Monday, September 14, 2015

The Rule of Law: Laws Require Rules

Remember these two from when you were a kid?

Watching the video brings back fond memories... and highlights some pretty significant gaps in the process, as well.  

So it looks like California is putting the concept of a drug formulary into law (thanks, in no small part, to PRIUM's own Mark Pew and host of others that stayed close to the process, educated the stakeholders, answered a multitude of questions, and made the case clear that formularies are in the best interest of injured worker safety).  Assembly Bill 1124 passed through the California state legislature late on Friday night and will likely be signed by the governor sometime in the next few weeks.

Then what?

Then the hard work starts.  Where the charming childhood educational video ends, the real work of governing and public policy begins.  Most (though admittedly not all) laws are conceptual in nature.  AB 1124 is a good example.  The law instructs "the Administrative Director of the Department of Workers' Compensation to create an evidence-based drug formulary, with the maximum transparency possible, for use in the workers' compensation system..."  There are some other instructions and caveats in the bill, but this sums it up.

Perhaps you're wondering about that phrase "with the maximum transparency possible."  That language is a reminder to the DWC that the real work of creating regulatory infrastructure around the drug formulary needs to be an open, transparent process so that stakeholders throughout the system not only understand what's going to happen, but also have an opportunity to influence the ultimate outcome.

Some key questions that the rule-making process needs to address:

  • What guidelines will we use?  In other words, what will be the "source" for determining inclusion / exclusion for specific drugs?
  • How will the formulary leverage (or not) the existing utilization review and dispute resolution processes in California?  
  • How will we deal with the concepts of dependence and addiction for long term, but medically inappropriate, opioid use?  
  • How will the formulary balance the concepts of "authorization" and "access"?
  • How will we measure the success or failure of the formulary?  
California needs a formulary.  The DWC now has a legislative mandate to create one.  Now we have to decide what it will look like and how it will work.  

On Twitter @PRIUM1 

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