Monday, July 1, 2024

Chevron ruling could clog the drug pipeline

Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
Jul 01, 2024 View in browser
 
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By Chelsea Cirruzzo and Ben Leonard

Driving the Day

Medical research is pictured.

The Supreme Court's Chevron ruling could have implications for speedy drug research. | Getty Images

HOW CHEVRON COULD SLOW THE FDA — A Friday Supreme Court ruling could mean it will take longer to develop new drugs and medical devices, former FDA attorneys say.

The Supreme Court overturned a Reagan-era precedent, called the Chevron deference, which required judges to defer to federal agencies’ interpretations of ambiguous federal laws.

The White House said the rule takes the country “backwards” and could “thwart efforts to respond to a global pandemic.”

The ruling could also mean new court challenges for the Biden administration’s Medicare drug negotiation policy and more pressure on Congress and the federal courts to hone their knowledge of health policy.

Slowed response time: The former FDA attorneys worry that the FDA’s process to reach decisions could fall under greater scrutiny, they said, leading to more lawsuits and potentially longer lead times for agency decisions as government lawyers work to shore up their legal standing, POLITICO’s Lauren Gardner and David Lim report.

“The agency is really going to have to build in a lot more explanation of why it comes to the decisions that it does,” said Jerry Masoudi, a partner at Covington & Burling and former FDA chief counsel.

Some former FDA officials said they expect the decision to especially impact federal agencies that use science to support their policies, given the history of deference the courts have paid to them. They anticipate it will spawn more lawsuits challenging agencies that make decisions as scientific evidence evolves.

While the industry might be more inspired to challenge FDA rules, the Chevron reversal also disturbs the relative stability that medical product manufacturers have relied upon through regulation, Maarika Kimbrell, a partner at Morgan Lewis and former director of the FDA’s Office of New Drug Policy, said.

Other ways the Chevron case could impact health policy include:

Private insurance: While the Affordable Care Act requires most insurers to cover preventive health services without any cost-sharing, the services that aren’t in statute could be subject to new court challenges.

EMTALA: Another suit could come up questioning whether 2022 guidance the Biden administration issued reaffirming that the decades-old Emergency Medical Treatment and Labor Act requires doctors to provide an abortion to stabilize a patient suffering a medical emergency takes precedence over state law prohibiting abortion.

NIH: National Institutes of Health rules related to clinical trial transparency or its requirements around the registration of publicly funded clinical trials could be subject to challenge.

WELCOME TO MONDAY PULSE. It’s a short holiday week, so let’s make the most of it! Send your tips, scoops and feedback to ccirruzzo@politico.com and bleonard@politico.com and follow along @ChelseaCirruzzo and @_BenLeonard_.

Programming note: We’ll be off this Thursday and Friday for the Fourth of July but will be back in your inboxes on Monday.

 

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Health Costs

A doctor treats a patient.

A new study suggests that federal programs implemented during the pandemic made health care more affordable for low-income patients. | Getty Images

MAKING HEALTH CARE AFFORDABLE — Low-income adults had an easier time affording their health care and prescriptions during the pandemic than before the pandemic, according to a study published Sunday in JAMA.

Researchers at Harvard Medical School and Beth Israel Deaconess Medical Center looked at how nearly 90,000 U.S. adults answered Census surveys in 2019, 2021 and 2022.

Health care costs: They found that low-income adults were less likely to delay medical care during the pandemic compared with pre-pandemic levels and also less likely to experience problems paying medical bills — although worry about bills remained unchanged. Patterns were similar among high-income adults, although they reported greater difficulty in paying medical bills during the pandemic.

Prescription drugs: Overall, low-income adults reported greater difficulties in affording prescription drugs throughout the entire study period, but both low- and high-income adults said affordability improved during the pandemic. Low-income adults were less likely in 2022 to avoid filling prescriptions because of costs or take less medicine to save money.

What researchers say: The improvements for low-income adults might be the result of federal safety-net programs implemented during the pandemic, such as stimulus checks and expanded tax credits.

Starting last year, the federal government began phasing out some of those programs, such as Medicaid continued eligibility.

“This unwinding of federal support threatens to reverse the improvements in affordability of care and the narrowing of income-based disparities in 2021 and 2022, which could have major implications on the health of low-income adults as the US emerges from the COVID-19 pandemic,” researchers wrote.

AROUND THE AGENCIES

CATHETER FRAUD TARGETED — A surge in spending on catheters has prompted the Biden administration to propose a rule Friday that would help protect providers from Medicare fraud, POLITICO’s Robert King reports.

The rule addresses fraudulent spending that providers say unfairly impacts their bottom lines and inflates their patients’ health care costs.

How we got here: Accountable care organizations — groups of doctors, hospitals and other providers who agree to accept Medicare payment based on the quality of care provided and the savings generated — reported a sudden and suspicious increase in catheters in 2023.

In April, HHS’ inspector general said scammers were contacting Medicare enrollees offering free services to get their enrollment information, then billing Medicare for catheters. The National Association of ACOs trade group reported catheter spending increased from $153 million in 2021 to $3.1 billion last year, according to a report in The Washington Post.

What the rule does: This proposal would allow CMS to exclude payments for two specific urinary catheter codes when it calculates the ACO’s financial performance for 2023.

FDA: PASTEURIZED MILK IS SAFE — Commonly used pasteurization techniques — where raw milk is heated to a certain temperature — inactivates bird flu virus in dairy products, according to a study released by the FDA and the Department of Agriculture on Friday.

Why it matters: An ongoing outbreak of avian flu in cattle herds across the country has led to concerns about dairy products after fragments of the virus were found in commercial milk in April.

It comes after federal officials in May sampled nearly 300 samples of commercial dairy products and found them all to be negative for viable virus — meaning virus that can infect.

For the pasteurization study — which has yet to be peer-reviewed — federal officials obtained 275 raw milk samples from multiple farms in four states with infected herds. More than half were found to be positive for virus fragments, and of those, 39 had infectious virus. Researchers warmed milk with infectious virus to temperatures used commonly for pasteurization in a number of repeated experiments and found that pasteurization inactivated the virus.

“Collectively, these studies provide strong assurances that the commercial milk supply is safe,” the FDA said in a statement, adding that it continues to urge against consuming raw milk.

CYBERSECURITY THREAT RETURNS — HHS is again warning the health care sector about vulnerabilities in a file transfer system that was also breached last year, exposing tens of millions of health records.

HHS’ Health Sector Cybersecurity Coordination Center has warned of a “critical vulnerability” in MOVEit, a file transfer platform used in the health care system, and urged health care organizations to make patching any vulnerabilities they find in MOVEit a high priority.

“This vulnerability exposes healthcare organizations to cyberattacks, especially ransomware and data breaches,” an HHS alert said last week. The same platform was targeted by foreign hackers in a sweeping attack last summer, which led to health records being stolen from some health care systems.

Why it matters: Health care breaches, particularly hacks and ransomware attacks, have skyrocketed in recent years. Federal officials have warned that foreign hackers are specifically targeting the health care sector.

“The identified critical vulnerabilities in MOVEit are another stark example of how hospitals and health systems are exposed to significant cyber risk through insecure third-party technology and service providers,” John Riggi, the American Hospital Association’s national adviser for cybersecurity and risk, said in a statement.

 

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Names in the News

Sean Brown is the new vice president of communications for the Healthcare Leadership Council. He previously was vice president of public affairs and digital strategy at the Federation of American Hospitals.

WHAT WE'RE READING

The Washington Post reports how a warmer climate could increase dengue fever outbreaks.

The Wall Street Journal reports on doctors’ love for Apple watches to help diagnose patients.

POLITICO’s Arek Sarkissian reports on the backlash from abortion-rights groups over Florida’s estimated cost for putting abortion on the ballot.

 

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