The Research is Catching Up to our Experience

I see a theme among recent posts: pointing to new research that confirms things we already knew because we see them in claims every day.  This is good news.  The science is catching up to our practical experiences with opioids, addiction, and chronic pain.

The latest confirmation comes from the Cleveland Clinic.  In an article published in the Journal of Pain late last year, researchers assessed the likelihood of opioid abuse based on past history of non-opioid substance abuse.  For those of us close to complex chronic pain cases, we know that a history of, say, alcohol abuse, is correlated with opioid abuse.  But until now, we didn't have compelling data from peer reviewed literature to back our intuition.  Granted, cross-substance abuse is a well known research area... but this study focused specifically on opioids among patients with chronic, non-cancer pain.  

Among other important conclusions, here's what I thought was most important: In a pain rehab program, participants with a history of a nonopioid substance use disorder had 28 times the odds of having an addiction to prescribed medications.   

What does this mean for you?  

1. Every injured worker, every claim, every doctor... must have an opioid risk assessment performed prior to any potentially addictive prescriptions are written.  
2. Doctors must be educated on how to interpret the opioid risk assessment and use it to tailor treatment to the individual needs (and risks) of the injured worker.  

Failure to complete these two steps will invite tragedy.  

Michael
Follow us on Twitter @PRIUM1 

Opt Out: A Tale of Two Tweets

[A guest post from Ben Roberts, PRIUM's General Counsel]

When I checked my twitter feed one morning last week, two tweets caught my attention:

1. ARAWC: Tennessee Legislators Introduce Workers’ Comp Option Legislation http://goo.gl/fb/Wt7hWh 

2. Supreme Court Asked to Review Constitutionality of Opt-Out Process. Full story at: http://ow.ly/JeAlt 

I find the juxtaposition interesting: Tennessee legislators are trying to create an opt-out process in their state; meanwhile, attorneys in Oklahoma are trying to undo their opt-out process by challenging its constitutionality.  

Oklahoma’s opt-out provision was created by the passage of SB 1062 in 2013 and, at the time, several constitutional challenges were made.  But now a group of attorneys is again taking the constitutional challenge directly to the Oklahoma Supreme Court, hoping to have the opt-out provision struck down. 

The Tennessee legislation, SB 721, requires employers who choose to opt-out of the system to set up their own plans meeting certain requirements.  This is similar to the opt-out provision in Oklahoma, and while we haven’t heard any constitutional objections from Tennessee, I am sure they will follow.

It appears as though OK and TN are trying to replicate the results of Texas -- the only other state that permits “opting-out”.  The Texas non-subscriber provision has been in place for nearly 100 years, and many companies have seen significant cost savings and better claim outcomes in that state.

The goals associated with providing employers with the option of opting out are well outlined by the Association for Responsible Alternatives to Workers’ Compensation (ARAWC):

• An Option can reduce the overall costs of treating employee injuries and support local job growth and economic development.

• An Option can deliver better medical outcomes and higher satisfaction for injured workers.

• Employers in Option states see significant savings and improved medical outcomes.

But, these changes aren’t made overnight.  

I often equate making changes to the workers’ compensation system to changing a tire on a moving vehicle.  The solution has to fit an ever-changing system.  It’s not something that can be done easily, and in order to be successful, it must be well thought out, well planned, and well executed.

Ben Roberts

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

As always, you can follow PRIUM @PRIUM1

The Right Target in Chronic Pain Cases: The Brain

Need convincing that the key to chronic pain management lies in behavioral health?  NPR has a great piece today on the human brain's ability to deal with pain signals and what this might mean for chronic pain management.

"The brain also determines the emotion we attach to each painful experience, Linden says. That's possible, he explains, because the brain uses two different systems to process pain information coming from our nerve endings.

One system determines the pain's location, intensity and characteristics: stabbing, aching, burning, etc.

"And then," Linden says, "there is a completely separate system for the emotional aspect of pain — the part that makes us go, 'Ow! This is terrible.' "

Linden says positive emotions — like feeling calm and safe and connected to others — can minimize pain. But negative emotions tend to have the opposite effect." 

The article also references a study published in 2011 that found 8 weeks of "mindfulness" practice appeared to enhance a subject's ability to manage pain.

These articles and studies add to a growing body of evidence that suggests that when workers' compensation payers ignore the link between behavioral health and chronic pain, they do so at their own peril.  We must begin to routinely incorporate these modalities into chronic pain care, at every stage of the claim.  We have to stop being scared of psych diagnoses and begin addressing the route causes of chronic pain.

If you're focused on relief of non-specific low back pain and ignoring what's going on in the injured worker's brain (including the injured worker's emotional state), you're shooting at the wrong target.

Michael
On Twitter @PRIUM1

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