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…
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.… 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…
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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