The Solution to Every Healthcare Debate: Access vs. Cost

Two things you need to know about Suboxone (or buprenorphine) this morning highlight the essential elements of all past, present, and future healthcare debates.

First, the manufacturer is being sued by the Attorney General of Illinois (and 35 other AGs) for violation of antitrust statutes.  The states allege that Reckitt Benckiser Pharmaceuticals (now known as Indivior, because someone clearly new to marketing thought that would actually be easier to say) has effectively blocked generic competition for Suboxone by scheming to devise a new formulation (the film, an upgrade from the pill) in order to extend the patent protection of its franchise.  Believing, of course, that they are more sinned against than sinning, Indivior took to their web site to issue a statement that they will vigorously defend themselves against the charges.  I'm not sufficiently informed to weigh in on the merits of the suit.  I'll just point out that the company's actions are fairly typical of pharmaceutical companies and that were this a cholesterol medication instead of a potential addiction mitigation drug, I'm not sure we'd see this much attention paid to it by 36 state attorneys general.

Second, current physician capacity for treating opioid use disorder with Suboxone isn't being utilized.  A research letter published last week in the Journal of the American Medical Association shows that despite initial limits on the number of patients a certified physician may treat at any one time of 30 and subsequent limits (after 1 year of prescribing) of 100 patients, these doctors are treating numbers of patients far below those thresholds.  In the 7 states with the highest number of certified physicians, the monthly median patient census per doctor was found to me as follows:

• California: 7
• Florida: 11
• Massachusetts: 22
• Michigan: 7
• New York: 11
• Pennsylvania: 18
• Texas: 10

Increasing the number of certified prescribers and the number of patients they may treat at any one time is a linchpin of the federal government's response to the prescription opioid epidemic.  So it's somewhat concerning that we're so focused on increasing capacity when we're clearly not even close to utilizing the capacity we have.  

Why is this?  Why the law suit?  Why the lack of utilization of existing capacity?  

Like every other debate in healthcare, when you peel back the onion far enough, you find two competing philosophical concepts that dictate nearly every public policy decision that confronts us: COST and ACCESS.  

The law suit is primarily about COST and secondarily about ACCESS (presumably, if a more affordable - read 'lower COST' - generic were to become available, more patients could potentially ACCESS therapy).  

The JAMA study is about ACCESS and it shows that despite our investment in capacity (which COSTS money), we're still not very good at ACCESS itself.  

Follow the money.  Follow the patients.  The solutions to all healthcare issues rest somewhere in the incentives, structure, and balance of the two.  

Michael 

On Twitter @PRIUM1

Bad Pharma: This is What We're Up Against

We all know that lobbyists exist.  We all know the role they play in American politics, however frustrating that fact might be to us.  We all know that pharmaceutical companies have plenty of them and they appear to be pretty good at their jobs.

But thanks to some great work by the Associated Press, we now have a better sense for the magnitude of malfeasance that has occurred over the last 10 years in the halls of state capitol buildings, the US Congress, the White House, and our federal regulatory agencies.

The articles are here and here and I recommend reading both in full. For those crunched for time, some highlights I found particularly disturbing (in form of "what we've known" and "what's new"):

We've known for quite some time that there are a lot of dollars and a lot of brains devoted to maintaining the top line revenue of pharma companies operating in the pain space.  We now know:

• They spent $880 million over a 10 year period from 2006-20015
• This amount is 8 times the amount the gun lobby spent in the same period (read that again... just for emphasis)
• $140 million of this went directly to political campaign contributions, $75 million of which went to candidates for federal office
• Various advocacy groups employed an average of 1,350 lobbyists per year in state capitols across the country

We've known for a while that there were hidden forces behind the scenes attempting to squash public policy initiatives intended to stem the tide of prescription drug misuse and abuse.  We now know:

• Back in 2012, when New Mexico came close to becoming the first state to limit initial opioid scripts to seven days, lobbyists got in the way.  "The lobbyists behind the scenes were killing it," said Bernadette Sanchez, a Democratic state senator who sponsored the measure.  We celebrate what New York and Massachusetts have done just this year, but forget that New Mexico tried it four years ago.  In the interim, we continued down the primrose path of opioid over-prescribing.  How many preventable deaths occurred between then and now? 

We've seen influence exercised among federal regulatory agencies, particularly at FDA. Former FDA Commissioner Margaret Hamburg consistently spoke about the need to balance access to pain medication for those in need with the public health crisis that is the prescription drug epidemic.  In so doing, she often referenced the 2014 NIH report that suggested 100 million Americans suffered from chronic pain.  We now know:

• The Pain Care Forum (aka, the lobbying group backed by pharma) spent nearly $19 million on lobbying efforts that led to the legislation requiring the creation of this NIH report
• Almost half of the report authors had served as leaders of groups affiliated with the Pain Care Forum - all of which were supported by pharma dollars.  

We all witnessed the controversy regarding the CDC guidelines earlier this year.  While the federal government's public health agency worked to develop guidelines for opioid prescribing among primary care physicians, other groups within the federal government were not only questioning the CDC's process and conclusions, but also going so far as to call the draft version of the guidelines "horrible" and "shocking."  Who were these critics?  We now know:

• Dr. Richard Payne, who voiced concerned about conflicts of interest within the CDC advisory group, was himself paid over $16,000 by Purdue Pharma (makers of Oxycontin) for meals, travel, and speakers fees
• Myra Christopher, another vocal critic of the CDC who openly stated that her NIH committee could not support the CDC guidelines, is a long time participant in the Pain Care Forum and holds a chair at the Center for Practical Bioethics - a chair endowed via a $1.5 million gift from Purdue Pharma.  

The most effective lobbying efforts come not as obvious broadsides with clear agendas and transparent motives.  Rather, the most effective efforts come with the trappings of genuine concern and the suits of science.  And that's what makes them scary.

Michael

On Twitter @PRIUM1

Market Failure and Medications: The Consequences of Healthcare Economics

I have a friend who happens to be an economist.  He's a really (really) smart guy and I value his views on everything from parenting to high finance.  So when he struck up a conversation about a recent blog post of mine that covered the intersection of drug prices and basic economic principles, I was all ears.  

"You haven't identified the market failure," he said.  

I was caught a little off guard.  I needed a moment to recall the specific definition of "market failure." It's not what most people think.  If the average person hears the term "market failure," they're likely to believe the S&P 500 dropped precipitously that day.  But when an economist uses the term, he means that the supply and demand dynamics of any given market have failed to reach a market clearing price.  The market could be for guns, butter, iPhones, or medications.  Doesn't matter. Buyers are unwilling to buy, sellers are unwilling to sell.  The market isn't working.  It has failed to produce transactions of any kind.     

My friend's point was that the market for naloxone was still functioning.  Buyers were complaining vociferously (in the press, to Congress, to manufacturers, etc.) but naloxone was still being bought and sold.  Howls of protest are one thing, he was saying, but the market still looks like it's working - albeit at a significantly higher market clearing price than a few years ago.  

From a purely economic perspective, he's exactly right.  But this isn't "pure" economics.  This is healthcare economics.  And the difference isn't that we in healthcare don't get it, it's that we have to get it sooner... because the stakes are much higher.  

In my original blog post, I told the story of my son Will and his experience with the supply and demand of chocolate.  I pointed out some of the differences between his experience selling Hershey bars to 1st graders and the pharmaceutical companies raising prices of medications like naloxone.  But there's one difference I did not identify in that original post and it's critical to understanding the current public discourse around naloxone and EpiPens and other medications whose price has risen substantially as of late.  

If Will's market for chocolate fails, then kids neither buy nor sell chocolate.

If the market for EpiPens fails, a kid dies.  

Overly dramatic?  Not in the least.  If access to potentially live saving medications is inhibited by market failure, then preventable death is not only a possible consequence, it's a probable one.  Those of us who work in this space have to anticipate market failures and prevent them from happening. We cannot sit back and wait for the market to fail and then act to correct it.    

Economics is different in healthcare for lots of reasons (government participation in price setting, employer-based health coverage, third party payers, just to name a few), but ultimately, what makes the domain of healthcare economics so unique is that it carries life and death consequences at every turn.  What's past is prologue... and we have to get it right.    

Michael 

On Twitter @PRIUM1

FDA and Off-Label Drug Use: Danger Ahead

The FDA has scheduled hearings for November (and a public comment period that will extend to January) regarding the agency's current approach to the marketing of off-label uses of FDA-approved medications.  Drug and device manufacturers have been waiting years for this opportunity to change the agency's stance on off-label marketing.  

This is not good news.    

First, a definition: Drugs approved by the FDA are approved only for the specific conditions for which they were tested in clinical trials conducted by the manufacturer.  These approved medications have an FDA "label" which stipulates those conditions for which the drug has been approved.  FDA approval, however, does not govern the practice of medicine.  Doctors are free to prescribe FDA approved drugs for conditions not included on the "label" (thus, off-label use of FDA approved drugs).  While the practice is common among doctors, pharmaceutical and medical device companies are restricted from "marketing" off-label uses of drugs.    The 1938 Food, Drug, and Cosmetic Act gave the FDA the power to regulate promotional materials on medications and to this day, they do. Very closely.  

Second, some basic statistics:

• 1 in 5 medications prescribed today is for off-label use. (Example relevant to you: tricyclic antidepressants do not have FDA approval as a treatment for neuropathic pain, yet this class of drugs is considered by many physicians to be a first-line treatment option.) 
• In recent years, antipsychotic drug use for unapproved FDA indications has increased. One study estimated that the cost of off-label antipsychotic drug use in 2008 was $6.0 billion.
• The fines connected to illegal off-label marketing by pharmaceutical companies appear material (though this is debatable in light of the annual sales of some of these drugs): 
• 2009: Eli Lilly paid $1.4 billion off-label marketing of olanzapine for dementia
• 2009: Pfizer paid $2.3 billion for alleged off-label marketing of 4 of its medications
• 2012: GSK paid $1.3 billion for off label marketing of paroxetine
• 2012: Abbott paid $1.6 billion for off label marketing of valproic acid 

So here's the core question: Should the FDA allow pharmaceutical and medical device companies to market to doctors off-label uses of medications?

In a word, no.  But let's dig a little deeper into the argument the pharma companies are making.

Their position is summed up best by the quote in the Bloomberg article (linked above) from Deborah M. Shelton, deputy general counsel for healthcare at the Biotechnology Innovation Organization (BIO):  “Removing current regulatory barriers, and clarifying the ability of companies to share truthful and non-misleading information [emphasis added] about medicines, is essential to our collective ability to realize the full potential of 21st century medicines and helping to ensure that patients are able to get the right medicines at the right time for them,” 

Two key words here: truthful and non-misleading.  Leaving aside that the use of both terms appears redundant, we're still left the the fundamental question of who decides what is truthful and non-misleading.  

We have three choices available to answer that question: the FDA, the drug companies, and broad clinical experience.  

The FDA seems like the most logical answer.  They approved the drug in the first place, why can't they be responsible for approving additional indications (or uses) of that same medication?  The reply from the drug companies to this idea is understandable: it's really expensive.  The FDA requires a similar level of data and similar level of rigor from clinical trials to approve an additional indication as they do to approve the initial indication.  In many cases (though not all), the costs are clearly prohibitive.  

The drug companies cannot be trusted to decide what's truthful.  If you can't see the obvious conflicts of interest here, then you should stop reading.  You're not worth another word.    

Broad clinical experience, or the general body of knowledge developed as a result of actually practicing medicine, is a valuable source of information and the means by which some portion of off-label prescribing comes to occur in the first place.  When such knowledge is documented in well-respected, peer reviewed journals, the medical community gains a trusted and codified source that might prove valuable to other clinicians.  But how to get that information disseminated?  Could the pharma companies do that?  Isn't that what they're asking for here?  To relay "truthful and non-misleading information" to doctors about off-label uses of medications?  

Here's the thing: they can already do that.  From the Mayo Clinic's article by Chistopher Wittich, et al [emphasis added]: "The 1997 FDA Modernization Act allowed manufacturers to distribute to health care providers peer-reviewed journal articles about unapproved uses of medications.  If a given drug company chose to engage in distribution of this type of information, it was required to submit an application for approval of that indication within a rigid and pre-specified period. These requirements were subsequently revised in 2009 with the approval of new FDA guidelines. The new guidelines clarified existing rules and allowed distribution of information on off-label uses by pharmaceutical manufactures if specific regulations were followed.  After 2009, pharmaceutical manufacturers could distribute information, including journal articles and textbook chapters, describing unapproved uses for their medications. The FDA demanded that the information in these... publications be accurate, the relationship between the distribution of information and the sponsoring drug manufacturer be disclosed, and the published material not be edited or presented in an abridged form. In addition, the manufacturer is no longer required to submit an application for approval for that indication."

Sounds reasonable to me.  What do the drug companies want to be able to do beyond this?  Makes me very, very nervous.  

Michael 

On Twitter @PRIUM1

Standing Orders: Are You Prepared?

The Missouri PDMP watch goes on... I think CNN should have a clock for it.  Instead of counting down to an event, the clock would continually count up, marking the years, months, days, hours, and minutes since Missouri became the only state without a law creating a Prescription Drug Monitoring Database.  For the record, the District of Columbia enacted its own PDMP legislation on Saturday, February 22, 2014.  So by my count, the clock would read: 2 years, 6 months, 7 days, 10 hours, 59 minutes, 32 seconds... 

But the state did make some progress recently.  Missouri HB 1568 creates a "standing order" for naloxone.  There's a legitimate debate regarding standing orders for naloxone, but regardless of where you stand in that debate, there's little doubt we're going to see more and more of these across the country.  So let's establish some definitions and pose some interesting questions for the payer community.

First, looking up "standing order" in an average dictionary isn't terribly useful.  We're looking for a clinically oriented definition and I found the best one at medical-dictionary.com:

"a written document containing rules, policies, procedures, regulations, and orders for the conduct of patient care in various stipulated clinical situations. The standing orders are usually formulated collectively by the professional members of a department in a hospital or other health care facility. Standing orders usually name the condition and prescribe the action to be taken in caring for the patient, including the dosage and route of administration for a drug or the schedule for the administration of a therapeutic procedure. Standing orders are commonly used in intensive care units, coronary care units, and emergency departments."

Translation: Pre-approved treatments that can be dispensed and administered by non-physicians because a doctor said it was ok ahead of time.

The language in Missouri is indicative of what we're likely to see elsewhere: "Notwithstanding any other law or regulation to the contrary, any licensed pharmacist in Missouri may sell and dispense an opioid antagonist under physician protocol" and "Notwithstanding any other law or regulation to the contrary, it shall be permissible for any person to possess an opioid antagonist."  Additonally, the bill also contains language that relinquishes pharmacists from any liability associated with dispensing naloxone as well as protection of individuals who administer naloxone.  This is an important component of any legislation in this area.

Translation: Want naloxone?  Show up at a pharmacy in Missouri with some money and you can have some.  No questions asked.  And no one is going to get arrested or sued for dispensing or administering the drug.  

But this begs several important questions for the work comp payer community.

First: How much is naloxone going to cost?  Are we talking generic syringes?  Or EVZIO auto-injector pens?  This "standing order" in Missouri spells out the ingredient a patient can obtain, but not any preferred form of administration.  Notably, the cost of this stuff is skyrocketing.

Second: Who is going to pay for this, ultimately?  If an injured worker pays for EVZIO pens out of pocket via a standing order, will he submit for reimbursement to the employer/carrier?  How will this be handled?

Third: Will we submit this to utilization review?  Are the guidelines sufficiently thorough to cover this type of scenario?  (I can answer that one, actually: no, they're not).  So where does that leave us? Do we really want to deny payment and then have the unthinkable happen?  Imagine the headlines. "Work Comp Screws Up Again: Injured Worker Dies of Overdose After Employer Denies Payment for Life Saving Antidote."

No one wants that.  But we also want to ensure we're addressing the underlying issue.  Why do we have injured workers on sufficiently high doses of opioid medications that the patient (or, likely, a loved one) feels the need to take advantage of a "standing order" and obtain naloxone from the local pharmacy?

Which brings us to a fourth question: Does the employer have an obligation (ethically, not necessarily legally) to inform the prescribing physician that the injured worker has obtained naloxone via a standing order?  "Hey doc, just thought you'd be interested to know... Injured Worker Joe?  Yeah, his wife just picked up a pack of two EVZIO pens at Walgreens.  We're going to reimburse them the $800, but thought you might interested in your patient's perception of overdose risk."  That's a pickle: the reality is that the adjuster may be the only one that knows about both the opioid scripts and the naloxone secured via a standing order.

Unintended consequences abound.

Michael
Follow me on Twitter @PRIUM1

Health Literacy and Pain Management: How to Do Patient Education

Whether or not opioid pain medication might actually worsen pain is a legitimate clinical discussion and an important claims management topic.  While the phenomenon is researched and written about in medical journals, talked about at various conferences, and acknowledged among physicians, I had not yet seen a committed attempt by a state regulator to educate injured workers about what might be happening to them.

And then New York State Workers' Compensation Board published this gem.  The brochure was developed in cooperation with the New York State Office of Alcoholism and Substance Abuse Services (smart move by the WCB) and posted on the "Workers" section of the www.wcb.ny.gov website under the link "Pain Medication Dependence Fact Sheet."  

The brochure is appropriately titled: "Is My Pain Medication Making Me Worse?"

The brochure starts with the story of Jim, a 55-year-old construction worker with a low back injury who is prescribed pain medication... and experiences a steady decline in functionality and engagement.  It also includes a list of common medications, a phone number to call for help, a list of common side effects, a phone number to call for help, a list of FAQs, and last, but not least... you guessed it, a phone number to call for help.  The number appears multiple times in multiple locations on a relatively simply brochure.  And that's the point.    

Educational pieces like this are harder to create than you might think.  I recall when PRIUM created our own injured worker education piece (which you can download and use for free here).  I was so proud of the first few drafts.  I thought we had nailed it.  Then our Medical Director, Dr. Pamela Thomas, got a hold of it.  She tore our draft to shreds.  

Dr. Thomas is an expert in health literacy.  She helped us understand that patient education messages have to be aimed at the lowest common denominator.  Too many big words, too many messages, too much clinical language, too few attempts to engage at the patient's level... all lead to poorly executed patient education materials.  Which is not to say that all injured workers require reading materials at a remedial level.  But the reality is that some do and good patient education ensures that the maximum number of patients can comprehend the information being conveyed.  These things are hard to put together.  

I give the New York piece one and half "thumbs up" (a couple of infographics for visually-geared learners would have taken taken it all the way to two thumbs up).  The fact that they published this at all is fantastic and the bold title (Is My Pain Medication Making Me Worse?) is engaging, educational, provocative, and appropriate - all at the same time.  

Well done, New York State Workers' Compensation Board.  

Now... where is every other jurisdiction on injured worker pain management education?  

Michael 

On Twitter @PRIUM1

So Why is Naloxone Getting So Expensive?

Last week, I posted a piece on the public health debate around naloxone.  Since then, I've received a stream of new and interesting data to share.  

First, a report showing that naloxone scripts led to fewer ED visits... of the 2,000 patients in this study focused in safety-net clinics around San Francisco, those receiving naloxone along with long-term opioid prescriptions had 47% fewer visits to the emergency department.  That appears to be compelling evidence to suggest co-prescribing naloxone makes sense (though the focus on the safety net clinic population begs the question of how translatable the conclusions might be to other populations).

We also saw the release of a white paper from Fair Health that suggests diagnosis of opioid dependence is skyrocketing.  Fair Health is a non-profit organization dedicated to transparency in health care costs.  They analyzed their database of 20 billion privately insured healthcare claims and found a 3,203% rise in opioid dependence diagnosis between 2007 and 2014.  So maybe we need to focus more on the underlying issue of opioid dependence after all?   

Third, the price of naloxone is rising... this excellent an in-depth piece from Business Insider details the controversy surrounding the price increases.  Out there in social media land, I've seen several comments regarding the price increase that indicate a basic understanding of microeconomics, but that lack the depth necessary to understand what's happening here.  "Demand has gone up," read many of these comments, "so price goes up, right?"

Not necessarily.  A personal story to illustrate the point:     

Some of you have heard me tell one of my favorite “Will stories".  Will is my 10 year old and the kid is a natural entrepreneur.  Back when he was in 1st grade, his school had an activity called Economics Day.  Each of the six 1st grade classrooms in Will's school had to make a simple product and then sell it to their peers in an open “marketplace” (which, in this case, was a series of tables in the school gym).  One class made puppets out of brown paper bags.  Another class made pet rocks.  One class did the classic lemonade stand.  Will’s class made “S’more packs” (two graham crackers, a marshmallow, and a small Hershey’s chocolate bar all in a small plastic sandwich bag).  Each kid had earned “money” to spend through good behavior and acts of service to others over the course of the semester. 

All the first graders gathered in the gym and awaited the signal from one of the teachers.  When she blew her whistle, nearly all of the children would begin freely “shopping” the various tables of merchandise around the gym.  Only a small group of students from each class would remain at their respective “cash registers” to do the actual selling.  William volunteered for this duty first.  While everyone else shopped, Will would be in charge of selling his class’s S'more Packets.  I stood behind him and made sure order was maintained.  Easy duty… or so I thought.

The whistle blows.  Nearly every kid in the gym makes a run for Will’s table.  There’s chocolate there, right?  The kids who don’t run for the chocolate instead go for the lemonade.  The Pet Rock and hand puppet kids are immediately bored.

Suddenly, Will finds himself in the middle of an old fashioned Wall Street trading pit.   He’s surrounded by kids, each holding out $5 of play money and shouting for chocolate.  Initially, Will is collecting money and handing out ‘Smore Packets just as he’s supposed to do. He’s happy his class’s product is popular and he’s clearly grateful for the business.  But as the crowd thickens and the kids grow louder, I begin to notice what Alan Greenspan once called “irrational exuberance.”  The kids are frantic.  Markets are psychological and this one is getting crazy.  Kids are elbowing for position.  They’re screaming Will’s name in an attempt to get his head to swivel in their direction, potentially increasing the probability they’ll be the next to walk away with chocolate.  He’s getting bumped, jostled, and hit.  I’m getting worried about him and I wonder if he’s going to lose it under the pressure.  Should I step in?  Be an adult?  Organize this chaos?  It’s getting out of control…

And at that moment, Will did something both courageous and, to him, completely logical.  Without permission from his teacher, without encouragement from me, without any warning at all…

He raised the price.

“These aren’t $5 anymore,” he yelled over the din, “they’re $10!”  Only a few kids drop out of the crowd.  The rest simply reach into their pockets and pull another $5 of play money out to add to the $5 they’ve already been waving in Will’s face.  He sells a few packets at $10 and realizes he can go higher.  “Now they’re $15!” he yells.  I glance over at his teacher, Ms. Foster, who takes one step toward Will.  I can see she’s a little unsure of what to make of this scene and I have a moment of panic that she’s going to shut down the most perfect example of an efficient market I’ve seen in my life.  Then she pauses, steps back, looks at me, and smiles.  Thank goodness, I think, she gets what’s happening.  This is Economics Day… and these kids are learning economics!

Little did anyone know that the laws of supply and demand would be as intuitive to Will as eating, sleeping, and breathing are to you and me.

By the time I turn my attention back to Will, he’s at $30 and the flow of ‘Smore Packets into the greedy hands of first graders is starting to ebb.  He senses he’s neared the market price, the equilibrium between supply and demand.  This is what economists call it, economists who have studied this phenomenon and only this phenomenon, for longer than Will’s been alive.  To Will, though, there are no fancy terms or theories.  There’s just a point, he says later, that “felt right.”

So how do pharma companies justify jacking up the price of naloxone?  It’s just supply and demand, right?  What’s the big deal? 

Here’s the key difference: Will had a finite supply of chocolate.  Once it was gone, it was gone.  When supply is fixed and demand rises, price increases.  But that’s not true of naloxone.  This stuff is easy to make and has been around for 40 years.  When demand rises (and it certainly has), supply should increase commensurately and price should remain relatively stable over the long term.  That’s how economics works.  Anticipating objections from the "econ major" crowd who will argue we're experiencing a "shift in the demand curve" for naloxone (which is different than a simple increase in demand), I would argue that a commensurate shift in the supply curve is not only possible, but easily achievable given the nature of the underlying molecule.  

"We're not talking about a limited commodity. Naloxone is a medicine that is almost as cheap as sterile sodium chloride — salt water," said Dan Bigg, the executive director of the Chicago Recovery Alliance.

Unless you’re a pharma company.  Then you get to smile and smile... and be a villain.  You get to exploit the average American's lack of understanding of microeconomic theory and suggest that a rise in demand logically leads to an increase in price. 

Supply and demand, right?   

Michael
On Twitter @PRIUM1

Nuance is Necessary in the Naloxone Debate

American Medical Association white paper headline: "Help save lives: Increase access to naloxone"
New York Times headline: "Naloxone Saves Lives, but Is No Cure in Heroin Epidemic"

These headlines aren't inconsistent, but they do hint at the evolving national dialogue around naloxone.  I would say there's a debate brewing around the appropriateness of naloxone access, but the truth is that the debate isn't new - it's been going on for decades.  What makes it feel new to many of us is that the prescription drug and heroin epidemic is pushing our medical and public health professionals to more aggressively pursue any and all possible solutions at our disposal. And with every solution comes a critique.

Let's start with a few basic facts:

• Naloxone was approved by the FDA in 1971.  
• Naloxone is an opioid antagonist, which means (in layman's terms) that the drug kicks opioids off of the receptors in the brain and replaces them, eliminating the "high" and reviving the patient (and also sending them into immediate withdrawal).
• Naloxone works quickly (approximately 2-3 minutes) and its effects last between 30 and 90 minutes depending on the type of opioid that was used; sometimes, more than one administration of naloxone is necessary to reverse an overdose.  
• There is virtually zero potential for abuse of naloxone and virtually zero effect on an individual given naloxone who is not experiencing an overdose.  
• Naloxone comes in various forms: generic via syringe, branded injector pens (EVZIO), nasal spray (Narcan or naloxone w/ atomizer).

Now to the debate, literally an existential one at that (you might say naloxone is the "to be or not to be" drug... that is the question...)   

There are many (Centers for Disease Control, American Medical Association, Substance Abuse and Mental Health Services Administration, American Society of Addiction Medicine) who support widespread access to naloxone.  According to the CDC (and quoted in the AMA's white paper), from 1996 to 2014, the lives of more than 26,000 people were saved by naloxone.    

There are others who express concern that widespread access to naloxone will give addicts a safety net, encouraging risky behavior.  Governor Paul LePage (R) of Maine, never shy and certainly never concerned about causing offense, summed up the argument this way (in light of his veto of naloxone-related legislation): "Naloxone doesn't truly save lives; it merely extends them until the next overdose.  Creating a situation where an addict has a heroin needle in one hand and a shot of naloxone in the other produces a sense of normalcy and security around heroin use that serves only to perpetuate the cycle of addiction."  

As so often occurs in complicated policy debates, blanket assumptions and blunt statements lead to poor dialogue and lack of action.  So let's explore the nuance by segmenting the population of potential naloxone beneficiaries.  Note that this isn't the only way to segment the population nor is it the most detailed, but it's better than lumping everyone together.

1. First responders: Here, there is little debate.  First responders should be equipped with naloxone. They have a professional duty to save lives and naloxone will help them do that.  They are trained medical professionals and to withhold a vital life-saving antidote in the midst of a prescription drug and heroin epidemic is blatantly irresponsible.  

2. Drug abusers: Whether its prescription drugs or heroin, this is obviously a group at high risk for overdose. What Gov. LePage is missing in his inelegant portrait quoted above is that the person who overdoses will not be the one who administers the naloxone (having naloxone "in the other [hand]" doesn't do one any good if one is unconscious).  He also misses the reality that naloxone administration leads to immediate withdrawal - rather than experiencing "normalcy and security," the addict, while thankfully alive instead of dead, is thrust directly into hell on Earth.  

This segment of the patient population actually highlights two axes along which the debate takes place:  First, should drug abusers have access to naloxone at all?  Second, should we enable non-medically trained people (possibly fellow addicts) to administer the drug? If you believe in LePage's premise, that naloxone "merely extends [lives] until the next overdose," well, then... you are a cold and callous person who doesn't believe in the basic human aspiration toward redemption and recovery.  Might it be a long and hard road?  Yes.  Might there be relapses and multiple overdoses requiring naloxone?  Yes.  If it was your loved suffering from the addiction, would you want to give them every possible chance at recovery?  Yes.  As to whether non-medically trained people should be able to administer it... if I can give my kid an EpiPen injection when he gets stung by a bee, then I can administer naloxone.  No medical degree necessary.  

Thank goodness the Maine Legislature had the good sense to override LePage's veto, allowing Maine to count itself among the 34 states with a standing order for naloxone.   

3. Legitimate prescription drug users: This group is tricky.  These patients are under the care of a doctor, receiving legal prescriptions for opioids, and securing those medications at a pharmacy. I note there could be overlap between this group the group 2 (drug abusers), but this group has the benefit of a doctor overseeing their prescription regimen. The CDC and AMA guidance on naloxone prescribing among primary care doctors is fairly consistent.  A co-prescription for naloxone should be considered if the patient has a history of overdose, a concomitant script for a benzodiazepine, a history of substance use disorder, a mental health condition, or a medical condition that might make the patient susceptible to respiratory distress.  

But wait. Aren't these all the same factors that should cause the doctor to reevaluate the appropriateness of prescribing opioids at all?  Should a doctor manage the risk of overdose by prescribing an overdose antidote?  Or should the doctor be more diligent in exploring non-opioid alternatives first?  

This isn't just theory.  We're seeing it in PRIUM cases.  It's expensive, the cost is rising, and the benefit is unclear.  Surely, there are circumstances in which naloxone will be appropriate for co-prescribing (perhaps immediately post-injury or post-surgery when opioids are indicated for acute pain and the patient has a history of overdose, for example).  But the practice of co-prescribing naloxone for chronic pain patients is troubling.  

When it comes to high dose opioid therapy for chronic pain, we need to demand more from prescribing doctors than a "just in case" antidote.  Chronic pain care requires rigorous exploration of alternatives, difficult conversations with patients, careful management of medications, and a commitment to patient safety.  

Michael 

On Twitter @PRIUM1 

Mental Illness: What Are We Going To Do About It?

My family and I just got back from a trip to our nation's capital (read: I just dragged my three children through a three day, 25 mile hike that will forever be known as The Monument March).  I wanted them to see the White House, the Capitol, the Supreme Court... I wanted them to see our founding documents - The Declaration of Independence, the Constitution, the Bill of Rights... I wanted them to see my alma mater, Georgetown University, and the places I lived and worked during my years in DC.  And we did all of that and more in 95 degree heat with surprisingly few complaints.

There were some surprises on our trip, too, things we had not planned to see.  I happened upon Thomas Jefferson's personal library on display at the Library of Congress.  We encountered a free live jazz concert inside of the Smithsonian Museum of Art and I played checkers with my seven year old daughter while listening to great music and sitting amidst the original portraits of most of the founding fathers.  And at the Smithsonian National Air and Space Museum, we found a full sized Douglas A4 Skyhawk suspended from the ceiling, the plane my father-in-law flew in combat in Vietnam.

And my children encountered homelessness and mental illness for the first time.

Sitting on a bench in Union Station, a woman close by was engaged in a heated argument regarding Social Security, the banking system, and the wisdom of 30 year mortgages.  She was gesticulating wildly and was clearly talking to someone she believed was sitting next to her.  In this age of gadgetry, my kids initially assumed she was talking on a blue tooth head set.  But I knew better.  All of her belongings were in a shopping cart next to her and she clearly hadn't bathed in quite some time.  While we walked from Union Station to the Capitol building, I tried to explain to my kids what they had seen.  At twelve, ten, and seven years old, this was a new experience and they were having trouble processing it.  They began to notice that many of the benches on the US Capitol grounds were occupied by homeless people.  The following conversation with my ten year old ensued:

Will: "How do you become homeless?"
Me [thinking hard about how to explain this to a 10 year old]: "There are a lot of ways people end up homeless... but many people become homeless due to mental illness."
Will: "What's mental illness?"
Me [definitely not a clinician]: "The human brain is a really complex thing... and sometimes, it breaks... it doesn't work right... and the person suffering from mental illness loses touch with reality. They have a really hard time doing normal things like sleeping, working, and talking with others."
Will: "So they're sick?"
Me: "Yes."
Will [thinking this over and jumping right to the heart of the matter]: "What are we going to do about it?"

This incredibly insightful question was put to me by my ten year old in the literal shadow of the US Capitol building.  His timing couldn't have been better.  "A big part of the answer," I told him, "starts right here with the people who were elected to sit in this building."

I'll spare you the detailed policy proposal, but suffice it to say that homelessness and mental illness have become problems we deal with predominantly through the criminal justice system.  Therein, the patient must minister to himself, giving us little to no hope of long term recovery for the mentally ill, including (perhaps especially) those suffering from addiction disorders.  Instead, we need to treat mental illness through the healthcare system, including the appropriate funding (enter Congress) that will entail.

Mental health parity provisions in the Affordable Care Act are a start.  The Comprehensive Addiction Recovery Act is a start.  But to really answer my ten year old's question (what are we going to do about it?), we're going to need broad social, moral, and political commitment to helping those who cannot help themselves.

Michael
On Twitter @PRIUM1

What Will $180 Million Buy Us?

The Senate just voted 92-2 to pass a piece of legislation, one already passed by the House 407-5.  Can you remember the last time you saw a vote tally like that in Congress?

The President will now sign the Comprehensive Addiction and Recovery Act (CARA), a new law intended to stem the tide of drug misuse and abuse in this country.  Given the ubiquitous and devastating nature of the epidemic, it's no wonder the vote was such a slam dunk.  Better three hours too late than a minute too soon, I suppose, but this Congress after all.

And yet, this bill nearly died an ignominious death before reaching the President's desk.  Even though we all agree that something must be done (and our representatives in Congress see it the same way, at least in principle), there remained the issue of how to pay for it.  Obama asked for $1 billion.  Lots of numbers were tossed around with respect to appropriations... $500 million... $300 million... $600 million.  This surprised even those who watch the sausage making process as a full time profession (from thehill.com: "But the fight over funding threatened to doom the bill, surprising longtime policy watchers who expected the legislation to coast through both chambers as the country faces an epidemic of opioid overdose deaths.")

The final bill allows for $180 million per year for the programs it creates.  The Department of Health and Human Services will dole out grants to treatment programs, law-enforcement assisted diversion, prisons, educational programs, and increase the number of patients able to receive medication assisted treatment (MAT).

So how far can we stretch $180 million?  What can we expect the public health impact to be? Let's do some simple math.

If we just take the 16 million people in the US who suffer from some form of substance use disorder... that leaves us with about $11 per person per year.

If we just look at the most vulnerable subset of the substance use disorder population, those with concomitant mental health disorders - of which there are 8 million in the US - we're left with about $22 per person per year.  

If we take the number of counties (the public health departments of which often compete for and implement these grants), of which there are about 3,000, we get $60,000 per county per year, probably enough to hire a single new public health worker to help those struggling with addiction.

And if we take the population of chronic, non-cancer pain patients in the US, a group at high risk for opioid dependence and addiction - of which there are approximately 38 million - well, that's a little less than $5 per person per year.

Think the math is unfair?  Think my analysis isn't framed correctly?  I'd love to see an alternative approach that shows this investment can and will make a difference.  From my perspective, it's woefully insufficient.

But it's a start... which is why President Obama is going to sign it.

Michael
On Twitter @PRIUM1

Lawmakers Dictate to Doctors: New Legislative Approaches to Opioids

Amidst all the talk of 7-day initial opioid script limits in New York, Massachusetts, and New Hampshire (with New Jersey, Connecticut and others likely not far behind), we appear to have missed a piece of legislation that, in my view, represents the single most stringent legal construct for opioid prescribing in the country.   Before we get to Maine's new law, a quick aside on the new approach sweeping the northeastern US: These new limits are extremely helpful, but not the panacea some are making them out to be.  A 7-day limit for new scripts (in most states, for acute pain only) will absolutely help limit black market diversion and over-utilization generally... but we'll also see more office visits (on day 8!) and not enough progress on long term chronic pain cases.  A necessary step, no doubt, but insufficient to address the entirety of the problem.  

Back to Maine: Guess what they did back in April that no one noticed?  They put a statutory cap on morphine equivalent dosage per day.  The state legislature passed it, the governor signed it, it goes into effect on January 1, 2017... and not a lot of people are talking about it.

The cap is 100 mg MED per day.  Specifically, a licensed practitioner in Maine "may not prescribe... to a patient any combination of opioid medication in an aggregate amount in excess of 100 morphine milligram equivalents of opioid medication per day."  But what if a patient is already on more than 100 mg MED per day?  Doctors cannot prescribe to such individuals opioid pain medication in excess of 300 mg MED per day between January 1, 2017 and July 1, 2017.  But starting July 1, 2017, even those individuals need to be weaned down to at or below 100 mg MED per day.

Enforcement mechanisms?  They thought of that, too.  "An individual who violates this section commits a civil violation for which a fine of $250 per violation, not to exceed $5,000 per calendar year, may be adjudged. The Department of Health and Human Services is responsible for the enforcement of this section."    

The bill also includes several other requirements including mandatory PDMP checks, mandatory electronic prescribing, and mandatory education for prescribers (3 hours of CE) to be renewed every 2 years.  There are exceptions, of course, but the exceptions are logical and do not undermine the intent and broad application of the bill (active treatment for cancer, hospice care, inpatient settings, etc. are all exempt - as they well should be).

What does all of this mean?

Some will see this as a huge step forward in fighting the most significant public health crisis of a generation.  Some will see this as a vast government overreach into the practice of medicine.

It's both, really,  And it's what we get when the clinical community fails to educate and police itself. "Our remedies oft in ourselves do lie..."  And when they don't, we get new laws.  Look for this approach in a state legislature near you...

Michael
On Twitter @PRIUM1

The Bio-psycho-social Model: Challenges in Application

Hardly a day, a conference, a meeting, or a case goes by without a serious discussion about the need for a 'biopsychosocial' approach to injury resolution.  In fact, I've recently heard griping in some circles that the discussion has run its course.  "We get it... can we talk about something else now?"

Sigh.  We don't get it.  And we still have a lot of work to do.  I offer the following observation as proof of such...

A study hit my desk this past week from the Journal of Occupational and Evironmental Medicine and I'd like to ask for your forbearance as I share the abstract:

"The cost and prevalence of chronic work-related musculoskeletal pain disability in industrialized countries are extremely high.  Although unrecognized psychiatric disorders have been found to interfere with the successful rehabilitation of these disability patients, few data are currently available regarding the psychiatric characteristics of patients claiming work-related injuries that result in chronic disability.  To investigate this issue, a consecutive group of patients with work-related chronic musculoskeletal pain disability (n = 1595), who started a prescribed course of tertiary rehabilitation, were evaluated.  Psychiatric disorders were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders.  Results revealed that overall prevalences of psychiatric disorders were significantly elevated in these patients compared with base rates in the general population.  A majority (64%) of patients were diagnosed with at least one current disorder, compared with only 15% of the general population. However, prevalences of psychiatric disorders were elevated in patients only after the work-related disability.  Such findings suggest that clinicians treating these patients must be aware of the high prevalence of psychiatric disorders and be prepared to use mental health professionals to assist in identifying and stabilizing these patients.  Failure to follow a biopsychosocial approach to treatment will likely contribute to prolonged pain disability in a substantial number of patients."  

Great study, right?  Isn't that the right message?  And we couldn't ask for a more specific sample set: Work related!  Musculoskeletal pain!  Disability!

Here's the kicker: this study was published in 2002 (J Occup Environ Med, 2002; 44:459-468).

I thought that had to be a typo.  It's not.  Sadly, even in these modern times in which information flows freely and ubiquitously, contemporary healthcare and insurance models still take close to two decades to translate research into clinical practice.  Some see this phenomenon as madness without method.  My own view is that the disconnect is driven not by laziness, lack of awareness, or lack of desire to apply new clinical knowledge.  Rather, the time lag between the establishment of evidence and its clinical application is created by the very hard work of leaping from intellectual recognition to actual clinician behavior change.  We sometimes fall victim to the assumption that chronic pain patients are the only constituency in need of behavior modification.  In fact, all stakeholders must adapt to evolving notions of clinical best practices; adjusters, nurses, claims leadership, doctors, attorneys, service providers, therapists, pharmacists, injured workers, actuaries, underwriters, brokers... all must adapt to both the clinical and economic realities of (what should be contemporary) chronic pain management.

I hear near unanimous intellectual recognition of the need to apply a biopsychosocial model to chronic pain care.  We must now do the hard work of applying this new knowledge.  For knowledge itself is insufficient to solve the problem.  One can know something to be factually true and yet fail to apply that knowledge.  Ever know it's raining... and still forget your umbrella?  Knowledge, when applied, is wisdom.  

And we have work to do.

Michael
On Twitter @PRIUM1

A Tax on Opioids: Who Pays? And Why?

A new bill was introduced last week by US Senator Joe Manchin (D-WV).  The bill calls for a tax on opioids to the tune of 1 cent per milligram.  This tax will fall primarily to the payor community.

Manchin compares this newly proposed tax to current taxes on alcohol and cigarettes.  This analogy is a poor one: the alcohol and cigarette taxes are born by consumers with the express consequence of changing use patterns.  In the case of the opioid tax (as with most economic propositions in a 3rd party payor system), the tax will likely be paid by an entity (the insurer) that is not a party to the originating transaction (the doctor writing a prescription for the patient).  It is therefore doubtful that the proposed tax will have any material impact on utilization.

There are two notable exceptions to this line of logic.  First, cash-based transactions whereby patients pay for the entirety of the opioid prescription will now be more expensive.  At 1 cent per milligram, a standard prescription for Oxycontin 40 mg q12h would lead to a monthly tax of approximately $25. That might not seem like much, but for the patient paying cash, that adds up quickly.  The second possible exception may occur if certain insurers choose to structure plans such that this tax is passed along to the patient in the form of co-pays, deductibles, co-insurance, etc.  This will surely be the case in many health plans and may cause at least certain patients to seek alternative, non-opioid medications from their doctors.

Neither of these potential exceptions will be available to workers' compensation payers.  For work comp payers, the entirety of the tax will be paid by the insurer and neither the doctor nor the patient will have any financial incentive to do anything differently as a result.  A tax, if you will, on all your houses.  

The other interesting consequence of the proposed tax is that it treats a milligram of a brand name drug and a milligram of a generic drug as equivalent for tax purposes despite the fact that the underlying cost of the generic is significantly less than the brand.  This proposed tax will be yet another factor pushing the cost of generics up for payers, a trend that we've already seen unfold over the last 24 months.

If the proposed tax passes, it's expected to raise somewhere in the neighborhood of $1.5 to $2.0 billion.  These dollars will be used to fund outpatient and residential addiction recovery programs, an increase in the number of doctors certified to provide medication-assisted treatment, and other services to support addiction recovery (like housing and employment assistance for those in recovery).

Candidly, lack of access to these programs today is a major barrier to injured worker recovery. If the bill passes, workers compensation payers will bear the brunt of this new tax burden. Perhaps rather than fighting against the tax, we should collectively lobby to ensure that injured workers can easily access any and all of the new programs/centers/providers funded by the new tax?  

Just a thought...

Michael
On Twitter @PRIUM1

ProPublica: Drug Seeking Irony

Say the name "ProPublica" in a work comp meeting these days and watch what happens.  It's like a pinata at a little kid's birthday party... everyone takes a swing, only a precious few actually connect (but when they do connect, we all get candy... or something like that).  Metaphors and Mondays don't always mix.

By way of brief background, ProPublica is an independent, non-profit news organization that focuses on investigative journalism.  "Journalism in the public interest" is their tagline.  Regardless of how you feel about the organization, they've done good work in the past and the pieces they publish deserve at least a glance, regardless of where you think the organization sits on the political spectrum.

Over the last year or so, ProPublica's Michael Grabell and NPR's Howard Berkes have teamed up for a memorable series of articles on the work comp industry.  I chose the word "memorable" carefully - the aim of this post isn't to offer my view of the work.  Topics ranged from the state politics surrounding system change to how much one's arm would be worth if one lost it in a work-related accident, from the wisdom of opt-out initiatives to the appropriateness of benefit levels.  These articles were the source of much conversation and the target of a great deal of criticism, much of it obviously emanating from our industry.
 
Another of ProPublica's efforts that made news over the last couple of years was the publication online of a trove of Medicare Part D data in the form of a searchable database.  Journalists have used this data to identify trends in prescribing patterns that might be newsworthy.  Public health officials have used the data to develop and support both policy initiatives as well as fundamental research. Doctors and health systems have used the data to measure how they stack up against other groups.

And guess who else uses the data?  That's right!  Opioid seekers aiming to identify doctors most likely to prescribe pills. 

First of all, this isn't ProPublica's fault.  Secondly, they rushed to both publish their own story on this phenomenon and add additional warnings to their site regarding the dangers of opioid misuse and abuse.  So this is obviously a simple case of unintended consequences.  And frankly, the benefits of having the prescription data made public still outweigh the risks of inappropriate use.  The database is neither good nor bad; it's use makes it so.  

But it does beg the question: How many of those "drug seekers" on the ProPublica web site are injured workers?  And how many of them went to the site initially to satiate their appetite for complaining about the work comp system... and ended up learning where they might be able to get more opioids?

Michael
On Twitter @PRIUM1



  

Remember, Effective [Pain] Relief Just Takes Two

I hope you're sitting down.  Turns our Purdue Pharma may have engaged in inappropriate marketing for OxyContin.  Shocking, I know.  But read on... it's worse than you think.

Most of the news coverage around the plethora of lawsuits in which Purdue is engaged focuses on whether or not Purdue leadership and sales personnel misrepresented the abuse and/or addiction potential of OxyContin.  While this is a critical issue that continues to be litigated, my sense is that this particular line of attack has faded into a sort of white noise amidst the overall opioid crisis.

From the LA Times late last week, though, comes a new thing of darkness, a perhaps more clinically dangerous question about Oxycontin.  First, a few quick background facts:

• OxyContin is a brand name for oxycodone which, according to CWCI's latest (excellent) research, is the 3rd most often prescribed opioid in the California work comp system and the fastest growing opioid from 2005 to 2014.  And OxyContin itself is clearly the opioid on which more money is spent in work comp than any other (according to NCCI, 7.4% of 'total paid' across all drugs, all classes in work comp).    
• Purdue created a huge competitive advantage over other long acting opioids by submitting (and receiving approval for) an application focused on OxyContin providing pain relief via just twice a day dosing (q12h).  
• This led to Oxycontin sales reaching a high of over $3 billion in 2010 and total franchise revenue of over $30 billion.

While past allegations of inappropriate marketing led to a $635 million fine paid by senior Purdue executives back in 2007, the issue of appropriate dosing was never a central theme in the public health debate about OxyContin.

Until now.

Turns out a material percentage of patients don't actually get 12 hours worth of relief from an Oxycontin script.  Through access to previously undisclosed records, the LA Times has uncovered the following:

• Purdue has known about the problem for decades.  Even before OxyContin went on the market, clinical trials showed many patients weren't getting 12 hours of relief. 
• The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin's market dominance hinges on its 12-hour duration.
• When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to "refocus" physicians on 12-hour dosing. Anything shorter "needs to be nipped in the bud.  NOW!!" one manager wrote to her staff. 

Here's where things get dangerous. Purdue reps routinely encountered doctors who were dosing at shorter intervals, typically every 8 hours.  This creates two fundamental issues:

First, when the Oxycontin doesn't relieve the pain for the expected 12 hours and instead only offers relief for 8 hours, this creates a 4 hour gap during which pain comes roaring back... and makes the craving for the next dose all that much more powerful.  If this sounds like a recipe for addiction, it is. Dr. David Egilman, a Brown University professor, described this phenomenon to the FDA and summed it up as follows: "In other words, the Q12 dosing schedule is an addiction producing machine." 

Second, Purdue trained the reps to recommend that prescribing doctors (and this is the part that makes me viscerally angry)... up the dose.  That's right.  OxyContin 20 mg every 12 hours not working?  Try 40 mg every 12 hours.  Or 80 mg every 12 hours.  Safe MED levels?  Overdose potential?  Not a care in the world from Purdue about such matters of life and death.  Just make sure to hang on to the 12-hour dosing competitive advantage.

Take a look at your files.  How many claims do you have with OxyContin?  Lots, right?  So let's ask two critical questions... 1) Was the dose artificially increased over the years because some Purdue rep was telling the doctor to maintain the 12-hour schedule?  2) Or do you have lots of injured workers on 8-hour cycles of OxyContin that fall outside of Purdue's recommended dosing... thus providing further evidence that their 12-hour pain relief claim is fictitious?

Either way, I hope you're as fed up as I am.

Michael
On Twitter @PRIUM1

Because What We Really Need Right Now... Is Another Opioid

A twice-daily, extended release, abuse deterrent formulation of oxycodone, to be exact.  And just in time, too.  I was becoming concerned that FDA's recent commitment to take a new approach to the opioid crisis might have actually been genuine.  I guess you can't have too much of a good thing.

The trade name you'll want to look out for is Xtampza ER.  And no, I didn't misspell it.  Wondering how to pronounce it?  Your guess is as good as mine.  The pharma industry appears to be running low on catchy, hip drug names with the letters "x" and "z" that play well in the market.  Someday soon, we're going to see a drug called Xyz ER.  You won't see Xtampza pop up right away - Purdue (makers of Oxycontin) are (predictably) suing Collegium (makers of Xtampza) for patent infringement (because, really, how many extended-release, abuse-deterrent formulations of oxycodone do we need?)  But alas, Collegium appears to have a solid case: you can open up Xtampza capsules and sprinkle the oxycodone on your food without sacrificing its abuse deterrent properties. Science!

First, let's talk mandatory physician education.  While you probably hadn't yet heard of Xtampza, you can be excused for that lack of awareness given that you likely have neither the authority nor the inclination to prescribe it.  But the doctors who can prescribe it are going to learn about it from the sales reps who are pushing it.  We can do better than that.  We need to do better than that.  

And to celebrate the advent of every new abuse-deterrent opioid formulation, I like to remind readers of this blog, both new and returning, that abuse-deterrence is a tool, not a solution.  As I have written before, but share again here:

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

A Wake Up Call for Employers: One-Third of Opioid Scripts Are Being Abused

Castlight, a health benefits platform provider focused on self-insured employers, published a report last week on the opioid crisis.  The authors were able to take a unique look at the problem through the lens of current data from self-insured employer clients (vs. latent data from public sources).

Lots of interesting data in the report, but here's the headline:

1 out of every 3 opioid prescriptions is being abused.   

I had three reactions, in the following order:

First, I knew that number would seem astronomically large to most people ("Seriously, one-third of all opioid scripts are being abused?  How can that be?")  Fact is there are more sad opioid statistics than most people realize.  It is the disease of not listening.  While it makes for admittedly depressing cocktail party conversation, it is a predictable interchange.  People know there's an issue... they just don't realize how broad and deep it goes.

Second, I personally thought that number seemed low.  While I recognize PRIUM's data is somewhat skewed by our focus on chronic and sub-acute pain (vs. acute pain), our physician consultants conclude that approximately 70% of the the medications we review are not medically necessary based on evidence based guidelines.  I recognize that "lack of medical necessity" and "abuse" are two different phenomenon, but when it comes to opioids specifically, the former tends to lead to the latter. So I thought 1/3 was low.

And that led me to my third reaction: How did Castlight define "abuse"?  They're looking at de-identified diagnosis and prescription data.  I wondered what methodology they used to identify opioid abuse.

Page 12 of the report details their approach:
Excluding cancer diagnoses and hospice care, Castlight defined abuse as meeting both of the following conditions:

1. Receiving greater than a cumulative 90-day supply of opioids; AND
2. Receiving an opioid prescription from four or more providers over the 5 year period between 2011 and 2015.  

Let's acknowledge that this is, at best, a proxy for abuse.  Might there be patients who are defined as "abusers" in the Castlight data who are not, in fact, opioid abusers?  Is it possible that a patient could receive opioid scripts from 4 or more docs over 5 years and not be an abuser?  Of course it's possible.  

But I think the Castlight approach is actually quite conservative.  Using a cut off of 4 prescribers likely leaves out a material number of patients who are abusing opioids but happen to secure their prescriptions regularly from as few as a single provider.  By the way, Castlight doesn't capture work comp data.  So we know (unfortunately) that 1/3 statistic is low.  

A wake up call for self-insured employers?  Hopefully. 

Michael 

On Twitter @PRIUM1

When CMS and CDC Conflict: Medicare and Opioids

A few weeks back, the National Alliance of Medicare Set-Aside Professionals (NAMSAP) published a press release calling for a revised approach to MSAs that include opioid medications.  Specifically, NAMSAP stated that it supports the following changes:

1. A hard cap of 90 MED based on the CDC guidelines for no more than one month when the Work Comp MSA includes a surgical projection; and/or,
2. A hard cap of 40 MED for no more than one month, followed by a 10% per week mandatory tapering and weaning plan, as recommended by the CDC, until fully weaned from opioids

I find this attempt at hoisting the federal government with its own petard laudable.  When the federal government's public health agency says one thing, but that same government's healthcare payment policy agency says another, they ought to be called to account for it.  Just about anyone who reads this blog with any regularity is familiar with the crushing clinical and financial burden of opioids in general, but also specifically in regard to MSAs.  Long term use of expensive and potentially addictive medication is driving huge pharmacy allocations and prohibiting settlements.  So good for NAMSAP for putting this issue front and center with more than just a tired complaint, but rather with a specific call to action.  Good stuff.

Only one small problem.  I don't think it has a chance at being implemented. 

There are plenty of smart people in our industry that have forgotten more about MSAs than I will ever know.  But if I were writing the CMS response to NAMSAP, I would probably write: “We recognize that some of the treatment for which we demand allocation is outside of evidence based guidelines.  We support any and all efforts to bring care for these injured workers within those guidelines.  However, we respect the sanctity of the doctor-patient relationship and should a projection include long term use of opioids above the evidence based threshold, CMS will still demand an appropriate allocation for those medications.”  

I think the NAMSAP idea is fantastic - it should start a necessary dialogue around conflicting federal government policies and the clinical and financial risks it creates for patients and payers.  But I believe it has little hope of changing CMS policy, at least in the short term.  Hasn't CMS historically deferred to the treating physician’s approach, even when it makes no sense? 

One might argue that this is different, people are dying of opioid overdoses and the Medicare eligible population is not immune from that phenomenon.

I hope I'm wrong.  

Michael 

Follw me on Twitter @PRIUM1

Economic Insecurity and Chronic Pain

Earlier this year, the estimable industry consultant Peter Rousmaniere published a report entitled The Uncompensated Worker: Financial Impact of Work Comp on Households.  In the report, Peter summarizes the realistic impact that workers compensation has on families: "The scenarios [explored in the report] show that a brief work disability often results in a sharp cut in take-home pay, after the deductibles are applied. An extended disability lasting for months can cause many injured workers to struggle to meet their household expenses, forcing these employees to dig into their savings and risk losing their financial cushion."

And in an article last week published on Insurance Business America, Mark Walls, Vice President of Communications and Strategic Analysis at Safety National, noted the economic anachronism that is our current work comp system.  "Today, there are lots of skilled craftspeople who earn more than that [an indemnity cap of $1,100/week].  For anyone who earns a good living, going on workers comp can be a devastating blow, when it should not be."

While the world certainly affords no law to make an injured worker rich, our current system doesn't even appear to allow some injured workers to avoid poverty.  These two pieces came to mind when I saw this headline recently in the Harvard Business Review: The Link Between Income Inequality and Physical Pain.  Researchers from UVA and Columbia hypothesized that there might be a link between fiscal pain and physical pain.

First, they looked at the consumption patters of over-the-counter painkillers among 33,000 US households.  Compared to households in which at least one head of household was employed, those in which both were unemployed exhibited 20% higher spend on OTC painkillers.  Next, researchers asked people how much physical pain they were currently experiencing, but did so after informing the respondent of the unemployment rate in his or her state.  Employment status again proved to be a predictor of physical pain levels and, interestingly, simply living in a state with a high unemployment rate appears to lead to higher reports of physical pain.  They also did a fun experiment involving undergraduates and buckets of ice water, but you can read the article see how that went.

The researchers sum up their findings across studies as follows: "When people encounter economic insecurity, they typically feel a lost of control.  A sense of control is one of the foundational elements of well-being.  When people lose their sense of control, their body goes a bit haywire and responds to stimuli differently - displaying a weakened resilience and a lower pain threshold."

So here's an existential question for you this Monday morning: Might the very system we've devised to address pain resulting from workplace injury actually induce pain instead?  

Michael
On Twitter @PRIUM1

President Obama at the National Rx Drug and Heroin Abuse Summit

Imagine getting the chance to hear the President speak in person.
Now imagine he comes to your home town to offer some thoughts on a given topic.
Finally, imagine the topic of his remarks is the very center of your professional life and something you eat, sleep, and breathe every day.

That was my day today.

As my legendary 12th grade English teacher Ross Friedman would say: today was a 9.9 on the groovy scale (note: there are no 10s... so this was clearly a really great day).

President Obama came to Atlanta today to talk about prescription drug and heroin abuse.  Rather than give a speech from a prepared text, he sat on a panel moderated by CNN's Dr. Sanjay Gupta along with two recovering addicts and an emergency room doctor who also serves as Baltimore City's Health Commissioner, Dr. Leana Wen (who, by the way, proved to be an incredible advocate for changing the way we view chronic pain and addiction... she issued a standing order in Baltimore so that any citizen in the city can secure a Naloxone prescription - an overdose antidote - under her name.  Just walk into any pharmacy in Baltimore and pick it up.  Beat that with a stick).

This format enabled President Obama to speak extemporaneously and candidly on a range of topics under the umbrella of prescription drug and heroin abuse.  He talked about the Affordable Care Act, mental and behavioral health, criminal justice reform, patient and physician education, addiction prevention, treatment, and recovery.  While I'm not supposed to betray my personal politics on the blog (at least according to my PR advisers), most people who know me know that I'm a fan of the president.  Despite my admitted admiration for Obama, I expected today to be filled with presidential sounding platitudes like "we need more addiction treatment in this country" and other relatively obvious and safe statements.  And he said most of the things I expected him to say along those lines.

But he said more than that.  My impression is that President Obama understands both the policy nuance and personal tragedy of this issue at a level I honestly didn't expect.  This is a guy fighting multiple battles against an array of terrorist organizations, he's steeped in a Supreme Court nomination fight, he's trying to figure out how and where to weigh in on the circus that has become the 2016 presidential election, and he's dealing with a hundred other issues on a daily basis.  But he came to Atlanta today to talk about prescription drug and heroin abuse.  And amidst all of the other issues on his desk, it's evident that he gets this.  And it shows.

When asked by Sanjay Gupta what brought him to Atlanta this afternoon, President Obama offered this: "When I show up, the cameras usually do, too."  He wasn't being arrogant.  He was suggesting that his mere presence, regardless of what he said, helps bring needed attention to this critical issue.  He was saying that he consciously chose to use the power of his office to shine a light on prescription drug and heroin abuse.  And he's right - there certainly were a lot of cameras there today.

He said "we need to think about this [drug abuse issue] as a public health problem, not a criminal justice problem."  Many of us close to this issue agree with that statement, but when the President of the United States says it out loud, it reshapes the broader public dialogue and helps further the aims of those of us who have been thinking that way for years.  Such a public statement will help reshuffle the priorities of agencies like the FBI, DEA, ATF, CDC, and NIH.

He said he was "shocked to learn how little education medical residents receive in pain management."  And as a result, 60 medical schools announced today their intention to significantly enhance pain management training in medical school residency programs.  The bully pulpit is real.

Finally, he said "we medicate... self-medicate... a lot of problems in this country."  I was floored when he said that.  We know that's true, he knows that's true, but for the president to say it out loud is to acknowledge the fundamental need for cultural change necessary to truly stem the tide of prescription drug and heroin abuse.  Perhaps the most deeply rooted of all the root cause issues behind prescription drug abuse is the notion that Americans expect to be pain free, stress free, anxiety free.  Opioids aren't ragingly popular simply because they help manage pain.  Opioids also have psychoactive attributes that make the slings and arrows of our difficult and complicated lives seem easier to handle.  And President Obama said it.  And that matters.

Today was a great day for me, personally and professionally.  I think today might also turn out to be a great day in the broader fight against prescription drug misuse and abuse.  And that's a great day for all of us.

Michael
On Twitter @PRIUM1