Biden readies federal vaccine requirements — A big first step for Senate’s infrastructure deal — FDA greenlights first generic insulin

From: POLITICO Pulse - Thursday Jul 29,2021 02:02 pm
Presented by Humana: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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By Adam Cancryn and Sarah Owermohle

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Quick Fix

— The Biden administration is set to issue new requirements that federal employees get vaccinated against Covid-19.

— The Senate took its first step toward passing a bipartisan infrastructure deal financed in part by health-related provisions.

— The FDA approved its first generic insulin product, in a move that could make the drug more affordable for patients.

WELCOME TO THURSDAY PULSE — and welcome back, Gawker. Gossip and tips to acancryn@politico.com and sowermohle@politico.com.

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Driving the Day

BIDEN READIES FEDERAL VACCINE REQUIREMENTSThe president will roll out a new directive today requiring federal employees to get Covid-19 vaccines or be subjected to regular testing — marking a significant escalation in his administration’s effort to jumpstart inoculations nationwide.

What to expect: The new measures would require the vast majority of federal employees to attest that they’ve been vaccinated against the virus. Those that haven’t would need to submit to weekly testing with the possibility of facing additional restrictions, said four people familiar with the plans.

Biden officials were still finalizing the policy on Wednesday. But under the plan, federal agencies would get leeway to go even further than an attestation — with some, including HHS, mulling the possibility of following the VA’s lead in forcing certain employees to show proof of vaccination.

Biden is expected to announce the move during a speech at 4 p.m. ET, with agencies like OMB distributing the specifics throughout the government afterward.

The requirement is perhaps the highest profile of several recent measures aimed at slowing the surge of Covid-19 cases and boosting the vaccination rate.

And in addition to incentivizing federal workers, officials are quietly hoping for an outsized ripple effect: Already, some states, localities and businesses are implementing similar rules, and many more could follow suit once the federal government sets the precedent.

One thing it’s not: A mandate — a point every administration official PULSE spoke to this week was eager to hammer home. That’s in part because the White House is wary of triggering political blowback in GOP strongholds that are both the least vaccinated and most suspicious of any suggestion of mandates.

But it’s also the truth; under the attestation rules, people wouldn't need to prove they’re vaccinated, just say they are. That could limit the measures’ effectiveness among the Americans most resistant to taking the vaccines, as long as they’re more opposed to the shots than they are to lying.

A BIG FIRST STEP FOR SENATE’s INFRASTRUCTURE DEALThe Senate advanced a bipartisan infrastructure deal Wednesday night, securing a major win for Biden and the centrist lawmakers who spent weeks negotiating the agreement.

But it’s a victory that could be short-lived, POLITICO’s Marianne LeVine and Burgess Everett report. The legislation’s details have yet to be finalized, and Republicans are already signaling they’ll want amendment votes and last-minute input. The end result will also need to hit a 60-vote threshold to close debate.

Senators indicated they could work through the weekend on the proposal, as they try to resolve final issues. And even if they manage to get it through the upper chamber, an uncertain future awaits the bill in the House — where Speaker Nancy Pelosi has kept open the possibility of further amending it.

Also a winner in the deal: pharmacy benefit managers and providers. The infrastructure bill would delay a Trump-era Medicare rebate rule for three years, said a source familiar with the matter. That would rack up roughly $49 billion in savings, according to a list of the pay-fors obtained by POLITICO’s David Lim.

— The bill would also repurpose $205 billion in certain unused coronavirus relief dollars. The document didn’t specify where the money would come from, leading to confusion, though a source familiar with the matter said there wouldn’t be cuts to the provider relief fund, a win for the hospital and nursing home lobbies.

— It also saves $3 billion by aiming to reduce Medicare spending on discarded medications from large, single-dose drug vials.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
Drug Pricing

FDA GREENLIGHTS FIRST GENERIC INSULINThe agency determined that the insulin product Semglee is biosimilar to — and interchangeable with — brand-name Lantus , paving the way for Americans with diabetes to get access to the drug at lower costs, POLITICO’s Lauren Gardner reports.

The approval allows patients to buy Semglee instead of the pricier brand name without having to get a doctor to write a specific prescription. It’s a move that comes three years after the FDA first issued guidance outlining plans to reclassify insulin as a biologic, in an effort to clear the way for generic versions.

— J&J's shots get a shelf-life extension. The FDA Wednesday said Johnson & Johnson's Covid-19 vaccine can now be stored for up to six months, from the original four-and-a-half month limit. States had warned in prior weeks that their supplies were at risk of expiring as vaccination demand dropped off.

 

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On the Hill

THE SENATE GOP’s VOCAL VACCINE CAUCUSTop Senate Republicans are stepping up their promotion of the Covid-19 vaccine as inoculation rates slow and masking recommendations make a comeback, POLITICO’s Burgess Everett reports.

The increasingly vocal vaccine advocates include Senate Minority Leader Mitch McConnell — who’s running ads in his home state to combat disinformation — and Roy Blunt, who’s traveled around Missouri to push the shots. Several other GOP senators released new PSAs after the Biden administration urged people to resume mask-wearing in high-transmission areas.

It’s the latest sign of diverging GOP approaches to Biden’s vaccination campaign. Republicans in the House have sent mixed messages, with many insisting it’s not their place to pressure people to get vaccinated. And others are wary of appearing aligned with the White House.

But the faction of senators now going to greater lengths to promote the vaccine argue that the need to end the pandemic has reached a post-politics stage: “The idea that this is a political issue is beyond me,” said Sen. Mitt Romney (R-Utah). “This is an issue that is keeping people alive.”

SENATE SETS FDA SPENDING BILL MARKUP — Senate appropriators will mark up their fiscal 2022 Agriculture-FDA spending bill next week, along with two other funding measures, POLITICO’s Caitlin Emma reports.

The trio will mark the start of appropriations action on the Senate side, as the House readies floor passage of nine out of 12 annual spending bills. Still, government funding runs out at the end of September — so Congress will almost certainly need to pass a continuing resolution to buy more time for negotiations.

 

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Coronavirus

UK EASES TRAVEL RESTRICTIONS — Fully vaccinated travelers to England from the U.S. and European Union will no longer need to quarantine beginning Aug. 2, POLITICO Europe’s Esther Webber writes.

The country will still require everyone to take Covid-19 tests before and shortly after arriving. But dropping the quarantine requirement could make it easier for business travelers and those with family in the U.K. to visit.

The change comes even as the U.S. has refused to adjust its own travel ban for people from the U.K. and EU, which the White House earlier this week said it is keeping in anticipation of rising Covid-19 cases.

Names in the News

Connecticut Gov. Ned Lamont named Manisha Juthani as the state’s public health commissioner. Juthani is an infectious disease physician at the Yale School of Medicine.

Meaghan O'Brien is now director of state-federal relations for Iowa Gov. Kim Reynolds. She most recently was Renolds' deputy health policy adviser.

A message from Humana:

Medicare Advantage: Saving seniors money. At Humana, we’re committed to affordable, quality care. Did you know: with Medicare Advantage, seniors save an average of $1,640 in annual out-of-pocket spending compared to fee-for-service Medicare. Learn More.

 
What We're Reading

The Biden administration quietly reversed a Trump-era policy limiting the fines on nursing homes that endangered or injured residents, The New York Times’ Reed Abelson reports.

The face of the pandemic is changing — and getting younger, Bloomberg News’ Emma Court reports.

Vaccinated people experiencing Covid-19 breakthrough infections could be at risk for long-term symptoms, NPR’s Rob Stein writes.

 

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