HEALTH CARE BRIEFING: Biden Virus Fight Balances Goals, Reality
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Joe Biden effectively took ownership of the fight against the coronavirus on Monday with a presidential-style call to action, but he can do little more than plan, plead for the wearing of masks and hope the “dark winter” he predicted doesn’t sour the nation on his ability to quell the pandemic before he gets into office on Jan. 20.
Biden beat Donald Trump by promising to do a better job defeating the virus, and with a short and unforgiving window to show progress, Biden was left on Monday trying to raise hopes without unrealistically raising expectations as the virus spreads.
“No question, he starts with a handicap, for sure, in the sense this will be much more of a burden when he takes over,” said George Abraham, chair of the Infectious Disease Board at the American Board of Internal Medicine. “It’s not that he’s going to inherit some rosy version of the recovery.”
The U.S. hit a grim milestone and recorded more than 100,000 daily cases for the first time on Nov. 5 — and has remained above that threshold every day since. Deaths, a lagging indicator, are rising again. The virus is now uncontrolled in nearly every state.
Biden used the symbolism of his first big statement following his acceptance speech to show that, unlike Trump, containment of the virus and a deference to science would be his first priority. He unveiled a coronavirus task force to develop policy for the early days of the administration.
The stakes are high — experts widely expect the virus, already at record daily case levels, to worsen in winter, fueled by both colder weather driving people indoors and by Thanksgiving and Christmas gatherings sure to fuel outbreaks. Yet Biden’s options are decidedly mixed.
Until then, he is left to focus on messaging in the hopes of improving the hand he’ll be dealt: Encouraging Americans and governors to heed advice of scientists so that the virus plateaus or at least slows its growth by the time he takes office. Biden needs to change the trajectory now or take over in what will be the depths of the outbreak. Read more from Josh Wingrove.
Biden Convenes Virus Task Force: Biden yesterday warned that the U.S. was facing a “dark winter” and many more deaths as the coronavirus continues to spread unabated. “There’s a need for bold action to fight this pandemic. We’re still facing a very dark winter,” he said in somber remarks after meeting with his newly appointed coronavirus task force. Biden called on all Americans to wear masks consistently as the best way to fight infection. “We can save tens of thousands of lives if everyone would just wear a mask.”
His transition team is seeking to fulfill a campaign promise to develop a dramatically different approach than Trump’s to contain the virus. The 13-member task force is composed largely of doctors and health experts who will work beside Biden, Vice President-elect Kamala Harris, and the transition team to map out the public health policies needed to curtail Covid-19.
Biden’s team will be led by former U.S. Surgeon General Vivek Murthy, former Food and Drug Administration Commissioner David Kessler, and Marcella Nunez-Smith, a professor of public health at Yale University. It will include about a dozen specialists, many of whom already were advising Biden and his staff throughout the campaign. Kessler and Murthy, in particular, were deeply involved in shaping the Biden campaign’s plans for responding to the virus, and they both regularly briefed the president-elect. Read more from Tyler Pager.
- Murthy plans to brief Senate Democrats by phone during their caucus lunch today, according to a senior Democratic aide.
Related: Fauci Tells CNN He Has No Intention of Quitting Amid Transition
Biden Health Agenda’s Economic Impact: Elsewhere on Biden’s health agenda, the former vice president has said that his goal as president would be to ensure that no American buying insurance in the individual marketplace pays more than 8.5% of their annual income on health care. That could save people hundreds of dollars a month, but it could also hurt the employer-sponsored health insurance market. Meanwhile, Biden has also proposed a public option for those who can’t afford private coverage and would lower the age for Medicare eligibility to 60 from 65. Read more from Misyrlena Egkolfopoulou.
Supreme Court Hears Case Key to Obamacare’s Future
The fate of the Affordable Care Act is once again in the hands of the Supreme Court, which today hears oral arguments in a case over the law’s constitutionality.
The latest action in the case comes as Covid-19 is increasing in most states and during the ACA’s open enrollment period for 2021.
The Supreme Court case centers around the law’s individual mandate that initially required all consumers to have health insurance or pay a penalty, which the Supreme Court in 2012 upheld as within Congress’ taxing authority. Congress effectively repealed the penalty in 2017, however, and a group of states, led by Texas, brought a lawsuit.
BGOV analyst Danielle Parnass provides an overview of the ACA and the issues that led to its latest challenge, along with data on enrollment figures and Medicaid expansion. Read the analysis.
Murray Slams Trump for Proceeding With ACA Suit: Sen. Patty Murray (D-Wash.), the top Democrat on the Senate Health, Education, Labor and Pensions Committee, blasted Trump for proceeding with the legal bid to strike down the Affordable Care Act at the Supreme Court, as justices begin hearing arguments on California v. Texas today. She said she would work with an incoming Biden administration to “repair the damage Republican leaders have done over the last four years.”
- Meanwhile, roughly 3.1 million adults have lost employer-sponsored insurance through the coronavirus pandemic, but the uninsurance rate was impacted by Obamacare, according to a report released yesterday by the Urban Institute. The share of adults with employer-sponsored insurance fell from 64.9% in late March and early April to 63.4% in mid-to-late September. Among adults who experienced job loss, the share with employer coverage fell 7.9 percentage points to 48% in September, it said.
- The losses in employer coverage were mostly offset by a four percentage point increase in Medicaid or Children’s Health Insurance Program coverage, rising to 16.8%, and a 3.2 percentage point increase in private nongroup coverage. “These data demonstrate that the Affordable Care Act’s protections are working as intended,” said Mona Shah, senior program officer at the Robert Wood Johnson Foundation, Sara Hansard reports.
The Coronavirus Pandemic
Pfizer Results Leave Safety, Longevity Questions: Covid-19 vaccine results from Pfizer and BioNTech fueled optimism that the world will soon have a potential way out of the pandemic, yet experts cautioned that the shot still has many hurdles to clear.
Questions about production, distribution and most importantly the safety and efficacy of the shot itself still need to be answered, even if the numbers look highly promising, according to vaccine specialists. The Pfizer-BioNTech trial began less than four months ago, and how long the shot will confer protection and how many will benefit are almost total unknowns for now.
“The key question still centers upon time,” said Michael Kinch, a drug development expert and associate vice chancellor at Washington University in St. Louis. “Will time tell us that the protection remains useful for the larger population?”
In a remarkable scientific feat—achieved without funding from the U.S. government’s vaccine accelerator known as Operation Warp Speed—Pfizer and BioNTech produced positive results just over 11 months after the emergence of Covid-19 in Wuhan, China. An early analysis of data from the trial of more than 40,000 volunteers suggested the vaccine was more than 90% effective in preventing the illness, the partners said yesterday, the same day the U.S. hit 10 million cases.
The results were published in a press release, not a peer-reviewed journal study. Nonetheless, they electrified investors, as stocks surged and bonds tumbled worldwide. The likely success of the first vaccine in a large, late-stage trial raised hopes that others, like those developed by Moderna and AstraZeneca with the University of Oxford, will also work. Yet infectious disease researchers cautioned against getting too excited over the limited data that Pfizer has posted. James Paton and Robert Langreth have more.
- The result is based on an interim analysis conducted after 94 participants, split between those who got a placebo and those who were vaccinated, contracted Covid-19. The trial will continue until 164 infections have occurred. If the data hold up and a safety readout Pfizer expects in about a week also looks good, it could mean that the world has a vital new tool to control a pandemic that has killed more than 1.2 million people worldwide.
- With effectiveness for the first vaccines previously expected to be in the range of 60% to 70%, a rate of more than 90% “is just extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, on a call with reporters. Read more from Robert Langreth, Naomi Kresge and Riley Griffin.
- The U.S. and Europe are first in line to get the vaccine doses. Regulators on both sides of the Atlantic are working to speed a review of safety and efficacy after the data placed the two drug companies firmly in the lead of the Covid-19 vaccine race, ahead of Moderna and AstraZeneca. Read more from Naomi Kresge.
- Vice President Mike Pence said support from the administration’s Operation Warp Speed program helped accelerate the development of the vaccine. The truth is that Pfizer didn’t receive any funding from Warp Speed for the developing, clinical trial and manufacturing of the shot. Rather, BioNTech received money from the German government. Read more from Riley Griffin and Drew Armstrong.
Meanwhile, Novavax has been granted a “Fast Track Designation” from the Food and Drug Administration for the company’s Covid-19 vaccine candidate. Novavax expects to begin its pivotal Phase 3 clinical trial in the U.S. and Mexico by the end of this month, Malak Saleh and Luzi Ann Javier report.
Eli Lilly Gets Emergency FDA Clearance: Separately, Eli Lilly’s antibody therapy was granted an emergency-use authorization by U.S. drug regulators for treating Covid-19, widening access to a treatment that early data suggests is effective in keeping people infected with the coronavirus out of the hospital. Read more from Riley Griffin.
McConnell Eyes Smaller Stimulus After Pfizer Data: Senate Majority Leader Mitch McConnell (R-Ky.) said yesterday Congress should pass a limited stimulus bill before the end of 2020, in the wake of the encouraging vaccine data and a slide in unemployment. His comments showcased continued Senate Republican opposition to the larger-scale aid that Democrats want, risking a stalemate into next year. Senate Democratic leader Chuck Schumer (N.Y.) said Republicans “have proposed totally inadequate solutions” on Covid relief efforts. Read more from Erik Wasson and Mike Dorning.
States Intervening on Vaccine, Cuomo Says: New York Gov. Andrew Cuomo (D) said the Trump administration’s coronavirus vaccine plan will bypass poor areas and health-care deserts, and warned that once it gets rolled out, the Biden administration will be hard pressed to reverse it. “The good news is that the Pfizer tests look good,” Cuomo told ABC’S Good Morning America. “The bad news is that it’s about two months before Joe Biden takes over, and that means this administration is going to be implementing a vaccine plan.” Read more from Keshia Clukey.
Carson, Bossie Infected With Covid-19: Trump Housing and Urban Development Secretary Ben Carson tested positive for coronavirus yesterday and is isolating at his home after experiencing symptoms. HUD’s Chief of Staff Andrew Hughes said in the memo sent to the department’s staffers that Carson was “resting at his house and is already beginning to feel better.” Jordan Fabian and Jennifer Jacobs have more.
- Separately, David Bossie, an outside adviser to Trump who is leading his post-election fight over vote counts, tested positive for coronavirus yesterday, according to people familiar with the matter. Bossie, Carson and Chief of Staff Mark Meadows attended an election night party last Tuesday at the White House. Meadows tested positive for coronavirus the day after he attended the same party. Aside from Meadows, at least five other White House officials have tested positive in recent days, as well as a senior Trump campaign adviser. Read more from ordan Fabian and Jennifer Jacobs.
HHS Suspends Shipments of Rapid Tests to Eight States: The HHS will pause shipments of rapid Covid tests to eight states it says aren’t utilizing tests the federal government already provided. “We can’t let tests sit unused,” Department of Health and Human Services official Brett Giroir told reporters yesterday. He leads the federal testing effort for coronavirus. The eight are Hawaii, Massachusetts, North Dakota, Nevada, New Mexico, Virginia, Vermont and West Virginia. The federal government bought 150 million rapid tests from Abbott in August and has distributed millions to governors and localities since September, Jacquie Lee reports.
- GOP Sen. Todd Young to Self-Isolate After Staffer Tests Positive
- New York ‘Dangerously Close’ to Second Wave, De Blasio Says
- HHS to Use Equity Financing for Long-Term Covid Investments
- Hydroxychloroquine Provides No Clinical Benefit for Covid: NIH
- China Disinfects Cold-Chain Shipments to Avoid More Infections
- Encouraging Breakthroughs Offer Hope for Controlling Virus
- Pfizer, Eli Lilly Breakthroughs Provide Hope for Ending Pandemic
What Else to Know Today
Senate to Release Spending Bills: Senate appropriators will release their fiscal 2021 spending bills this morning, a Senate Republican aide said, ahead of negotiations on a 12-bill omnibus in the lame-duck session. The bill release serves as Senate Republicans’ opening offer ahead of bicameral negotiations to fund the government beyond Dec. 11. All 12 bills will be released by the Republican-controlled Senate Appropriations Committee, though Democrats traditionally have had input on the bills. The two parties agree on the vast majority of issues addressed in the bills, Senate Appropriations Chairman Patrick Leahy (D-Vt.) said yesterday.
Senate appropriators will propose a $2 billion increase from the fiscal year 2020 enacted funding level for the National Institutes of Health and more than $4 billion for pandemic preparedness programs as part of a fiscal 2021 spending bill for the Department of Health and Human Services. Sen. Roy Blunt (R-Mo.), chairman of the Senate panel responsible for funding the HHS, said the spending bill’s priorities “have been and should continue to be, bipartisan priorities.”
“As we have seen first-hand this year, medical research is key to responding to diseases we have fought for years, like cancer and Alzheimer’s disease, as well as novel viruses like COVID-19,” he said in a statement.
That increase for the NIH and the funds for public health programs is about half of what House Democrats proposed this summer. That spending plan (H.R. 7617), passed by the House in July, included $24.4 billion in emergency funding the Senate package is not expected to have.
The Senate spending bill is slated to fund the NIH at $43.6 billion in fiscal 2021 and dedicate $518 million to the White House’s initiative to end the spread of HIV/AIDS, according to a Blunt spokesperson. There will also be $3.9 billion for combating the opioid crisis and $4 billion for mental health programs, Alex Ruoff reports.
- House to Consider Spending Bill, Cannabis Measure Hoyer Says
- BGOV OnPoint: Dates to Watch as Congress Holds Lame-Duck Session
Medicare Enrollees Turn to Rural Hospitals: Rural Medicare beneficiaries are becoming more dependent on hospitals to access clinician care, even though rural hospital closures have been trending upward for years, a government advisory panel reported yesterday. In 2018, rural beneficiaries had 34% to 40% of their physician visits in hospitals, compared to about 29% of urban beneficiaries, Brian O’Donnell, a senior policy analyst at the Medicare Payment Advisory Commission, said. But 16 rural hospitals shuttered this year. Read more from Tony Pugh.
- HHS Final Rule Loosens Medicaid Managed Care Requirements
- Agencies Want Massachusetts Birth Control Rules Fight Tossed
- Viiv Two-Month HIV Prevention Drug Works Better Than Truvada
- Whistleblowing VA Pharmacy Doctor Wins Hearing on an Appeal
- Stampede Meat Sues N.M. Over Post-Outbreak Shutdown Order
- Bayer Submits Regulatory Applications in U.S., EU for Finerenone
- CNS Pharma Plans to Submit IND Application for Berubicin to FDA
Editor’s Note: Bloomberg Government’s Health Care Briefing will not publish tomorrow, Nov. 11, for the Veterans Day federal holiday. We’ll resume publication Thursday, Nov. 12.
With assistance from Alex Ruoff and Sara Hansard
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