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

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