Tuesday, October 21, 2014

Chronic Pain Malpractice Claims Are Rising

I've been in more than a few meetings with payers discussing the problems with opioids when someone wonders aloud, "Why aren't some of these patients suing their doctors?"

Turns out, they are doing just that... in increasing numbers.

A study of malpractice claims over the last 30 years presented at the 2014 Annual Meeting of the American Society of Anesthesiologists concludes that the number of claims related to chronic pain management is increasing far out of proportion to the growth in the number of pain management practitioners.  Further, the analysis shows the prescription medications are playing a significant role.

As a proportion of anesthesia malpractice claims, those claims related to pain management rose from 3% in 1980 to 18% in 2012.  Medication management claims increased from 2% to 17% of anesthesiology malpractice claims.

Perhaps more alarming: in the 1980s, death was the cited reason for a claim 6% of the time and severe injury for another 6% (the rest of the claims related to temporary and/or minor injuries).  After 2000, death was cited in 19% of claims and severe injury in 28%.  That's nearly half of all chronic pain malpractice claims.

Not only are chronic pain malpractice claims becoming more frequent, but the resulting injuries are becoming much more severe.

What to do?

I'm not a lawyer, but it strikes me that payers should probably be having conversations about provider network strategy and sticky things like subrogation, right?  Where does work comp leave off and med mal pick up?  When a payer has done all they can legally do to provide safe care for an injured worker and the doctor continues to prescribe absurd levels of opioids... what are the options when that injured worker doesn't wake up one morning?


Monday, October 20, 2014

A Name You Should Know: Jack Conway

David Armstrong has written a piece on Bloomberg.com that should be required reading.  Not only does it recap the overarching legal strategies currently being pursued by various municipalities against manufacturers of painkillers, but it dives keep into Kentucky's battle - by far the longest and potentially most successful suit thus far.

Recall that in 2007, Purdue Pharma paid a $634 million fine in connection with inappropriate marketing of Oxycontin.  Of that fine, $160 million was specifically earmarked to reimburse the federal government and state governments for damages suffered by the Medicaid program.  Kentucky's share of that fine was to be $500,000.

Kentucky said "no thanks" and filed its own lawsuit.

Seven years later, we're as close as we've ever been to a trial and it's more likely than not that we'll see this trial play out at "ground zero" (Pike County prosecutor Rick Bartley's phrase, not mine) of the opioid epidemic.  For Purdue, whose chief financial officer is on record as saying that this could be a billion dollar case and would have a "crippling effect on Purdue's operations and jeopardize Purdue's long-term viability," this is nothing less than a "save the company" moment.

On the opposite side of the courtroom will be Kentucky Attorney General Jack Conway, a rising political star in the state.  He lost the 2010 US Senate Race to Rand Paul, but remains an up and comer in the Democratic party in Kentucky.  This is one of those cases in which an Attorney General can set himself up for future political wins.  And beyond that, I think he genuinely wants to do the right thing here.  And the right thing, according to Mr. Conway, is to hold Purdue accountable.  I met Mr. Conway and got to talk with him for a few minutes at last year's National Prescription Drug Abuse Summit in Atlanta.  He's the real deal.  He cares about the issue of prescription drug misuse and abuse.

The most interesting take-away from the article: Purdue hired an outside consultant to assess the likelihood of getting a fair trial in Kentucky.  The findings?

  • 40% of Pike County residents knew someone who had run into criminal trouble because of an Oxycontin addiction;
  • 33% knew someone who overdosed to was otherwise seriously hurt by the drug;
  • 29% knew someone who had died;
  • 90% agreed that Oxycontin had a "devastating effect" on the community.  
I'm not a legal expert.  I don't know if Purdue can get a fair trial in Pike County or not.  But either way, it sounds to me like there's going to be a fight - and a very public and very ugly fight at that.


Thursday, October 16, 2014

Guidelines: How to Make Them Matter

There has been a lot of talk in the last couple of weeks about medical treatment guidelines.  North Carolina, Tennessee, Arizona, and several other states are looking into adoption of guidelines.

There is a lot of discussion about "evidence-based" vs. "consensus-based" guidelines as well.  While I'm an outspoken proponent of the evidence-based variety, I recognize that local political conditions can make adoption of such 3rd party guidelines difficult.  Politics is a poor excuse - states can benefit significantly not only from the credibility of 3rd party guidelines, but also from the fact that providers of such guidelines work constantly to ensure those guidelines reflect the most contemporary view of the medical evidence.  Consensus-based guidelines (where a state medical director or agency gathers a bunch of stakeholders and they all decide what's best for injured workers in a given state) tend to be static - they age... and they tend not to age well.  They also tend to be subject to influence from outside parties with vested economic interests (see Louisiana as an example).

But the debate between the two competing approaches to guidelines is actually a sideshow, a distraction that prevents regulators from focusing on what matters most: enforcement.

When reading proposed or adopted treatment guidelines for a given state, make sure you explore the extent to which you can successfully challenge treatment that falls outside of the guidelines.  For instance, let's say a medical treatment guideline states that prescribing opioid analgesics in excess of 50 mg MED daily is not recommended (as the ACOEM guidelines suggest).  And assume you have a case where the doctor is prescribing 250 mg MED daily... and that doctor has been unresponsive to requests for discussion regarding the case and has not provided the rationale for why he's prescribing outside of the evidence based guidelines.  Question: Now what?  

There are states that have good answers to this question.

In Texas, if those opioids are N drugs, the answer is required pre-authorization based on a 3rd party guideline (Official Disability Guidelines) and a utilization review process that is statutorily supported and has clearly defined dispute resolution mechanisms.

I was encouraged to read that in Tennessee, the goal is to ensure that any adoption of treatment guidelines is consistent with existing utilization review regulations (which include the ability for a payer to subject any schedule II-IV medication used for the purposes of pain management for more than 90 days to utilization review).

Those are guidelines with enforcement mechanisms.  If the adoption of guidelines doesn't come with enforcement mechanisms, they're still worth having (because good doctors will still be responsive to guidelines).  But those guidelines won't be as valuable as they could be if appropriate enforcement mechanisms are in place (because not-so-good doctors will ignore contemporary medical evidence and continue to administer sub-optimal treatment until the payer stops paying for it).


Friday, October 10, 2014

What's Old is New Again: The Real Opioid Wars

Addiction is not a new phenomenon.  Opioid analgesics aren't new either.  And as we fight our current war against the man-made epidemic of opioid misuse and abuse, let's not forget that actual wars have been fought over opium.  The Chinese and the British, in fact, fought two wars in the 19th century that hinged, at least in part, on the alarming growth in the number of opium addicts in China.  In fact, the first Opium War started when the Chinese government seized 20,000 chests of opium (or about 2.7 million pounds) belonging to the British East India Company.  The opium had been grown in India and transported to China by British traders who were making lots of money selling it to Chinese merchants.  (As an aside, the treaty that ended this war resulted in the cessation of Hong Kong to the British in 1841... the beginning of the political drama still playing out in Hong Kong to this very day).

Opium isn't new to the US either (see photo below).  In the early 20th century, opium addiction had become a sufficiently important public health issue that the Harrison Act of 1914 required doctors and pharmacists that prescribed and dispensed opium to register with the government and pay taxes on the sale of opium.  Nine years later in 1923, the US Treasury Department's Narcotics Division banned the sale of opium and other narcotics altogether (creating a vibrant black market for drugs that still thrives today).

Our public health and regulatory response to today's crisis is more nuanced and more measured than in the early 20th century, as it should be.  Opioid analgesics absolutely have a role to play in contemporary treatment of pain.  The challenge today remains how to balance the real needs of people in pain with the public health crisis that is the opioid epidemic.  But we've been here before and we'll figure it out.

Don't think history repeats itself?  Here's a "selfie"... 1920s style.

Have a great weekend.


Thursday, October 9, 2014

California: Predictions and Politics

The latest study from CWCI suggests that implementation of a Texas-like or Washington-like formulary could produce substantial savings in the CA work comp system on the order of $124-$420 million.  I was extremely impressed with the detailed methodology CWCI developed.  Not only did they dig into the formularies at the NDC level and build the analysis from the bottom up, Alex Swedlow and team also created a model that incorporates the effects of drug substitution in light of formulary implementation.  And it's not an overly simplistic approach, either.  They use the Medispan GPI number to assess the likelihood of substitution for drugs not included on the formulary.  The reader of this report learns more than just dollars and cents in CA; some of the key take-aways relate to the vast differences between the TX and WA approaches.  Bottom line: the report is educational and insightful and should be required reading.

There's just one major variable the report doesn't include: politics.

That's not a shot at CWCI - that's not their role, their mandate, or their mission.  But I couldn't help look at the numbers and think, "there's no way a closed formulary concept survives a fight in Sacramento."  I'm always encouraging people to avoid cynicism and here I am dishing it out.  But it's hard to imagine a politically diverse state like CA (was that diplomatic enough?) implementing something remotely close to what Texas did (a much more politically homogeneous state) or what Washington did (a monopolistic work comp system).  Keep in mind that even in Texas, the legislation that called for the creation of a closed formulary was signed into law in 2005.  Full implementation of that closed formulary finally occurred in 2013.  That's 8 years of regulatory wrangling in a state where less than 10 percent of injured workers are represented by attorneys and employers need not bother with work comp at all if they so choose.

On the other hand, we learned this morning from the Oregon Workers' Compensation Premium Rate Ranking Summary that California is the most expensive state in the country.  While there has always been a lot of debate about the methodology of this annual report, perhaps it's enough to create the burning platform CA so desperately needs to get a handle on medical costs.


Tuesday, September 30, 2014

A World Without Work Comp

"I was carrying a steel pipe at work and it brushed up against an electrical wire.  When I woke up, I saw that everything was gone, and I just started crying... I've been begging for money in this same spot for 20 years.  All I can do is try to get my bread every day until God decides to take me home."

(If you don't follow Humans of New York on Facebook, you're missing something in your life.  This amazing project has gone from the streets of New York to a worldwide photo documentary of the highs and lows of human existence.  If you're looking for a little perspective, this is a great source.)    

This particular picture and quote was taken in Mexico City some time Monday afternoon.  On the one hand, it made me sad for this man and his circumstances.  On the other hand, it caused me to reflect on the positives of our workers' compensation system in the US.  Frankly, it's not hard to criticize the system.  But there's also a lot good that occurs and I'm grateful to know that should I ever brush a steel pipe against an electrical wire while on the job, my prospects would likely be better than this gentleman's.  

To paraphrase Churchill's thoughts on democracy: "Workers' compensation is the worst form of protection for injured employees... except for all those other forms which have been tried."  


Friday, September 26, 2014

Hard Choices: Mental Illness vs. Medications

The recently released report and follow up webinar from the Workers' Compensation Research Institute (WCRI) shines more light on the complicated world of chronic pain.  (Full disclosure: PRIUM is a WCRI Core Funder... and proud of it).  WCRI doesn't take policy positions, they work hard to inject data and academic rigor into policy debates without taking a stance one way or the other.  As if often the case, however, the data in this report appears to speak for itself.

The report measures the utilization of modalities that should be used to support chronic pain patients in the healing process.  Physical therapy is the most common (moving from 87% of injured workers in chronic pain to 88%).  Still more work to do here - why are 12% still not getting PT? - but that statistic isn't particularly alarming.

Only 25% of injured workers in chronic pain are being monitored for compliance with drug therapy regimens.  From our vantage point, this statistic is slightly misleading.  We see pockets of extremely high and inappropriate utilization of drug testing among some physicians and virtually zero testing among others.  The net statistic is 25%, but we see a tale of two extremes in this area.  Again, this is our view from PRIUM - admittedly skewed by our focus on complex claims.

Finally, the dismal news.  Only 5% of injured workers in chronic pain go through psychological evaluation and only 4% receive psychological treatment of any kind.

We know why this is.  Adjusters: Raise your hand if you're willing to let a potential psych diagnosis get within 10 miles of any of the claims on your desk.  Seeing no hands raised, let's address the issue as candidly as possible.

On many long term complex claims, you are left with two bad choices: continue the meds or deal with the psych.  This is the proverbial "rock" and "hard place."  And years of training and bad experiences have left the work comp community with a clear answer to this quandary - under no circumstances are we to explore the psych.  Just pay for the meds, cross your fingers, and hope...

A favorite aphorism from one my business school professors comes to mind: "Hope... is not a strategy."

So what's the strategy?  I don't have all the answers, but here are a couple of ideas:

First, keep in mind that some modalities, like cognitive behavioral therapy (CBT), which are often used in support of the weaning process, do not necessitate or lead to psych diagnoses.  These are supportive and therapeutic modalities, not diagnostic.  And they can be billed under physical medicine CPT codes.  So don't freak out when you see a CBT recommendation.

Second, many treatment options require a psych eval to assess whether the option is viable for the injured worker.  Things like spinal cord stimulator trials, inpatient detox, and surgery often require (via medical treatment guidelines) a psych eval.  This can be complicated and you should consult with your supervisor and/or defense counsel on a case by case basis, but we've seen positive clinical outcomes as a result of a claims organization's willingness to choose the right clinical path, even if a psych eval has to be done first.

Finally, recognize the brutal fact that on some cases, the only way to reach resolution, the only way to for the injured worker to truly heal, is to deal with the underlying psychological issues faced by that person.  Note that according to the CDC, more than 60% of us experienced some kind of childhood trauma or abuse (verbal, physical, psychological, sexual, etc.)  We are a society of broken people.  Workplace injuries can trigger, exacerbate, or prolong our struggles with inner demons that have nothing to do with our non-specific low back pain.

I'm not declaring you should take on psych without regard to the potential consequences.  I'm simply suggesting that the first step to solving a problem is recognizing we have one.  And the second step is to have a real dialogue about the nature of that problem.