Naloxone, Fences, and Ambulances

[The following is a guest post from PRIUM's General Counsel, Ben Roberts]

Every day we are hearing more news and reporting on the “anti-overdose” drug Naloxone. Just looking at my Google feed this morning I see articles from Maine, West Virginia, Pennsylvania, and Virginia discussing legislation and it widespread use.

Last year, New Jersey passed the Overdose Prevention Act which permits broader access to naloxone and provided criminal and civil protections for those who administer it.

The Governor of West Virginia is about to sign SB 335  which allows medical responders and law enforcement to carry naloxone as well as allows physicians to prescribe the drug to those at risk of an overdoes as wells as their family and friends.

Many more state have passed and proposed similar legislation.

I think that these efforts should be applauded.  Given the state of the prescription drug epidemic, overdose prevention is something that should be on every legislative agenda this year.  But when I see these reactive approaches to public health issues I can’t help but be reminded of a poem from my childhood. 

In Joseph Malines “The Fence or the Ambulance” a great debate arises in a community about their own “public health” issue:

Twas a dangerous cliff, as they freely confessed

though to walk near its crest was so pleasant

But over its terrible edge there had slipped a duke and many a peasant

So the people said something would have to be done

But their projects did not at all tally

Some said, "Put a fence around the edge of the cliff"

Some, "An ambulance down in the valley.”

The poem continues with the community making the choice of the ambulance over the fence.

'For the cliff is all right if you are careful,' they said,

"And if folks even slip or are dropping

it isn't the slipping that hurts them so much

as the shock down below when they're stopping."

…

Then an old man remarked: "It's a marvel to me

that people give far more attention

to repairing results than to stopping the cause

when they'd much better aim at prevention

…

if the cliff we will fence, we might also dispense

with the ambulance down in the valley.

Overdose prevention, like abuse deterrent formulations of opioids is a positive step, but legislators need to be focusing on proactive steps to help avoid this problem and stem this epidemic.

Ben Roberts

Ben is PRIUM's General Counsel.  You can follow him on Twitter @WC_Compliance

As always, you can follow PRIUM @PRIUM1

Non-medical Use and Addiction: Distinctions in the Opioid Crisis

A new study coming out soon in the Annual Review of Public Health attempts to reframe our discussion regarding the opioid crisis.  Often, we focus attention on nonmedical use of opioids.  Those of us in the insurance world know that while nonmedical use is a serious societal issue, it's only one part of the opioid problem.

From the study (among the authors of which is Andrew Kolodny, one of the most well known and recognized voices of reason in the public dialogue around the opioid crisis):
"Policy makers and the media often characterize the opioid crisis as a problem of nonmedical opioid pain reliever abuse by adolescents and young adults.  However, several lines of evidence suggest that addiction occurring in both medical and nonmedical users, rather than abuse per se, is the key driver of opioid-related morbidity and mortality in medical and nonmedical opioid pain reliever users."  

This distinction is critical because it focuses our attention, our resources, and our solutions in a different direction (or, at least, in more directions) than if we were to simply assume that opioid overdose deaths are driven by diversion, misuse, and abuse among young people.

The reality is that there are likely as many as 5 million people in this country addicted to prescription opioids and as many as half of them are receiving legitimate prescriptions from legitimate doctors for legitimate pain.  Not all chronic pain patients on long term opioid therapy will exhibit drug seeking or otherwise aberrant behavior.

Another important insight from the paper is the analogy that Dr. Kolodny and his colleagues draw between the methods of combating other public health crises and the approach we should consider taking toward the opioid crisis:
"... our purposes is to demonstrate that prevention strategies employed in epidemiologic responses to communicable and noncommunicable disease epidemics apply equally well when the disease in question is opioid addiction.  Interventions should focus on preventing new cases of opioid addiction (primary prevention), identifying early cases of opioid addiction (secondary prevention), and ensuring access to effective addiction treatment (tertiary prevention)."  

We have a long way to go in all three categories, but papers like this push our collective thinking in the right direction.  Worth a read.

Michael
On Twitter @PRIUM1

Zohydro Is Now Abuse-Deterrent... And It Doesn't Matter

Zogenix, the makers of Zohydro - the first "hydrocodone only" opioid analgesic - announced last week that the FDA has approved a new formulation of Zohydro that now includes abuse-deterrent technology.  For frequent readers of the blog, here's a warning: I'm about to repeat myself.  For what must be the fourth or fifth time in the past year.  That said, I will continue to repost these thoughts on abuse deterrent opioids every single time one is approved.

So... once again, here's your friendly public service announcement:

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

The New Mexico Marijuana Case is Even Weirder Than You Think

Of all the states, who would have guessed that New Mexico would be the hotbed of medical marijuana court decisions?  Between the Vialpando v. Ben’s Auto. Servs., in May and the Maez v. Riley Industrial case, handed down earlier this month, New Mexico’s Court of Appeals appears to be one of the most pro-marijuana courts in the nation.

Back in May, when I first wrote about this issue, I wondered why the reasonableness and the necessity of the marijuana treatment was not questioned and our corporate counsel told me that surely there be additional case law to clarify this issue. 

Sure enough, the Court in Maez decided to take on the issue of the reasonableness and necessity of the marijuana treatment.  Mr. Maez suffered from an industrial accident and was being treated by Dr. Reeve.  Dr. Reeve had prescribed a variety of medications including several opioids and, as required for patients on long term opioid therapy, performed regular urine drug tests.  During one of those tests, Mr. Maez tested positive for marijuana.  Typically, recreational marijuana use, or the use of any illicit substance raises red flags with the prescriber.  But not Dr. Reeve! 

Dr. Reeve informed Mr. Maez that if he was going to use marijuana, he needed to have a medical marijuana license.  Luckily for Mr. Maez, Dr. Reeve was happy to provide him with one.  According to Dr. Reeve, “patients are going to use cannabis either one way or the other . . . if a patient requests that I sign [a license], I will sign it . . . but I’m not recommending . . . or in any way advocating for the use of medical cannabis.”  Dr. Reeve also considers the use of medical marijuana to be the patient’s decision “as it’s private and voluntary and it’s not overseen by a physician.”

So the guy ended up on a medical marijuana regimen due to a failed drug test.  That should be sufficient for the Court to find in favor of the payer, right? 

Nope.  And it gets worse. 

The Court went on to rationalize and interpret Dr. Reeve’s actions as reasonable and necessary stating that “[Dr. Reeve] adopted a treatment plan based on medical marijuana.  He would not have done so if it were an unreasonable treatment.”  Imagine if that logic was applied to all work comp medical treatment.  The doc says it’s reasonable… so it is.  State statutes and regulations have been evolving for over a decade to specifically counter this argument.   But not in New Mexico.    

And it gets even worse.

To take this determination one step further, since the physician said that it is Mr. Maez's decision to use medical marijuana, the Court, by default, has determined that the self-directed use of marijuana by this injured worker is reasonable and necessary because the physician signed off on it.  This is patient-directed care at its absolute worst. 

So, to recap what led to this decision: Illicit drug use, perpetrated by the injured worker, condoned by the doctor, and supported by a court of law.

I wish I could tell you that marijuana should be the least of your concerns, but if this is the specious logic to which we’re beholden… we’ll need better guidelines, better tools, and better lawyers.

Michael

On Twitter @PRIUM1

Smoking, Obesity, Mental Illness and Chronic Pain

A study published late last year (but which I just now got around to reading...) establishes a clear link between smoking and chronic back pain.  I know what you're thinking: file that under "stuff we already knew and didn't need an academic study to prove."  But this study is interesting not simply because it establishes a link we all observe daily in workers' compensation claims management; it also focuses on the underlying mechanism that associates the behavior of smoking and the condition we know as chronic back pain.

The study concludes that the risk of sub-acute back pain progressing to chronic back pain is 3X greater among smokers vs. non-smokers.  Further, the subjects were subjected to functional MRI scans and it turns out that the relationship between smoking and chronic back pain is "mediated by corticostriatal circuitry involved in addictive behavior and motivated learning."  I don't know what that means, exactly, but it's clear that smoking wires the brain in such a way that chronic pain becomes a common outcome of acute injury.

Here's the hard question: What can we do about it?  If we know, objectively, that the likelihood of a workplace injury developing into chronic pain is significantly increased due to smoking... what are our options?   Some of you have access to fancy algorithms (or predictive models, I think you call them) that will tell you to put a case manager on a claim like this right away.  And I think that's great.  But what options does the case manager have?

I'm asking because I think this is one of three fundamental issues the workers' compensation medical management world is going to deal with over the next five years.

• How do we deal with chronic pain in light of smoking?
• How do we deal with chronic pain in light of obesity?
• How do we deal with chronic pain in light of mental/behavioral illness?  

Most of you are dealing with claims wherein all three of these crucial questions have come together in a perfect storm of complexity, confusion, and cost.

So...
How do we (legally) avoid hiring high risk people in the first place?
How do we prevent them from getting injured once we do employ them?
And the hardest question of all: How do we fix them once they're injured?

We spend so much time focused on the last question.  The answers are hard to devise and even harder to implement.  I suppose the least we can do is put some focus on the first two questions in an attempt to limit the number of times we have to find answers to the third.

Michael
On Twitter @PRIUM1

Physician Dispensing: I've Changed My Mind

In the past, I've argued that there are legitimate reasons a doctor might dispense medications to a patient and that legislative and regulatory efforts to curb abuses of physician dispensing should be focused on the elimination of the financial incentive to do so while preserving the practice for the limited circumstances in which it might be necessary.

I've changed my mind.

The WCRI report published this week makes it crystal clear that the creativity of physician dispensers will always lead to maximization of revenue (and clearly inappropriate utilization of medications) unless the practice itself is eliminated.  Essentially, drug re-packagers in California created novel dosages of certain medications in order to evade the constraints of the physician dispensing regulations.  This allowed them to return to the typical physician dispensing practice of creating new NDC codes and charging exorbitant amounts of money for drugs that would be have been substantially cheaper had they been secured through a retail pharmacy.  Worse, utilization of these medications sky rocketed as a result of the physician revenue incentive (my conclusion, not WCRI's).

Physician dispensing doesn't make sense.  Not in any circumstances.  I could see a potential allowance for a one-time, short-term fill, but the routine dispensing of medications by physicians to patients should be banned.  Immediately.

Michael
On Twitter @PRIUM1

(Disclosure: PRIUM, and our parent company Ameritox, provide financial support to WCRI).

Drug Distribution: Friends in High Places

Here's the simple version: a drug is discovered, researched, and developed by a pharmaceutical company.  The company takes a new chemical compound from the work bench of a scientist through the various stages of animal testing and then through phases I, II, and III (and sometimes IV) trials mandated by the Food and Drug Administration before a drug is approved.  This process is expensive, takes a long time, and is fraught with risk.

But have you ever wondered how a pill gets from the pharmaceutical company to your local pharmacy?  Who handles that part of the value chain?  Turns out this is, by itself, a multi-billion dollar industry called "drug distribution" and it's dominated by two very large firms, McKesson (#15 on the Fortune 500 list with $122 billion in revenue) and Cardinal Health (#22 on the Fortune 500 list with $101 billion in revenue).  

And with the responsibility for drug distribution comes the risk of law suits connected to prescription drug misuse and abuse.  

A judge in West Virginia has just decided to allow a lawsuit against drug distributors to move forward, overruling objections from the companies (thanks to Alix Michel for the tip).  The companies sought to have the suit dismissed on the grounds that, among other things, they hadn't broken any laws in the state of West Virginia.  Boone County Judge William Thompson ruled that the two state agencies bringing the suit, the Department of Health and Human Resources and the Department of Military Affairs, have the right to sue.  The suit alleges that the drug distributors did not have proper diversion-prevention programs in place and turned a blind eye to suspicious orders from local pharmacies for prescription opioids, thus fueling the epidemic of prescription drug misuse and abuse in West Virginia.  

When I got to the list of drug distributors associated with the suit, I scanned the list for McKesson and Cardinal.  They were conspicuous in their absence.  

So I kept reading... 

The state agencies actually asked the West Virginia Attorney General to add McKesson to the law suit.  He declined to do so based on the state's "ongoing investigation" into McKesson.  Cardinal is part of a separate law suit (the article doesn't disclose how it's different).  That seemed odd to me.

So I kept reading... 

Turns out the AG used to be a lobbyist for McKesson in DC and his wife was a lobbyist for... you guessed it... Cardinal. 

You can't make this stuff up.  

Michael
On Twitter @PRIUM1

Another New Opioid: Cheeky, This One

Yesterday, I wrote about generics and the distraction of cheap, but still potentially dangerous, medications.  Never fear: there's always an expensive new brand name drug with which to contend.

On December 23, Endo Pharmaceuticals put out a press release announcing that the company has filed a New Drug Application with the FDA for Buprenorphine HCI Buccal Film for the "management of pain severe enough to require daily, round the clock, long-term opioid treatment and for which alternative options were inadequate" (the precise language required on the labeling of any extended release/long acting opioid).  The buccal film will be a strip placed on the inside of the patient's cheek.

According to Endo, this medication is a "partial opioid agonist and a potent analgesic."  Let's break those phrases down so you know what you'll be dealing with if this gets approved.

A partial opioid agonist means that although buprenorphine is an opioid, and thus can produce effects similar to other opioids (more on that next), its effects are less than those of "full agonists" like heroin or methadone.  Many of you will recall buprenorphine as a primary ingredient of Suboxone, a medication indicated for helping patients wean off of other opioids.

But Endo isn't intending this medication to assist in the weaning process.  Rather, Endo is also describing this as a "potent analgesic," with all of the issues associated with other long acting opioids.  The press release does say that the medication demonstrated a "low incidence of typical opioid like side effects."  No mention of the specific side effects or what "low incidence" actually means.

Next, look for the marketing folks to put an inspiring and cool-sounding trade name on this.  For now, we have Exalgo... Nucynta...  Opana... Zohydro... Hysingla... Palladone... This list would be hilarious if it wasn't so tragically true.

Any guesses for this new one?

Michael
On Twitter @PRIUM1

Generic Drugs Are Not the Answer

I've written on several occasions that I believe abuse-deterrent opioids to be a potentially dangerous distraction.  Specifically, I've said:

I am 100% supportive of abuse-deterrent formulations of prescription opioids.  To me, though, this conversation is a distraction. 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.  

We saw in 2014 a plethora of drug trend reports noting cost savings associated with generic medications.  We'll see more of the same in 2015.  Like abuse-deterrent technology, generic medications represent a potential Pyrrhic victory in the battle against misuse and abuse of prescription drugs.  Yes, we're saving money.  No, we're not really solving the problem.  Here's a reprise of the language above with GENERIC substituted for ABUSE-DETERRENT.

I am 100% supportive of GENERIC formulations of prescription opioids.  To me, though, this conversation is a distraction. The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is GENERIC 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.  GENERICS [are] great, but if we focus on GENERICS over medical necessity, we will have missed the mark and the crisis will continue.  

Don't let a single digit % drop in drug costs fool you.  There is a lot of work to be done.  Cheap drugs can still be dangerous drugs.

Michael
On Twitter @PRIUM1

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