Federal officials have spent the past few days scrambling to move one factory’s inventory of IV fluid out of Florida as a powerful hurricane bears down on the state today.

The rush to preserve German drug and device maker B. Braun’s supply of IV solution in Daytona Beach comes as hospitals warn that they’re facing shortages after Hurricane Helene damaged and closed another factory in North Carolina late last month.

“They’re going to move some [supply], we’re going to assist in moving some and getting it to higher ground up the Eastern Seaboard so it can then be put into the supply chain when needed,” Dawn O’Connell, head of the Administration for Strategic Preparedness and Response, told Pulse.

“But we couldn’t risk losing an additional part of our IV fluid supply in light of Baxter coming offline,” she said.

Baxter International owns the North Carolina factory that closed due to damage from Helene. The factory, responsible for 60 percent of the nation’s IV fluid supply, has cut its fluid allocations to hospitals and is working with the FDA to receive a special license to import products from outside the U.S.

O’Connell told Pulse the agency also helped to build a temporary bridge to help access the facility.

The bigger picture: Hospitals have reported substantial shortages of IV fluids, and the American Hospital Association has urged the FDA to declare a shortage, which would ease up certain rules to alleviate it.

An HHS spokesperson told Pulse it hadn’t issued a shortage designation and has yet to see a need to, according to notes from a call among the FDA, ASPR and other federal officials on Friday. Instead, the officials are seeking other IV fluid sources like B. Braun’s factory, O’Connell said.

Alli Longenhagen, director of corporate communications at B. Braun, told Pulse the company will close its Florida factory today, hoping to reopen Friday.

“In partnership with ASPR, we are taking immediate steps to increase production of critical IV fluids at our plant in Irvine, CA, and will resume this plan at Daytona Beach following Hurricane Milton’s departure,” she wrote in an email.

Other preparations: O’Connell said the agency has 450 employees in North Carolina working on the Helene response and another 100 stationed in Atlanta to prepare for Milton. The response includes disaster medical-assistance teams to provide clinical care in affected hospitals and medical supplies that could fill several trucks.

The agency is also ready to activate a program that provides a free 30-day supply of prescription medication to uninsured people.

PREMIUMS RISE AGAIN — Family premiums for employer-based health insurance rose 7 percent this year , according to a KFF survey released today.

This is the second consecutive year that premiums have risen, per the random, nationally representative survey of more than 2,100 employers.

Among their findings are that most employers don’t cover GLP-1 drugs for weight loss, which have skyrocketed in popularity in recent years. The firms that cover the drugs have imposed restrictions, including requiring workers to first meet with a dietitian or participate in another weight-loss program.

A quarter of large firms said they cover in vitro fertilization and other fertility benefits. This comes as policymakers nationwide mull how to protect the procedure following an Alabama court ruling that deemed frozen embryos created via IVF to be people.

Other key findings:

— Workers who pay for an annual deductible for single coverage pay around $1,787 — similar to last year and up 8 percent from 2019.

— About a third of the firms with at least 5,000 workers say they receive “most” of the rebates negotiated by a pharmacy benefit manager. Another third said they receive “some,” and 8 percent said “very little.”

— Around half of the firms with at least 200 workers have increased mental health counseling resources through an employee assistance program or a commercial app like Headspace.

from STAT:

gene therapy
Seven children develop cancer after receiving Bluebird gene therapy for rare neurological disease
Seven of the 67 children who received Bluebird Bio’s gene therapy Skysona have developed blood cancer, new research shows — and one patient has died from complications stemming from the cancer treatment.

In all seven cases, it seems as though the lentivirus used to ferry the therapy throughout the patients’ bodies disrupted a gene linked to cancer, STAT’s Jason Mast writes. Six patients developed myelodysplastic syndrome, an early malignancy that can progress into acute myeloid leukemia, or AML. One patient has developed AML. It’s still unclear why this particular treatment is so prone to triggering blood cancers.

But Skysona is still a critical treatment for cerebral adrenoleukodystrophy, a deadly neurodegenerative disorder, and doctors still intend to offer the treatment.

“This disease is awful, and until we have better, I think families and patients need to have choices,” the physician who detailed these cases in the New England Journal of Medicine told STAT.

Read more.

A crack of light for Pfizer
From STAT’s Matthew Herper: In other Pfizer news, the company said this morning that the combination of its drugs Talzenna and Xtandi extended survival in men with metastatic castration-resistant prostate cancer compared to Xtandi alone.

The effect held true both in the limited group in which Talzenna is approved — patients whose cancer has gene mutations that lead to issues with homologous recombination repair (HRR) — and in an “all comers” group that included tumors that don’t test positive for HRR.

The new data could lead to a broader approval for Talzenna. Currently, Pfizer markets the drug for the treatment of prostate cancer only for patients whose tumors have HRR mutations. Pfizer did not provide more detail on the new data.

The more limited approval by the FDA in 2023 was viewed as a disappointment at the time, and Pfizer listed it as one reason for lowering its earnings expectations later that year. Right now, Talzenna, a type of drug called a PARP inhibitor, is not a big seller, with sales of only $32 million in the second quarter of 2024. Pfizer acquired the medicine, originally developed by BioMarin, when it bought Medivation for $14 billion in 2016.

from Politico:

MOVING CARE TO THE HOME — Vice President Kamala Harris has an ambitious plan to overhaul the way the nation cares for older Americans by allowing Medicare to offer home care benefits, Ben reports with POLITICO’s Robert King.

Currently, Medicare covers home nursing care and home health aides in only limited circumstances, and Medicaid coverage is a patchwork across states.

Many older Americans say they prefer receiving care at home than in institutional settings like nursing homes and hospitals. Harris’ proposal comes amid a broader push to bring more care into the home, sometimes using technology like telehealth and remote monitoring. The issue has bipartisan support in Congress and has been pitched as a way to reduce rampant health care spending.

But making that plan a reality has roadblocks, including Congress and cost. Some questions remain, including:

1. How much will it cost? Experts say the proposal could save money by curbing unnecessary and pricey hospitalizations, and Harris’ proposed pay-fors could offset the costs. But there’s significant uncertainty.

“There are just so many unknowns,” said Rachel Prusynski, assistant professor in the department of rehabilitation medicine at UW Medicine.

The Harris campaign pointed to a proposal from a left-leaning think tank estimating a similar proposal would cost $400 billion over a decade. Marc Goldwein, senior vice president for the nonpartisan Committee for a Responsible Federal Budget, an advocacy group that supports “fiscal responsibility,” called that estimate “plausible.”

Harris said the “large majority” of costs would be paid for by expanding Medicare drug price negotiations, boosting discounts pharma companies provide for some drugs in Medicare and requiring pharmacy benefit managers, which negotiate drug prices on behalf of insurers, to reveal more about their business practices.

In 2019, the Congressional Budget Office estimated that expanding drug price negotiation to include more than twice the currently eligible medications could save more than $450 billion over a decade. But Harris has other ambitions that will cost money.

“Is this enough also to cover these costs and cover the entire rest of their agenda?” Goldwein asked. “The answer appears to be no.”

2. What would it include? The benefit would aim to cover older adults’ everyday vital services like bathing and eating; current home health coverage in Medicare isn’t intended for longer-term care.

Some of the uncertainty surrounding the cost stems from the lack of details about the benefit structure, said Rachel Prusynski, assistant professor in the department of rehabilitation medicine at UW Medicine.

The campaign said doctors or nurses would evaluate Medicare enrollees. Medicare would designate aides, such as “qualified home health aides, personal care attendants, or direct care workers.”

3. Who’s eligible? If passed by Congress and signed into law, the new benefit would be available to everyone on Medicare.

However, it’s unclear whether beneficiaries’ income would affect cost-sharing amounts.

“You can make this thing as expensive or inexpensive as you need it to be,” said Sherry Glied, a Brookings fellow and dean of New York University’s Robert F. Wagner School of Public Service.

ON THE BALLOT: ASSISTED SUICIDE, IVF, MEDICAID — Ten states, ranging from Arizona to New York, will consider abortion-related ballot initiatives next month. It’s a politically potent issue candidates up and down the ballot are focusing on to claim victory in November.

And some states are also considering other health care-related initiatives on the ballot:

— California: Proposition 35 would codify a tax on managed care plans to raise reimbursement rates for some specialties in the state’s Medicaid program. Between state and federal contributions, around $40 billion is at stake. Taxes like these require federal approval, and CMS has said it would crack down on tax schemes like California’s, so states with similarly structured taxes might want to pay attention.

— Illinois: Voters will decide on an advisory question — a nonbinding referendum that will give officials a sense of voters’ positions on whether health insurance plans that cover pregnancy benefits should also cover reproductive services like in vitro fertilization. It comes as policymakers nationwide consider how to protect the procedure following an Alabama court ruling that deemed frozen embryos created via IVF to be people.

— South Dakota: The state seeks voter approval of Medicaid work requirements for able-bodied beneficiaries. Such requirements were initially allowed via waiver under the Trump administration and then withdrawn by the Biden administration. But the requirements have reappeared after a court order granted Georgia the right to implement them last year.

— Washington: Voters will decide whether to opt out of paying for the nation’s first state-operated long-term care insurance program. The state passed the program in 2019 to address long-term care needs. It imposed a payroll tax on workers to create funding for older residents to help pay for their essential services like bathing assistance or transportation. The program’s benefits aren’t slated to become available until 2026. However, some policymakers have argued that wealthier individuals paying the tax are unlikely to ever receive the benefits.

— West Virginia: This ballot initiative, if approved, would ban people from using medically assisted suicide in the state. Several other states allow people to seek assisted suicide under certain circumstances. Last month, a judge upheld New Jersey’s requirement that people seeking assistance live in-state.

ANTITRUST THE PROCESS: “US Weighs Google Breakup in Historic Big Tech Antitrust Case,” by Bloomberg’s Leah Nylen: “The Justice Department ‘is considering behavioral and structural remedies that would prevent Google from using products such as Chrome, Play, and Android to advantage Google search and Google search-related products and features,’ the agency said. … Antitrust enforcers said Google gained scale and data benefits from its illegal distribution agreements with other tech companies that made its search engine the default option on smartphones and web browsers.”