Monday, July 27, 2015

Fear Not, Be Smart: How to Deal with Medical Marijuana

The headline from workcompcentral today is Comp Industry Urged to Prepare for Medical Marijuana.  As usual, it's a solid and informative article from a great source (and I'm not just saying that because PRIUM's own Mark Pew is quoted throughout).  Nonetheless, I'm always concerned when I hear talk of medical marijuana that takes on a foreboding and troubling tone.  I'm sure Sedgwick's Mr. Canavan meant no harm.  And I have to admit that I wasn't present.  But comments like, "You can blame New Mexico the next time you pay for medical marijuana" strike me as fodder for filling hotel ballrooms at conferences and not reflective of the actual medical and legal realities with which we're dealing.

Back in April, I wrote the following:

"Did you know that of the 24 states with medical marijuana laws, most have either explicit or implicit provisions allowing for commercial payers to avoid reimbursement for medical marijuana?

Did you know that most of these states have a list of allowable conditions that provide a second layer of potential protection for commercial payers? 

Did you know that most of these states have medical treatment guidelines that address the use of medical marijuana?

Did you know that the New Mexico cases that have most of our industry concerned about this issue exhibit systemic failure on the part of the payers in those cases to take advantage of these various provisions and protections?" 


So let's all take a deep, cleansing breath.  If we're smart about this - if states are thinking about evidence based guidelines and payer carve outs, if payers are thinking about UR and peer review, if doctors are thinking about what's best for patients - we can keep medical marijuana in the box in which it belongs.  Mark Pew is right that the legalization of medical marijuana is inevitable and the advent of recreational marijuana is upon us.  But the risk management issue should be in the areas of drug-free work place issues and on-the-job safety.  

When it comes to injured worker treatment, we're not suggesting that medical marijuana is a non-event that deserves no attention.  We're suggesting that smart payers with smart medical management strategies need not fear being overwhelmed with medical marijuana spend.  

Michael 
On Twitter @PRIUM1

Tuesday, July 14, 2015

Unpacking the California Closed Formulary

With ever greater frequency, I'm encountering questions regarding California's legislative attempt to create a closed formulary.  "What do you think?" is the intentionally loaded question.  This is one of those interrogatives that requires unpacking, like a suitcase that's been the companion of a traveler on a long road trip.  There are a lot of layers, some messier and more complicated than others.  Courage is required to unload the suitcase and it'll take a while to sort through all the laundry.  And yes... the "baggage" metaphor is intentional.  So much baggage.  

Should California adopt a closed formulary?
Of course they should.  All state workers' compensation systems should.  A well designed formulary, properly implemented, is the best and fastest way to disseminate clinical best practices and contemporary medical evidence throughout the provider community (a community that is, I might add - through no fault of their own - perennially behind the curve on the latest science regarding appropriate, safe, and efficacious use of medications).  Doctors and patients clearly benefit from the "guide rails" of a formulary.   

What will the California closed formulary look like?  How will it work?
I have no idea.  No one does.  And should you encounter someone that claims to know, tread carefully and remain skeptical.  The sausage-making process is in full swing in Sacramento and everyone wants a seat at the table.  What's clear at this point is that the usual suspects have taken their predictable positions (Chamber of Commerce likes it, applicant attorneys don't, etc.)  Also clear is that each amendment added to the current bill creates significant swings in support.  At this point, it's hard to even ascertain the score, much less who has the momentum.  

If (emphasis on that word "if) this happens, when will it go into effect?
Likely not until mid-year 2017 at the earliest.  Keep in mind that the Texas closed formulary was phased in starting in September of 2011 and applied to legacy claims in September of 2013... after the legislative mandate for the formulary was signed into law via HB 7 in 2005.  These things take time.  
What will this mean to you?
Well, CWCI says it could mean injured workers are treated more appropriately... to the tune of $120 million - $420 million in annual savings.  That's a lot of prescriptions never dispensed... a lot of drugs never taken... a lot of addiction never rearing its ugly head... a lot of injured workers saved from greater pain and suffering brought on by inappropriate treatment.

What are the chances?
Perhaps the most complicated question of all... because it's really two different questions.  What are the chances of something passing... something the state calls a "formulary"?  Pretty good, I think. What are the chances the resulting regulatory approach really creates a safer medical treatment environment for injured workers that subsequently saves payers millions of dollars?  It's possible... but not probable.  Like any major legislative/regulatory change, this will be flawed.  Let's hope it's not so flawed that it's not worth doing.  

Michael
Follow us on Twitter @PRIUM1  

Tuesday, July 7, 2015

1 in 4 Opioid Scripts Ends Up "Long Term"

The Mayo Clinic wanted to assess the risk factors associated with opioid use.  They started by asking, "How many opioid prescriptions end up leading to long term use?"

Turns out, 1 in 4.  

Specifically, the researchers found that 21% of first-time prescriptions led to use for 3-4 months and 6% of first-time scripts led to use longer than 4 months.

Those time intervals are silly, aren't they?  From our perspective in work comp, we're seeing material numbers of injured workers progress (or, perhaps, regress) to 3-4 years of opioid use after the first script.  Personally, I'd like to see a study that tests use patterns over much longer duration intervals.  I also suspect that the work comp population exhibits a higher "long term use conversion rate" than a randomly selected patient population.  System design tends to reward certain stakeholders for disability duration.

The research is also intriguing because it examined the specific risk factors that lead to long term use. Nicotine use and prior substance abuse issues were the top risk factors.  While this isn't necessarily surprising, we see scant evidence that these risk factors are being taken into account at the time of the first opioid script.  The best predictive models in our industry are certainly telling us that these patients are at higher risk, but if the prescribing doctors aren't taking this information seriously and using it to inform an alternative, non-opioid treatment plan... what's the use?

Faster, more focused interventions with prescribers will be key to preventing long term opioid use.

Michael
On Twitter @PRIUM1

Thursday, June 25, 2015

What Primary Care Docs Don't Know Can Hurt You

Caleb Alexander is an associate professor at Johns Hopkins Bloomberg School of Public Health and the co-director of school's Center for Drug Safety and Effectiveness.  He and some of his colleagues decided to ask 1,000 primary care physicians about their beliefs and attitudes about opioids.  The results are both unsurprising and unsettling:

First, the good news:

  • More than half of doctors recognize prescription drug abuse as a "big problem" in their community; 
  • 90% strongly supported requiring patients to get opioids from a single doctor and single pharmacy; 
  • Two-thirds supported the concept of physician-patient "pain contracts"; 
  • More than half supported the use of urine drug monitoring for chronic opioid patients.  

However, the survey also uncovered significant gaps in knowledge among primary care docs:
  • About one-third said they thought most prescription drug abuse occurs by means other than swallowing the pills.  (In fact, crushing/snorting/injecting/etc. happens with far less frequency than simple ingestion.  Multiple studies suggest ingestion accounts for anywhere from 64% to 97% of prescription drug abuse.) 
  • Almost 50% believe that abuse-deterrent pills are less addictive than the standard formulation. (In fact, there's absolutely no difference.)  
This last data point is scary.  To me, it shows the success that pharmaceutical companies are having in creating a "halo" of safety around new abuse-deterrent formulations.  There is no "halo" and there's still a great deal of harm that can occur with the use of these medications.  

The primary issue isn't the kind of abuse against which abuse-deterrent formulations can protect patients.  The primary issue is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins.  
Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue. 

Michael 
On Twitter @PRIUM1



Tuesday, June 23, 2015

Will Robots Change Work Comp?

My answer: I don't know.  Yet.  But I'm going to be reading the latest issue of Foreign Affairs to inform my view.  The issue is titled Hi, Robot - Work and Life in the Age of Automation.  Still not convinced you should run to your local book store and pick up a copy?  Here's the table of contents:

The Robots are Coming
How Technological Breakthroughs Will Transform Everyday Life
by Daniela Rus (Professor of Electrical Engineering and Computer Science and Director of the Computer Science and Artificial Intelligence Lab at MIT)

Will Humans Go the Way of the Horses?
Labor in the Second Machine Age
by Erik Brynjolfsson (Professor of Management Science at MIT's Sloan School of Business) and Andrew McAfee (Principal Research Scientist at MIT's Sloan School of Business)

Same as It Ever Was
Why the Techno-optimists Are Wrong
by Martin Wolf (former World Bank economist and chief economics commentator for the Financial Times)

The Coming Robot Dystopia
All Too Inhuman
by Illah Reza Nourbaksh (Professor of Robotics at the Robotics Institute of Carnegie Mellon University)  

The Next Safety Net
Social Policy for a Digital Age
by Nicolas Colin (former senior civil servant in the French ministry for the Economy and Finance) and Bruno Palier (CNRS Research Director at the Center for European Studies)

I've not read all of the articles yet - the issue just arrived in my mailbox yesterday.  But these authors aren't light weights and Foreign Affairs isn't a trade rag.  These are serious insights from brilliant people provided in a well-respected setting.  We should be paying attention.   

And to give credit where credit is due, Jeff White of Accident Fund has been pushing all of us to think about these issues for a while now.  How will the nature of work change over the next 10 or 20 years?  How will the labor environment evolve?  Will technological advancement lead to significant unemployment?  What should we do now to prepare for the future of work?  

We need to be thinking about these questions and gathering insights from smart people both inside and outside of workers' compensation in order to properly prepare for what could be fundamental changes in the nature of work.  

Happy reading.

Michael
On Twitter @PRIUM1




Monday, June 22, 2015

A Consequence of a Compensable Injury

"Here, given the documented downturn in the decedent's mood and concerns her family had that
she might do herself harm, along with the autopsy report's conclusion that the manner of death
was suicide, the WCLJ had ample facts in the record to infer that the decedent's suicide was a
consequence of her compensable injury and consequential mental health condition.  Therefore, upon review of the record and based upon a preponderance of the evidence, the Board  Panel finds that the decedent's suicide was a consequence of her compensable injuries including  her established consequential depression."

Get used to language like this.  While we've made strides in workers' compensation with respect to opioids (see Peter Rousmaniere's special report out today), we still have a long way to go, particularly with so-called "legacy claims."  The decision quoted above comes from the New York State Workers' Compensation Board and covers the very sad story of woman injured in 1999 and the long, slow decline she experienced, resulting in her eventual suicide by oxycodone and diazepam.

You're going to be reading a lot more court decisions like this in the months and years to come.  The opioid prescription bonanza of the last 10 years is going to create a wave of cases like this over the next 10 years.  We're far more effective today than we've ever been in controlling early opioid use (though even in this category, we have a lot of work to do).  The challenge is going to be the claims that arose before we knew how severe this problem would turn out to be.

One of the many insights in Peter's report that struck me was the relative danger faced by injured workers in chronic pain.  He points out that the riskiest jobs in America (like logging, for instance) typically lead to about 1 death per 1,000 workers per year.  But injured workers on medium-to-high dose opioids for a year experience about 1.75 deaths per 1,000 patients per year.  

That's crazy.

Follow the link above, read Peter's report.  This should be required reading for everyone in work comp.

Michael
On Twitter @PRIUM1

Wednesday, June 17, 2015

The Pen, the Price, the Panacea?

The Washington Post attempted to capture America's drug overdose epidemic in four charts/maps. I'm not sure they pulled it off, but I certainly appreciate the attempt to highlight the issue in a way people can easily understand it.

Of the four charts/maps, the last one highlights an issue about which all of us in work comp need to be aware.  This map captures the mix of nalaxone access and "Good Samaritan" laws throughout the country.  Essentially, "Good Samaritan" laws protect drug abusers and those that might assist them (i.e., calling 9-1-1 or driving them to the emergency room in light of an overdose) from criminal prosecution.  All states and local jurisdictions should pass such laws. It makes no sense for people to die because someone else is afraid of getting in trouble.
 



The nalaxone access issue is also important.  But it's more complicated.

Yes, emergency responders and others on the front lines of the drug abuse epidemic should have access to this potentially life-saving drug.  But there are two challenges with respect to nalaxone that we're not openly discussing, mostly because its uncomfortable to do so.  And the two challenges happen to be the critical questions we should ask of any new medication:

1) Cost.  Nalaxone itself is an old drug and long off patent.  A simple syringe filled with a single dose would cost about $3.  But last year, the FDA approved EVZIO, a portable nalaxone injector.  This device is costing payers about $500 for two doses packaged together.  We see EVZIO being paid for in our payer data and we've seen fees closer to $800 for EVZIO.  This drug is a critical public health tool, but does Kaleo Pharma (the makers of EVZIO) deserve patent protection for putting a drug originally approved in 1971 into an injector pen?  Is that really the type of innovation we want our patent system to protect?  

2) Utilization. We just heard from a prescribing physician during a PRIUM follow up call to a peer-to-peer review that he was prescribing EVZIO for the injured worker in question.  We further learned that he was being encouraged by the "drug rep" to prescribe EVZIO to all of his patients being prescribed opioids.  Just in case they overdose.

The answer to the epidemic of opioid misuse and abuse shouldn't be layering on another $800 prescription for a nalaxone injector for every patient on opioids.  Are there instances where such a prescription will make sense?  Certainly.  But why not focus our efforts on eliminating the possibility of overdose completely by focusing on non-pharmacological pain management and non-opioid medications?  We need to focus physician education efforts on the lack of evidence for the effectiveness of opioids among chronic, non-cancer pain patients... and not allow a nalaxone injector to be perceived as the panacea it will never be.

Michael
On Twitter @PRIUM1

Wednesday, June 10, 2015

Cognitive Therapy, Cognitive Dissonance

One of the most frequent recommendations I see resulting from our peer-to-peer discussions on chronic pain claims is Cognitive Behavioral Therapy (CBT).  CBT is a short-term, goal-oriented psychotherapy treatment that takes a hands-on, practical approach to problem-solving.  Its goal is to change patterns of thinking or behavior that are behind people's challenges and, thus, change the way they feel about and deal with those challenges.

Despite the growing body of evidence regarding the effectiveness of Cognitive Behavioral Therapy, it still seems to cause a great deal of cognitive dissonance in our industry.  We want to mitigate chronic pain symptoms for injured workers so they can take fewer medications, have a higher quality of life, and perhaps even return to work.  But we're resistant to the idea that 6-12 CBT sessions can actually help with those goals, despite what the evidence suggests.

The essential concept here is that low-cost, short-term clinical strategies that focus on how we feel, react, and deal with life experiences, including symptoms of pain, can be more effective than long-term use of medications.

An article in the New York Times this week lends more evidence to this notion.  While not focused on chronic pain, the article does highlight one of the most significant side effects of chronic pain (and the opioids too often used to manage it): insomnia.  Look at the medications you're paying for on a typical legacy chronic pain case and you're likely to see Lunesta, Ambien (zolpidem), Restoril, etc.

Turns out CBT by itself is more effective than both the medications as well as the medications plus CBT.  Across 20 clinical trials including more than 1,000 patients, CBT yielded more sleep and higher quality sleep than the medications delivered.

Here's the bottom line: All of us, at one time or another and with varying degrees of frequency, need coping mechanisms.  Life is hard.  Sometimes we hurt.  Sometimes, we hurt all the time.  But medication therapy isn't the best option for long-term pain or insomnia or lots of other chronic conditions that fundamentally emanate from the human mind and all of its experiences and perceptions.  CBT sounds simple.  It's not.  CBT is hard work.  We're trying to rewire our brains so that we experience life in a healthier way.  But it's hard work worth doing, particularly given the alternatives.  

Michael
On Twitter @PRIUM1

Monday, June 8, 2015

Opana, HIV, and Unintended Consequences

With the exception of a great piece on medical billing from back in March of 2013, Time magazine hasn't managed to publish much worth reading.  But the forthcoming issue of the magazine features a cover story titled "Why America Can't Kick Its Painkiller Problem."  And it's worth 15 minutes of your time, albeit not for the most obvious reasons.

Yes, the article offers a fairly thorough overview of the recent history of pain management in this country.  The usual suspects make their appearances (big pharma, Russell Portenoy, the Joint Commission, etc.) and the standard statistics are rolled out ($8 billion painkiller market, 17,000 annual deaths from overdose, more than 200 million annual prescriptions written for opioids, etc.)  You know most of this and it would be easy to scan the article and think (as I usually do), "If Time Magazine is only now publishing a story about the problem, we must be making progress..."

But this article turns out to shine some important light on three issues we normally miss when we contemplate the epidemic of prescription drug misuse and abuse:  First, that there are incredibly harmful unintended consequences that no one could have foreseen; second, seemingly harsh punitive measures taken against pharma companies haven't put a dent in the problem; third, the FDA isn't helping.

Perhaps the scariest among many unintended consequences is the one highlighted in this article - the rise of Hepatitis C and HIV infections among intravenous drug users addicted to opioids.  In January, Scott County reported an alarming jump in new HIV cases: eight new HIV-positive patients in a small, rural community.  By March, there were 81 new cases.  As of June 2, there were 166 HIV cases in Scott County.  Of those patients interviewed by the CDC, 96% reported injecting Opana intravenously.  I wonder if there are any injured workers among them.  And this is being driven by a formulation that Endo claims is abuse-deterrent.  Turns out the supposed abuse-deterrence makes it much harder, if not impossible, to crush and snort the drug.  As for cooking it down to liquid form and injecting it?  Endo hasn't figured that out yet.    

The federal government has taken aim at big pharma's painkiller marketing tactics.  Purdue Pharma, makers of Oxycontin, paid a $635 million fine in 2007 in connection with a guilty plea for misleading doctors about the abuse potential of the drug.  The next year, Cephalon, makers of Actiq, paid a $425 million fine for misleading marketing.  That's more than $1 billion in fines in an $8 billion industry... and it just keeps rolling.  What do you imagine the gross margin per pill is for Opana (which does $1.16 billion in annual sales)?

Finally, the FDA has proven to be a misguided and inconsistent ally in the fight against prescription drug misuse and abuse.  In the midst of an epidemic, they've not hesitated to add new opioids to the market (Zoyhdro and Hysingla come to mind).  They've also focused a lot of energy on "abuse-deterrent" formulations of extended release opioids.  While they did not grant Opana ER that distinction, I've held the view for some time that abuse-deterrence is necessary, but by itself, entirely insufficient to stem the tide of misuse and abuse of opioids.  

We have a long way to go.

Michael
On Twitter @PRIUM1

Friday, May 22, 2015

A Warning to Work Comp Payers

This new ruling from West Virginia's Supreme Court reminded me of a post I first wrote almost exactly three years ago.  I decided to re-post it here today.  This WV case, in a nutshell, says that the illegal acts of the plaintiff (in this case, addicted opioid users) does not disqualify them from taking legal action against the defendants (in this case, physicians and pharmacies) for being at fault for their own harmful acts.  And as Stephanie Goldberg points out in the linked article, work comp payers should be on alert.  It's not a big leap in logic to apply this same line of reasoning to a payer who chooses to finance the addictive behavior of an injured worker instead of intervening to do something about it.

Here's my post from May 25, 2012:

We Know Too Much: New Liabilities Associated with Opioid Abuse

A new ruling from Texas adds to the list of states that have found payers liable for a range of opioid-related side effects ranging from addiction to death. In this particular case, the payer was found liable for death benefits in light of the injured worker's death caused by hydrocodone overdose. This adds to recent rulings in several other jurisdictions (e.g., Pennsylvania, Texas, North Carolina - these are the ones I've seen, I believe there are others) in which payers have found themselves on the hook for death benefits due to drug overdose.

Prediction: This is just the beginning. Why? Because we know too much. And our unwillingness (or inability), as an industry, to apply what we know is going to cause a lot of financial pain over the next several years.

We really do know too much. We have sound, evidence-based clinical guidelines. We have peer reviewed studies (many of which are incorporated into the guidelines) that suggest the limited benefits (and significant harm) that results from chronic opioid therapy. We have thought leaders, in both the clinical and business realms, offering a constant drumbeat of warnings that solutions are needed. We have industry conferences devoted entirely to this issue. We have a growing body of regulatory mechanisms intended to help control opioid misuse (e.g., Texas closed formulary rules, new Tennessee UR rules, Washington's guidelines, etc.) We have public health agencies, including the CDC, calling the issue of prescription drug abuse an "epidemic" and a "public health crisis".

I hear various excuses for why payer organizations aren't attacking the problem with greater force. "Look," they say, "this is really complicated... these people are addicted". Or "we don't have sufficient clinical resources"... or "we're pretty sure plaintiff's counsel is going to come at us pretty hard"... or "we're working on it"... or "our PBM has a handle on it".

Enough. There's going to be noise. Deal with it. We're on the right side of this fight. By taking aggressive action, we have the opportunity to improve overall patient health while simultaneously saving money. This is exactly what our health care system needs.

Let's get to work.

Michael
On Twitter @PRIUM1