Good morning ... Virginia, get it together.
An Impella heart pump. Photo: Jeff Gritchen/Digital First Media/Orange County Register via Getty Images
Axios’ Bob Herman reports this morning on the saga of a heart pump called Impella RP and what it says about the data the FDA has to work with when it evaluates medical devices.
Details: The FDA approved Impella RP in 2017, relying on studies showed 73% of patients who got the pump were still alive within a month.
The results aren't good. The FDA warned providers this week that survival rates have dropped precipitously — just 4 of 23 patients (17%) who got the Impella RP were alive within a month.
Between the lines: The FDA and Abiomed both said patients in the post-approval study were a lot sicker than people who were in the original studies.
The big picture: "We don't have great randomized trials ... for many of the devices like Impella. As a result, we are left to a data-free zone," Yeh said.
Flashback: The International Consortium of Investigative Journalists published a series that explained why devices have a lower bar for clinical safety and effectiveness than drugs.
The Trump administration is approving Medicaid work requirements but isn't requiring states to assess the impacts of those policies on their programs, the Los Angeles Times' Noam Levey reports. That appears to violate Obama-era rules that govern the program.
The big picture: Of the 17 states that have sought federal permission to add work requirements to their Medicaid programs, 9 have not included estimates of how many people would lose their coverage as a result.
Quick take: This could complicate the Trump administration's job as it defends work requirements in court, where it has to show that the new restrictions are consistent with Medicaid's goals as a health care program.
The number of underinsured Americans — meaning, people whose out-of-pocket costs eat up a significant percentage of their income — is steadily climbing, according to a new survey by the Commonwealth Fund.
Why it matters: A person is considered underinsured if their out-of-pocket spending exceeds 5-10% of their income, or if their deductible is more than 5% of their income.
Go deeper: Workers' health care costs just keep rising
An increasing number of patients suffering from rosacea are self-medicating with a product that was designed for horses. And dermatologists want them to stop.
Correction: The top item misstated the number of adverse events associated with the Impella RP heart pump. There have been 21 adverse events, not 23, and that includes 3 deaths, not 5, according to a Device Events analysis. We regret the error.