Washington’s very short memory on testing

From: POLITICO Pulse - Tuesday Mar 22,2022 02:02 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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By Krista Mahr and Sarah Owermohle

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QUICK FIX

The U.S. could face another testing shortage if a new Covid-19 wave hits and Congress fails to authorize new funds.

The health care industry is on alert as Biden warns that Russia is mulling cyberattacks against the U.S.

The FDA will discuss authorizing additional Covid-19 booster shots after Pfizer and BioNTech and Moderna asked the agency to greenlight boosters of their shots.

WELCOME TO TUESDAY PULSEIt’s Oscar week again? I happen to be at the stage of parenthood when the only films I’ve seen in the whole lineup are animated. “Luca” for the win! Send your Oscar wagers, news and tips to kmahr@politico.com and sowermohle@politico.com.

 

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ICYMI: A decisive majority of Americans (86%) agree Congress should crack down on abusive health insurance practices impacting patients’ access to care. Voters overwhelmingly support policies that would lower out-of-pocket costs and bring greater transparency and accountability to the health insurance system. Read more in new poll.

 
Driving The Day

HERE WE GO AGAIN? Manufacturers are cutting back on Covid-19 test production as case numbers plummet in the U.S. and demand for the tests dwindles. At the same time, cases in Europe are surging.

Biden Administration officials are eyeing Europe’s numbers and making preparations for another U.S. wave, warning Congress that if it doesn’t approve another $15 million in Covid-19 funding, the White House won’t be able to buy new drugs, vaccines, masks and tests.

Testing manufacturers have told administration officials demand has fallen so precipitously that without existing investments — like the government’s commitment to contract for 1 billion at-home tests — they would already be shutting down lines. The number of tests shipped each week by major manufacturers in the U.S. has fallen by more than 50 percent over the last month, POLITICO’s David Lim reports.

“If we get to a point where companies really are turning off lines or laying off people — are not making investments in the Covid test market — and we have another surge, then we will not be ready to go,” Tom Inglesby, White House senior adviser for Covid response, told POLITICO. “We will be in a situation that is potentially much worse than what we had with Omicron.”

The appetite on the Hill for rallying around more Covid-19 money is low, with lawmakers frustrated over the lack of transparency on how money has been spent and being asked for more when the CDC says most of the country can now relax and unmask.

“We’re seeing numbers decrease, and so I think because of that, people on the ground don’t really understand why we need to keep purchasing this stuff,” one Senate Democratic aide said. “It sounds terrible, but people are just over it. And nobody wants to talk about it.”

HEALTH CARE SECTOR ON ALERT FOR CYBERATTACKSRussia is “exploring” possible cyberattacks against the United States, President Joe Biden said Monday, POLITICO reports.

Though Biden didn’t single out the health care sector as a potential target, experts say it’s vulnerable, with the industry lagging behind in cybersecurity measures. The sector is an attractive target for hackers given the trove of sensitive information in health records and health care organizations’ perceived willingness to pay ransoms to unlock systems, given that disrupting care delivery can be catastrophic.

Some health care cybersecurity experts tell POLITICO’s Ben Leonard they’re already seeing an increase in cyber threats potentially tied to Russia in recent days.

“People are just seeing more traffic, more email bombs, so to speak,” said Mac McMillan, CEO of the cybersecurity firm CynergisTek. “They’re more of a nuisance at the moment — not full-fledged attacks that are doing anything — but clearly, there’s stuff going on now.”

Hospitals and health care organizations have been bracing for the impact of potential Russian cyberattacks during the Ukraine invasion. Particularly, the American Hospital Association has been warning of threats from the conflict since December.

The threat also has escalated at Ukrainian-based vendors of health care organizations. Carter Groome, CEO of the health care risk management consulting firm First Health Advisory, said malware attacks on Ukrainian targets have risen about 10 times in the past two weeks.

FDA TO MEET ON ADDITIONAL BOOSTERS — The FDA said Monday it will meet on April 6 to discuss additional Covid-19 booster shots for adults, POLITICO’s Katherine Ellen Foley writes.

Last week, Pfizer and BioNTech asked the FDA to authorize another booster of its Covid-19 vaccine for people 65 and older and Moderna asked the agency to authorize another booster of its shot for all adults. Immunocompromised adults are already authorized to receive a fourth mRNA Covid-19 vaccine dose.

The committee won’t vote on a vaccine application but will discuss considerations for boosters and how select strains of the SARS-CoV-2 virus for future vaccinations. Members from the Centers for Disease Control and Prevention and the National Institutes of Health will also be present.

 

SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today.

 
 
Lobby Watch

COVID-19 THERAPEUTICS FIRM HIRES JEFF RICCHETTI Pardes Biosciences, a relatively new company founded at the pandemic’s outset to create therapeutics for Covid-19, is establishing a footprint in Washington, D.C., registering an in-house lobbyist and hiring the firm co-founded by Jeff Ricchetti with his brother, top Biden aide Steve Ricchetti.

Recently filed lobbying disclosures show that the company seeks to advocate on issues related to the “funding for COVID-19 therapeutics, specifically oral antivirals,” the Strategic National Stockpile and pandemic preparedness. It’s racing to test PBI-0451, Pardes’ oral antiviral medication, which is in Phase I trials.

Jeff Ricchetti has said in the past that he doesn’t lobby his politically powerful sibling. Asked whether Richchetti has any meetings or calls with any White House officials on behalf of the company, a White House official said there’d been no contact.

Pardes Biosciences has raised more than $200 million, according to the San Diego Business Journal , and went public in late December through a Special Purpose Acquisition Company, or SPAC. It registered John Martin, a former top Food and Drug Administration official during the Trump administration, to serve as its head lobbyist at the end of January, new forms show, and hired Ricchetti days later. Martin also did not respond to a request for comment.

 

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Around the Nation

CMS RELEASES MEDICAID UNWINDING TOOLS TO STATES — Federal health officials Monday released a template states must complete detailing their plans to process renewals for millions of Medicaid recipients who’ve remained on their state’s welfare rolls during the pandemic.

States will be required to share with the federal government how many renewals they plan to begin processing during each month of the 12-month unwinding period, what approaches they’ll take in completing their work and how they’ll plan to limit coverage losses.

They’ll be required to submit the form to CMS by the 45th day before the end of the month in which the public health emergency ends.

States will also be expected to submit data on the Medicaid renewal process monthly, using a template also released by CMS on Monday.

LEGISLATING PSYCHEDELICS — Statehouses across America are considering legalizing psychedelics, POLITICO’S Mona Zhang and Liz Crampton report, a push using the same playbook advocates drew from in the fight to legitimize marijuana use over the past decade.

Bills from both Republicans and Democrats in more than a dozen states include a range of proposals, from studying the medical benefits of psychedelics to bills that would allow adults to consume such drugs under supervision.

In 2020, Oregon led the nation when voters approved a ballot measure to legalize and regulate psilocybin therapy and decriminalize drug possession more broadly. Voters in Denver, Oakland and Washington, D.C., have also pulled back on enforcing laws against magic mushrooms and other plants that contain psychedelic compounds.

Financial backers of the efforts also overlap with marijuana advocacy. New Approach PAC, which has backed most of the successful marijuana legalization ballot measures across the country, chipped in more than $3.8 million to two ballot committees backing Oregon’s psilocybin initiative. The group is also backing a campaign to put psilocybin legalization on the ballot in Colorado in November. Dr. Bronner’s, purveyors of castile soap, has given millions to back marijuana reform and psychedelics decriminalization.

 

DON’T MISS POLITICO’S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE.

 
 
What We're Reading

Manufacturers with Covid-19 vaccines in the pipeline are confronting an increasingly crowded market and the prospects for success are getting slimmer, STAT reports.

‘Addiction tech’ entrepreneurs see a $42 billion market and an addiction treatment field ‘ripe for disruption,’ writes Kaiser Health News.

The New York Times profiles the British virus hunter at the center of the debate over the virus’ origins.

 

A message from PhRMA:

According to a new poll , voters overwhelmingly support policies that would lower out-of-pocket costs and bring greater transparency and accountability to the health insurance system.

 We need to make the cost of medicine more predictable and affordable. Government price setting is the wrong way. The right way means covering more medicines from day one, making out-of-pocket costs more predictable and sharing negotiated savings with patients at the pharmacy counter.

Learn more.

 
 

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