President TrumpDonald TrumpMan sentenced to nearly four years for running scam Trump, Biden PACs Meadows says Trump's blood oxygen level was dangerously low when he had COVID-19 Trump endorses David Perdue in Georgia's governor race MORE is slated to give a long-awaited speech laying out proposed actions to lower drug prices.
The health-care industry is on edge. It’s unclear what exactly Trump is going to propose, and the president has a well-known propensity to go off script.
Even key congressional Republicans have not been briefed on the speech or what the administration is planning, sources say.
A GOP health-care lobbyist said the administration is intending the actions to be a “disruptive, provocative document that really shocks the system.”
The speech was initially expected Tuesday but also could be pushed to later in the week.
Here are five things to watch when it happens.
How hard will Trump attack drug companies?
Trump has been unsparing in his criticism of drug companies and their prices. He has previously said they are “getting away with murder,” rhetoric more traditionally heard from Democrats.
The speech will give Trump a forum to perhaps go even further and build up public pressure against the companies.
Taking on drug prices is a chance to highlight a popular issue heading into the midterm election campaign. A Kaiser Family Foundation poll in March, for example, found that 52 percent of the public said legislation to bring down the price of drugs should be a "top priority.”
Rodney Whitlock, a former GOP congressional staffer who now lobbies for the Campaign for Sustainable Rx Pricing, noted Trump's unpredictability, even at scripted events.
“That’s what makes Tuesday so interesting for everybody, which is wondering what will actually get said,” Whitlock said.
How far will Trump’s actions go?
Trump is sure to have some tough words for drug companies, but what advocates will really be watching is how aggressively he moves on the pricing issue.
Advocates for lowering drug prices have lamented since Trump took office that his actions have not matched his words. His administration has so far not taken any action that directly targets pharmaceutical companies — but that could change on Tuesday.
“I am hopeful,” said David Mitchell, founder of the advocacy group Patients for Affordable Drugs. “There are good signs.”
He pointed to Secretary of Health and Human Services Alex Azar’s recent remarks that Trump wants to “go further” than the proposals that were in the White House budget this year, ideas that were criticized as insufficient.
“Action is desperately needed: There’s little difference for a sick patient between a miracle cure that hasn’t been discovered and one that is too expensive to use,” Azar said.
One key question is whether the administration will target pharmaceutical companies directly, as opposed to taking aim at other actors like the pharmacy benefit managers that negotiate drug prices and have come under scrutiny for a lack of transparency.
Lobbyists said they expect that Azar wants to take some actions that directly draw opposition from pharmaceutical companies, in part to avoid headlines about backing down from a fight or catering to industry.
Will the actions take effect immediately?
The White House has said that part of the announcement will be requesting feedback on possible proposals, which is known as a Request for Information (RFI). But some of the actions could also start right away.
Having some firm new announcements could be a way to increase the shock factor of the announcement.
“The fact that they keep using the phrase ‘disruption’ is attention-grabbing,” Whitlock said.
Food and Drug Administration Commissioner Scott Gottlieb hinted at coming actions this week when he said the plan will include new guidance to crack down on drug companies using delay tactics to prevent cheaper generic drugs from coming to market.
Another possible idea is passing discounts that insurance companies get on to consumers to lower patients’ out-of-pocket costs.
Will Trump follow Obama on Medicare changes?
One of President Obama’s main drug pricing initiatives was an attempt in 2016 to reform the way Medicare Part B pays for drugs. But his administration eventually dropped the plan in the face of fierce opposition from drug companies and doctors groups.
Trump is well known for wanting to do things that Obama didn’t, and Trump’s administration has already floated similar proposals in the White House budget.
The problem, some advocates say, is that Medicare Part B incentivizes the use of pricier drugs by reimbursing doctors a percentage of the cost, rather than a flat fee.
Trump could try to change the system to bring down costs, either through the administration’s Medicare innovation center, or perhaps more likely, a lobbyist said, through authority already provided under the 2003 Medicare Modernization Act.
Will Trump mention his biggest proposals?
During the campaign, Trump backed two of the most far-reaching ideas on drug pricing: Medicare negotiating prices directly and allowing importation of drugs from abroad. Both ideas are broadly supported by Democrats and strongly opposed by drug companies.
Almost no one expects those ideas will be part of the administration’s plan going into the speech, but Trump could still give the ideas a shoutout.
Steve Ubl, the CEO of the Pharmaceutical Research and Manufacturers of America, preemptively pushed back on those ideas in a recent interview with The Hill, calling them the “wrong way.”
He instead called for a “holistic” approach, with a focus on insurers and the discounts that they get. But he said he did not know for sure what the administration would do.
“I'm always worried,” Ubl said. “We know what's at stake in this discussion and we want to make sure that we're carefully threading the needle.”