New Research from Ameritox Shows Prescription Painkiller Abuse Epidemic is Ever-Changing

A research report releasedtoday by AmeritoxSM showed an increase in the number of samples testing positive for a drug not prescribed by a doctor or for an illicit drug. But on a positive note, the report also revealed a modest improvement in likely adherence in patients prescribed opioid medications for chronic pain management.

The new research shines a spotlight on 10 states with the greatest number of troubling samples in each of the three categories of concern – “prescribed drug not found,” “non-prescribed drug found” and “one or more illicit drugs found.” Four states ranked in the top 10 in two categories.

Click on the link above to find out where your state ranks.

Michael
On Twitter @PRIUM1

Physicians and Painkillers: A Tale of Two Statistics

See if you can reconcile the following two sets of data points from a survey published by the Journal of the American Medical Association last week regarding physician perceptions of prescription drug abuse:

1) 90% of doctors report prescription drug abuse is a moderate to large problem in their communities and 85% think prescription drugs are overused in clinical practice.

2) 88% of those same doctors are confident in their skills related to prescribing painkillers and almost half of them are comfortable using the drugs for chronic, non-cancer pain.

And there's the rub.  Call this the old "there's a problem, but I'm not contributing to it" phenomenon.  Doctors who profess confidence and comfort prescribing prescription painkillers for chronic, non-cancer pain may be contributing the problem of misuse and abuse, albeit unwittingly.  The study doesn't offer any insights into dosage levels or medication classes or individual drugs, so one cannot draw conclusions.  And I'm certainly not suggesting that painkillers can't be used appropriately for time limited, function-focused management of chronic, non-cancer pain.  But the contrast between the data points struck me.  85% think the drugs are overused... 50% are confident using them with a group of patients for which there's little to no evidence of long term efficacy.  

And this is a commonly observed phenomenon.  Rewind the clock five, six, seven years and a material number of work comp payers (from carriers to TPAs to self-insured employers) were saying the same thing.  "There's a problem, but I'm not contributing to it." I personally heard it at least a dozen times in my first year here at PRIUM (which was five years ago... time flies).  I don't hear it much these days.  As an industry, we're beginning to make concerted, strategic effort to combat prescription drug misuse and abuse and we largely recognize that all payers have a role to play.  While there's still A LOT of work to be done, we've passed through the first step on the road to recovery: payers are not only admitting they have a problem, they're recognizing their past contributions to that problem.

The physician community appears to have the first half down - they're clear we have a problem.  I wonder if they recognize their past and current contributions to the problem.  I know many physicians do.  I hope more come to recognize the need to change patterns of practice in light of the largest man made epidemic in history.

Michael

On Twitter @PRIUM1

What Are You Doing About Compounds?

I've been on the road visiting with customers and I'm hearing a lot about compounds.  Most of us are aware that compound medications are intended to provide certain medications in forms or dosages not commercially available, therefore necessitating a pharmacist create or mix a compound medication.  More of us are becoming aware that compounding represents a significant and growing clinical and financial risk in workers' compensation.  Only a few of us have clear and well documented processes and procedures for dealing with these prescriptions.

While compounding isn't new, the attention being paid to it is, in fact, overdue.  Recently, Express Scripts was sued by several compounding pharmacies for allegedly issuing blanket denials for over 1,000 different active ingredients in compound medications (this policy was in the group health space, not work comp).  While we know such blanket denials aren't feasible in work comp, the tug of war between the compounding pharmacies and the payer community is playing out in our space all the same.

Compounds can be medically necessary and effective, but use should be limited to situations where the oral medication has proven ineffective and/or has produced serious side effects.  Clearly, we're seeing a frequency of compound prescriptions in work comp that far exceeds what is likely medically reasonable and necessary.

So what's your strategy?  What are you doing?  Many compound pharmacies are making obscene amounts of money exploiting gaps in the claims management processes of work comp payers.  How do you plan to close those gaps?

Michael

Two post scripts:

There are a precious few compounding pharmacies trying to do this right.  You should be looking for them and putting them into your networks.

And for a more comprehensive view on compounds in work comp, I'd direct you to the excellent CompPharma white paper from earlier this year.

On Twitter @PRIUM1

New Opioid Coming Soon: Hysingla ER

Because not only do we need another opioid on the market... but we need a new one from Purdue Pharma.

On the heels of the much debated approval of Zohyrdo ER, the market's first hydrocodone-only painkiller, comes the FDA's approval of Hysingla ER, the market's first hydrocodone-only painkiller with abuse-deterrent technology.  Purdue plans to launch the medication in "early 2015."

Like Zogenix (the makers of Zohydro), Purdue is touting the lack of acetaminophen as an attractive feature of the new medication.  But unlike Zohydro, Hysingla leverages Purdue's RESISTEC technology, which is "expected to deter misuse and abuse via chewing, snorting, and injecting.  However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible." (quoting from the Purdue Pharma press release).  

Now is as good a time as any to restate my position on abuse deterrent technology:

I am 100% supportive of abuse-deterrent formulations of prescription opioids.  These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication.  But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).  

To me, though, this conversation is a distraction.  While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem.  The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed.  Very little pill crushing.  Very little intravenous injections.  Very little drug dealing.  

The problem as we see it 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

Dangerous Databases? Security Risks and Public Health Benefits

Prop 46 was defeated in California on Tuesday by a 2-1 margin.  The proposition, among other things, required drug testing among doctors and lifted the caps for medical malpractice damages.  Prop 46 also would have required physicians to check the CURES database before prescribing or dispensing any schedule II-IV medication.

Predictably, the bill was unpopular among California physicians.  Disappointingly, the Prop 46 attack ads apparently devolved into scare tactics and silliness.  According to a WorkCompCentral article this morning, California voters heard things like the following, probably in the form of a voice over that made it sound dark and evil and conspiratorial:

"The vulnerable, government-run database is subject to being hacked, compromising the security of every Californian's personal prescription drug history" and "your personal prescription drug history could be made available for anyone to see."

Political ads are anathema to sound, rational policy debate.

Yes, there are risks associated with the existence of any public database (or private data, for that matter: see Home Depot, Target, etc.)  But no, those risks do not outweigh the obvious public health benefits of mandated PDMP use by prescribing physicians.

As I've written before, mandating that pharmacies report prescription drug data into the PDMP is a start.  Mandating that physicians register as users is a next step.  But mandating that doctors check the database before writing prescriptions that could be potentially dangerous to a patient or a community is the key to a successful PDMP program.  

Otherwise, it's just data sitting in a database.  

Apparently, plans are in the works to bring back this particular component of Prop 46 in front of the legislature.  Hopefully, this time around, the scare tactics will be drowned out by the voices of reason.

Michael
On Twitter @PRIUM1

Opioid-Related Emergency Room Visits Driving Costs

With all the focus on opioid overdose deaths, it's easy to forget that the actual death rate from opioid overdoses is surprisingly low.  In fact, the most common destination for most opioid overdoses isn't the grave - it's the emergency department, followed by an expensive hospital stay.

A new study published this week in the Journal of the American Medical Association estimates that there were over 92,000 ED visits related drug overdoses in 2010.  Of these visits to the emergency department:

• 68% involved prescription opioids (vs. 16% for heroin)
• 55% were admitted to the hospital where the average stay was 3.8 days, costing an estimated $1.4 billion in hospital care;
• 53% were women;
• 40% were in the South;
• Only 1.4% of overdose-related ED visits resulted in death, suggesting our healthcare system's growing sophistication in dealing with this crisis.  

Overall, inpatient and ED costs for overdoses resulted in $2.4 billion in healthcare expenditures in 2010.  

I wonder how many claims organizations examine this specific metric as a proxy for injured worker safety: ED visits and/or costs that are medication related.  

In other words, how much of that $2.4 billion did you pay for?  

Michael

On Twitter @PRIUM1

NNT in Pain Management: You've Been Right All Along

The National Safety Council's Dr. Don Teater, MD has penned a white paper that contains powerful data and interesting insights regarding the use of opioids for chronic non-cancer pain.  And it turns out, you've been right all along...

First, a pause for acronym education.  Just when you were getting a handle on MEDs... let me introduce you to NNT (number needed to treat).  This is a common measure in clinical studies that answers the question: how many people need to be treated with a given intervention for 1 person to receive a defined effect.  A lower NNT means the intervention is more effective (1 is the ideal... if you treat 1 person and that person achieves the defined effect, an NNT = 1 means you've got a really effective treatment).  A higher NNT means the intervention is less effective.

For instance, how many people need to be treated with Oxycodone 15 mg for 1 person to receive 50% pain relief?  Turns out the answer to that question is 4.6.

How many people need to be treated with a combination of ibuprofen 200 mg + acetaminophen 500 mg for 1 person to receive 50% pain relief?  Drum roll, please........ 1.6.

He also shares similar data from couple of other studies.

Why do providers turn to opioids so frequently in light of data such as this?  Why does this inherent belief exist that suggests opioids are more powerful analgesics?  Dr. Teater sites several reasons, but the two that caught my eye:

1. Opioids exhibit powerful psychotherapeutic effects not found with ibuprofen and acetaminophen.  If a patient's back hurts, tylenol and advil will work fine.  If a patient's back hurts and they're depressed, opioids are more likely to be perceived by the patient as effective.  This sounds obvious to most of us, but separating the clinical effects of opioids into "analgesic" vs. "psychotherapeutic" has significant implications for the use of these medications.  
2. The pharma companies have spent several billion dollars over two decades getting doctors comfortable with opioids.  Where there's money to be made... there's usually a rep standing by to help a doctor make a decision that may not be fully informed.  

Bottom line: You've been right all along.  For most patients, ibuprofen and acetaminophen are safer and more effective than opioids.  

Michael
On Twitter @PRIUM1

Guidelines That Matter, Part 2

Michigan is in the midst of developing opioid guidelines that matter (and yes, some guidelines matter more than others).  Guidelines that matter are specific, based on clinical evidence, and are tied to reimbursement.  Any guidelines that don't meet those criteria are mere suggestions that only help ensure the safety of injured workers in the most extreme circumstances (e.g., when a judge finally says to a doctor and patient, "that's enough with the opioids..." - and we all know how hard and expensive it is to get to that point).  Guidelines that matter exist within a regulatory structure and dispute resolution process that allows for mitigation of patient safety concerns without consistent involvement of judges.  Medical professionals should be able to work out these differences based on rational discussion and evidence based guidelines.

Michigan has taken a huge leap toward such an approach with the proposed draft of rules developed by the Health Services Committee of the state's Workers' Compensation Agency.  Paul Kauffman from Accident Fund chaired the committee and several other devoted members worked along with him for over a year on these draft guidelines.

Voices of dissent have cropped up, predictably from plaintiff's attorneys that fear this is simply a mechanism to take away needed medications from injured workers.  I don't think that's the case here.  Candidly, Michigan is a state where it's far too hard to ensure injured worker safety and far too easy for injured workers to remain on dangerous levels of opioids for too long.  These guidelines clearly aren't aimed at people who genuinely need pain management therapy.  Rather, these guidelines are aimed at ensuring the safe and effective use of these medications.

In an effort to provide some transparency to the discussion, here's the exact proposed language.  In it, you'll find a list of best practices all doctors should follow.  You'll also find that doctors can be reimbursed for checking the state's prescription drug monitoring database.


Rule 1008a. (1) In order to receive reimbursement for opioid treatment beyond 90
days, the physician seeking reimbursement shall submit a written report to the payer
not later than 90 days after the initial opioid prescription fill for chronic pain and every
90 days thereafter. The written report shall include all of the following:
 (a) A review and analysis of the relevant prior medical history, including any
consultations that have been obtained, and a review of data received from an automated
prescription drug monitoring program in the treating jurisdiction, such as the
Michigan Automated Prescription System (MAPS), for identification of past history of
narcotic use and any concurrent prescriptions.
 (b) A summary of conservative care rendered to the worker that focused on increased
function and return to work.
 (c) A statement on why prior or alternative conservative measures were ineffective or
contraindicated.
 (d) A statement that the attending physician has considered the results obtained from
appropriate industry accepted screening tools to detect factors that may significantly
increase the risk of abuse or adverse outcomes including a history of alcohol or other
substance abuse.
 (e) A treatment plan which includes all of the following:
 (i) Overall treatment goals and functional progress.
 (ii) Periodic urine drug screens.
 (iii) A conscientious effort to reduce pain through the use of non-opioid medications,
alternative non-pharmaceutical strategies, or both.
 (iv) Consideration of weaning the injured worker from opioid use.
 (f) An opioid treatment agreement that has been signed by the worker and the
attending physician. This agreement shall be reviewed, updated, and renewed every 6
months. The opioid treatment agreement shall outline the risks and benefits of opioid
use, the conditions under which opioids will be prescribed, and the responsibilities of
the prescribing physician and the worker.
 (2) The provider may bill the additional services required for compliance with these
rules utilizing CPT procedure code 99215 for the initial 90 day report and all
subsequent follow-up reports at 90-day intervals.
 (3) Providers may bill $25.00 utilizing code MPS01 for accessing MAPS or other
automated prescription drug monitoring program in the treating jurisdiction.
R 418.101008b Denial of reimbursement for prescribing and dispensing opioid
medications used to treat chronic, non-cancer pain.
 Rule 1008b. Reimbursement for prescribing and dispensing opioid medications may
be denied, pursuant to the act. Denial of reimbursement shall occur only after a
reasonable period of time is provided for the weaning of the injured worker from the
opioid medications, and alternative means of pain management have been offered.

Judge for yourself.

Michael
On Twitter @PRIUM1

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?

Michael
On Twitter @PRIUM1

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.

Michael
On Twitter @PRIUM1

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).

Michael
On Twitter @PRIUM1

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.

Michael
On Twitter @PRIUM1

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.

Michael 
On Twitter @PRIUM1

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."  

Michael  
On Twitter @PRIUM1

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.

Michael
On Twitter @PRIUM1

Calls for FDA Commissioner to Step Down Over Opioids

Anti-addiction advocates have sent a letter to Secretary of Health and Human Services Sylvia Burwell calling for FDA Commissioner Margaret Hamburg to step down.  The letter itself is worth reading.

I was in the audience at the National Prescription Drug Abuse Summit here in Atlanta back in April when Dr. Hamburg attempted to address some of the decisions the agency has made.  I can understand the tension created by the need to balance public health with the FDA's role of approving medications on which million upon millions of R&D dollars have been expended.  My view: it's not that she doesn't get it, it's that she's erring on the wrong side of the issue.  Public health concerns should be the primary lens through which her agency assesses new pain medications and that's simply not the case right now. 

The letter is signed by many organizations, most notably Physicians for Responsible Opioid Prescribing (PROP).  This organization has worked tirelessly to push back against the tide of prescription drug misuse and abuse and the regulatory system that enables it.  If you haven't seen or taken advantage of their education materials, you absolutely should.  Every person in medical and claims management can learn something about opioid abuse here: PROP web site. 

While I don't think Commissioner Hamburg will step down, the press coverage of the letter shines a spotlight on the issue and calls into question the behavior of the key federal regulatory agency responsible for approving new pain medications.  I think this will help push us toward a more comprehensive and responsible view of opioid prescribing.  

Michael
On Twitter @PRIUM1

Unfunded Mandates and Patient Safety

Last week, several New Jersey state legislators convened a press conference to announce a legislative package intended to stem the tide of opioid and heroin overdoses in the Garden State.  And quite a package it turned out to be: 21 bills are included, covering everything from mandatory insurance coverage for behavioral health to the use of naloxone to prevent overdoses.  There appears to be enough in the package that everyone has something they like... and everyone has something they don't like.  Should make for interesting politics.

One key piece of legislation in the package caught my eye.

The bill requires the mandatory registration and use of the Prescription Monitoring Program (PMP) among New Jersey physicians.  Everyone likes the concept of the PMP, but the Medical Society of New Jersey has an issue with requiring doctors to consult the database prior to writing prescriptions. Should this bill pass, New Jersey would join Oklahoma, Kentucky, New York, Tennessee, and Massachusetts as the only states that require doctors to consult the database prior to writing prescriptions for pain management medications.  If New Jersey legislators are smart, they'll include provisions (like Oklahoma did) creating exemptions for hospice and other end-of-life care situations.  Additionally, they'll prohibit lawsuits against physicians for not checking the database.  While a patient can't sue a doctor for not checking the database, the doctor would still be in violation of the law and subject to sanctions, punishment, etc.

Doctors often refer to such requirements as an "unfunded mandate."  By that, they mean additional requirements are being placed on them with no additional remuneration.  But this is fundamentally about patient safety.  Are the pre-surgical verification steps outlined by JCAHO an "unfunded mandate"?  What about the commonly expected best practice of physicians washing their hands between patients?  These are things we do in the healthcare community to protect patients, physicians, and other stakeholders from the unintended consequences of care delivery.  I can't understand how that logic doesn't extend to opioid prescribing.

New Jersey is headed in the right direction.  I hope they don't screw it up.

Michael
On Twitter @PRIUM1

Medical Marijuana is NOT the Answer to the Opioid Problem

At least not yet.  But the conclusion being drawn by many a reporter in our industry would have you believe otherwise.  "Fewer Opioid Related Deaths in States with Medical Marijuana" read one headline.

A study published in the Journal of the American Medical Association at the end of August is causing a lot of confusion in our space.  The abstract of the study (which is, unfortunately, all that most reporters seem to have read) states the following: "States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate... compared with states without medical cannabis laws."  One has to crack the cover and actually read the study to understand this conclusion results from a multi-variate linear regression model that compares behavior of individual states that have medical cannabis laws to what the behavior might have been in that state without such laws.  I have absolutely no issue with the the methodology or the related conclusion.  I'm a data geek and I love a good linear regression model as much as the next guy.

But on page 3 of the study, you quickly learn that the actual observed historical data tells the opposite story. States with medical cannabis laws exhibit a consistently higher opioid overdose mortality rate vs. states without such laws.  Marcus Bachhuber, the lead author of the study, points out that its hard to compare states to each other and much more statistically relevant and reliable to compare states to themselves (what does California look like vs. what we would expect California to look like without a medical marijuana law?)  This is a perfectly valid academic exercise, but not one from which we should be drawing policy conclusions.  Dr. Bachhuber himself writes in the study, "In summary, although we found a lower mean annual rate of opioid analgesic mortality in states with medical cannabis laws [again, according to the linear regression model, not the observed historical data], a direct causal link cannot be established."

Kudos to Ben Miller at WorkCompCentral, who actually read the entire study and presented a balanced view of the issue in his article yesterday.  I was interviewed for and quoted in the article and stated the case much like I'm stating it here. I was impressed that Ben was willing to dig beyond abstract and take his story in a direction he may not have originally intended.  We need more reporters like him in our industry.

Bottom line: Medical marijuana laws cannot be said to lead to a reduction in opioid overdose deaths.  

Michael
On Twitter @PRIUM1

What's Actually Happening at the Pharmacy?

A lot, it turns out.  The local retail pharmacy represents another front, and a complicated one at that, in the battle against prescription drug misuse and abuse.  And you need to be aware of what some injured workers are facing when they take their prescriptions to the pharmacy.

Pharmacists are asking doctors questions about medical necessity... and doctors don't like that.  "They [pharmacists] call us sometimes and if (a prescription) is medically necessary," says Dr. Rafael Miguel, an anesthesiologist in Tampa.  "Well, if I write a prescription and it's got my DEA number and my signature on it, what do you think, I'm joking around?"

No, no one thinks this is a joke.  But pharmacists, insurance adjusters, case managers, other physicians, public health workers, and many others think you might be lacking key clinical knowledge regarding the appropriateness of certain prescriptions (yes, even doctors can be under-educated).  We don't think it's funny, we think it's tragic.

Then again, are pharmacists the right ones to be asking this question?  I have neither the clinical knowledge nor the courage to weigh in on that, but it's a question with which the healthcare industry is currently wrestling.  There is new tension in the traditionally high functioning relationship between doctors, pharmacists, and patients and pain killers are at the center of that tension.

For pharmacists and doctors reading this, nothing new here.  But for insurance industry personnel, it's important for you to get up to speed on the details of what's happening in the midst of an ordinary pharmacy visit.  We're revisiting some fundamental questions about the roles and responsibilities of various clinical constituencies.  I'm confident the pendulum (currently swinging at different rates in different directions in different places) will eventually come to rest where it should.

In the meantime, be on the look out for injured workers caught in the crossfire.

Michael
On Twitter @PRIUM1

The Rescheduling of Hydrocodone: Don't Get Too Excited

The Drug Enforcement Agency has published its final rule on HCPs - hydrocodone containing products - which will be rescheduled (from schedule III to schedule II) beginning on October 6.

The two areas that appear to be of greatest concern in the market regarding this move are:
1) The impact on pharmacies which will now be required to handle, store, and dispense these drugs with greater restrictions going forward, undoubtedly increasing costs for pharmacy operations; and
2) The impact on patient access.  Will patients in pain still be able to get these drugs?

On the first issue, we should all acknowledge the reality of retail pharmacy operations.  This will cause changes and those changes will lead to increased costs.  While I would argue the clinical and public health benefits of the rescheduling of HCPs outweigh those costs, I'm not running a retail pharmacy.  My hope is that these costs trend down over time as pharmacy operators adapt to the new routines required.

To the second issue regarding patient access, let's keep in mind that a rescheduling of a drug may not necessarily impact prescribing patterns.  Yes, schedule II drugs cannot be written for more than a 30 day supply and each prescription requires an office visit.  This will inconvenience some patients in chronic pain.  That said, there are "work arounds".  At the Georgia Workers' Compensation Education Conference here in Atlanta yesterday, I moderated a panel regarding medication usage for the treatment of chronic pain.  A suggestion was made that some doctors may just write two 30 days scripts with a "do not fill before" date on the second script.  Voila! 60 day supply.

Most troubling, though, is the sentiment I've heard from several workers' compensation professionals that goes something like "if a patient really wants the drug - and they will still want HCPs - they'll jump through whatever hoops necessary to get it."  On the one hand, I get it.  It's not as if cynicism in our industry doesn't have obvious and ubiquitous roots.  On the other hand, we cannot allow patient directed care to dictate appropriate treatment pathways for injured workers.  The rescheduling of HCPs should signal to physicians that the drugs are potentially more dangerous than we originally thought.  Doctors, not patients, should therefore be engaged in differential decision making.  If patients are going to be involved in that decision at all (and they certainly should be), the discussion should surround the significant risks and limited long term benefits of opioid use - not figuring out what hoops they have to jump through to continue getting it.    

Bottom line: The rescheduling of HCPs is more symbolic than anything else.  After 15 years of debate and discussion, the DEA, FDA, and clinical community have finally decided that virtually all opioid analgesics should be scheduled the same way (on schedule II, indicating high potential for abuse).

But don't expect to see a huge drop in HCP scripts in work comp.  Our expectations of what's possible are far too low for that to happen.   

Michael
On Twitter @PRIUM1

A Defense of New Opioid Guidelines

[Another guest post from Dr. Pamella Thomas, PRIUM's Medical Director.  Recently, another physician challenged both the science behind ACOEM's 50 mg MED threshold as well as its applicability to chronic pain cases. This was the response from Dr. Thomas.]

Dr. ----

Hope all is well.

I am a bit surprised that you would challenge the 50 mg morphine equivalent dose (MED) threshold supported in the updated ACOEM guidelines.  We are in a CDC-declared opioid epidemic.  People are dying needlessly.  It is difficult to dissent against ACOEM’s 50 MED threshold when the reported death rate is 3 to 5 times greater in patients prescribed 50 mg MEDs and above than in patients prescribed 49 mg MEDs and below.  For context the current CDC VitalSign report shows that, nationally, 46 opioid overdose deaths occur each day.

Furthermore the ACOEM guidelines are – contrary to your suggestion – both applicable to and directed toward chronic cases.  As the most recently updated standards for the practice of occupational medicine, ACOEM further reveals our developing understanding of opioid best-practices.  There is simply no credible evidence to support long term opioid use for chronic non-cancer pain.  Conversely a Cochrane review demonstrated that back pain patients taking opioids for more than a week, when compared with a similar cohort taking opioids for a week or less, were twice as likely not to return to work within a year.  A related review contradicted the practice of escalating doses.  High doses of opioids were shown to be no more effective than lower doses of opioids, supporting the intuitive notion that once opioid receptors are saturated, increasing the dose does not yield additionally beneficial results.  If you have not yet read the two studies used to confirm the new ACOEM morphine equivalent dose (MED) level, you should.

Another concerning issue that pain management physicians among others are not taking into account?  Up to 30% of patients can’t properly metabolize approximately 25% of drugs currently used clinically due to inherent pharmacogenetic deficiencies (Wang et al., 2009).  Drugs in this grouping include codeine, tramadol, oxycodone, hydrocodone and many synthetic and semisynthetic opioids which are not adequately metabolized by other CYP450 isoenzymes.  As result many patients are building up levels of the parent drug causing cascading effects such as hyperalgesia, which in turn often causes the treating physician to further increase dosage.  Dose escalation is often pursued instead of weaning without documenting either improved function or reduced pain.

Following a psychosocial evaluation, most patients feel better once weaning starts in conjunction with pain management and mind-body therapies (e.g. cognitive behavioral therapy, motivational interviewing, etc.).  However, only about 4-7% of patients are ever evaluated for these potential treatment options despite prolonged treatment and a history of attenuated improvement.  Similarly medically indicated evaluations for dependence and addiction or interventions for smoking cessation are often left unaddressed.

My feeling is that a number of clinicians still practice based on an outdated biomedical model instead of utilizing a growing body of evidence supporting a psychosocial model of pain and its correlation to impairment and disability.  It is ignored that psychologically and/or socially distressed people seek medical treatment for psychosocial conditions.  Due to this lack of recognition, many psychosocial conditions are being managed through inappropriate modalities and passed off as anatomically  diagnosed biomedical pain.  These inappropriate modalities (e.g. opioids, surgery, and interventional treatment) share complicit complications and side effects that further exacerbate long term disability and failed syndromes.

Consider that in October 2010, the CDC published a report indicating that over 60% of US children had suffered some form of traumatic abuse prior to the age of 18.  These same children grow up and enter the work force.  Some of them eventually file claims because of unresolved, unaddressed issues amplified by a work related injury, leaving the worker feeling victimized by a supervisor, a poor work environment, or low wages.  Injecting opioid treatment into this psychosocial complexity without addressing the underlying issues leads to long term disability and frequent social isolation due to unsympathetic family, friends, and coworkers.

I hope that this will help clarify why the decision was made that, when people are dying daily, we cannot apologize for taking action to ensure patient safety.  While we realize guidelines take time to be updated (MTUS is being rewritten currently), an epidemic exists at this moment which can be controlled by removing the cause.

We do not want to be downstream catching bodies but upstream saving lives.

Thank you for your understanding.

Dr. Thomas
On Twitter @PRIUM1

PDMPs: At Least Someone in Missouri is Paying Attention

Missouri is the last state in the union without an approved Prescription Drug Monitoring Program.  While that's inexcusable and embarrassing, it also has real consequences for the state.  Past legislative attempts to create a database have met with resistance from Dr. Robert Schaaf, a family practice physician and Missouri state senator.  The St. Louis Post Dispatch published an op-ed on the topic yesterday, which reads, in part:

"Sen. Schaaf, a family practice physician, said his opposition to the database is about freedom. The drug database would infringe on patients’ personal liberty, he says.

Of course, his opposition makes life easier for greedy doctors and unscrupulous pill-pushers, and more dangerous for drug addicts.

Dr. Schaaf is not opposed to all databases or impinging on the freedom of poor people. He voted in favor of legislation in 2011 that required the state Department of Social Services to set up a database to screen some welfare recipients for drug use.He also voted last session for a bill that would have required the state Division of Workers’ Compensation to develop and maintain a database allowing employers access to workers’ compensation records. 

So much for freedom, eh, Dr. Schaaf?"

Ouch.  

I've spoken to Senator Schaff directly on this topic and asked him to explain the inconsistency of his positions.  I'm not sure he understands the importance of the issue at hand.  

You can find a front page article from the NY Times on this here.

The St. Louis Post Dispatch op ed is here. 

My past critique of Sen. Schaaf is here and here. 

Hopefully this national media attention will get things moving in Missouri... and convince Sen. Schaaf to change his position.  

Michael
On Twitter @PRIUM1

H.R. 4709 Offers Little Help in the Fight Against Prescription Drug Abuse

If you want to bill that purports to mitigate prescription drug misuse and abuse, but actually has no hope of doing so - well, look no further than the 113th Congress.  Turns out they can be counted on for something.

Rep. Tom Marino (R-PA) is sponsoring H.R. 4709 which passed the House yesterday and now heads to the Senate.  The bill's purpose is to "improve enforcement efforts related to prescription drug diversion and abuse..."  It does so by amending the Controlled Substances Act (CSA) to more clearly define that certain drugs may represent an "imminent danger" to the public (though it doesn't name those medications, it just makes it possible to designate such medications) and to make it easier for the DEA to leverage the CSA to suspend certain medications that pose a substantial public health risk (though, of course, pharma companies are given the opportunity for remediation with the Attorney General before a drug is actually suspended).  The bill also calls for the Department of Health and Human Services to report back to Congress on law enforcement activities related to patient medication access and, in so doing, consult with every possible constituency and stakeholder on the planet (including tribal law enforcement agencies).

I wonder if anyone in Congress will ever have the courage to do what's actually needed.  Namely:

• Take on the American Medical Association around the issue of mandatory physician education for pain management and opioid prescribing.  The AMA consistently argues such a measure would infringe upon the practice of medicine.  That ship has sailed.  The good doctors want this education and seek it out anyway.  Doctors who either aren't aware of the need for education or are willfully ignorant of best practices in opioid prescribing should be required to engage in such education before prescribing opioids.  
• Provide more federal funding for state level Prescription Drug Monitoring Programs (PDMPs) and additional funding for a fully integrated, national PDMP database.  We're seeing regional efforts along these lines that are promising (see Ohio and Kentucky collaborating on PMIX), but more needs to be done in the areas of standardization, integration, data sharing, access, etc.  The federal dollars currently flowing to these initiatives are minuscule given the severity of the problem.  The Harold Rogers Prescription Drug Monitoring Program and the National All Schedules Prescription Electronic Reporting Act are both under-funded and under-utilized.  California legislators fought tooth and nail over $3 million to fund its CURES database and it's still woefully under-funded and under-utilized. The federal government's FY2015 HHS budget contains $10 million through the Substance Abuse and Mental Health Services to "help state substance abuse authorities develop comprehensive prevention approaches through collaboration with state partners and integration of health information exchange systems with strategic plans."  A) I don't know what that means; B) It's not enough.  
• Leverage data and surveillance from the Medicare and Medicaid programs to identify and deal with high prescribers of opioid medications.  To be fair, the federal government is already working toward this.  See page 73 of the HHS budget overview.    
• Take on the pharma companies through better Congressional oversight of the FDA approval process.  FDA is and should be an independent agency, but serious doubts have been cast regarding the agency's independence and consistency regarding approval of opioid analgesic formulations.  

More needs to be done.  More can be done.  HR 4709 has little chance of moving the needle.  

Michael
On Twitter @PRIUM1

Abuse Deterrent Opioids: Technology vs. Medical Necessity

Last week, the FDA approved Targiniq ER, an extended release / long acting opioid with abuse deterrent properties.  In this case, the Purdue Pharma medication contains naloxone, which blocks the euphoric effects of the oxycodone when the pill is crushed and snorted (or crushed, dissolved, and injected).

I've posted thoughts along these lines before, but I'd like to remind everyone that abuse deterrent opioids are an excellent solution to a limited set of misuse and abuse issues posed by prescription analgesics.

I wish to be perfectly clear on this point: I am 100% supportive of abuse-deterrent formulations of prescription opioids.  These formulations are effective in combating abuse and diversion (at least in the short-term - it seems drug addicts often find a way to crack the code of each newly formulated medication.  But that doesn't mean we should stop trying, nor does it mean we should eliminate the economic incentive for the pharmaceutical companies to develop such technology).

To me, though, this conversation is a distraction.  While eliminating abuse and diversion would be great for the work comp system, these aberrant behaviors are not driving the bulk of the problem.  The vast majority of cases in which PRIUM intervenes involve legitimate prescriptions being taken as prescribed.  Very little pill crushing.  Very little intravenous injections.  Very little drug dealing.

The problem as we see it 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

Utilization Review: Tough Love is Best Practice

[A guest post from David Price, PRIUM's Compliance Counsel.  I'll direct any comments you might to have for response.]

“If you would persuade, you must appeal to interest rather than to intellect.”
                                                                                                            -- Benjamin Franklin

Promoting change is hard.  I feel like it’s particularly difficult in the sphere of workers’ compensation.  Between physicians, injured workers, payers, employers, and attorneys, there are multiple competing interests at stake, and policy makers are hesitant to change the existing laws and risk inviting backlash from the groups that don’t feel like they’re benefiting from the change.  The people that shape workers’ compensation law – whether they’re legislators, administrative officers, or judges -- want to promote the public good, but most importantly, they want to make sure that the system is fair.  They want to make sure that no one is getting cheated.  Once they feel like someone is getting cheated by the law, change suddenly becomes much easier.

When a new law is being discussed, there’s always a temptation for us to discuss only the aspects of the changes that benefit us – to only consider our side of the overall story.  What we say might be true, but it’s not always persuasive, particularly if we don’t discuss how the change will benefit other interested groups.  When we only talk about how the change benefits us, it’s no surprise when some of those other groups start to complain that the change is unfair… or when policy makers start to believe them.

Promoting good policy requires honesty, but more importantly, it requires effective honesty. 

I recently had the opportunity to attend the annual Tennessee Workers' Compensation Educational Conference.  This year, the conference was set up so that audience members could text their comments and questions to the speakers throughout each presentation.  This way, audience members could ask their questions while they were still fresh in their minds, and the speakers could finish their presentations without interruption and then come back to address the questions afterward.  As a bonus, because the comments were submitted anonymously, people weren't afraid to ask questions or offer their perspective on each issue.

For better or worse, there was a lot of honesty in the room.

Dr. Robert Snyder, the Medical Director of the DWC, discussed the DWC's plan to adopt treatment guidelines by 2016.  Additionally, several presenters made reference to Tennessee's current UR process, and there was some brief discussion of what the UR process would look like once the treatment guidelines were implemented.  

The comments from the audience, understandably enough, were more concerned with how UR could be used effectively to reduce medical costs.  Unfortunately, many of the comments were essentially expressions of outrage at the irresponsibility and attitude of entitlement of injured workers.  Commenters made a strong case for how UR (and by extension, the guidelines) could be a useful tool to beat drug-seeking claimants.  That may not have been the most effective form of honesty.

With legislators and workers' compensation judges in attendance, commenters touted UR and the guidelines as purely cost-reduction tools and, at one point, a presenter, in response to a question, made the suggestion that in 2016, adjusters, not UR physicians, should apply the new treatment guidelines, and that any request complying with the guidelines should not be subject to UR.  

The overall message was clear: the point of treatment guidelines is to reduce medical costs.  Since they’re really just a tool for the adjuster to use to “beat” the injured worker, maybe we should let the adjustor apply them directly, without getting a medical opinion.

If you ask any claimant's attorney, they'll tell you that all injured workers (or at least their clients) have a legitimate medical need for whatever treatment their doctors recommend, and that payors are just using treatment guidelines and UR as tools to get out of paying for treatment in order to save money.  UR and treatment guidelines are just tools to “beat” the injured workers -- at least, that’s how they tell the story.  Notably, their version frames UR and treatment guidelines as tools aimed solely at saving payors money.  They do this because they know that if they can show UR and treatment guidelines as being implemented solely to benefit the payor by harming the injured worker, it makes the whole process seem unfair.  Any policy maker with the slightest sense of empathy will try to find a way to undermine or limit application of the guidelines.

So here's where I say something that may be controversial:  The primary goal of UR and evidence-based treatment guidelines is to ensure proper treatment for the patient.  Cost reduction is a bonus -- a secondary effect.

Don't get me wrong: from the perspective of insurance carriers and self-insured employers, cost reduction is going to be the primary goal.  Most payers are for-profit entities, and their focus is (and should be) on reducing costs.  That said, policy makers have a different role.  Their focus should be on the public good, and if we continue to allow the debate to be framed as "patients' medical need vs. payers' bottom line," payors will lose every time.  If we talk about treatment guidelines as something that only benefits payers, we can expect to see those guidelines undermined at every opportunity.

We need to be careful in how we tell the story.

There is a very real public policy battle here, and not just in Tennessee.  In Louisiana, several courts have limited the application of the state's treatment guidelines.  In California, the infamous Dubon decision is being used by injured workers' attorneys as a means to attempt to escape the UR/IMR process.  Oklahoma has implemented a closed formulary based on the Official Disability Guidelines, but the state legislature has effectively limited application of the formulary based on date of injury.  (Only claims under the jurisdiction of the new Workers’ Compensation Commission – those claims with a date of injury of 2/1/14 or later – are subject to the closed formulary).  In multiple jurisdictions, we're seeing judges and other policy makers limit the opportunities to apply objective medical standards.  

Why?  The primary reason is a concern for due process.  At the risk of greatly over-simplifying the points raised in each of these instances, the general underlying concern is that the objective medical standards aren't really objective at all (or at least aren't being applied objectively), and so a "fair" determination of medical necessity can only come from a judge.

Now, in Tennessee, the DWC is planning to adopt treatment guidelines by 2016, but which guidelines will be adopted -- or how they will be utilized -- remains to be seen.  We can be certain that the way we talk about treatment guidelines and the UR process now will greatly affect the way the process is shaped as the guidelines are implemented, and whether or not policy makers see application of the guidelines as an "unfair" intrusion onto injured workers' right to due process.

We can be just as certain that when the guidelines are implemented, work comp and appellate judges will see a host of objections.  No doubt, many of those objections will echo the arguments that have been made in other jurisdictions.

If we talk about treatment guidelines as something designed to benefit only the payer -- and especially if we promote them as something that payers should be able to use without requiring a physician’s opinion (I don’t envy the attorney that has to defend a non-medically-trained adjusters determination that a physician’s recommended treatment isn’t medically necessary) -- we’re buying into a very dangerous story.  It’s the same story every injured worker’s attorney will tell in 2016 when the guidelines are applied.

To be honest, treatment guidelines do reduce overall medical costs, but that's not the whole story.  If that's how we allow the discussion to be framed, we can expect to see more limitations on when and how guidelines are applied -- in Tennessee and elsewhere.

The vital part that’s missing from that story is that, in reality, evidence-based treatment guidelines are designed to benefit injured workers, and that’s precisely what they do.

The reality is that injured workers usually don't know what treatment is appropriate; they only know what their doctors tell them.  The reality is that treating physicians are torn between their duty to help the patient recover as quickly as possible and the lingering financial incentive toward excessive treatment.  The very nature of the workers’ compensation system, and sometimes even the patients, can pressure physicians to treat in ways that contradict their best medical judgment.  At the same time, even the most honest and strong-willed treating physicians are hard-pressed to keep abreast of current medical evidence as they try to operate a successful practice, and many are particularly under-educated regarding the proper prescription of opioids for pain.  The reality is that evidence-based treatment guidelines provide an objective standard of care and, when used correctly, can protect the injured worker from improper treatment, overdose, and addiction.

That's the truth, and that's how we should tell the story.

David
On Twitter @PRIUM1

Senate Bill 526 overwhelmingly passed the Missouri Senate on February 13, (26-7).  Not exactly a predictable outcome based on what we know about Missouri.

The bill calls for the development of a database of work comp claims that could be accessed by employers when hiring job candidates.  It will next be considered by the state House, and if passed the database would be implemented on July 1, 2015.

Creating a database of work comp claims could potentially allow employers to assess in a pre-employment screening process whether their prospective employee has submitted work comp claims.  It’s not the same as asking your age or your marital status that could potentially be used to discriminate, but that past history could certainly influence an employer’s willingness to hire you.  I’m all for transparency in the hiring process so you can make a well-informed decision on a very expensive process.  

Here's the odd part: if Missouri is willing to create this database, why are they unwilling to create a PDMP (prescription drug monitoring program) that could yield very important information about an individual’s entire drug regimen that has potential life and death consequences?  The primary obstacle to the PDMP in Missouri has been state senator Rob Shaaf, who has argued that "letting the government have your very personal and sensitive medical information on a government database, it's just wrong and Big Brother shouldn't have that effect on our lives."  He voted in favor of SB 526, perhaps because the bill includes a provision that requires employee consent for an employer to search the database.  Nonetheless, the database will be contain sensitive information on Missouri citizens, will be run by the government, and will have a much wider potential audience (all employers) than a PDMP (clinicians and law enforcement). 

Still waiting

Michael
On Twitter @PRIUM1

I like David DePaolo.  A lot.  He is a voice of reason in our industry and I've enjoyed his musings, both personal and professional, for years.

But on the issue of urine drug monitoring, I think he's off the mark.  On the one hand, I'm coming at this from an admittedly self-interested perspective (PRIUM is a wholly owned subsidiary of Ameritox), but on the other hand, the context and conclusions of David's recent post on drug monitoring beg for someone to clear up the confusion.

What did he miss?  Nowhere in his piece did he mention that:

• People are dying.  Overdose deaths from prescription opioids now outpace deaths from traffic accidents and have tripled since 1990; 
• The CDC has identified the opioid crisis as an epidemic, a term the CDC does not use lightly; 
• More than 12 million people reported using prescription painkillers nonmedically in 2010; 
• Urine drug monitoring technology is relatively new.  David's quote from the CWCI data that suggests 192X growth in spend on urine drug monitoring in CA doesn't recognize the point at which the health care community sat on the adoption curve for this technology in 2004.  Nor does it recognize that we still didn't realize the enormity of the opioid crisis in 2004.  And don't tell me we knew in 2004 how bad this was going to get.  I came into this industry in 2010 and spent my first two years here at PRIUM trying to convince payers there was an opioid problem in the first place.   
• There's a distinction between point-of-care testing in a doctor's office and reference lab testing. Failing to make this distinction leads the reader to conclude that all inappropriate behavior rests with reference labs and fails to recognize that some physician practices are by themselves driving inappropriate utilization.  Physicians who partner with experienced and capable reference labs that understand payers' perspectives and expectations can help align stakeholders (injured worker, physician, lab, and payer).   
• There are guidelines for the appropriate use of urine drug monitoring and these guidelines are based on risk stratification of the patient.  We follow these guidelines.  We help payers follow these guidelines. Testing beyond the guidelines is as inappropriate as not testing patients that should be tested.  
• Even in light of these guidelines, WCRI data tells us that less than 25% of injured workers on long term opioid therapy are being tested at all.   David states "we know [the guidelines] are specific case recommendations particular to a certain set of medical facts, not to be applied universally."  Agreed.  Perhaps David doesn't realize how many injured workers fit that "certain set of medical facts."  A lot more than he apparently realizes.  
• Not all companies offer direct financial incentives to physicians.  He lumps an entire industry together and does so just a couple of paragraphs after he details that Millennium's practices were found by a jury to be illegal and that all counterclaims against Ameritox were dismissed.  Perhaps David missed the most important take-away: there's at least one company trying to do it right. 

Bottom line: what David blithely dismisses as "nonsense" is, in fact, a critical patient safety tool, a mechanism for effective claims management, and a necessary application of clinical technology that isn't going anywhere. To suggest otherwise in light of the largest man-made epidemic in the history of the world is simply irresponsible.  

Michael
On Twitter @PRIUM1

CDC Reports: First Substantial Decline in Overdose Deaths in any State in the Last 10 Years

New reports from the CDC show that progress is possible in the fight against prescription drug misuse and abuse.  Highlights from each of two reports released yesterday:

From Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines:
States can take other actions that will affect prescribers. Developing or adopting existing guidelines for prescribing OPR and other controlled substances can establish local standards of care that might help bring prescribing rates more in line with current best practices. State Medicaid programs can manage pharmacy benefits so as to promote cautious, consistent use of OPR and benzodiazepines. In addition, a number of states have passed laws designed to address the most egregious prescribing excesses. Florida, for example, enacted pain clinic legislation in 2010 and prohibited dispensing by prescribers in 2011. It subsequently experienced a decline in rates of drug diversion (17) and a 52% decline in its oxycodone overdose death rate (18). Guidelines, insurance strategies, and laws are promising interventions that need further evaluation.

And from Decline in Drug Overdose Deaths After State Policy Changes, Florida 2010-2012:
This analysis showed that policy changes in Florida were followed by declines in the prescribing of drugs, especially those favored by Florida prescribing dispensers and pain clinics, as well as by declines in overdose deaths involving those drugs. Florida has reported that approximately 250 pain clinics were closed by 2013, and the number of high-volume oxycodone dispensing prescribers declined from 98 in 2010 to 13 in 2012 and zero in 2013 (2). Law enforcement agencies in Florida also reported that rates of drug diversion (i.e., channeling of prescription drugs to illicit markets) declined during 2010–2012 (6). Preliminary data for the first half of 2013 from the FMEC indicate a continued decline in oxycodone and alprazolam overdose deaths (4). These changes might represent the first documented substantial decline in drug overdose mortality in any state during the past 10 years.


Progress is possible.  Guidelines, insurance strategies, regulatory/legislative action, and common sense education are the keys to mitigating this epidemic.  The CDC reports yesterday put data behind what we already knew to be true.

Michael
On Twitter @PRIUM1