What Primary Care Docs Don't Know Can Hurt You

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

First, the good news:

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

However, the survey also uncovered significant gaps in knowledge among primary care docs:

• About one-third said they thought most prescription drug abuse occurs by means other than swallowing the pills.  (In fact, crushing/snorting/injecting/etc. happens with far less frequency than simple ingestion.  Multiple studies suggest ingestion accounts for anywhere from 64% to 97% of prescription drug abuse.) 
• Almost 50% believe that abuse-deterrent pills are less addictive than the standard formulation. (In fact, there's absolutely no difference.)  

This last data point is scary.  To me, it shows the success that pharmaceutical companies are having in creating a "halo" of safety around new abuse-deterrent formulations.  There is no "halo" and there's still a great deal of harm that can occur with the use of these medications.  

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

Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue. 

Michael 

On Twitter @PRIUM1

Will Robots Change Work Comp?

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

The Robots are Coming

How Technological Breakthroughs Will Transform Everyday Life

by Daniela Rus (Professor of Electrical Engineering and Computer Science and Director of the Computer Science and Artificial Intelligence Lab at MIT)

Will Humans Go the Way of the Horses?

Labor in the Second Machine Age

by Erik Brynjolfsson (Professor of Management Science at MIT's Sloan School of Business) and Andrew McAfee (Principal Research Scientist at MIT's Sloan School of Business)

Same as It Ever Was

Why the Techno-optimists Are Wrong

by Martin Wolf (former World Bank economist and chief economics commentator for the Financial Times)

The Coming Robot Dystopia

All Too Inhuman

by Illah Reza Nourbaksh (Professor of Robotics at the Robotics Institute of Carnegie Mellon University)  

The Next Safety Net

Social Policy for a Digital Age

by Nicolas Colin (former senior civil servant in the French ministry for the Economy and Finance) and Bruno Palier (CNRS Research Director at the Center for European Studies)

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

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

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

Happy reading.

Michael

On Twitter @PRIUM1

A Consequence of a Compensable Injury

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

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

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

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

That's crazy.

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

Michael
On Twitter @PRIUM1

The Pen, the Price, the Panacea?

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

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



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

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

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

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

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

Michael
On Twitter @PRIUM1

Cognitive Therapy, Cognitive Dissonance

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

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

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

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

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

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

Michael
On Twitter @PRIUM1

Opana, HIV, and Unintended Consequences

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

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

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

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

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

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

We have a long way to go.

Michael
On Twitter @PRIUM1

A Warning to Work Comp Payers

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

Here's my post from May 25, 2012:

We Know Too Much: New Liabilities Associated with Opioid Abuse

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

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

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

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

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

Let's get to work.

Michael

On Twitter @PRIUM1

Two Reasons You Should Care About Hepatitis C

Let's talk about Hepatitis C for just a moment.  

Hep C is a disease of the liver.  It can be mild, nearly asymptomatic... or it can be a lifelong battle, requiring a potential liver transplant.  Hep C isn't genetic or environmental - rather, it's contagious. The virus is spread when the blood of someone with Hep C enters the body of someone who is not infected.  The two most common methods of transmission both involve needles and both impact workers' compensation: 1. accidental needle stick injuries in a health care setting; 2. the sharing of needles and syringes among drug addicts.  

Regarding injuries to healthcare workers... while most payers won't see many Hep C cases that are work comp related, it's best for payers to be prepared if and when a case does arise.  Why?  Because treatment is both complex and enormously expensive.  The recently released Drug Trends Report from pharmacy benefit manager Healthcare Solutions has an excellent section on specialty drugs and a very informative sub-section on Hep C.  "The new Hepatitis C medications, such as Harvoni, Olysio, and Sovaldi, have a treatment success rate of 94-100%, or double that of previous therapies," says the report. "These medications cost $90,000 to $226,000 for a 12 to 24 week course of therapy.  Effectively, a client with a $1 million drug spend could experience a 2% increase in overall drug spend with one claimant receiving these medications." (Emphasis added).  

Regarding Hep C transmission among drug abusers... the CDC's Morbidity and Mortality Weekly published a piece on Friday regarding the growth of Hep C in Kentucky, Tennessee, Virginia, and West Virginia.  Surveillance data from these four states showed a 364% increase in Hep C cases from 2006 to 2012 among persons <= 30 years of age.  This rise was strongly correlated with opioid misuse and abuse rates as well as substance abuse treatment admissions.  While I've often pointed out that the work comp population is not a primary driver of the type of drug abuse that involves drug tampering and needle sharing, we should nonetheless recognize that work comp is a significant source of diversion (both intentional and unintentional), and therefore the drugs being paid for by work comp payers are, at some level, likely contributing to the rise in Hep C cases.

Hep C is complicated and expensive.  Two lessons for payers:

1. When a work-related Hep C case pops up, put your best clinical resources to work on that claim to ensure prompt, appropriate, adherent, and thorough care; 
2. Make sure you're doing everything you can to stem the tide of prescription drug misuse and abuse. 

Michael   

Follow me on Twitter @PRIUM1

   

Free Speech, FDA, and Short Selling

I was entertained by an article this morning on workcompcentral regarding a drug manufacturer that is suing the FDA for infringing its right to free speech.  Amarin Pharma is upset that it cannot market its fish oil drug for "off-label" uses.  You can't make this stuff up.

A quick refresher (admittedly oversimplified) on the FDA's role as a regulatory body:  A drug manufacturer discovers (or purchases) a chemical entity which they believe has a therapeutic benefit for a particular disease state.  The drug manufacturer runs studies (typically across three phases) to test both the safety and efficacy of the chemical entity for that specified disease state.  Application is made to the FDA and the FDA evaluates all of the evidence.  If the application is approved, the FDA mandates that the drug only be marketed to doctors, patients, and other stakeholders for the specified disease state on which the research and development were conducted.  The FDA does this through the drug's "label" and any marketing for uses not contained on the label (or "off-label" uses) is a violation of federal law.  

So... if you come up with a drug to manage, say, prostate enlargement... and you conduct years worth of studies on the safety and efficacy of the drug for prostate enlargement... and it turns out, after all that, the drug is also causing men with male pattern baldness to grow new hair... you can't simply change your mind and market the drug for male pattern baldness instead of prostate enlargement.  You have to go back through the phase I, II, and III development process (or, at least, recast the data drawn from those studies) to create sufficient evidence for FDA approval to allow you to market the drug for that purpose.  (This actually happened, by the way.  Ever heard of Propecia?)

The argument being made by Amarin is a great example of unintentional comedy: they feel their free speech rights are being infringed because the off-label uses which they'd like to communicate are "truthful" and "non-misleading."  They should be able to market fish oil for off-label usage... because it really works... trust them.

This comes down to a fundamental question of regulatory oversight:  "Truthful" and "non-misleading" according to whom?  

This is why the FDA exists.  I have been a vociferous critic of the agency for its lack of consistency, its approval of questionable medications, and its lack of emphasis on the public health effects of its approval process.  But I have never questioned the necessity of a third party regulatory agency intended to protect Americans from potentially delusional and dangerous claims of safety and efficacy from the pharmaceutical industry.

By the way, Amarin is publicly traded (NASDAQ: AMRN.)  My investment advice is worth exactly what you're paying for it... but I might think about a short position on any company willing to waste money on this kind of frivolous lawsuit.

Michael  

A Legal Challenge to Prescription Drug Monitoring Databases?

Dr. Alwin Lewis was investigated by the Medical Board of California because of an odd diet he had apparently advised patients to undertake.  (The “five bite” diet… don’t eat breakfast, then eat five bites of food for the rest of the day.  I would have demanded an investigation, too.)  During the course of the investigation, the Medical Board uncovered inappropriate prescription patterns in California’s PDMP (the CURES database).  The Medical Board found that he had kept poor medical records and had over-prescribed medications to two patients.  He was placed on three years’ probation. 

And that’s when all heck broke loose…

Dr. Lewis took the case to court, arguing that the Board had gone too far in using information from the PDMP against him.  There’s a lot of confusion here, even by California standards.  Here are some key points to keep in mind:

First, the ACLU, civil rights attorneys, the California Medical Association (CMA), and several other groups are making a lot of noise about this case.  All of them are trying to push this issue far beyond the scope of the challenge that is actually being raised by the Dr. Lewis.  If Lewis prevails, the result will be a revision of the Medical Board’s investigation/disciplinary process, not an invalidation of the CURES statute.

Second, this case is not about protecting patients’ privacy; it’s about protecting patients’ privacy when doing so protects the doctor from a Board investigation.  Lewis has made it clear that this is not a facial challenge to the CURES statute; in fact, he concedes that in most instances, such as in an administrative audit of a pharmacist (but not a physician), pulling a patient’s prescription info is constitutional.  His position is that when a CURES audit is performed “for the express purpose of investigating physician practices,” the auditor should not be able to access patient records without a subpoena, warrant, or good cause.

Third, it’s also about protecting the doctor’s right to privacy.  Lewis is arguing that he has a direct, personal, right to privacy in regards to his prescribing patterns, and that the Board violated that right when they performed the CURES audit of his prescribing history without an administrative subpoena.  While that may sound like a terrible argument, this is California, and so there is actually appellate case law that supports him on that point.  This is actually a central theme in his petition.  He argues that when a pharmacy auditor looks at the medications dispensed to a patient by that pharmacist, neither the rights of the pharmacist nor the rights of the patient are violated; when a physician auditor views the medications prescribed to a patient by that physician, both the rights of the patient and the rights of the prescriber are violated.  Makes complete sense, right?  

The Board’s conduct – however excessive – was aimed at protecting patients.  The PDMP rules are aimed at protecting patients.  The only real danger to the patients’ interests came from the guy that is now trying to pose as their protector in order to get out of a disciplinary action. 

This case, regardless of what you might read elsewhere, shouldn't have a significant impact on PDMP use in California or any other state. 

Michael
Follow us on Twitter @PRIUM1 

A Terrible Excuse for a Formulary

I'm sitting in New Orleans, Louisiana at the annual RIMS conference and right down the road in Baton Rouge, the state is about to do something that will put a lot of injured workers at risk.  Ironic, right?

Louisiana Senate Bill 256 is scheduled for a hearing at 10 am central tomorrow.  I hope someone at that hearing points out the following:

1) Evidence based medicine isn't produced by a panel.  The bill calls for a panel (made up of one doctor and four pharmacists) to meet regularly and, by majority vote, decide what changes should be made to the formulary.  This is an awful idea.  Evidence based medicine is developed through peer reviewed research and should be adopted as the evidence dictates, not according to a majority vote.  For a brief glimpse into how guidelines adoption by committee works (or, rather, doesn't work) in Lousiana, check this out.

2) But should the state insist on a committee, we need to move beyond a single doc and four pharmacists.  Where is the voice of the employer on this proposed panel?  Where is the voice of the injured worker?  Wh y does a single doc and four pharmacists get to decide?

3) Worst of all... and the point that will lead to the greatest risk to injured workers... and the part of the bill that shows how very little its authors know about medical management: All "non-narcotic drugs" will be approved and not require pre-authorization.  Since when are narcotics the only dangerous drugs in work comp?  Hydrocodone might require authorization under this bill, but injured workers can have all the benzodiazepines, antidepressants, antipsychotics, anticonvulsants, sleep aids,  muscle relaxants, etc that they'd like.  The distinction between drugs that require authorization vs those that do not shouldn't be based on the drug's class.  Rather, good formularies assess the appropriateness of a given medication for first line therapy, regardless of class.  The approach outlined in SB 256 is worse than silly; it's dangerous.

A closed formulary is a great idea in concept and I genuinely hope to see Louisiana adopt one.
Just not this one.

Michael
Follow us on Twitter @PRIUM1

The Worst Kind of "Whack-a-Mole"

I've heard the "whack-a-mole" analogy applied to nearly every facet of business.  Frankly, it's a tired and worn out analogy.  But it's also an image that paints a clear picture of a common issue and, thus, we can't seem to escape its constant use.  We're always solving one problem only to create a myriad of unanticipated and unintentional consequences that require ever greater effort to address.  Hit one "mole" on the head and another quickly pops up elsewhere to take its place.

Yesterday, the Journal of the American Medical Association released a study that highlights the worst kind of "whack-a-mole" imaginable.

The good news: After the introduction of an abuse deterrent formulation of Oxycontin and the discontinuation of propoxyphene in the latter half of 2010, overall opioid prescriptions appear to have declined 19% vs. where we would have expected them to be.  Mind you, that's not a 19% reduction in scripts; rather, it's a 19% reduction vs. a statistical forecast of a line that was trending up.

So where did the next mole pop its head up?

During the same period, there was a 23% increase in heroin overdose.  

We can add this to the list of reasons abuse deterrent opioids are not the answer.

The study does not establish a causal link between the reduction in opioid scripts and the increase in heroin overdoses, but this phenomenon has been a recurring theme in various reports and studies across the country for some time now.  When Massachusetts Governor Deval Patrick declared a public state of emergency in March of 2014, he cited both prescription opioid abuse and heroin overdoses as grounds for his decision.  Is it any wonder that just a week later, Blue Cross Blue Shield of Massachusetts released an 18 month "check up" on its first-in-the-country program requiring pre-authorization for prescription opioids?  In it, BCBS brags that, starting in July 2012, they decreased claims for short acting opioids by 20% and long acting opioids by 50%.  And yet, the Governor is declaring a state of emergency in early 2014?  Could that be due to at least some portion of BCBS members whose Oxycontin was cut off turning to cheap street drugs?  Perhaps because the insurer, in an effort to stem the tide of prescription drug spend (instead of prescription drug abuse) failed to address the underlying medical issues faced by its members?

PRIUM's own parent company, Ameritox, produced a very compelling piece of research based on our own data that shows:

• 4 out of 5 heroin users abused prescription drugs first
• 56% of the time, in heroin positive samples, the opioid prescribed to the patient was not found
• 66% of heroin users abused both heroin and prescription painkillers in the last month

The most cynical among us in workers' compensation will think (though never say publicly), "Fine with me.  I'm not paying for heroin and I can either settle or cease benefits on this claim with relative ease."  

Those of you that care about injured workers will see this data for what it really is - a warning.  A warning that we must be careful and measured and caring in our approach to issues of prescription drug misuse and abuse in workers' compensation. 

We haven't really solved a problem until we've addressed the underlying issues of dependence and addiction.   

Michael
Follow us on Twitter @PRIUM1 

Don't Be Fooled: Abuse Deterrence Isn't the Answer

One of the consistent themes of this blog is a critique of abuse deterrent formulations of opioids.  While absolutely necessary as one tool among many to stem the tide of prescription drug misuse and abuse, such technology runs the risk of creating a perception of safety among both patients and prescribers that is downright dangerous.

The best discussion I've seen on the topic came out last week on Forbes.  In an article and video by Matthew Herper, the pros and cons, risks and rewards of abuse deterrent opioids are covered quite thoroughly.  The video, in particular, is worth 5 minutes of your time.

And, of course, I would never miss a chance to restate my own position on the matter:

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

@PRIUM1 on Twitter

The Fight Comes to My Own Back Yard

Fulton County, Georgia has filed a lawsuit against several of the major drug distribution companies (McKesson, Cardinal, etc.) seeking damages related to the prescription drug abuse epidemic.  I haven't read the full court filing, but it appears this action is similar to West Virginia's approach (i.e., to sue the distributors and not the manufacturers, as the City of Chicago and Orange/Santa Clara Counties in California chose to do).

This suit is interesting for two reasons:

1) It's politically cleaner than the West Virginia law suit.  In that state, the primary law suit left out (at least initially) McKesson and Cardinal, the two largest drug distributors.  Turns out the Attorney General in West Virginia used to be a lobbyist for McKesson and his wife is a lobbyist for Cardinal.  While the legal concept being used by Fulton County of focusing law suits on distributors is similar to West Virginia's, the potential conflicts of interest are absent.

2) I live in Fulton County, Georgia.  I'll have a front row seat for this battle.  My county is a politically, racially, and economically diverse county; but like the rest of America, we have more in common than we have differences.  Among the things residents of Fulton County have in common is that many of us have felt, witnessed, or experienced the impact of prescription drug misuse and abuse.

My community is a lot like yours, probably.  Except that we now have an aggressive and creative legal strategy we're pursuing that may offer a pathway for communities across the country to recoup at least some of the costs we've expended in public health, our judicial system, and our law enforcement agencies.

Or... this could fall flat on its face and prove a waste of taxpayer resources.  I'm not taking a position either way, but I'm fascinated to see how this plays out.

Michael
Follow us on Twitter @PRIUM1

Medical Marijuana: Fear Not

Ben Roberts and David Price, who head up PRIUM's regulatory and compliance consulting team, have authored a great piece on medical marijuana rules and statutes across the country.  The article is data-driven, well-researched, and should have a calming effect on payer organizations concerned about the potential need to reimburse for medical marijuana.

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

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

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

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

We're not suggesting that medical marijuana is a non-event that deserves no attention.  We're suggesting that smart payers with smart medical management strategies need not fear being overwhelmed with medical marijuana spend.

Check out the full article here.

Michael
On Twitter @PRIUM1

Data Suggests We Still Have a Long Way To Go

A quick scan of this morning's news shows we have a long way to go in the fight against prescription opioid misuse and abuse.

From a survey conducted by the National Safety Council we learned that:

• Nine in 10 opioid painkiller users are not concerned about addiction as a side effect, though 60 percent of users have at least one addiction risk factor 
• 69 percent of opioid painkiller users feel opioids are the most effective medications to treat pain, though research shows this is not true
• Americans mistakenly believe gun violence, severe weather and commercial airline travel are more significant threats to their safety than opioid painkillers
• Many Americans do not realize they have taken opioids

And from a study entitled "Adherence to Prescription Opioid Monitoring Guidelines Among Residents and Attending Physicians in the Primary Care Setting" reported on by workcompcentral this morning, we learned that:

• 42.9% of the 1,285 patients on long term opioid therapy had signed a treatment agreement
• 62.8% of those patients had been subject to a urine drug test within the last year. 
• The study's lead author, Laila Khalid, told workcompcentral, "It should be 100% adherence."  

So once more unto the breach, dear friends, once more.  Another week in the battle against prescription drug abuse.  Lots of work to do.  

Michael
Follow us on Twitter @PRIUM1  

Inconsistent Standards of Care, Judicially Mandated

Very little good has ever come from judges attempting to interpret legislative intent in the face of disputed medical treatment.

Barbara Shepard injured her back, neck, and left shoulder in 2005 while employed with the Oklahoma Department of corrections.  The OK Work Comp Court ordered that the carrier pay for treatment, inclusive of office visits and (you guessed it) pain management medications.  "This provision," stated the order, "shall be reviewed by the Court upon application of either party for good cause shown."  

Turns out evolving contemporary medical evidence and the risks of opioid medications do not amount to "good cause."  

Despite Oklahoma's adoption of the Official Disability Guidelines as of March 1, 2012, the Court found that those guidelines do not retrospectively apply to Shepard's case.  Simply because of the date on which she was injured, Shepard is subject to a different (and, frankly, inferior) standard of care.   While physicians on both sides of the dispute agree that the guidelines indicate she should not receive the pain management medications she has been taking, the Court instead relied on a purely legal framework to make its decision.  Thus, not only has the Court failed to contemplate the growing body of medical knowledge from which the patient could benefit, but it has also created two standards of medical care for Oklahoma work comp patients that depends entirely on one's date of injury.   

Let's consider an admittedly controversial analogy: Instead of being injured in 2005, let's pretend for a moment that Shepard was hurt in 1917.  And instead of an injured back, she had a work-induced cough.  During this time, she might have been prescribed a popular cough suppressant manufactured and sold by Bayer pharmaceuticals.  The chemical compound was diacetylmorphine, but it was marketed under its trade name: heroin.      

Seven years later, in 1924, in the face of a public health crisis and mounting evidence of heroin's harmful properties, Congress passed the Heroin Act, which outlawed the sale, importation, and even the manufacture of heroin.  

According to the Oklahoma Supreme Court, however, Shepard should still get heroin for her cough... despite the evolving medical evidence and the statutory support for recognizing that medical evidence, Shepard should still get her heroin, simply because she developed her cough seven years before we knew that heroin was more likely to harm her than help her.

Opioids, thankfully, are not illegal.  There are many patients, particularly the terminally ill, that benefit greatly from these medications.  But it's also true that we didn't know in 2005 everything we now know about opioids in the treatment of chronic, non-cancer pain.  For instance, in 2005, the National Safety Council had yet to publish this informative graphic:

We cannot create a sustainable system of medical care for injured workers that does not allow for the incorporation of the best available medical evidence.  

Michael
On Twitter @PRIUM1

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