Scoop: HHS’ next effort to boost Covid-19 testing

From: POLITICO Pulse - Wednesday Nov 10,2021 03:02 pm
Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
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Quick Fix

— The Biden administration will put $650 million toward accelerating manufacturing of Covid-19 tests, in anticipation of greater demand from schools and businesses.

— Pfizer and BioNTech are applying for authorization to make their Covid-19 booster shot available to all adults.

— HHS Secretary Xavier Becerra travels to the Mayo Clinic today to tout the administration’s pediatric vaccination campaign.

WELCOME TO WEDNESDAY PULSE — where a trash can traveled 3,500 miles, crossed an entire ocean and lived to tell the tale — only to find itself pressed into service once again as a garbage receptacle .

You can’t escape your destiny, but at least you can get out of Myrtle Beach. Tips to acancryn@politico.com and sowermohle@politico.com.

 

A message from PhRMA:

At a time when the science has never been more promising, the Democrats’ latest drug pricing scheme puts patients in harm’s way by threatening future treatments and cures. Learn more.

 
Driving the Day

SCOOP: HHS RAMPS UP TESTING INVESTMENT — The Biden administration will spend $650 million to bolster domestic manufacturing of Covid-19 tests, ahead of an expected rise in demand driven by school testing programs, the administration’s own workplace vaccine-or-test mandate and increased holiday travel.

The money will go toward making professional molecular point-of-care tests that providers can use to quickly confirm the results of more widely available — but less accurate — over-the-counter antigen tests, POLITICO’s David Lim reports.

The point-of-care molecular tests generally perform similarly to lab-based PCR tests, according to a senior administration official.

The administration is planning to officially announce the investment today, but the actual contracting process will occur in the coming weeks, and it will likely take time for manufacturing capacity to come to fruition.

“Given the demand is going up for testing around all the serial testing programs [and] screening programs that are getting established, many of these companies are not able to completely keep up with demand,” the official said. “This investment is intended to expand capacity, but also to make sure that these lines stay open when, or if, demand from the marketplace diminishes for a period of time.”

Scott Becker, who heads the Association of Public Health Laboratories, applauded the investment, calling it a “needed insurance policy so we don't lose time having to restart the manufacturing base.”

PFIZER WANTS TO BOOST ALL ADULTS — Pfizer and BioNTech are seeking authorization for their Covid-19 booster shot to be available to all adults — the latest bid to expand Americans’ access to the additional dose, POLITICO’s Lauren Gardner reports.

The filing with the FDA followed trial results showing a third shot bumped up the vaccine’s efficacy to 95 percent, though the median time between the second dose and the booster in that study was 11 months — well past the six-month mark the FDA and CDC have relied on.

Pfizer boosters are currently available to people 65 and older and those at increased risk of contracting Covid-19 or becoming severely ill. Yet those parameters are not tightly policed, and opening the shots up to all adults would simplify who is eligible for the additional dose.

More than 16 million people have received a Pfizer booster to date, according to CDC data. That surpasses the nearly 9 million who have gotten a Moderna booster and the roughly 240,000 who sought out a second Johnson & Johnson shot.

Bourla: Boosters could be annual. Pfizer CEO Albert Bourla reiterated his belief Tuesday that people may need Covid-19 boosters every year, calling it the “likely scenario” during an Atlantic Council event on Tuesday. “However, I have been surprised many times in my life with things like that in science,” he added. “We need to wait and see.”

Bourla also blasted those who knowingly spread misinformation about the vaccines, calling them “criminals” who “literally cost millions of lives.”

“The only thing that stands between the new way of life and the current way of life, frankly, is the hesitancy to get vaccinated,” he said.

BECERRA VISITS THE MAYO CLINIC — HHS Secretary Xavier Becerra is in Minnesota today, where he’s slated to tour the world-renowned Mayo Clinic and hold a presser alongside Gov. Tim Walz and Sen. Amy Klobuchar (D-Minn.).

The event is aimed at touting the administration’s drug pricing plans and promoting pediatric Covid-19 vaccinations.

But it also marks the highest-profile visit by a federal official since then-Vice President Mike Pence traveled to Mayo in April 2020 — and famously refused to wear a mask.

Pence’s break with CDC and hospital policy at the height of the initial Covid-19 outbreak turned into a multiday PR disaster. The vice president initially defended his decision by saying he’d been regularly tested, while his wife claimed he was unaware of Mayo’s mask policy (an assertion the institution refuted). Pence would acknowledge days later he should have worn one, even as he insisted it wasn’t necessary.

Given that history, PULSE checked in with Becerra’s office and confirmed: He’ll be masked up today. A Mayo Clinic spokesperson also verified the medical center “alerted everyone of our mask policy, just as we did before.”

 

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Coronavirus

TODAY: BLINKEN CHECKS IN ON GLOBAL VAX PROGRESS — Secretary of State Antony Blinken is meeting with foreign ministers today on the worldwide vaccination effort, in the first follow-up to Biden’s September global Covid-19 summit, POLITICO’s Carmen Paun reports.

Just a fraction of the more than 1.4 billion doses wealthy countries pledged to donate by 2022 have reached the highest-need countries so far. And while the U.S. has delivered 235 million doses on its own, it still has a ways to go to fulfill its 1.1 billion-dose pledge.

It’s unclear whether the group will set any new goals, with the administration characterizing it only as the start of a conversation on what’s needed to respond to the current pandemic and prevent future ones. But it comes as global health groups are pressuring the administration to accelerate progress toward Biden’s target of vaccinating 70 percent of the world by next September.

Who’s attending: About 35 ministers were invited, including some from G-20 countries and Israel. WHO head Tedros Adhanom Ghebreyesus will also participate.

On the Hill

CBO TO CONGRESS: SETTLE IN, FOLKS — The Congressional Budget Office could take weeks to finalize a full score for Democrats’ $1.75 trillion social spending bill, prolonging the House’s plans for a vote, POLITICO’s Caitlin Emma reports.

The office signaled Tuesday that forecasts for parts of the bill could be completed this week, but the rest could take longer.

“The analysis of the bill’s many provisions is complicated,” CBO Director Phillip Swagel said, “and CBO will provide a cost estimate for the entire bill as soon as practicable.”

The House isn’t required to wait for a CBO score before voting, but five moderate Democrats have demanded they hold off until the analysis comes through — even as leadership pushes for action by the end of next week.

 

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Telehealth

FIRST IN PULSE: PPI, AMERICANS FOR PROSPERITY BACK TELEHEALTH EXPANSION — The left-leaning Progressive Policy Institute is teaming up with conservative group Americans for Prosperity to call for an expansion of telehealth services, publishing a report today that argues remote care can “dramatically expand health care access without raising costs on taxpayers.”

The two organizations studied the impact the pandemic-era rise of telehealth has had on health spending and utilization, finding that telehealth patients spent less and used fewer health services over time. In particular, those patients’ monthly rate of emergency room visits fell significantly — a shift PPI and Americans for Prosperity chalk up to the providers’ ability to intervene earlier through telehealth and avoid relying on pricier interventions down the road.

“For seven of 10 observed conditions, the average number of total appointments with the health care system — one way to measure utilization — was the same or fewer for people who used telehealth relative to people who did not,” the study found.

PPI and Americans for Prosperity are advocating for legislation that would further expand telehealth availability, including a bill from Sen. Brian Schatz (D-Hawaii) permanently extending Covid-era telehealth flexibilities and another from Sen. Tim Scott (R-Fla.) allowing more providers to deliver virtual care to Medicare beneficiaries.

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 
Names in the News

Paula Witt joined the Association for Accessible Medicines as its senior manager of state government affairs. She was previously director of judicial education in the Law & Economics Center of George Mason University’s Antonin Scalia Law School.

What We're Reading

The Ivy League was the first conference to cancel its college basketball season in March 2020. But as others resumed play amid the pandemic, the Ivies remained shut down – raising questions about how to balance caution and risk in a still-unpredictable environment, The Washington Post’s Dan Diamond writes.

For Bloomberg Businessweek, Upmanyu Trived, Chris Kay and Malavika Kaur Makol chronicle the logistical challenges and deep mistrust making it difficult to get vaccines to India’s poorest and most remote areas.

Oklahoma’s Supreme Court overturned a ruling holding Johnson & Johnson liable for contributing to the opioid crisis – the second legal ruling this month to side with drug makers in opioid lawsuits, The Wall Street Journal’s Jennifer Calfas reports.

 

A message from PhRMA:

The Democrats’ hyper-partisan drug pricing plan is a detriment to patients and the future of medical research.

The plan guts the very incentives necessary to encourage investment in further research and development after medicines are approved, giving the government the power to pick winners and losers for lifesaving medicines.

While some would have you believe this is “negotiation,” it isn’t. It’s government price setting that does little to address patient affordability and will decimate the competitive ecosystem in the United States that has brought hope to so many Americans in the form of new medical advances where before there were none. No matter what they call it, this plan will result in the same outcome: negative consequences for the patients with the most need. Read more.

 
 

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