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
Assuming HHS uses the normal rulemaking process, an NPRM could be released soon. That NPRM would involve months of public comment before being finalized. If HHS attempts to bypass the NPRM stage, though, it would add legal challenges for the rule. 3/7 statnews.com/2020/09/03/tru…
Second (and this is new) HHS is instructed to create a payment model for applying international reference pricing to Part D drugs as well. This would apply much more broadly than any policy change we've seen so far from the administration, and is an exciting new development. 4/7
However, since the admin has not yet released any Part D model publicly, they cannot simply proceed to the IFR stage. Even if the admin introduced an earlier-stage version of this model tomorrow, it would need to be reviewed by OMB and subject to public comment. 5/7
It would be very surprising if the admin tried to add the Part D reforms to the existing Part B model. The Part B international reference pricing model is embedded in a set of reforms to the Part B buy and bill system - and Part D works differently. 6/7
Finally, HHS is using the legal authority granted to the Centers for Medicare & Medicaid Innovation to create the Part B (& presumably Part D) demos. CMMI was created by the Affordable Care Act, which the administration is currently trying to invalidate in the Supreme Court. 7/7
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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)
The plaintiffs now ask for the "choice" to require patients to pay for these services out of pocket once again, later concluding that it is "likely" that at least some plans will choose this option. (3/4)
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)
"Safe and effective" is the standard for FDA's traditional approval pathway, and as CDER Director Cavazzoni stated last week, “we agreed with the advisory committee that the data did not support traditional approval.” (About the 3:32:00 mark.) (3/5) energycommerce.house.gov/committee-acti…
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)
At the time, experts (including @jcubanski and @tricia_neuman) immediately identified that Aduhelm’s approval would have significant cost implications for Medicare beneficiaries. kff.org/medicare/issue… (3/6)