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Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. | | | | | |  | | By Sarah Owermohle and Adam Cancryn | | | With Dan Goldberg, Carmen Paun and Darius Tahir Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro. | | | — The U.S.-based Novavax has struggled since last year to mass-produce its Covid-19 vaccine while slated to be one of the world’s biggest suppliers. — Health systems are grappling with a wave of labor turmoil, as burnt-out workers quit in droves while others organize strikes and walkouts. — Major elements of the Democrats' health agenda would expand coverage to millions more people — but also cost a hefty sum, the Congressional Budget Office found. WELCOME TO WEDNESDAY PULSE — Tell us: Are you swiping right for the surgeon general’s dating talk with Hinge? (“How do I know if it is Covid-19 or just first-date jitters?”). Send tips to sowermohle@politico.com and acancryn@politico.com. | | | | A message from PhRMA: Some in Congress are considering a plan that would tie medicine prices in Medicare to those in the U.S. Department of Veterans Affairs. This misguided approach is just the latest in a series of government price-setting proposals that threaten patients’ access to medicines and future innovation. Read the five reasons tying Medicare Part D prices to the VA misses the mark. | | | | | | NOVAVAX WOES REVERBERATE IN GLOBAL VACCINE EFFORT — The U.S. company, once seen as the linchpin in global efforts to vaccinate low-income countries against the coronavirus, is grappling with core manufacturing problems that threaten plans to share more than 1 billion doses. The delay, confirmed by six people familiar with a discussion between Novavax and the U.S. government, represents the latest setback for the international vaccine consortium’s COVAX Facility, which already curtailed its 2021 vaccine goals. It’s also worse than previously reported and could take several more months to set right, your authors report with POLITICO’s Erin Banco. The U.S. government invested $1.6 billion in Novavax in 2020 — the most it devoted to any vaccine maker at the time. But the company — which has never before brought a product to market — has consistently run into production problems. The methods it used to test the vaccine’s purity have fallen short of regulators’ standards, and the company hasn’t been able to prove it can produce a shot that’s consistently up to snuff, according to multiple people familiar with Novavax’s difficulties. The U.S. has enough doses; the world doesn’t. COVAX, which recently downgraded its 2021 goal from 2 billion to 1.425 billion shots, has already estimated that it faces a supply shortfall of as many as 1 billion doses in its effort to vaccinate the developing world. If Novavax falters, it could double the deficit through 2022, leaving hundreds of millions of people without immunity against Covid-19 and extending the pandemic. “COVAX continues to be challenged for adequate supply … in that context, Novavax’s manufacturing challenges and delays have been massively disruptive,” said Krishna Udayakumar, director of the Duke Global Health Innovation Center. In a statement, Novavax Senior Vice President of Investor Relations and Corporate Affairs Silvia Taylor told POLITICO the company’s analytical testing methods have been “validated” — but didn’t answer questions about whether the FDA had signed off on them. The company still plans to file an emergency use authorization by year’s end, Taylor said. “The vaccine development and regulatory submission processes are highly complex and often require years to advance to the point where we are now. We will fulfill all of our committed doses both in the U.S. and globally,” Taylor said. | | | | 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. | | | | |
HOSPITALS’ NEW COVID-ERA CHALLENGE: LABOR TURMOIL — Hospitals taxed by the pandemic over the past year and a half are facing a new set of crises: labor strife and a near-unprecedented level of resignations that have people waiting longer for care , POLITICO’s Darius Tahir, Victoria Colliver and Alice Miranda Ollstein report.
The one-two punch hitting the health sector has resulted in roughly a half-million workers quitting their jobs in August — the highest number in the past 20 years. Those who remain are increasingly organizing walkouts and labor strikes prompted by frustration because of overwork and verbal and physical abuse. That unrest extends to some of the nation’s largest health systems, from Kaiser Permanente on the West Coast to Catholic Health in Buffalo, N.Y. On Monday, 250 nurses in Chicago’s Community First Medical Center voted to go on strike. Despite all the attention around vaccine mandates, that’s not what’s driving the vast majority of the unhappiness, workers said. Instead, it’s burnout from battling Covid-19 in a country that’s turned their work into a political issue — as well as ever-present issues like inadequate pay and staffing shortages that have persisted throughout the pandemic. “It got to the point where seeing signs outside the hospitals — ‘Heroes Work Here’ — appeared a little hollow,” Denise Duncan, president of United Nurses Associations of California/Union of Health Care Professionals. “It’s almost like it’s been forgotten.” CBO: DEM SPENDING BILL WOULD EXPAND COVERAGE, COST $550B — Major health provisions included in the Democrats’ initial proposal for their social spending bill would expand coverage to 4.1 million people across Medicaid and the individual insurance market over the next decade, according to a new Congressional Budget Office analysis. The report also projected the provisions would cost $553.2 billion over the same period, with much of the spending tied to efforts to close the coverage gap in states that have yet to expand Medicaid. That forecast doesn’t include the impact of new Medicare benefits, which progressives have insisted be in the bill. Instead, it evaluated provisions that would affect people under 65 like the Medicaid proposal and policies aimed at strengthening Obamacare. Those elements could ultimately be stripped out as Democrats shrink their ambitions. But CBO found they would extend coverage to 4 million new Medicaid enrollees and 3.6 million people who would be newly eligible for subsidized Obamacare coverage over the next 10 years. That would be offset by 1 million people who no longer need unsubsidized coverage, and 2.8 million giving up their employer-based plans. In addition to spending more than $323 billion on the Medicaid coverage provision over the next decade, the Democrats’ bid to expand subsidies on the Obamacare markets would cost about $209.5 billion, CBO projected. But first: Biden still needs to broker an agreement on the broader bill, a challenge that’s has led the party around in circles for weeks. After a White House meeting Tuesday, House Progressive Caucus leader Rep. Pramila Jayapal (D-Wash.) told reporters that progressives had winnowed their priorities and that Biden agreed with their “strategy.” Still, she called his plan to limit the bill’s size to no more than $2.2 trillion “not the number that we want.” | | | |   | | | DHS SECRETARY HAS COVID — Homeland Security Secretary Alejandro Mayorkas tested positive for Covid-19 Tuesday, according to a DHS spokesperson, who said he was fully vaccinated. “Secretary Mayorkas tested positive this morning for the COVID-19 virus after taking a test as part of routine pre-travel protocols,” spokesperson Marsha Espinosa said in a tweet. “Secretary Mayorkas is experiencing only mild congestion; he is fully vaccinated and will isolate and work at home per CDC protocols and medical advice. Contact tracing is underway.” Mayorkas was supposed to travel to Colombia with Secretary of State Anthony Blinken, but will now be working from home, POLITICO’s Claire Rafford writes. FDA CLEARS TOBACCO PRODUCT … THAT NO LONGER EXISTS — The Food and Drug Administration gave marketing orders for four smokeless tobacco gums and chews Tuesday after determining they’re appropriate for the protection of public health. A catch: The company that made the products hasn't sold them since early 2019, POLITICO's Katherine Ellen Foley reports. The FDA decision covers four kinds of mint-flavored gums and chews made by Verve, a brand name owned by Philip Morris parent company and Juul stakeholder Altria. “While we discontinued selling Verve on Feb. 2, 2019, we applied learnings from this successful application to our [other oral nicotine pouch] submissions, which remain under review by FDA,” a spokesperson from Altria said in a statement. The FDA announcement came as the agency works through remaining applications from companies seeking permission to market "new" tobacco products introduced after Feb. 15, 2007 (Altria submitted Verve in 2018). That includes e-cigarettes, the first of which the FDA authorized for sale this month. SCOTUS WON’T STOP MAINE’S VAX MANDATE — The Supreme Court Tuesday declined to hear an emergency appeal challenging Gov. Janet Mills’ statewide vaccine mandate. Opponents had hoped the nation’s high court would take the case because the mandate, which doesn’t allow Covid testing as an alternative, takes effect October 29. A district judge denied a request for a preliminary injunction last week, and the U.S. Court of Appeals for the 1st Circuit let that ruling stand. Dozens of health care workers in Maine have quit rather than be vaccinated, forcing some health care facilities to cut services or reduce beds. ADVOCACY GROUPS PUSH TO KEEP DRUG PRICING PROVISIONS — A slew of health care, labor, religious and other advocacy groups wrote to Speaker Nancy Pelosi and Senate Majority Leader Chuck Schumer today demanding they not yield to calls from centrist Democrats to weaken the drug pricing provisions of the social spending bill and expressing “growing concern” with the state of the negotiations. The letter specifically urges party leaders not to drop the excise tax on drug companies that don’t comply with the negotiation scheme laid out in the House’s HR.3 bill, POLITICO’s Alice Miranda Ollstein reports. Signers include the American Federation of Teachers, Communications Workers of America, Indivisible, and Public Citizen, along with dozens of state-based groups. Other progressive advocacy groups sent a separate letter to the Congressional Progressive Caucus today expressing disappointment that the House members aren’t prioritizing Medicaid expansion in holdout states as they push to preserve other pieces of the reconciliation bill. | | | GATES FOUNDATION TO AID POORER COUNTRIES’ ACCESS TO COVID TREATMENT — The Bill and Melinda Gates Foundation is funneling $120 million toward developing more affordable generic versions of Merck’s Covid-19 antiviral drug, POLITICO’s Carmen Paun reports. Merck, which developed molnupiravir with Ridgeback Biotherapeutics, is seeking emergency authorization from the FDA for the treatment, which appears to halve the risk of hospitalization or death from Covid-19. The U.S. has already purchased 1.7 million courses, with other countries racing to do the same — a process likely to disadvantage the world’s lower-income nations. While five Indian generic manufacturers have a deal with Merck to produce the drug, other foundations and governments will need to help other countries access it once it’s authorized, Gates Foundation Co-Chair Melinda French Gates said.
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| | | Mexico’s underground abortion networks are preparing for a wave of demand triggered by the Texas government’s virtual ban of the procedure, Andrea Guzman reports for Mother Jones. A new report from a panel of Brazilian senators concluded that President Jair Bolsonaro intentionally allowed the coronavirus to spread throughout the country, killing thousands in a failed attempt at herd immunity, The New York Times’ Jack Nicas reports. Brendan Borrell describes the first days of what would come to be known as Operation Warp Speed in an excerpt from his upcoming book “First Shots” published in Esquire. | | | | A message from PhRMA: Some in Congress are considering a plan that would tie medicine prices in Medicare to those in the U.S. Department of Veterans Affairs. This misguided approach is just the latest in a series of government price-setting proposals that threaten patients’ access to medicines and future innovation.
Here are five reasons why the VA is a wrong model for Medicare:
1. Unlike Medicare Part D, the VA uses a one-size-fits-all system that restricts access to medicines.
2. The majority of VA beneficiaries rely on other sources to help supplement their drug coverage, including Medicare Part D.
3. The VA relies on quality-adjusted life year (QALY)-based assessments to set prices for medicines.
4. Imposing the VA system on Medicare is wildly unpopular with seniors.
5. Comparisons between Medicare Part D and the VA fail to acknowledge inherent structural distinctions between the two programs.
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