October 02, 2019
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Situational awareness: President Trump plans to nominate Stephen Hahn, chief medical executive at MD Anderson Cancer Center, to lead the FDA, BioCentury reported last night.
Today's word count is 882 words, or 3 minutes.
1 big thing: A new electronic health records solution
Northwell Health, one of the biggest not-for-profit hospital systems in the country, is planning to develop its own system for electronic medical records. The ultimate goal is to sell the technology to other hospitals and clinics, Axios' Bob Herman writes.
Why it matters: Physicians, nurses and others generally dislike most of the existing electronic health record systems. But this is an unusually proactive effort from a hospital system to actually solve those problems.
- Clinicians often say the technology is clunky, involves too much typing and clicking, isn't user-friendly, and makes caring for patients more difficult.
- "Most of the [electronic health record companies], if not all of them ... haven't really addressed the dissatisfaction that physicians have," John Bosco, Northwell's chief information officer, told Axios.
What's next: Northwell will use an existing Allscripts product called Avenel, which uses artificial intelligence and Microsoft's cloud technology, as the chassis of its new system. Clinicians will then shape how the screens look, how voice assist will work and other details that encumber the current process.
- Northwell plans to roll out the electronic health record in its physician offices and outpatient settings in the next 12–18 months, and perhaps into its hospitals down the road, Bosco said.
- He did not disclose how much this would cost, but he said it will be "beyond the tens of millions."
- The bigger goal is to sell this system to other hospitals and doctors, and "our agreements with Allscripts envision that," Bosco said.
Yes, but: Many physicians have expressed skepticism about AI's potential to change electric health records. Hospital systems also have little to no experience as tech companies.
2. Gene therapies' accessibility problem
Gene therapies are physically out of reach for many patients, on top of their high prices, according to a new PwC Health Research Institute report.
Why it matters: This further exacerbates the rural-urban divide in access to care.
By the numbers: The report looks at 4 treatments approved in the U.S. In 13 states, none of the 4 treatments were available, as of July. And there are only 5 zip codes nationwide in which all 4 are available.
Between the lines: These treatments can be prohibitively expensive even for patients with access to them.
- The gene therapy Zolgensma is the most expensive drug in the world, with a list price of $2.1 million.
- There are also affordability questions surrounding CAR-T, as hospitals often aren't fully compensated for the cost of administering it.
What we're watching: There are 30 gene therapies in late-stage testing, per PwC, and the number of clinical trials has grown rapidly over the last decade.
Go deeper: The real drug pricing debate is upon us
3. J&J's opioids settlement
Johnson & Johnson said on Tuesday that it has reached a tentative $20.4 million settlement with 2 Ohio counties ahead of a massive opioid trial, my colleague Orion Rummler writes.
Details: Johnson & Johnson said it has agreed to pay the Ohio counties a combined $10 million, in addition to reimbursing the counties $5 million for legal and trial expenses and directing $5.4 million in charitable contributions to non-profits "in connection with opioid-related programs" in both counties.
What's next: If this settlement is finalized, there would be 6 defendants scheduled to stand trial in October for their alleged role in the opioid epidemic, per the Washington Post.
4. Obama officials vetoed FDA vaping flavors ban
The FDA during the Obama administration tried to ban flavored vaping products in order to protect kids, but White House officials blocked the plan following aggressive lobbying from the vaping industry, according to hundreds of documents obtained by the LA Times.
Why it matters: The evidence suggesting that flavors could have a significant impact on youth vaping was essentially covered up, Axios' Marisa Fernandez writes.
- Flavors enticing to teens — like cotton candy or bubble gum — would have been banned from stores. What ended up happening instead was that by 2018, 4.9 million teens had taken up vaping.
Details: 44 meetings between 100 tobacco and vape advocates and Obama officials occurred between October 2015 and February 2016.
- These lobbyists were interested in tossing out a draft of the tobacco rule that required the removal of any flavored e-cigarette fluid from the market within 90 days of when the rule took effect.
- The rule published in May 2016 without any mention of flavored products. Juul sales, which then included flavored vape pods, skyrocketed.
The Obama administration's explanation for pulling the requirement was that vape shops' predicted economic struggles would outweigh the potential health benefits of the ban, the officials told the Times.
The bottom line, per LA Times: Today's youth epidemic is "exactly the kind of crisis the Food and Drug Administration had warned of four years ago."
5. New congressional approach to surprise billing
The House Ways and Means Committee is considering banning surprise medical bills and forcing the administration to decide how providers get paid for out-of-network care, according to a letter sent by Chairman Richard Neal to Democratic members.
- In the letter, Neal said he's offered the approach — referred to as "negotiated rulemaking" — as a compromise to the panel's top Republican, Kevin Brady.
The big picture: Payment resolution has sparked an intense fighting among insurers, hospitals and doctors.
- Instead of landing on one method, the proposal would have administrative agencies convene a committee with stakeholders before creating a regulatory solution.
The bottom line: This approach would allow Congress to say it protected patients from surprise medical bills without having to side with one industry group over another.