Smoking, Obesity, Mental Illness and Chronic Pain

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

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

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

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

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

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

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

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

Michael
On Twitter @PRIUM1

Physician Dispensing: I've Changed My Mind

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

I've changed my mind.

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

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

Michael
On Twitter @PRIUM1

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

Drug Distribution: Friends in High Places

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

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

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

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

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

So I kept reading... 

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

So I kept reading... 

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

You can't make this stuff up.  

Michael
On Twitter @PRIUM1

Another New Opioid: Cheeky, This One

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

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

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

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

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

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

Any guesses for this new one?

Michael
On Twitter @PRIUM1

Generic Drugs Are Not the Answer

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

I am 100% supportive of abuse-deterrent formulations of prescription opioids.  To me, though, this conversation is a distraction. The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is abuse-deterrent or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins.  Abuse deterrent technology is great, but if we focus on technology over medical necessity, we will have missed the mark and the crisis will continue.  

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

I am 100% supportive of GENERIC formulations of prescription opioids.  To me, though, this conversation is a distraction. The problem as we see it is lack of medical necessity.  In most cases, it doesn't matter if the patient's opioid is GENERIC or not.  If it's medically unnecessary, if it's leading to loss of function, if it's leading to dependence and addiction... it needs to go away.  The doctor will be better educated.  The patient will get better.  The cost of care will go down.  Everyone wins.  GENERICS [are] great, but if we focus on GENERICS over medical necessity, we will have missed the mark and the crisis will continue.  

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

Michael
On Twitter @PRIUM1