HEALTH CARE BRIEFING: Stimulus Disruption Threatens Vaccine Push

Successful vaccine distribution, sufficient safety equipment for health care workers, and reliable testing systems are all on the chopping block without another timely federal aid infusion for struggling states, according to policy analysts.

President Donald Trump halted stimulus talks with a tweet Oct. 6, declaring a stimulus bill wouldn’t come before the election. Throughout the week, Trump championed separate bills to assist airlines and small businesses, along with another round of stimulus checks for individual Americans.

But the stutter-step approach to reaching a consensus on a stimulus package creates even more anxiety among state leaders who need a financial boost to afford essential services like coronavirus testing and protective equipment for health providers. Disruptions to additional stimulus for states may also botch federal efforts to distribute an eventual vaccine as states can’t afford to create that distribution system on their own.

“States are already facing challenges with getting enough testing for Covid-19 and enough contract tracing,” according to Jen Kates, senior vice president at the Henry J. Kaiser Family Foundation and head of global health & HIV policy, adding “vaccine distribution is a bigger undertaking than anything else done,” in the U.S.

The federal government will provide the vaccine, but states will be in charge of distributing it across the country. States will have to track who gets a vaccine to make sure they get a second dose. They’ll need to start campaigns to convince vaccine hesitant people to get shots. Local leaders also have to help coordinate where shots will be provided, whether via public health facilities or pharmacies like CVS. All that takes money, Kates said.

So far states have gotten $200 million from previous funding to help with Covid- related expenses, but states will need at least $6 billion for vaccine distribution, the head of the Centers for Disease Control and Prevention Robert Redfield told lawmakers in September.

“Every day that goes by where there’s not a package is a day state authorities can’t prepare in the way they should be,” Kates said. Read more from Jacquie Lee and Alex Ruoff.

Happening on the Hill

Democrats Use Barrett Fight to Elevate Health Care in Campaign: Senate Democrats are prepared to lose the fight over Amy Coney Barrett’s nomination to the Supreme Court, but her confirmation hearings give them a platform to highlight a timely issue just before the election: health care. More than almost any other issue, Democrats say the fate of the Affordable Care Act in the middle of a pandemic will drive home the stakes of GOP control of the White House and Senate.

If Republican plans for Barrett’s confirmation hold, she would be on the court when it hears arguments just one week after the Nov. 3 election in a case that could undo the law, which provides health insurance for 20 million Americans and other benefits — like parents being allowed to keep children on their plan until they turn 26 — for millions more. Read more from Laura Litvan.

McConnell Says He’s Avoiding Visiting White House: Senate Majority Leader Mitch McConnell (R-Ky.) said he hasn’t visited the White House in two months over concerns that White House officials weren’t adhering to proper mask-wearing or physical distancing protocols. “My impression was their approach to how to handle this was different from mine,” said McConnell, a survivor of polio. Some people are “paying the price” for not wearing masks or being socially distant, McConnell said, Steven Dennis reports.

• Meanwhile, the District of Columbia Health Department asked people who have worked inside the White House in the past two weeks or attended the Supreme Court event in the Rose Garden on Sept. 26 to get a test for Covid and contact their local health service on their potential need to quarantine. Recipients of the letter also include those who have had close contact with people working in those spaces. Read the statement here.

HHS Asked for Leeway on Covid Reporting: House Oversight Consumer Policy Subcommittee Chairman Raja Krishnamoorthi (D-Ill.) urged the Health and Human Services Department to detail “reported plans to impose draconian penalties”—the loss of Medicare and Medicaid funding—”against hospitals that do not satisfactorily comply with new coronavirus reporting requirements. The action will potentially strip tens of millions of Americans of health care,” he said in a statement. Read the letter here.

Pelosi Eyes Discussions on 25th Amendment: Pelosi said at her weekly news briefing yesterday that “we are going to be talking about the 25th Amendment” tomorrow, which lays out the plan of succession if a president is incapacitated, and raised questions about Trump’s mental faculties. The speaker said Trump “is, shall we say, in an altered state right now” and “the disassociation from reality would be funny, if it weren’t so deadly.” Trump, during his Covid-19 treatment, was given dexamethasone, a steroid that could produce mind-altering side effects. Read more from Christopher Anstey.
Related: Pelosi and Trump Question Each Other’s Mental Faculties

• White House spokeswoman Alyssa Farah said yesterday that Trump’s doctors want to keep the timing of his most recent negative Covid test private. Anstey reports.

The Coronavirus Pandemic

SCOTUS Won’t Halt by-Mail Abortion Pill for Now: The U.S. Supreme Court let women, for now, keep obtaining abortion-inducing pills by mail during the Covid-19 outbreak, deferring action on a Trump administration request to reinstate a requirement that patients visit a medical facility. Read more from Greg Stohr.

FDA’s Marks on Crusade to Defend Vaccine Safety: Peter Marks is becoming the poster child of Covid-19 vaccine promotion. He’s made virtual appearances every day this week touting the robust requirements that the FDA places on any vaccine that will be approved for general public distribution. The director of the FDA’s Center for Biologics Evaluation and Research is a career scientist who has made confidence in the Covid-19 vaccine his personal mission.

Other public health officials, including HHS Secretary Alex Azar, are also touting the safety of the Food and Drug Administration’s process, stating Covid-19 vaccines in development are receiving as much, if not more, medical scrutiny than in other clinical trials. Marks said his worry that too many in the U.S. will decline a vaccine “keeps me up at night.” Jeannie Baumann has more.

• Marks also said resuming normal safety inspections for many drug plants won’t start as early as initially hoped, raising concerns about how Covid is gumming up the agency’s inspections backlog. “We’re doing what we can with our authorities, with paper inspections and record reviews,” he said. Read more from Jacquie Lee.

Military Rethinks Hospital, Medical Staff Cuts: The pandemic is causing the Pentagon to reassess an overhaul of the military health system that’s aiming to eliminate 17,000 medical positions and force 190,000 beneficiaries into private care, the Defense Health Agency said. Defense Secretary Mark Esper is collecting data on the effects of Covid-19 and recommendations to decide if the military should go ahead with its plans after pausing them at the beginning of the virus outbreak, Lt. Gen. Ronald Place, the agency’s director, said yesterday. Read more from Travis J. Tritten.

CDC Expands Warning to Include Overweight: The link between extra pounds and severe Covid-19 grew stronger, as the CDC said that people who are merely overweight, not just the obese, may be at high risk of serious disease from the infection. The warning, posted on the agency’s website on Tuesday, means about two-thirds of Americans could face higher risks. Nearly 40% of American adults are obese and 32% are overweight, according to the agency. Read more from Emma Court.

U.S. Gears Up to Mass Produce Regeneron Drug: The federal government is preparing to help Regeneron Pharmaceuticals manufacture “tens or hundreds of thousands of doses” of the Covid-19 antibody cocktail given to Trump, Azar said. The experimental treatment is one of several monoclonal antibody therapies in testing that may help patients with Covid-19. Read more from Shira Stein.

• Separately, Trump today said Eli Lilly’s antibody drug to treat Covid-19 will get approval from the Food and Drug Administration, and insisted he’s no longer contagious. Read more from Josh Wingrove and Emma Kinery.

More on the Coronavirus:

• President Required Doctors to Sign NDAs in 2019: Trump Update
• FEMA Sees New U.S. Cases, ICU Use on the Rise, ABC Reports
• Moderna Will Not Enforce Vaccine Patents Through Pandemic
• Ethics Board Rules for Studies Eased in Pandemic, HHS Says
• Covid-19 Vaccine ‘Unlikely’ to Be Ready for Use This Year in EU
• NIH Begins Testing Remdesivir, Antibodies Solution for Covid
• Europe Strikes Deal With J&J on Vaccine, Gilead on Remdesivir
• China Joins WHO-Backed Virus Vaccine Program Snubbed by Trump

What Else to Know

Health Providers Get More Time to Repay Medicare Loans: Health-care providers and equipment suppliers who received $106 billion in loans under the Medicare Accelerated and Advance Payment Program will have more time to repay the money, the Trump administration announced yesterday.

Under terms of the continuing resolution recently signed into law by Trump, repayment will now begin one year after the issuance date of a recipient’s original loan. More than 24,000 loans had been approved for doctors, other medical providers, and durable medical equipment suppliers since March 28 under the program, which allows them to receive advance reimbursements from Medicare. Read more from Tony Pugh.

Rare Diseases Researchers Win $16 Million From FDA: Researchers studying rare disease will receive a total of $16 million from the FDA over the next four years, the agency announced yesterday.

The six new clinical grants will fund research into rare diseases with no other available treatment options or to improve treatments for other rare conditions. Awarding the grants, the Food and Drug Administration acknowledged the additional costs researchers face as a result of the coronavirus this year. Read more from Andrew Childers.

• Related: Ethics Board Rules for Studies Eased During Pandemic, HHS Says

More Headlines:

• Virginia Providers Lose Challenge to Medicaid Pay Reductions
• Labor Department Backs ERISA Suits for Mental Health Denials
• Allergan Implant Users Argue Cancer Risk Claims Not Blocked
• Services by Health Contractor Exempt From Tax, EU Court Says
• FDA Should Strengthen Efforts to Provide Effective Oversight (GAO)

Editor’s Note: Bloomberg Government’s Health Care Briefing will not publish on the Monday, Oct. 12, federal holiday. We’ll resume Tuesday, Oct. 13.

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com