Drugmakers blast HHS negotiation argument, again

Everyone wants a quick end to the court battles over Medicare drug negotiation— just the right end for them. Bristol-Myers Squibb and Johnson & Johnson are pushing back on the government's own attempt to bring the court battles over negotiation to a quick close, arguing in documents filed this weekend (first spotted by D.C.D's intrepid Rachel Cohrs) that the New Jersey district court judge should issue a summary judgment, but in their favor.

Both pharmaceutical companies make profitable blood thinners (Eliquis for BMS, Xarelto for J&J) that are included on Medicare's list of the first 10 targets for negotiations. Each company is pushing back on the HHS assertion that companies aren't forced to participate, arguing that if they opt-out, they will incur massive fines and lose access to a patient pool of more than 60 million people. Or as J&J put it: "A demand to 'give us an arm or we will take an arm and a leg' does not make handing over an arm voluntary."

Both cited the Fifth Amendment, which protects accused parties' right to a grand jury, and the First Amendment right to free speech. The latter argument is based on the idea, as BMS lawyers write, that the government program would force drugmakers to "feign agreement with this scheme." J&J similarly argues that the IRA "forces" its drug arm Janssen to amplify the HHS message that these are fair prices.

These aren't new arguments (and have been seen in strikingly similar suits filed by PhRMA and other drugmakers in different districts), but this could be an early test of their merit.

congress

Doctors might get lump of coal for Christmas

Senate leadership's year-end agenda does not include any of the health care policies that many senators want, including legislation to cap insulin costs for people with private insurance or no insurance at all.

Senate Majority Leader Chuck Schumer spelled out his end-of-year plans in a letter to Democratic colleagues over the weekend, and there's not a single mention of health care policy. Since there's also no year-end funding efforts, after Congress passed a stopgap bill to keep the government running through Jan. 19, there's little hope for much action.

That's got to be especially frustrating for Sen. Raphael Warnock (D-Ga.), who just last week made a public push for a vote on his insulin bill before the end of the year. And there are several other health care policies that many lawmakers would like to get to. Many of them want to avert a looming Medicare pay cut to doctors. Lawmakers are also interested in reauthorizing a federal substance abuse program and a federal pandemic-preparedness program. Reforming drug middlemen business practices also is on Congress' honey-do list.

in the courts

States take turn in insulin price fight

A growing number of state and local governments around the country are suing insulin makers and pharmacy benefit managers over claims the companies conspired to illegally drive up prices. Just in recent weeks, officials in Utah, parts of New York, Virginia, Maryland, and Ohio have filed lawsuits accusing the companies of making the must-need medicines unaffordable to residents, my colleagues John Wilkerson and Ed Silverman report.

These aren't new claims, but the pace of state and local lawsuits has picked up considerably. Attorneys involved in the litigation tell John and Ed that even more suits are coming. Part of the concern is budgets: A recent Senate report notes that the U.S. spent approximately $327 billion on diabetes in 2017.

Another factor appears to be insurance arrangements. Some counties and cities run so-called self-funded insurance plans in which they collect premiums and assume responsibility for paying claims. That means they often have a better idea of the impact the price of medicines has on their budgets. Read more here.

eye on 2024

What will Trump's health care agenda look like?

Former President Donald Trump surprised the health policy world this weekend when he suggested he's still thinking about unspooling the Affordable Care Act, despite his own failed efforts in 2017. That got us thinking — what else in our sphere is on the table for Trump?

While other candidates have been hammered on the ACA, abortion, and even Medicare solvency questions, Trump hasn't joined them on the debate stage. So far, he's set his own agenda on what to talk about, and when.

That means that while other candidates are scrambling to find a winning stance on abortion, the president who touted Roe's overturn as a signature victory hasn't weighed in. He also has been uncharacteristically quiet about the government negotiating drug prices despite floating a similar plan in his first run for office (and memorably charging that pharmaceutical companies were "getting away with murder" as he entered the presidency.)

Democrats, of course, were quick to blast Trump's weekend remarks. "The American people forcefully rejected Republican officials' attempts to repeal the Affordable Care Act and hike prescription drug costs in 2018, 2020, 2022, and 2023," White House Deputy Press Secretary Andrew Bates wrote in a memo. However he also noted Trump's not alone: New House Speaker Mike Johnson has vocally support ACA repeal in the past.

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