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FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

Supreme Court declines to hear South Carolina attempt to block Medicaid funding from Planned Parenthood



a large white building: Supreme Court declines to hear South Carolina attempt to block Medicaid funding from Planned Parenthood


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Supreme Court declines to hear South Carolina attempt to block Medicaid funding from Planned Parenthood

The Supreme Court on Tuesday declined to hear an appeal of a lower court ruling that blocked the South Carolina Department of Health from cutting off Medicaid funding to Planned Parenthood.

The high court’s rejection means that last year’s ruling from the Fourth Circuit Court of Appeals will remain in effect, prohibiting the state from terminating Planned Parenthood as a Medicaid provider.

While it takes four justices to approve a petition, the court doesn’t publish the vote totals and it declined to hear the case without comment.

South Carolina Gov. Henry McMaster (R) signed an executive order in 2018 prohibiting abortion clinics from participating in Medicaid.

Video: ACA unlikely to be struck down; Roberts and Kavanaugh are expected to support severability: Turley (FOX News)

ACA unlikely to be struck down; Roberts and Kavanaugh are expected to support severability: Turley

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Medicaid, the health care program for the poor, generally doesn’t pay for abortions, but conservatives have longed pushed to cut any state and federal funding flowing to the Planned Parenthood, which also provides an array of other health care services.

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Under the order, South Carolina’s two Planned Parenthood Centers, which provide family planning and preventive care services, cancer screenings, and other health care, were terminated as Medicaid providers.

Planned Parenthood South Atlantic, representing one of its patients, filed suit, arguing the order is a violation of federal law that says Medicaid beneficiaries may get care from any qualified provider, and the Fourth Circuit Court of Appeals agreed.

South Carolina appealed to the Supreme Court, arguing that the state has the right to determine what providers are “qualified” to participate in the Medicaid program.

The Supreme Court has in recent years declined to hear similar appeals from Louisiana and Kansas.

The decision Tuesday came during Judge Amy Coney Barrett’s Supreme Court confirmation hearing before the Senate Judiciary Committee, where she repeatedly declined to offer her views on landmark cases establishing a woman’s right to an abortion.

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