseases, developing new treatments and collaborating like never before.
Today, there are several promising vaccine candidates in stage three clinical trials. These trials have tens of thousands of participants, from every walk of life. From development to robust clinical trials, and throughout manufacturing, these vaccine candidates follow the same rigorous process of other vaccines that have saved millions of lives.
America's biopharmaceutical companies are working day and night until they defeat COVID-19. Because science is how we get back to normal. | | | | | | INSURER HIRES TRUMP OFFICIAL INVOLVED IN CARES FUNDING DECISION — UnitedHealth hired a former HHS official who played a key role in the department's selection of the insurance giant to dispense $30 billion in Covid recovery funds to health care providers, two people familiar with the matter tell POLITICO's Daniel Lippman. William Brady, who was chief of staff to the deputy secretary at HHS, recently started as vice president for digital at UnitedHealth's Optum, where he is working on technologies for consumers. POLITICO reported in April that Brady and fellow senior HHS official Jim Parker led the decision-making process that chose UnitedHealth for the government contract to funnel the relief payments under the CARES Act. Brady didn't respond to a request for comment, but a UnitedHealth spokesperson said that Brady, in his role at Optum, won't be working with HHS or have any involvement in disbursing the funds. Brady previously worked in the insurance industry as associate legal counsel for Blue Cross and Blue Shield of Illinois, Montana, New Mexico, Oklahoma and Texas. He also worked on digital technology issues at HHS. Brady is the second Trump administration official involved with the recovery payment program to have a financial connection to UnitedHealth. Steven Parente, then a White House economist, decided the methodology for how to make the initial $30 billion in payments — drawing scrutiny because he had formerly served as a consultant to UnitedHealth, among other companies. ENVISION HEALTHCARE announces leadership shake-ups. The national medical group announced that CFO Wes Booysen and Chief Accounting Officer Kenneth Zongor are both stepping down in the coming months, and Chief Administrative Officer Dave Esler will transition into an advisory role. Meanwhile, former Hallmark executive Beth Sweetman is coming out of retirement to be Envision's chief people and communications officer. Meg Lafave, a former DaVita executive and current Envision staffer, will also take on a new role as Envision's senior vice president for people and government affairs. April Zepeda, a former Optum executive, is joining Envision as senior vice president of communication. | | | "60 Minutes" examined how California Attorney General Xavier Becerra, Biden's pick for HHS secretary, took on hospital chain Sutter Health. Doctors who spread pseudoscience should face disciplinary action from state medical boards, Richard Friedman argues in the New York Times. "They don't see how bad it truly is." Doctors and nurses at a Nebraska hospital treating Covid-19 patients open up to the Lincoln Journal Star's Chris Dunker, who shadowed them for 10 hours. Indiana public hospital CEOs can get millions of dollars in compensation — and keep it secret, Emily Hopkins, Tony Cook and Tim Evans write for the Indianapolis Star.
| | | | Follow us on Twitter | | | | Follow us | | | | |
No comments:
Post a Comment