Thursday, January 21, 2021

Very Brief Blog: Nullifying Recent CMS Policies, Congressional Review Act

One of the questions in many minds is which recent Trump administration health policies might be rapidly reversed, frozen, or nullified by the Biden administration.

My understanding of the laws here isn't complete, but I think (A) the administration can hold up things not yet published in the Federal Register, while (B) Congress has authority under the Congressional Review Act to hold things up with a 60-day lookback window.   See an excellent article on the Congressional Review  Act by Beckmann et al. at Faegre Drinker here, and what looks like an open access article at Bloomberg Law here.

Update Feb 5:  The original blog didn't have a link to the KLAIN MEMORANDUM, January 20, which provides rules for withdrawing notices not yet published in Federal Register, rules for opening a new comment period (which might lead to withdrawal), etc.  In addition, no rules which were in progress before Jan 20 can be published in Fed Reg without review by a new appointee coming in after January 20.  HERE.  

  • For example, in December, the Trump administration  finalized a remarkable rule that exploited its authority to do demo programs (under the Innovation Center, CMMI, aka "Section 1115A") to drastically change Part B drug pricing.  It's usually abbreviated as the MFN, or Most Favored Nation, rule, and pegs US Part B drug prices to European ones.
    • That's already been stayed by the courts due to some process irregularities, and biopharma would surely like the Biden administration to trash it.  On the other hand, it's a "costly drug price lowering measure," which may slow down the decision-making process.   
    • (For nerds, there's a long backstory here).  
    • (See MEDPAC's comment here.)
    • (See an excellent white paper from McDermott, here.)

    • Just days ago, the Trump administration finalized a rule that regulates the way prior authorizations are done (requiring online portals, uniformity, time limits. 
      • It doesn't really regulate the content and frequency of prior authorization).  
      • Payers have complained the P.A. rule was slapdash and slapped together in days; delays and fixes could be coming.

    For the  device community, one of the most important rules was the MCIT - the Medicare Coverage of Innovative Technology, which was released just over a week ago, and hasn't been published in the Federal Register yet. This would guarantee 4 years of Medicare coverage for FDA-authorized "breakthrough devices."  My instinct was that the MCIT was  not high enough to be on the White House radar, but we should probably assume that no absolutely-sure bets are possible (there were a few anti-MCIT voices, here.)   It was fully and finally published in Fed Reg on Jan 14 under Trump (here). So it's not one of the rules in limbo that was released by DJT in typescript form but not published in Fed Reg by January 19.