Abuse-Deterrent Opioids: Great Solution, Wrong Problem

I was asked recently what PRIUM's plan will be when the "opioid crisis" passes.  My first thought was that I'll probably be dead and gone by then (I'm not that old, mind you).  The answer I gave (and which I wholeheartedly believe) is that workers' compensation is the ultimate tail claim business and whether it's opioids or something else entirely, the need for medical expertise on complex claims isn't going away.  Nevertheless, the question got me thinking about the fact that this particular medical management crisis is, in fact, different from past waves of over-utilization exhibited by providers treating injured workers. 

One of the significant factors perpetuating the current struggle with opioid over-utilization is the source of the pills themselves: giant, multi-national pharmaceutical companies with huge marketing budgets and armies of sales reps.  Pain meds are a $7.3 billion market projected to grow 15% by 2017 to $8.4 billion (according to Cowen & Co).  These companies are not inherently evil - in fact, any discussion regarding pain management medications must begin with the fact that there exists a legitimate need for these drugs in the world today.  There is little doubt, however, that our society is experiencing a public health crisis related to the misuse and abuse of these medications.  The pharmaceutical companies themselves, while perhaps suffering from a public relations fiasco, are nonetheless generating incredible economic profit driven, at least in part, by the inappropriate and medically unnecessary use of their products.  (Anticipating objection, let me point out that I am aware of the efforts being made by Purdue, Endo, Pfizer and others to stem misuse and abuse of opioid medications.  I find the effort laudable, albeit largely ineffective). 

This 15% projected market growth is driven by a simple equation that relies on two variables, price and utilization.   How much do the pills cost?  How many of the pills are sold?  If you know both variables, it's easy to arrive at the dollars at stake.  Billions of them, in this case.  In the world of pharmaceuticals, price is a function of patents.  And as Timothy Martin of the Wall Street Journal points out, those patents are being extended in the interests of medication abuse-deterrence. 

I wish to be perfectly clear on this point: 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).  There is legitimate debate on this point.  I know several well respected clinicians who believe the work comp system would derive greater benefit from the drop in price of the drugs driven by generic conversion than from the protection of patents for branded drugs less likely to be abused by patients. 

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 My Desk: A Litany of Legislation

The past couple of weeks have seen a significant number of legislative and regulatory efforts that warrant the attention of anyone working in our industry.  I couldn't decide which one to dig deeply into first, so here's an overview of what's sitting on my desk.  Look for deeper dives into each one over the next couple of weeks.

Florida has managed once again to snatch defeat from the jaws of victory in the battle over repackaged medications.  Senate Bill 662 (and companion House Bill 605) stipulate a compromise approach to pricing for repackaged drugs - 112.5% of the original manufacturer's AWP plus an $8 dispensing fee.  Setting aside for a moment the lack of logic behind differential pricing models for pharmacies and physicians, the larger impact of the legislation will be felt from the repeal of 440.13(12)(c) which smart payers were using to re-price these repackaged medications.  Senator Alan Hays is celebrating the compromise and while I give him credit for leading the fight over the last several years, the outcome is not a victory for Florida payers. 

Minnesota is attempting to update its approach to long term use of opioids.  Senate Bill 1603 (and its companion House Bill 1799) call for the adoption of "rules establishing standards for health care provider treatment."  Such rules are already in draft form and could quickly follow the adoption of the legislation.  Rules could govern such practices as opioid agreements between doctors and patients, frequency and content of follow up visits, and referrals to pain management specialists.

New York is asking for comment on newly proposed medical treatment guidelines for non-acute pain.  Comments are due by June 10.  At first glance, the guidelines appear comprehensive (the document is 90 pages with a sole focus on non-acute pain management).  The question will be: are they sufficiently specific to actually make an impact in prescribing behavior. 

Last, but certainly not least, is Oklahoma's Senate Bill 1062 (all 556 pages of it).  While I do not believe the adoption of this bill will lead to either widespread "opting out" within Oklahoma or widespread adoption of similar legislation in other states, it's nonetheless indicative of broader systemic issues and frustration around the workers' compensation. 

Michael

Medical Treatment Guidelines: Evidence vs. Consensus

Senate Bill 200 is all but signed into law in Tennessee.  The bill brings broad reform measures to the state, some of which were desperately needed (e.g., the creation of an administrative dispute resolution system that will largely relieve the civil courts of the burden of work comp fights) and some of which will be deeply contentious (e.g., the revised definition of AOE/COE that will surely shift a material number of injuries that might have been covered by work comp historically into the commercial/group health insurance market). 

One seemingly minor point caught my eye.  The law gives the newly created position of Administrator of Division of Workers' Compensation, appointed by the governor, the charge to adopt medical treatment guidelines for the diagnosis and treatment of workplace injuries.  These guidelines need to be in place by January 1, 2016.  Assisting the Administrator in this task will be a medical advisory committee which will be assembled as soon as the law goes into effect and will expire on July 1, 2015.  Assuming the committee is formed over the next several months, it appears they'll have approximately two years to adopt medical treatment guidelines.

Two years? 

If Tennessee isn't careful, they'll end up with a Louisiana-like approach to the development and adoption of medical treatment guidelines - a process so fraught with lobbying, special interests, law suits, and covering of tracks that sections of the resulting guidelines more closely resemble instructions for Medtronic spinal implants than actual medical treatment guides. 

The choice for Tennessee's medical advisory committee is simple: they can choose evidence-based guidelines or consensus-based guidelines.  While it sounds reasonable that a group of Tennessee-based medical experts should assemble themselves and consider all stakeholder views to develop a set of guidelines for which there exists broad acceptance... the reality is that good politics often leads to bad medicine.  Before the citizens of Tennessee realize what's happening, lobbyists from pharma, medical device, and physician constituencies will take pen to paper to write sections of the guidelines - as a service, of course, to the very busy committee members. 

Instead, the role of the medical advisory committee should be to debate which set of existing, off-the-shelf, evidence-based, nationally recognized, constantly updated guidelines should be adopted by the state in their entirety with no edits, additions, or subtractions driven by special interests.  This will be tougher to accomplish politically, but will lead to the best, most consistent, most credible, and most reliable clinical and financial outcomes for the work comp system. 

(Note: See Texas.  This works.) 

Michael

Closed Formulary, Coming Soon to Your State?

There's little doubt that the Texas closed formulary rules (instituted for new injuries as of 9/1/11 and forthcoming for all claims as of 9/1/13) is having it's intended impact.  Opioid scripts have dropped, spending on medication therapy has dropped, and prescription habits are clearly changing.  Washington State and Ohio, both monopolistic work comp systems, have also implemented closed formularies with apparent benefit (both clinical and financial). 

This morning's article in WorkCompCentral on California's forthcoming efforts around prescription drug management opens the door for the concept in California as well.  CA Insurance Commissioner Dave Jones explicitly suggested that a closed formulary concept should be explored.  This would make California only the second non-monopolistic state to adopt such an approach.

Obviously, we're a long way from the state legislature passing and the governor signing any such bill, not to mention the time it would take for DWC to implement such a measure.  In Texas, House Bill 7 - which called for the closed formulary to be implemented - was passed and signed in 2005; the rules went into effect in September of 2011.  Nonetheless, the notion isn't as far-reaching in California as it might appear. 

When plotting the potential geographic adoption of closed formulary concepts around the country, my view is that we're most likely to see such rules adopted in states that share several characteristics.

First, closed formularies will be particularly attractive in states that have a significant opioid issue.  California certainly fits this criteria.

Second, states that already have medical treatment guidelines with which the provider community is used to complying will find the concept of a closed formulary easier to swallow.  When Texas opted to use Appendix A of the Official Disability Guidelines, there was little push back.  ODG has been the guideline set governing care for Texas work comp patients for several years now.  California has its own Medical Treatment Utilization Schedule, but these guidelines are weak on opioids.  Interestingly, Department of Industrial Relations Director Christine Baker admitted as much to a panel of California lawmakers yesterday.  She noted that updating these guidelines is a "top priority" for DWC's panel of medical advisers.

Third, closed formularies will be most easily negotiated in states that already have clearly supportive utilization review (UR) statutes and regulations.  I recently reviewed the Texas rules as part of an education session in a non-UR state and suggested that I thought it might be a good idea for this particular state to give it a try.  Several audience members reacted quite negatively with one particular gentleman suggesting that all of the state's doctors would immediately cease taking work comp patients.  If your state doesn't have experience with UR, jumping right to a closed formulary is a tough sell to the provider community.  In California, UR is nothing new, though it's not a mandate like it is in Texas.  Nevertheless, I believe it's still a good leading indicator that adoption is possible.

Fourth, the state's politicians must exhibit the political will to adopt measures that are clinically and financially necessary, but not necessarily popular - particularly among physicians.  There are others in our industry who know far more about California politics than I, but I'm not convinced that a closed formulary concept wouldn't be changed beyond all recognition as it worked it's way through the deal making, negotiating, and bargaining that is a matter of course in Sacramento (and in many other state capitals around the country). 

California lines up well with respect to recognizing the opioid issue, moving toward more effective guidelines, and having plenty of experience with utilization review.  The open question: will the politics allow it to happen? 

Michael

Addiction, Patient Rights, and Law Suits

The text of Nevada Senate Bill 75, authored by State Senator Tick Segerblom, is simple.  Here it is in it's entirety:

1.  Notwithstanding any provision of law, a person who suffers injuries as a result of an addiction to a prescription drug may bring and maintain an action for damages against:
a) The manufacturer of the prescription drug.
b) The provider of medical care who prescribed the prescription drug, if the provider of medical care knew or should have known of the person's addiction to the prescription drug. 
2. A person who prevails in an action brought pursuant to this section may recover his or her actual damages, including, without limitation, any costs associated with rehabilitation for the addiction, attorney's fees and costs of any punitive damages that the facts may warrant.
3. [definitions]

That's it.  Pretty straightforward.  But at the same time, incredibly complicated. 

To be clear, I'm in favor of the concept.  Patients that suffer the consequences of iatrogenic disease (including addiction... perhaps especially addiction) should have recourse against the responsible physician.  Addiction is a well-defined and legitimate diagnosis.  If a patient exhibits symptoms of addiction and the physician misses them or refuses to acknowledge them, that physician should bear responsibility for the consequences to the patient. 

That said, such broad language as included in Senate Bill 75 leaves lots of unanswered questions.  If the doctor is to blame, where does the liability of the drug manufacturer come into play?  How does such legislative language align with work comp's exclusive remedy?  What would passage of such a bill do to malpractice insurance?  I'm sure the plaintiff's bar loves this idea, but how do we separate the wheat from the chaff? (There will be no shortage of frivolous suits driven by this law).  Plus the hudreds of other questions you're thinking of right now as you read this...

I'm not sure that Senate Bill 75 is the panacea some hope that it will be.  But it's a bold suggestion in the face of a major public health issue. 

Michael

Opioid Abuse: Is there a Role for Self Management?

Today brings a guest post from PRIUM's Founder and CEO, Jim Pritchard. 

There is little argument with the statement that injured workers are suffering from a high incidence of opioid abuse.

With such widespread recognition of the problem, why is it so hard to correct?  A partial explanation is reflected in the erosion of the “no fault” intent of workers' compensation.  We want the problem to be fixed back to the pre-incident status without cost to the injured worker (which is reasonable) and without effort (which is not).

Perhaps this is reflected by society’s perception of health.  Our society has tacitly defined health as indemnification against cost of health care procedures as well as our own poor personal choices, not just being of “sound mind, body and spirit”.  In my view, this is patently false.  Real health is a personal responsibility not a physician responsibility.  There is so much money (public and private) in this system with so many stakeholders continually attempting to gain their share of that money that we are encouraged and many times required to abdicate responsibility for our own health.

In workers' compensation, this is reflected by the attitude that the injured worker is indemnified against not only cost but also any pain, discomfort or effort in the recovery from incident or injury.  There are just too many perverse incentives at play.  Secondary gain, a busted legal system and little motivation to get back to work are just a few of such conflicting incentives. 

We at PRIUM have seen thousands of narcotics abuse cases.  Of these cases, obesity is the number one co-morbidity.  Psychological and other issues are frequently seen and mismanaged as part of the work incident, but obesity is still number one.  We all know that obesity brings with it a myriad of other co-morbid conditions such as hypertension, hyperlipidemia, diabetes, reduced level of activity, etc.  All of these issues tend to create a set of confounding variables that seriously complicate management of the case. Both narcotics and obesity tend to reduce desire for mobility which is probably the single best therapy for typical musculoskeletal workers' compensation injuries.

Instead of addressing this co-morbid condition (which admittedly requires an uncomfortable conversation), too many physicians increase dosage and medications to the detriment of the patient’s overall health.  We hear all too often “the patient is stable with a reduced pain score” as sole rationale for long term prescription of opioids.  We lose focus on function thereby creating a vicious cycle of reduced activity, increased caloric intake, feeling less well about one’s self, increased hypertension, potential onset of diabetes and more pain.  Removing these confounding variables should be pre-requisite to considering long term use of opioids for chronic pain.

In order to address this pandemic of prescription opioid abuse we must educate the patient as to the high risk and questionable benefit of long term opioid therapy in chronic pain treatment.  Patients must have sufficient information in order to exercise a responsible role in the decision making process for their own health.  Unfortunately, many in the physician community have displayed poor performance in addressing opioid abuse without such shared responsibility.

So, to answer the original question (why is opioid abuse so hard to fix?), not only should there be a role for self management in addressing opioid abuse, it should be a requirement.

JAP

Medical Bills Are Killing Us

Normally, I find that Time Magazine isn't worth the paper on which it's printed.  Pretty cheap paper, too.  But the cover story of the February 20th issue caught my eye: Bitter Pill - Why Medical Bills are Killing Us. 

As I began to read the piece, I realized that this wasn't a typical, four-page, gloss-over-the-subject cover story.  This was 30 pages of in-dept analysis that took the author, Steven Brill, seven months to research, analyze, and synthesize.  The article balances the power of the anecdote with the realities of the data.  The conclusions are alarming.  For those of us that have spent a career in health care, the data, the stories, and the intricacies of the system are not news.  But Brill's cover story shines a light in a heretofore dark space for the vast majority of health care consumers in this country. 

This is the first mainstream piece of journalism I've read in which the concept of the illusive "chargemaster" is discussed in great detail.  The utter lack of logic on which the chargemaster is based is just the beginning of the problem.  The real issue is that a great deal of the negotiating that goes on between hospitals and insurance companies revolve around this massive database of fundamentally arbitrary codes and prices.   This isn't a fact most of us have to worry about - unless you are uninsured or underinsured.  Brill sums it up this way: "If you are confused by the notion that those least able to pay are the ones singled out to pay the highest rates, welcome to the American medical marketplace." 

Of particular interest to most regular readers of this blog will be the story of the $49,237 spinal cord stimulator from Medtronic.  Not a typo.  The patient was actually charged nearly $50k for a SCS (and this was for the device itself and did not include the outpatient surgery charges, the physician charges, or the blankets and surgical gown for which the patient was also charged).  And for those of you paying bills in the work comp space based on fee schedules driven off of Medicare rates, there's a lot of discussion about how CMS sets those rates and what it means for providers. 

We've spent a lot of time in this country over the last several years arguing about how to pay for growing medical costs.  I'm not going to weigh in on that debate.  But I do appreciate Brill's view on the subject: "When we debate health care policy, we seem to jump right to the issue of who should pay the bills, blowing past what should be the first question: Why exactly are the bills so high?"

Worth a read. 

Michael