On Wednesday, December 23, 2020, a Maryland Federal District Court Judge issued a TRO blocking the Trump administration’s attempt to institute, pursuant to an administrative rule, a Most Favored Nations approach for dozens of drugs under the Medicare Program.
The challenge made to the administrative rule was that it was issued under the “emergency” provisions of the Administrative Procedure Act. The Plaintiffs argued that the Federal government did not present adequate justification for the use of that provision for the adoption of an administrative rule, rather than use the normal avenue requiring public comment prior to the adoption of the rule.
It is highly unlikely that this issue will be resolved during the remaining couple of weeks of the Trump administration. Therefore, it will be up to the Biden administration as to whether or not they want to (i) continue the litigation to justify the rule, (ii) take the approach of readopting the rule pursuant to the provision for public review and comment prior to the adoption of the rule, or (iii) abandon the entire Most Favored Nations approach to pricing of pharmaceuticals in the United States altogether. What is clear, is that the rule will not be implemented during the remaining couple of weeks of the Trump administration.
As can be seen by our prior blogs we have been an advocate for the “Most Favored Nations” approach for a number of years.