//  9/13/18  //  Commentary

That’s the title of a new perspective piece from Rachel Sachs and me in the New England Journal of Medicine.

The Trump administration has refused to allow Massachusetts to experiment with a closed formulary, which would give the state some leverage in price negotiations over low-value drugs. But, as we explain, CMS has offered no written explanation whatsoever for its refusal.

From a legal perspective, that’s a problem. Administrative law requires agencies to provide reasons for their actions. Judges will usually defer to those reasons, but an unexplained action won’t stand up in court. If Massachusetts sues, the agency’s decision is at least as vulnerable as other actions that judges have recently invalidated, including CMS’s approval of Kentucky’s Medicaid work requirement. Indeed, CMS’s willingness to push the legal envelope on work requirements stands in stark contrast to its timidity when it comes to Massachusetts’ request to experiment with a closed formulary.

In subsequent statements to the press, HHS Secretary Alex Azar and CMS Administrator Seema Verma have suggested that granting the waiver would be illegal and would give states too much power in price negotiations.

These after-the-fact justifications track an argument that the pharmaceutical industry pressed in its campaign against the Massachusetts waiver. In its view, the establishment of a closed formulary would violate a “grand bargain” it struck with Congress as part of the 1990 legislation. The industry’s view of that bargain is that it agreed to sell drugs to Medicaid programs at a discount, and, in exchange, states would have to cover every FDA-approved drug.

Azar and Verma appear to believe that departing from the law’s purportedly neutral baseline would be unlawful, unfair, or both. But no part of the 1990 law limits CMS’s waiver authority over the portion of the Medicaid statute that governs prescription drugs. That’s an important omission. Congress knows how to restrict the scope of waivers when it wants to; indeed, it has done so in other parts of the Medicaid statute (for example, under the section covering cost-sharing requirements). For its part, CMS recently granted Oklahoma’s request to waive a different part of the same statutory provision that Massachusetts now seeks to waive, suggesting that the agency’s legal objections are a pretext.

What’s more, the grand bargain has already been violated—but not by Massachusetts. Since 1990, changes in pricing strategies, the proliferation of orphan drugs and complex biologics, and the decreasing rigor of the FDA approval process have placed an enormous strain on state Medicaid budgets. Massachusetts’ request reflects a thoughtful effort to restore the balance established by that bargain in light of an evolving pharmaceutical market. In rejecting the request, the Trump administration appears to have sided with the drug industry over the states.

You can read the whole thing here.

@nicholas_bagley


Versus Trump: Trump Loses On Family Planning, Wins In The Ninth, and More

5/16/19  //  Uncategorized

This week on Versus Trump, Jason and Easha go through a few updates to cases involving Title X, which provides money for family planning; the Administration's policy to have many asylum applicants removed to Mexico; and the controversial border wall. Trump lost one, won one—for now, and hasn't yet gotten a decision in the third. Listen now!

Jason Harrow

Equal Citizens

Easha Anand

San Francisco

Versus Trump: Trump Versus Trump's Banks

5/9/19  //  Uncategorized

This week on Versus Trump, Jason, Charlie, and Easha discuss a new lawsuit by the President seeking to prevent two banks from responding to Congressional subpoenas that seek information about the his business dealings. Listen now!

Charlie Gerstein

Civil Rights Corps

Jason Harrow

Equal Citizens

Easha Anand

San Francisco

Versus Trump: 2-For-39

5/2/19  //  Commentary

This week on Versus Trump, Jason discusses some fascinating research about how the Trump Administration has fared in the courts with Bethany Davis Noll, the Litigation Director at the Institute for Policy Integrity. They discuss challenges to Trump's regulatory agenda, why the Administration is losing at a historic rate, what is slipping through the cracks, and what come next. Listen now!

Jason Harrow

Equal Citizens