The Mistakes That States Make

As 2017 gets rolling, state legislatures are convening all over the country.  Several of them are about to make mistakes in the area of medication management in workers' compensation.  

My colleague, Mark Pew, and I have written and spoken extensively on the topic of drug formularies. And we're currently working, formally and informally, with regulators and other stakeholders in jurisdictions across the country on approaches that make sense for employers, doctors, pharmacists, and, most importantly, injured workers.  While there's not a lot to be gained for any of us in calling out individual states, there's a great deal at stake for all of us in the successes and failures of drug formulary implementations.  A failure (perceived or real) in one jurisdiction can lead another jurisdiction to delay its own attempt at a formulary - or to scrap it altogether.

So how can we tell if a law or rule set is headed in the right direction?  Or, alternatively, if a state's efforts are more likely to lead to sub-optimal results?  Here's a quick litmus test that you can apply to make your own determination:

1) Will the formulary rely on independent, 3rd party medical treatment guidelines?  
There's a great deal of industry discussion surrounding this topic, mostly focused on the definition of 'evidence-based medicine.'  While that conversation is interesting, it's not the critical factor in overall formulary success.  The crucial questions are two-fold: First, will there be room for political influence in the formation of the guidelines? Second, will the guidelines be updated with sufficient frequency?  

2) Does the formulary process build off of existing dispute resolution processes?
States that have successfully implemented drug formularies thus far have done so by relying on existing rules regarding resolution of medical treatment disputes.  States that try to simultaneously create a formulary and new dispute resolution processes to support it are, in reality, trying to do two things at once.  Not impossible, but certainly creates execution risk. 

3) Does the formulary allow for a remediation period for legacy claims?
On the one hand, a single effective date creates chaos as employers and physicians try to figure out how to address legacy claims, which tend to be more complicated. On the other hand, only applying new rules to new injuries creates two standards of care within a workers’ compensation system, where an injured worker’s treatment plan is driven entirely by the date on which they were injured (which makes no clinical sense). I look for regulatory language that takes a balanced approach – an initial implementation date for new injuries, followed by a remediation period for legacy claims, followed by a fully effective date for new rules and all claims. 

4) Is the formulary process scalable?  
I always look to see if the dispute resolution process can stand up to a significant volume of cases. While the goal of any formulary adoption should be to streamline access to medically necessary medications for injured workers, states should take a 'hope for the best, plan for the worst' approach.  Dispute resolution processes that rely on one individual or one office for ultimate resolution may lead to bottlenecks and, in a worst case scenario, undue influence.  I always ask myself - what will this look like if there are more disputes than the state expects?  

One bad apple can spoil the bunch.  Let's get this right.

Michael
On Twitter @PRIUM1  

States Take On Painkillers

Despite efforts at the federal level (CDC guidelines - such as they are, the Obama administration committing $1 billion to fight drug abuse, etc.), the real public policy movement on prescription drug and heroin abuse is happening at the state level.  And it's happening fast.

This morning, Massachusetts Governor Charlie Baker signed into law new restrictions on opioid prescriptions in his state.  Perhaps most notably, new opioid prescriptions are not to exceed a 7 day supply.  This is groundbreaking legislation and could lead to similar bills throughout the country. Yes, there are carve outs for cancer patients and chronic pain patients, but these are reasonable caveats necessary to maintain access to care.  Whether or not opioids are medically necessary for most chronic pain patients (they're not) is a separate discussion.  This law will help prevent dependence and addiction in new patients.  We still have a lot of work to do with the existing chronic pain population.  One more tidbit - there's no exception for work comp.  I've scoured the 42 pages of the bill and injured workers will be subject to the same protocol as everyone else.  

From today's New York Times, a recap of state-level efforts to curb painkiller and heroin abuse (highlighting the above mentioned efforts in Massachusetts).  Did you know that there are 375 proposals moving through state legislatures nationwide regarding prescription painkillers, pain clinics, and other aspects of treatment?  That's a dizzying pace of regulation.  The fault, our governors have decided, will not fall to the underlings of the federal bureaucracy - they're going to do something about this.  Now.  Governor Pete Shumlin of Vermont, who devoted the entirety of his 2014 State of the State speech to this topic, summed it up best: "The states are going to lead on this because Big Pharma has too much power."  I'd add that state medical associations have a lot of power, too, but they've come to the table across the country.  In Massachusetts, the president of the state's medical society put in plainly: "Usually we are opposed to carving anything in stone that has to do with medical practice.  But we are willing to go forward with this limitation [the 7 day supply restriction] because we recognize this is a unique public health crisis."  

The Times also has a piece today covering direct-to-consumer (DTC) advertising for pharmaceutical products, a practice that the American Medical Association has advocated be banned.  The research suggests that there may be benefits to DTC advertising.  Yes, utilization of advertised drugs goes up.  But so does utilization of competitive drugs in the same class. The article seems to think this is good news - conditions historically stigmatized (like depression) are being treated more frequently because DTC advertising is prompting doctor-patient conversations that might not have taken place otherwise.  I acknowledge this is a good thing, but can we not come up with a better way to remove stigma and treat mental health conditions than spending hundreds of millions of dollars on TV ads?  Finally, there appears to be an uptick in patient medication compliance as a result of DTC advertising (you see the ad, you're reminded to take the pill that's already been prescribed to you).  That's great, but again... can we not come up with better approaches to patient medication compliance?  I still think the risks and costs of DTC advertising outweigh the benefits.

Lots going on.  I sense progress.

Michael
On Twitter @PRIUM1

Formularies to the Right of Them, Formularies to the Left of Them

Formularies in front of them

Volleyed and thundered.

Everyone wants a formulary these days.  Louisiana, Nebraska, North Carolina, and South Carolina are the latest to make at least public mention of exploring a drug formulary for their respective states' workers' compensation systems.  They join California, Montana, Maine, Tennessee, and Arkansas, all of which are also thinking about formularies.  And this movement, of course, builds on varying degrees of success observed in those states that already have formularies: Texas, Washington, Oklahoma, and Ohio. 

Tennyson's Charge of the Light Brigade, to which I allude above, is a celebration of a very brave group of six hundred cavalry soldiers who fought in the Crimean War in the mid-19th century.  The British soldiers depicted in the poem didn't quite realize what they were getting themselves into. Neither do some state regulators who are contemplating formulary implementation.   

Formularies are an absolutely essential tool to mitigate prescription drug misuse and abuse within any workers' compensation system.  But they're not easy to implement and some of the states contemplating it have not done the work necessary to implement such a measure.  As I've stated time and time again, both here on this blog and in presentations and panels around the country, Texas passed HB 7 in 2005 - and finally got a formulary implemented in 2011 (and didn't get it fully implemented until 2013).  What took so long?  The hard work of creating, implementing, adopting and communicating critical prerequisites like pre-authorization processes, dispute resolution processes, medical treatment guidelines, and stakeholder acceptance. 

I recall presenting on the topic of formularies at the South Carolina Work Comp Education Conference back in February of 2013.  I talked about the concept generally and shared some of the early data coming out of Texas.  My enthusiasm for formularies must have been obvious... because the backlash was swift.  Several doctors in the room vowed they would cease taking work comp patients if such an approach was ever attempted in South Carolina.  Several adjusters commented that it sounded great, but they couldn't imagine how it would work in their state.  Defense attorneys told me they thought it was great... in theory.  And the applicant attorneys just chuckled.  

The desire to exercise better control of prescription drugs in work comp doesn't start with a formulary.  A formulary is the fruition of appropriate regulatory groundwork.  

My fear is that one or two bad formulary implementations at the state level will set the national movement toward formularies back several years.  We can't afford any setbacks in the fight against prescription drug misuse and abuse.  Better to do it right than to rush into something that a state lacks the infrastructure and experience to accomplish.  

One step at a time. 

Michael 

On Twitter @PRIUM1