Lawmakers Dictate to Doctors: New Legislative Approaches to Opioids

Amidst all the talk of 7-day initial opioid script limits in New York, Massachusetts, and New Hampshire (with New Jersey, Connecticut and others likely not far behind), we appear to have missed a piece of legislation that, in my view, represents the single most stringent legal construct for opioid prescribing in the country.   Before we get to Maine's new law, a quick aside on the new approach sweeping the northeastern US: These new limits are extremely helpful, but not the panacea some are making them out to be.  A 7-day limit for new scripts (in most states, for acute pain only) will absolutely help limit black market diversion and over-utilization generally... but we'll also see more office visits (on day 8!) and not enough progress on long term chronic pain cases.  A necessary step, no doubt, but insufficient to address the entirety of the problem.  

Back to Maine: Guess what they did back in April that no one noticed?  They put a statutory cap on morphine equivalent dosage per day.  The state legislature passed it, the governor signed it, it goes into effect on January 1, 2017... and not a lot of people are talking about it.

The cap is 100 mg MED per day.  Specifically, a licensed practitioner in Maine "may not prescribe... to a patient any combination of opioid medication in an aggregate amount in excess of 100 morphine milligram equivalents of opioid medication per day."  But what if a patient is already on more than 100 mg MED per day?  Doctors cannot prescribe to such individuals opioid pain medication in excess of 300 mg MED per day between January 1, 2017 and July 1, 2017.  But starting July 1, 2017, even those individuals need to be weaned down to at or below 100 mg MED per day.

Enforcement mechanisms?  They thought of that, too.  "An individual who violates this section commits a civil violation for which a fine of $250 per violation, not to exceed $5,000 per calendar year, may be adjudged. The Department of Health and Human Services is responsible for the enforcement of this section."    

The bill also includes several other requirements including mandatory PDMP checks, mandatory electronic prescribing, and mandatory education for prescribers (3 hours of CE) to be renewed every 2 years.  There are exceptions, of course, but the exceptions are logical and do not undermine the intent and broad application of the bill (active treatment for cancer, hospice care, inpatient settings, etc. are all exempt - as they well should be).

What does all of this mean?

Some will see this as a huge step forward in fighting the most significant public health crisis of a generation.  Some will see this as a vast government overreach into the practice of medicine.

It's both, really,  And it's what we get when the clinical community fails to educate and police itself. "Our remedies oft in ourselves do lie..."  And when they don't, we get new laws.  Look for this approach in a state legislature near you...

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

What Happens When Regulators Don't Trust Clinicians?

USA Today published an interesting point/counterpoint this week on the question of whether doctors should be forced to check a prescription drug monitoring database prior to writing a prescription for an opioid.  The advocates for such an approach (me included) argue that fundamental public health concerns trump the arguments against mandatory checks, primarily that this new step in the process of clinical delivery presents privacy and convenience hurdles.

But if one examines the true concerns of clinicians that have pushed back against mandatory PDMP checks, one would find a deeper, more meaningful, more consequential issue: when it comes to prescription drug misuse and abuse, government regulators are exhibiting ever higher levels of distrust of the medical community.   

Perhaps nowhere else has this been laid more plain than in Massachusetts.  Governor Charlie Baker, a former physician group and health plan CEO, has proposed an aggressive set of measures to stem the opioid epidemic in his state.  I'm not using the term "aggressive" lightly here...

Among several other potentially controversial provisions, the proposed bill would limit new prescriptions for opioids to 72 hours (with very limited exceptions for emergency situations).  A patient in Massachusetts might go to the doctor, complain of low back pain, and receive a script for pain management.  But the max a doctor would be able to write is a 3-day script.  After that, the patient would need to come back to the doctor for an additional script if the continuation of the medication is deemed necessary.

As expected, the reaction of Massachusetts doctors appears to range from supportive to skeptical to deeply concerned.

I haven't decided whether or not this is a good idea.  I'll be researching the approach and discussing it with others for a while before I come to any conclusions.

What strikes me is that regulatory bodies ranging from state work comp agencies (think "closed formularies") to state legislators (think "mandatory PDMP checks") to state governors (think "Charlie Baker's plan") are essentially saying: Enough of this.  It's gone on too long and too many people are dying.  The clinical community has had their chance.  It's time for us to step in and shut this down.

Will there be unintended consequences?  Yes.  Will it result in the mitigation of prescription drug misuse and abuse for which we all hope?  TBD.

Might the clinical community awake and recognize the necessity for them to self-correct this problem to avoid further unwelcome intrusion into clinical practice from the regulatory community?

I hope so.

Michael
On Twitter @PRIUM1

A Lesson in Chronic Pain Management from Friedrich Nietzche

"He who has a why to live for can bear with almost any how."  

I bet you've never seen a Friedrich Nietzsche quote in a work comp blog post before.  I came across this in a book recently, but I've also seen it plastered on social media and an occasional wall poster. Leaving aside for a moment the fact that the quote is almost always taken out of context (Nietzsche wasn't exactly the most uplifting philosopher of the 19th century), the quote still offers insight into the most difficult and frustrating dynamic of chronic pain management: 

The psycho-social disposition of the injured worker.  

How can we ask injured workers to take fewer pain meds... how we can ask them to engage in non-pharmacological therapies... how we can ask them to go through the weaning process... how can we ask them to contemplate a life that might not be totally pain free... if they lack the why.  If they don't have a job they're excited to get back to... if they don't have a supportive family or social environment... if they haven't worked through the devastating and often latent effects of childhood trauma... if they haven't dealt with co-morbid conditions like depression and obesity... then how can we ask them to change?   

No structure can be rebuilt on a faulty foundation.  And the life of a chronic pain patient cannot be rebuilt without addressing the underlying cause of the chronicity.

So what do we do?  Massachusetts has outlined a pretty compelling approach to addiction prevention and treatment in that state.  The Governor's Opioid Working Group has put together a comprehensive document built around 12 core principles (the detail behind each is contained in the document):

1. Create new pathways to treatment
2. Increase access to medication-assisted treatment
3. Utilize data to identify hot spots and deploy appropriate resources
4. Acknowledge addiction as a chronic medical condition
5. Reduce the stigma of substance use disorders
6. Support substance use prevention education in schools
7. Require all practitioners to receive training about addiction and safe prescribing practices (see my post from Monday on this topic)
8. Improve the prescription monitoring program
9. Require manufacturers and pharmacies to dispose of unused prescription medication
10. Acknowledge that punishment is not the appropriate response to a substance use disorder
11. Increase distribution of naloxone to prevent overdose deaths
12. Eliminate insurance barriers to treatment     

Are you thinking "this is intended for a group health / medicaid audience in the state of MA"?  Think again.  Most, if not all, of these principles should apply to us in workers' compensation.  If we don't get serious about treating the whole individual, we'll have little hope of making progress in the fight against prescription drug misuse and abuse. 

Michael 

On Twitter @PRIUM1