Health Care

Overnight Health Care — High court signals skepticism over Texas law

 

Welcome to Monday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: digital-staging.thehill.com/newsletter-signup.

Check out the story behind Evette Peeters, one of the first biracial American Girl dolls, who’s based in D.C. and an environmentalist focused on protecting the Anacostia River.

Roe v. Wade was not technically on the agenda, but the Supreme Court heard oral arguments on the Texas abortion law and seemed open to the idea of allowing the providers to challenge it.

For The Hill, we’re Peter Sullivan (psullivan@digital-staging.thehill.com), Nathaniel Weixel (nweixel@digital-staging.thehill.com) and Justine Coleman (jcoleman@digital-staging.thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8.

Let’s get started.

 

Court appears open to abortion challenge 

The Supreme Court sounded a note of skepticism Monday over Texas’s controversial six-week abortion ban, appearing ready to allow abortion providers to challenge the law in federal court.

The case did not deal directly with the ban’s lawfulness. Rather, the justices wrestled with whether the Department of Justice (DOJ) and abortion providers can bring federal lawsuits against Texas or state officials in an effort to block the law.

Monday’s case marked the second time the Texas law, known as S.B. 8, has reached the justices. In a previous 5-4 ruling, which broke largely along familiar ideological lines, the conservative-majority court denied abortion providers’ emergency request to block the law.

Since that Sept. 1 ruling — which did not address the measure’s constitutionality — litigation over S.B. 8 has percolated back up to the Supreme Court, while abortions in Texas have been curtailed.

Three liberal justices have already said they think the law is unconstitutional, and that it should be blocked while a lower court decides  

It’s complicated: The question of whether federal court is a proper forum to hear S.B. 8 challenges is complicated by the law’s unique legislative design, which critics have likened to a “bounty” system. The law was deliberately written to avoid judicial challenge; it puts private citizens in charge of enforcing the law, as opposed to state actors. Justices Brett Kavanaugh and Amy Coney Barrett were among the five-member majority in September who voted against blocking the Texas abortion ban. But during Monday’s arguments, they posed sharp questions to Texas solicitor general Judd Stone about S.B. 8’s implications and structure. 

Kavanaugh, citing an amicus brief by a Second Amendment advocacy group, asked whether S.B. 8 could become a model “for suppression of other constitutional rights.” The Biden administration argued that if the Court sided with Texas, no constitutional right would be safe. 

Read more here

 

Dems race to reach drug pricing deal 

Democrats are furiously negotiating a plan to lower prescription drug prices, making significant progress over the weekend but racing to finalize a deal before a House vote on President Biden’s mammoth social spending package as soon as this week. 

The fate of one of the party’s signature issues hangs in the balance after the White House last week left drug pricing out of the framework of Biden’s reconciliation package. 

Over the weekend, House leaders had been aiming for a Tuesday vote on both the infrastructure and reconciliation packages, but the votes got pushed back after drug pricing negotiators signaled they were on the cusp of a deal to include the issue in Biden’s Build Back Better plan.      

Negotiators may have won even more time to clinch a deal when Sen. Joe Manchin (D-W.Va.), a backer of lowering drug prices, told reporters on Monday he still had concerns about the broader $1.75 trillion framework Biden unveiled last week and isn’t fully on board.  

Of course, it’s not clear that Manchin will necessarily be on board with what’s being negotiated.

Much smaller: The compromise drug pricing proposal under discussion would be significantly scaled-back from Democrats’ earlier sweeping measures. For example, the proposal under discussion would allow Medicare to negotiate lower drug prices, but only for older drugs that are no longer under “exclusivity,” meaning the period when they are protected from competition. 

Rep. Scott Peters (D-Calif.) had warned that earlier versions of Democrats’ legislation, which would have allowed Medicare to negotiate prices for newer drugs, would harm innovation from drug companies to develop new treatments.

Anti-Big Pharma: The pharmaceutical industry, long known as a powerful force in Washington, has been fighting hard against Democrats’ sweeping measures, warning they would hinder investment in research and development, and lawmakers said they were eager not to let the industry win. The White House got significant pushback from Democratic lawmakers after leaving drug pricing out of the framework. Rep. Peter Welch (D-Vt.) said there was a “firestorm of reaction” from Democratic lawmakers when the White House left drug pricing out of its framework last week, with the administration saying the votes simply were not there yet. 

Read more here.

MARK YOUR CALENDARS

The Biden administration’s vaccination program for children ages 5 to 11 will be fully operational starting the week of Nov. 8, White House coronavirus response coordinator Jeff Zients said on Monday.

During a White House briefing, Zients said the administration has enough supply of the Pfizer-BioNTech vaccine for all 28 million eligible children, and is in the process of sending an initial 15 million doses to thousands of sites across the country.

The Food and Drug Administration’s authorization of the vaccine on Friday was the “trigger” to begin the packing and shipping process, Zients said, but it will take some time before vaccines reach the sites where they will be administered.

Where the doses are going: States are choosing where the administration will send vaccines every week, such as pediatricians’ offices and school-based clinics, and can change allocations based on demand, he said. 

The federal government is also sending vaccines directly to pharmacies and community health centers. 

What’s next: A Centers for Disease Control and Prevention panel will meet on Tuesday to decide how the vaccine should be used, including whether to limit the shots to vulnerable children only. CDC Director Rochelle Walensky could sign off on authorization the same day.

Read more here.

ADMIN SAYS DELAY WON’T IMPACT ROLLOUT

The delay in the FDA’s review of the Moderna COVID-19 vaccine for adolescents won’t impact the Biden administration’s vaccine rollout for children, White House officials said on Monday.

With the White House preparing for the potential forthcoming approval of the Pfizer-BioTech vaccine for 5- to 11-year-olds, officials said the postponement of the FDA’s authorization of the Moderna vaccine for those aged 12 to 17 will not interfere with the pediatric vaccination program.

The FDA told Moderna that it needed more time to review its application for adolescents, in particular to analyze the risk of a rare heart side effect, the company said on Sunday. In response, Moderna plans to delay its application to authorize its vaccine for 6 to 11 year olds. 

But White House coronavirus coordinator Jeff Zients said that the government has enough Pfizer-BioNTech vaccine doses for the nation’s 28 million children aged 5 to 11, if and when the Centers for Disease Control and Prevention (CDC) issues recommendations on giving the doses to the younger population. 

“We’re in great shape on supply, and the whole plan is based on the Pfizer vaccine,” Zients said during a briefing. “So we have more than enough vaccines for every child 5 to 11, specifically the Pfizer vaccine.”

Read more here.

Biden mandate to be published in ‘coming days’

The Department of Labor on Monday said that the Biden administration’s vaccinate mandate for businesses, which is being developed by the Occupational Safety and Health Administration (OSHA), will be published soon.

“On November 1, the Office of Management and Budget completed its regulatory review of the emergency temporary standard. The Federal Register will publish the emergency temporary standard in the coming days,” a Labor Department spokesperson said in a statement.

OSHA has been crafting an emergency temporary standard (ETS) to enact the mandate, which requires that all companies with at least 100 employees require vaccines or weekly testing for employees. Biden announced the sweeping vaccine-or-test mandate in September.

“Covered employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, unless they adopt a policy requiring employees to choose either to get vaccinated or to undergo regular COVID-19 testing and wear a face covering at work,” the spokesperson said. 

The standard will also require employers to provide paid time off for workers to get vaccinated and paid sick leave for vaccinated employees who have side effects from the shot. 

Read more here.

WHAT WE’RE READING

 

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OP-EDS IN THE HILL

 

That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Tuesday.