Turning the screws on cybersecurity

The Biden administration's plan to improve hospital cybersecurity starts with incentives but will eventually turn to penalties modeled after the transition to electronic health records a decade earlier, HHS Deputy Secretary Andrea Palm said at STAT's event in D.C.

Palm didn't want to share too much about the agency's regular meetings with insurers and hospitals in the wake of the Change Healthcare cyberattack, which froze millions of health claims. She insisted HHS's work had been well underway before the attack.

Palm's interview with STAT came two days before Andrew Witty, CEO of Change's parent company UnitedHealth, is set to testify before two congressional panels. Witty plans to discuss the company's efforts to withstand a barrage of cyberattacks and its endorsement of "mandatory minimum security standards – developed collaboratively by the government and private sector – for the health care industry," according to prepared remarks. More on Palm's comments.

drug pricing

Another one bites the dust

A federal judge in New Jersey on Monday dealt yet another blow to drugmakers challenging President Biden's Medicare price negotiation plan, ruling that the program is constitutional.

The loss — this time for Bristol Myers Squibb and J&J — is a setback for the pharmaceutical industry's strategy of getting split decisions in lower courts across the country to eventually get the attention of the Supreme Court, my colleague Rachel Cohrs writes.

Judge Zahid Quraishi, a Biden appointee, said that the drugmakers failed to show that they are legally forced to sell drugs to Medicare patients. The manufacturers argued that the Medicare program is so large, opting out would mean financial doom. More from Rachel.

tobacco battles

What's next in the fight over menthol cigarettes

Tobacco control advocates are apoplectic over the Biden administration's decision to indefinitely delay the FDA's 2022 proposal to ban menthol cigarettes, but they acknowledge there's likely nothing they can do before the November election to change the Biden administration's plans, my colleague Nick Florko reports.

STAT spoke to several of the top groups pushing for the menthol ban and none was able to articulate a plan to force immediate action before the election.

And while advocates are hopeful that the Biden administration's decision might prompt states and localities to pass their own menthol bans, those efforts have proven exceptionally difficult. So far just two states and Washington, D.C., have passed such a ban.

regulation

FDA's narrower LDT plan doesn't satisfy critics

The FDA is going its own way. The agency announced Monday that it will start regulating lab-developed tests, requiring some 12,000 labs to submit their diagnostics for reviews in the next four years. But while the plan is noticeably softer on requirements than a draft version, it's almost sure to face legal threats, STAT's Lizzy Lawrence writes.

The agency's action comes after Congress repeatedly failed to pass legislation that would clear the way for FDA review these types of tests. While lawmakers bandied about bills for years, GOP support, in particular, fell apart after labs mounted a campaign against costly reviews.

The FDA's latest version carves out exceptions for many tests already on the market and gives labs years to submit applications. But critics still question whether the FDA are allowed to make a plan at all without the congressional greenlight. Rep. Cathy McMorris Rodgers, chair of the E&C Committee, quickly blasted the regulation as federal "overreach." More from Lizzy.

virus watch

H5N1: Here's what we know

Avian flu has been around for decades, but not like this. How are cows getting infected? How might people be at risk? Does consuming milk laced with live H5 virus pose a hazard?

My trusty colleagues Helen Branswell and Megan Molteni delve into what we know about the virus' spread across dozens of herds in eight states, and what we don't — and why we don't.

For instance, farmers who largely haven't been willing to test their cows are also hesitant about getting workers tested as well, hindering a clear picture of transmission. And because of limited data, we also don't have a complete understanding of the risk of viral fragments in milk. More from Helen and Megan.

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What we're reading

AI is becoming the exclusive province of academic medicine. A new initiative aims to change that, STAT
Court says state health-care plans can't exclude gender-affirming surgery, The Washington Post
There's never a good time to drink raw milk. But now's a really bad time as bird flu infects cows, STAT
Personal data is easier to get than ever. Reproductive health workers are at risk, The 19th News