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

The Bio-psycho-social Model: Challenges in Application

Hardly a day, a conference, a meeting, or a case goes by without a serious discussion about the need for a 'biopsychosocial' approach to injury resolution.  In fact, I've recently heard griping in some circles that the discussion has run its course.  "We get it... can we talk about something else now?"

Sigh.  We don't get it.  And we still have a lot of work to do.  I offer the following observation as proof of such...

A study hit my desk this past week from the Journal of Occupational and Evironmental Medicine and I'd like to ask for your forbearance as I share the abstract:

"The cost and prevalence of chronic work-related musculoskeletal pain disability in industrialized countries are extremely high.  Although unrecognized psychiatric disorders have been found to interfere with the successful rehabilitation of these disability patients, few data are currently available regarding the psychiatric characteristics of patients claiming work-related injuries that result in chronic disability.  To investigate this issue, a consecutive group of patients with work-related chronic musculoskeletal pain disability (n = 1595), who started a prescribed course of tertiary rehabilitation, were evaluated.  Psychiatric disorders were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders.  Results revealed that overall prevalences of psychiatric disorders were significantly elevated in these patients compared with base rates in the general population.  A majority (64%) of patients were diagnosed with at least one current disorder, compared with only 15% of the general population. However, prevalences of psychiatric disorders were elevated in patients only after the work-related disability.  Such findings suggest that clinicians treating these patients must be aware of the high prevalence of psychiatric disorders and be prepared to use mental health professionals to assist in identifying and stabilizing these patients.  Failure to follow a biopsychosocial approach to treatment will likely contribute to prolonged pain disability in a substantial number of patients."  

Great study, right?  Isn't that the right message?  And we couldn't ask for a more specific sample set: Work related!  Musculoskeletal pain!  Disability!

Here's the kicker: this study was published in 2002 (J Occup Environ Med, 2002; 44:459-468).

I thought that had to be a typo.  It's not.  Sadly, even in these modern times in which information flows freely and ubiquitously, contemporary healthcare and insurance models still take close to two decades to translate research into clinical practice.  Some see this phenomenon as madness without method.  My own view is that the disconnect is driven not by laziness, lack of awareness, or lack of desire to apply new clinical knowledge.  Rather, the time lag between the establishment of evidence and its clinical application is created by the very hard work of leaping from intellectual recognition to actual clinician behavior change.  We sometimes fall victim to the assumption that chronic pain patients are the only constituency in need of behavior modification.  In fact, all stakeholders must adapt to evolving notions of clinical best practices; adjusters, nurses, claims leadership, doctors, attorneys, service providers, therapists, pharmacists, injured workers, actuaries, underwriters, brokers... all must adapt to both the clinical and economic realities of (what should be contemporary) chronic pain management.

I hear near unanimous intellectual recognition of the need to apply a biopsychosocial model to chronic pain care.  We must now do the hard work of applying this new knowledge.  For knowledge itself is insufficient to solve the problem.  One can know something to be factually true and yet fail to apply that knowledge.  Ever know it's raining... and still forget your umbrella?  Knowledge, when applied, is wisdom.  

And we have work to do.

Michael
On Twitter @PRIUM1

A Tax on Opioids: Who Pays? And Why?

A new bill was introduced last week by US Senator Joe Manchin (D-WV).  The bill calls for a tax on opioids to the tune of 1 cent per milligram.  This tax will fall primarily to the payor community.

Manchin compares this newly proposed tax to current taxes on alcohol and cigarettes.  This analogy is a poor one: the alcohol and cigarette taxes are born by consumers with the express consequence of changing use patterns.  In the case of the opioid tax (as with most economic propositions in a 3rd party payor system), the tax will likely be paid by an entity (the insurer) that is not a party to the originating transaction (the doctor writing a prescription for the patient).  It is therefore doubtful that the proposed tax will have any material impact on utilization.

There are two notable exceptions to this line of logic.  First, cash-based transactions whereby patients pay for the entirety of the opioid prescription will now be more expensive.  At 1 cent per milligram, a standard prescription for Oxycontin 40 mg q12h would lead to a monthly tax of approximately $25. That might not seem like much, but for the patient paying cash, that adds up quickly.  The second possible exception may occur if certain insurers choose to structure plans such that this tax is passed along to the patient in the form of co-pays, deductibles, co-insurance, etc.  This will surely be the case in many health plans and may cause at least certain patients to seek alternative, non-opioid medications from their doctors.

Neither of these potential exceptions will be available to workers' compensation payers.  For work comp payers, the entirety of the tax will be paid by the insurer and neither the doctor nor the patient will have any financial incentive to do anything differently as a result.  A tax, if you will, on all your houses.  

The other interesting consequence of the proposed tax is that it treats a milligram of a brand name drug and a milligram of a generic drug as equivalent for tax purposes despite the fact that the underlying cost of the generic is significantly less than the brand.  This proposed tax will be yet another factor pushing the cost of generics up for payers, a trend that we've already seen unfold over the last 24 months.

If the proposed tax passes, it's expected to raise somewhere in the neighborhood of $1.5 to $2.0 billion.  These dollars will be used to fund outpatient and residential addiction recovery programs, an increase in the number of doctors certified to provide medication-assisted treatment, and other services to support addiction recovery (like housing and employment assistance for those in recovery).

Candidly, lack of access to these programs today is a major barrier to injured worker recovery. If the bill passes, workers compensation payers will bear the brunt of this new tax burden. Perhaps rather than fighting against the tax, we should collectively lobby to ensure that injured workers can easily access any and all of the new programs/centers/providers funded by the new tax?  

Just a thought...

Michael
On Twitter @PRIUM1