Professor of Law, Washington University in St. Louis. Researching and writing about innovation policy, mostly in health law, FDA law, and patent law.
Oct 25, 2022 • 4 tweets • 2 min read
See thread (with links). The conservative plaintiffs are asking Judge O'Connor to take from ~150 million Americans their existing ACA benefits to no-cost preventive services: cancer screenings (colon, lung, breast, cervical, etc), prenatal screenings, and much more. (1/4)
The plaintiffs explicitly note that this was the state of affairs pre-ACA - that patients could be charged for these key preventive services. This was in fact the point of this provision of the law, to increase access to/ensure that patients could afford these services. (2/4)
Mar 31, 2022 • 7 tweets • 3 min read
Of all the arguments against an insulin out-of-pocket spending cap, this is the most incoherent. These bills would result in more (not less) money for industry, and thus presumably more (or at least not less) research. Short thread. (1/7)
First, let's be clear about what this bill does: it caps patients' out-of-pocket costs. It does not limit what drug cos can charge for insulin. So, though it may save $ for individual patients, it actually costs the system as a whole more money.
There's a lot to talk about in Biogen's comments on Medicare's draft NCD, especially their potential threat to sue, but I want to briefly talk about one of the issues raised: whether Aduhelm is "safe and effective," under FDA standards. (1/5)
Biogen argues that CMS must defer to FDA on whether a drug is "safe and effective," and that CMS cannot "second-guess" FDA on this. One (of many) problems with this is that FDA did not clearly determine Aduhelm to be "safe and effective" - though Biogen suggests they did. (2/5)
Nov 13, 2021 • 6 tweets • 3 min read
Thread unpacking part of today’s announcement from CMS about Part B premiums – and why seniors' premiums are going up because of high drug prices. cms.gov/newsroom/press… (1/6)
In June, the FDA’s approval of Biogen’s Aduhelm was controversial not only because of the lack of evidence the drug works, but also bc of its sky-high price tag. By one estimate, Medicare might spend as much on this single drug as it does on NASA. nytimes.com/2021/06/22/ups… (2/6)
Sep 13, 2020 • 7 tweets • 3 min read
The President has issued a new executive order (revoking the one issued in July) on the subject of international price benchmarking for prescription drugs in Medicare. A short thread on the implementation of this EO and executive action to watch for. 1/7 publicpool.kinja.com/subject-execut…
First, the order tells Secretary Azar to implement the existing ANPRM (from late 2018), which I summarized here, for drugs under Medicare Part B. The ANPRM had real practical challenges - it will be important to see how the next phase addresses them. healthaffairs.org/do/10.1377/hbl… 2/7
