Biden: "Finally we beat Big Pharma"

President Biden on Wednesday took a victory lap for drug price measures yet to go into effect, and repeated his calls for Congress to extend those Medicare drug price negotiations to 50 products per year, instead of the eventual 20 under current law, my co-author Sarah Owermohle reports.

"I think we should be more aggressive. It's time to negotiate lower prices for at least 50 drugs a year," he said at a White House event touting the administration's efforts to lower costs including seniors' out-of-pocket caps, reduce hearing aid prices and investigate inhaler costs. The president credited Sen. Bernie Sanders (I-Vt.) for leading the charge on the latter with a probe that preceded manufacturers' decisions to cap costs.

But Biden's effort to speed up the negotiation pipeline is still unlikely to find traction in a divided Congress, where no Republicans voted for the negotiation legislation in the first place.

finance

Massachusetts lawmakers dunkin' on Steward

Both Sens. Ed Markey and Elizabeth Markey led a HELP subcommittee field hearing yesterday slamming private equity's role in health care, following revelations about the financial crisis at Steward Health Care uncovered by our enterprising colleagues at the Boston Globe.

Steward's CEO didn't take them up on the offer to appear (the senators left an empty chair at the witness table), but Markey slammed him anyway. "Greedy corporate executives like Steward Health Care CEO Dr. Ralph de la Torre are failing in their responsibility to providers, patients, and communities," Markey said.

It remains to be seen whether an effort to require more transparency about private equity and for-profit ownership of health care organizations could actually gain traction — on the House side, their Massachusetts colleague Ways & Means ranking member Richard Neal has been calling for more private equity transparency in vain for years.

agencies

FDA faces fierce blowback over opioid addiction diagnostic

In December, the FDA approved a DNA test to measure how susceptible a patient might be to opioid addiction to help guide doctors' prescribing decisions. But now that it's actually coming to market, scientists are warning its accuracy may be "no better than a coin flip," my colleague Megan Molteni writes.

More than two dozen scientists called for the FDA to pull the test, called AvertD, off the market, and called for Medicare officials to refuse to pay for it. It's a case of the conflict between the intense pressures for the FDA to do something about the opioid addiction crisis, and critics calling for more stringent scientific rigor.

Stay tuned, as Megan will be updating the story with any responses provided by the test's manufacturer, SOLVD Health, or the FDA.

capitol hill

Without Congress, White House drug shortage plan goes nowhere

The White House's plan for stemming drug shortages relies heavily on Congress, which isn't the best bet these days. But it's also largely unavoidable.

The plan calls for grading drug makers based on the resiliency of their supply chains. It's expensive to ensure a reliable supply of drugs, so Medicare would pay more to hospitals that buy from drug makers with good grades. Hospital seeking bonuses also would be expected to enter long-term contracts and commit to buying sufficient volumes of drugs. Those that don't would be penalized. Here are more details from my colleague John Wilkerson.

There's a lot to like about Biden's plan, according to Erin Fox, associate chief pharmacy officer at the University of Utah Health and drug shortages expert. The ratings system is especially important, she said, but "it seems to depend on Congress doing a lot of work, and I am somewhat cynical that those actions will actually happen."

court watch

Hurry up and wait

As various legal challenges to the Inflation Reduction Act's Medicare drug price negotiation program lurch forward in fits and starts across the country (four cases were heard in a quadruple oral argument last month), we now have some more clarity on how another case will advance.

Judges in district courts don't have to hold oral arguments to rule on the facts of a case, but a Connecticut judge said he's open to holding one in a challenge brought by Boehringer Ingelheim. He wrote he is "willing to hold oral argument in this case and believes it would likely be helpful." The potential dates he proposed range from late May to the end of June.

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