Happy pandemic groundhog year

From: POLITICO Pulse - Monday Jan 03,2022 03:04 pm

Jan 03, 2022

Presented by

With Rachael Levy

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Quick Fix

— The U.S. is grappling with a pandemic surge for the second straight January, straining hospitals and raising questions about the government's response.

— The Biden administration is trying to get more Covid-19 tests on the market while easing guidelines for those who test positive.

— Biden officials are worried the need for widespread boosters could slow efforts to get poorer countries their first series of shots.

WELCOME TO 2022 PULSE — and Happy New Year, especially to the residents of Texarkana who survived “animal rain" to close out 2021.

Thanks for starting your weekdays with us, and feel free to send suggestions for areas we should cover more (or less) this year. We’re at acancryn@politico.com and sowermohle@politico.com.

A message from PhRMA:

In today’s health care system, PBMs and health insurers often leave patients paying far more than they should for medicines. Unfortunately, the drug pricing plan being considered by Congress would do nothing to address the shady practices these middlemen use to overcharge patients. Our seniors deserve better. Tell Congress to make middlemen share the savings they receive with patients at the pharmacy counter. Learn more.

Driving the Day

HAPPY PANDEMIC GROUNDHOG YEAR — It’s 2022, and the coronavirus is running rampant. Hospitals are swamped. The nation’s vaccination effort is struggling to keep pace. And if that sounds familiar, it’s because we wrote almost the exact same thing at this time last year.

For all the progress in the fight against Covid-19, the U.S. begins its third crisis year facing many of the same frustrating dynamics. Rather than crushing the virus through vaccination, we allowed it to linger and mutate. Instead of uniting behind mitigation measures, even the most basic steps became hopelessly politicized.

Despite vowing to treat the pandemic like a wartime emergency, those on the front lines still suffer from resource shortages and a lack of support.

The result is the most significant surge yet, fueled by Omicron and the federal government’s inability to stay consistently ahead of Covid-19’s next move. Caseloads in more than 30 states have hit or exceeded last winter’s peak, and while this variant appears less severe than its predecessors, hospitalizations are climbing steadily back toward the 100,000 mark.

If there’s a silver lining, it’s that those who are fully vaccinated and boosted remain well protected against severe disease. The death rate has remained low partly because of that. New treatments are now available, and scientists are hopeful Omicron’s rapid spread means it will burn itself out just as fast.

But if President Joe Biden entered 2021 planning to beat a deadly virus, the best hope for his second year may be to simply fight it to a draw.

The administration is still racing to catch up with an Omicron variant that exposed shortcomings in its Covid-19 response — and with pandemic exhaustion setting in and political opposition rising, there was little health officials could do over the holiday weeks other than plead for cooperation.

“How well each of these prevention measures is implemented, as well as adherence to isolation and quarantine recommendations, will determine the outlook in the coming weeks and months,” CDC Director Rochelle Walensky said last week of the agency’s new isolation guidelines. “These recommendations will only work if people follow them.”

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.

MORE TESTS, LESS ISOLATION — The Biden administration is clearing more at-home rapid tests, in a move that could eventually help alleviate persistent and widespread shortages. And for those who get their hands on one and test positive, they’ll now face a shorter isolation period.

That’s the upshot of a pair of decisions over the holidays likely to further shape the nation’s Covid-19 response. Over at the FDA, the agency authorized two new at-home tests — one manufactured by SD Biosensor and the other by Siemens.

The decisions come as the administration has sought to ramp up access to rapid testing as a key element in keeping schools and businesses open, as well as counter criticism that it failed to build out a universal testing system last year ahead of the Omicron surge.

The Defense Department also last week awarded a $137 million contract aimed at producing materials critical to the production of over-the-counter tests.

At the CDC, officials now recommend that Covid-19 patients with no symptoms isolate for just five days — down from 10. The agency cited indications that people are most infectious in the initial days after developing symptoms and therefore should only have to wear a mask after the five-day isolation period.

But the shift has faced skepticism in the days since, with critics noting it came after Delta Air Lines and other corporations had lobbied for the change because of workforce shortage concerns. Walensky drew further blowback after referring to the reduced isolation period as having “a lot to do with what we thought people would be able to tolerate.”

On Sunday, Anthony Fauci acknowledged the pushback, indicating that the CDC may soon alter its guidance again to recommend that people first test negative before breaking isolation.

BOOSTERS COULD BATTER THE GLOBAL VAX EFFORT — Top Biden administration officials are increasingly worried that the push for booster shots across the U.S. and Europe will disrupt the global vaccination effort, POLITICO’s Erin Banco, Adam and Sarah report.

The need for more doses in wealthy countries to respond to Omicron threatens to disrupt planned donations and take up more supply than anticipated, further setting back a worldwide campaign that’s already well behind schedule.

Global leaders already failed to hit an initial target of vaccinating 10 percent of every country by September. The World Health Organization has set a new goal to inoculate 70 percent of the global population by the middle of next year — but that’s heavily dependent on both nations and vaccine makers keeping their promises.

And while the U.S. has pledged 1 billion doses for low and middle-income countries this year, some in Europe have been slower to set aside similar amounts. Also concerning is whether additional boosters will be needed, which could suck up supply, especially in the face of a future variant.

One company to watch: Novavax, which could prove a major supplier to the global vaccination effort if it can overcome months of manufacturing delays. The company won WHO and European Commission signoff for its vaccine in December, but only for shots made by India’s Serum Institute.

It’s still unclear how many doses that Novavax-Serum partnership can produce, and whether its other facilities in the U.S. and Europe can win the necessary permissions.

A message from PhRMA:

Public Health

HOW FACEBOOK’S AD BAN COULD HURT DRUG RESEARCH — A sweeping ban on health-related ad targeting designed to shield people’s privacy could end up making it harder for drug companies to recruit volunteers for clinical trials, POLITICO’s Darius Tahir reports.

The concern is a side effect of Facebook’s new policy that prevents advertisers from targeting users based on “sensitive” topics, including their health conditions. While the move is winning measured praise from privacy advocates, it also threatens to hamper recruiters who have increasingly relied on Facebook to find the patients needed to fill drug trials.

At least half of all trials rely on Facebook to find enrollees, according to the head of one recruitment firm. And with 3 million people a year participating in trials, the company’s change could slow down research in areas heavily dependent on trials — such as treatments for Covid-19, or various dermatological and mental health conditions.

Still, patient privacy advocates contend Facebook must strike a balance in the access advertisers are granted, with critics warning the company’s prior policies allowed drug companies to intrusively target ads and makers of questionable health products to prey on patients.

Around the Agencies

CMS KILLS TRUMP-ERA DRUG RULE — The agency officially rescinded the most-favored-nation drug pricing rule proposed by the Trump administration in late 2020 but never took effect, POLITICO’s Rachael Levy reports.

The regulations sought to lower costs by linking what the government pays for certain medicines to the prices charged abroad. Yet the idea faced opposition from the drug industry and some Republicans, eventually getting bogged down in legal challenges.

After telegraphing earlier in 2021 that it would eliminate the rule, CMS on Dec. 29 issued its final rule rescinding the measure, citing procedural issues with how it was initially put in place.

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BIDEN PLOTS OBAMACARE TWEAKS — The administration plans to roll back a series of Trump-era policies governing the Obamacare markets as part of a proposed payment rule. Among the noteworthy changes that Rachael flagged:

— Reestablishing federal review of doctor and hospital networks to assess how accessible providers are for Obamacare enrollees.

— Planning standardization requirements that mandate, for example, an insurer offering a nonstandardized gold plan “must also offer a standardized gold plan in that same service area.”

— Prohibiting discrimination based on sexual orientation or gender identity by Obamacare marketplaces, insurers, agents and brokers. The Trump administration previously removed the sexual orientation and gender identity discrimination language from CMS’ regulations.

— Scaling back enrollment verification for special enrollment periods. The proposal would require only those who lost their health insurance to verify their circumstances when signing up for Obamacare coverage through a special enrollment period. The government currently requires verification from people seeking special enrollment coverage for a range of other reasons.

What We're Reading

Reporting from the Mayo Clinic, The Washington Post’s Dan Diamond surveys how Omicron is putting new strains on hospital staffers already burnt out by two years of battling the pandemic.

Gaps in government oversight allow hospitals where Covid-19 spread rapidly among patients to escape accountability, Kaiser Health News’ Lauren Weber and Christina Jewett report.

After years of legislative debates, many types of “surprise” medical bills are now illegal — though patients still face some out-of-network risks, Axios’ Bob Herman writes.

A message from PhRMA:

Last year, brand drug companies provided $187 billion in total discounts, rebates and other payments to pharmacy benefit managers, insurers, and other entities. In fact, the net prices paid by PBMs and health plans for brand medicines declined 2.9% last year, on average. So how come payers and middlemen often don’t share these savings with patients at the pharmacy counter? Policymakers should put an end to these gimmicks so patients can get a fairer deal at the pharmacy. Learn more.

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