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ML Strategies Health Care Preview – May 14, 2018
by: Health Law Practice, Eli Greenspan of Mintz  -  Health Care Viewpoints
Tuesday, May 15, 2018

With two weeks left in this work period, we are already seeing signals that the House E&C effort to pass an opioid package may spill into June. The House Ways & Means Committee is joining the conversation. On Friday, they released four packages which will contain language from as many as 21 pieces of legislation. While the Senate HELP Committee has legislation that it moved through Committee, the Finance Committee is still contemplating legislation. All of which is to say the June work period is a more likely target for floor action in both houses.

Once the House processes its opioid package, where will it go next? While it could move alone, Congress will also have to reauthorize the Pandemic and All Hazards Preparedness Act (PAHPA). Attaching opioid legislation to a ‘must-pass’ vehicle is always an approach. The strategic maneuvers necessary to get opioid legislation signed prior to the election remain unclear.

TRUMP & DRUG PRICING

The Administration put out its Drug Pricing Blueprint following the President’s speech on Friday. The proposals can be divided into two camps: those in Section IV that are more developed and closer to implementation and those in Section V that are intended to make more fundamental systemic change and are being released to stakeholders for comment.

Much of the immediate reaction to the speech and blueprint release was skepticism. It was noted widely that the blueprint did not suggest any specific imminent action. Further, the blueprint did not include a whiff of the more controversial proposals that the President has touted at times like government negotiation or reimportation.

So while the blueprint was met with initial skepticism, the reality is the Administration wouldn’t have written it down if they didn’t mean it.  Section V is a laundry list of ideas that could significantly change the nature of the market. Was FDA Commissioner Gottlieb talking about PBM rebates and antitrust for no reason or are they very serious about discussing it?

That’s the ultimate question. Does the Administration mean to actually explore the fullness of the report beyond ‘may’? Stakeholders should assume they do. If you don’t, you’ll be behind. And if the Administration doesn’t engage on the many proposals in the report, they should expect continued skepticism from stakeholders in the future.

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