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
On Twitter @PRIUM1

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
On Twitter @PRIUM1

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
On Twitter @PRIUM1

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
On Twitter @PRIUM1

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
On Twitter @PRIUM1

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
On Twitter @PRIUM1

Patient Education: Opioid Basics

PRIUM has put together a simple, one-page (front and back), graphically intensive, easy-to-understand education piece aimed at patients on opioid therapy for chronic pain.  We're offering this resource absolutely free of charge to anyone who wishes to use it: injured workers, adjusters, nurses, physicians, attorneys, etc.  While the PRIUM logo is shown on the page, we'd be happy to share an alternative version that doesn't contain our logo - just ask and we'll send it your way. 

You can find our patient education brochure here.

We spend a lot of our time here at PRIUM on the concept of education.  We conduct continuing education for claims professionals and clinicians.  We deliver informal education within the context of every peer-to-peer intervention we perform.  One of the purposes of this very blog is general industry education.  But we hadn't yet developed anything to engage the injured worker.  And that wasn't for lack of trying.  We had grand ideas about web sites, interactive tools, self-assessment techniques, etc. 

Then Dr. Pamella Thomas, our Medical Director, shared a glaring and critical insight about the need to create patient education that is simple.  Her rule: if the patient can't get through it while sitting on the toilet, it's probably not going to help.

Special thanks to Dr. Thomas for developing the content and to Marketing Works for turning the content into an engaging infographic. 

If this leads to even a single patient asking a single question that leads to better treatment of chronic pain, the effort will have been worth it.

Michael
On Twitter @PRIUM1

Physician Dispensing: Even More Expensive Than You Think

Fantastic research piece on the costs of physician dispensed medications from CWCI's Alex Swedlow, Laura Gardner, and John Ireland.

The statistics are compelling on many levels. 

No, there doesn't appear to be any overall claim cost savings associated with physician dispensed medication (as those that dispense medications have claimed).  In fact, claims involving physician dispensed medications exhibit 16.9% greater medical costs and 13.2% greater indemnity costs. 

While that data is troubling, I was more truly surprised by the contrast between the pre-2007-reform and post-2007-reform data sets.  While the percentage of claims which included physician dispensed medications dropped from 28% of claims to 6% of claims, the differential in medical and indemnity spend was actually exacerbated.  The pre-reform difference in medical spend was 16.4%... the post-reform differential jumped to 37.3%.  The pre-reform difference in indemnity spend was 6.9%... the post reform differential jumped to 28.2%. 

At about the same time that Mr. Swedlow was discussing this report in Boston at the Physician Dispensing Summit, I was in South Carolina presenting to a roomful of adjusters, case managers, attorneys and doctors at the South Carolina Workers' Compensation Education Conference.  As part of my presentation, I made mention of the CWCI report and its findings.  I'll share with you exactly what I shared in Charleston:

Just because you limit the physician's ability to charge outrageous prices (which South Carolina has done) doesn't mean you have eliminated the problem.  Don't take your eye off the ball.  There may be fewer cases in the future for which physicians dispense meds, but these claims can be real cost drivers if not monitored very closely. 

Michael
On Twitter @PRIUM1

NCOIL Picks Up Where IAIABC Left Off

There's hope for state legislators looking for guidance on how best to handle the opioid crisis within the work comp system.  And the source of that hope turns about to be the legislators themselves.

According to WorkCompCentral, the National Conference of Insurance Legislators (NCOIL) will take up the issue as part of its spring meeting in DC this year.  Specifically, the group's Workers' Compensation Insurance Committee has scheduled a special session to address the issue with the aim of providing a draft set of standards which specific jurisdictions can use to guide state-level reform efforts. 

The group had expected to review the IAIABC draft legislation and regulatory framework, but given IAIABC's failure to approve those drafts, NCOIL will begin the effort anew. 

Comments from NCOIL included in the WorkCompCentral article indicate an interest in the approach Kentucky has taken.  Last year's HB 1 isn't perfect and has certainly sparked controversy, but NCOIL is headed in the right direction.  (You can read my thoughts on Kentucky's HB 1 - and some of the colorful comments I received - here and here). 

Well done, NCOIL. 

Michael
On Twitter @PRIUM1

Abject Failure at the IAIABC

Bob Wilson and Joe Paduda have both covered this topic, but because I spent a significant amount of personal time and effort on this... and because I'm incredibly upset about it... I figured I'd pile on and write about it, too.

The International Association of Industrial Accident Boards and Commissions is a non-profit trade association representing government agencies charged with administering work comp systems, primarily here in North America.  For over a year, they've been working on both model legislation and a model regulatory framework to provide guidance to states on how best to deal with the opioid crisis in work comp.  I've commented on the those guidelines extensively (first here, then here).  The models needed work, but IAIABC was moving in the right direction.  And this is the mission of the organization, right?  "To advance the efficiency and effectiveness of workers' compensation systems throughout the world..."

Now comes word that IAIABC's Executive Committee has put the models in a drawer, failing to approve the model language that had been worked on for the past year. 
(You can find a list of Executive Committee members here.  See if your state is represented!)

The IAIABC told Mr. Paduda that the "models would be overreaching on the part of IAIABC... We believed the consequences of advancing this prescriptive approach could potentially harm jurisdictions more than help." 

That is absolute nonsense and an abject failure on the part of this organization. 

I cannot understand how "model" legislation would in any way harm a jurisdiction.  Can the elected leaders in any one of our great states not resist the vast power and influence of the IAIABC?  Is there no way that a suggested regulatory framework could be changed to the suit the needs of a specific jurisdiction?  Does the IAIABC hold such incredible sway over state legislatures throughout the land that the mere mention of controlling opioid abuse through model laws would cause political, cultural, and clinical mayhem? 

The IAIABC thinks too highly of itself.  They had an opportunity to take the high road on this incredibly important issue and show their membership that it takes courage, fortitude, and intelligence to deal with this issue.  Instead, they punted.

On the IAIABC web site, there is a list of Current Issues.  There are only four items on that list.  "Opioid Abuse in Workers' Compensation" is one of them.

They should remove that immediately.

Michael
On Twitter @PRIUM1

Big Pharma and Big Influence: Get the Reps Out of Med Schools

Two recently published studies suggest that big pharma's influence is real and that it starts very early in a doctor's career.  Medical schools have long been fertile ground for drug companies and their representatives to establish cozy relationships with doctors in hopes of influencing future prescribing habits.  Turns out, the tactic works.  More on that in a moment.   

In the interest of full disclosure, I began my career out of college working at a reputable management consulting firm.  The biggest client was a drug company and my first project was launching a new cardiovascular drug in the US market.  Medical schools were target rich environments - lots of young, relatively poor, impressionable future doctors all in one place.  Show up with some pizza and you had influence.  Host a nice dinner, be a consistent presence on campus, and perhaps even provide some gifts, then you had friends... and potential future prescribers.  This was a sales tactic I once advocated.  It works.   

American Medical News provides a nice overview of both pieces of research.  I'll highlight the results of the first study, published last month in a British medical journal, which showed a stark contrast between a group of 2,500 medical school graduates from 14 schools that had put pharmaceutical company gift bans in place starting in 2004 vs. a matching set of doctors from different schools that lacked such a ban.  The study looks at the prescribing habits of the two groups with respect to three separate drugs.  For one drug (an antidepressant from Pfizer), the statistical difference between the two groups was insignificant.  But for the other two drugs (an ADHD drug from Shire called Vyvanse and an antipsycotic drug from Janssen called Invega) the results were staggering: the med school graduates from the 14 school test group were 56% and 75% less likely to prescribe those two drugs, respectively. 

Percentage of medical schools with gift bans (from the American Medical Student Association):
2008: 13%
2009: 29%
2010: 43%
2011-12: 53%

We know the influence of big pharma has played a significant role in the over-utilization of prescription opioids in work comp and beyond.  Though it'll take the better part of two decades (and we certainly can't wait that long), I nonetheless find it comforting to know that the next generation of doctors may start out with a cleaner slate than their predecessors. 

Michael

(Thanks to Jeff Woldanski at Allsup for the link to the article.) 

On Twitter @PRIUM1

Let's Make a Deal: Pain Management in the Age of Opioids

From time to time, I read letters written by treating physicians to PRIUM reviewing physicians.  These letters represent a great deal of what is wrong with pain management today.  While not emblematic at all of the best practitioners out there, these letters nonetheless reflect the thinking of too many physicians treating chronic pain patients. 

These prescribers try to strike deals.  Some offer to wean the opioids in exchange for pre-authorization of injections or other procedures.  A recent letter suggested that, if we were so concerned about the opioids, the doctor would be happy to wean them... if he could make a little money in the process doing some procedures. 

Some suggest they're doing the payer a favor already.  Methadone is a lot cheaper than Oxycontin, right?  So we should all just be grateful that the 800 mg MED is coming from a cheap source and not an expensive name brand drug.  As if incredibly dangerous drug regimens are somehow made more appropriate because the monthly cost is lower than it might be. 

Some note the nobility of our efforts, but label them as futile from the start.  They suggest outright disbelief that a particular injured worker will ever be able to reduce intake of opioids, however medically unnecessary the drugs may be.  The doctor is happy to refer them to a comprehensive pain management program... and they'll be equally happy to begin prescribing opioids again when the program fails.  The prevailing attitude: these patients can't live without these drugs, so let's just prescribe away the pain. 

Here's the thing, payers: You're financing all of this.  Make no mistake: If you stop paying for it, there will be noise. Nasty phone calls, unsettling letters, complaints left and right. But there are ways to cease payment without creating emergent clinical events for the injured worker. There's a right way to do this. And while I wish there was a simple solution to this very complicated problem, there's not. The solution is sophisticated, multi-faceted, and requires clinical, medical/legal, and jurisdictional expertise. There are no cookie cutters here... just a lot of claims and a lot of hard work to do.     

Ask yourself this question: When will the real liability of continued payment for a dangerous drug regimen outweigh the perceived liability of NOT paying for it?

No more deals.  Let's get to work. 

Michael
On Twitter @PRIUM1

Toilet Paper, Plumbers, and the Death Penalty: Hyperbole Not Helping

California’s SB 863 created a new process for dispute resolution in connection with the utilization review (UR) process.  After the standard UR process has run its course and an adverse determination has been rendered, an injured worker can request an Independent Medical Review (IMR).  The IMR is a mechanism to remove disputes over medical necessity from judges and put them in the hands of doctors.  Not a bad idea. 

The vendor for IMR services is Maximus Federal Services.  As reported in a workcompcentral article, the company recently sent a recruitment letter to California doctors offering $150 per case for standard reviews and $200 per case for expedited reviews.  At least one doctor, a cardiologist in Southern California by the name of Paul Grodan, thinks those rates are “ridiculous.”  But not just “ridiculous”… he shared some other choice words with author Greg Jones:

Reports for which doctors were paid those rates “would be worth toilet paper.” 

“I can’t even get a plumber to my house for that.” 

And my personal favorite: “It’s tantamount to having a death penalty case and paying the death penalty lawyer $150 for the appeal.” 

Wow.

(Leaving aside for a moment that the vast majority of death row inmates don’t even have legal counsel and among those that do, most of the work is done pro bono…)

Clearly, Dr. Grodan has taken the offer as a personal affront.  But such hyperbole has no place in the discussion on how best to deal with the dispute resolution process and how to make the IMR process work.  While acknowledging that a flat-fee arrangement might work under certain conditions, Dr. Grodan predicts the imminent failure of the IMR concept as currently contemplated. 

Here’s the reality of work comp UR: it is much more process-oriented than Dr. Grodan thinks.  The typical UR case constitutes a request for a medical test, procedure, or therapy.  The request is compared to evidence-based guidelines.  There’s a match… or there’s not.  A decision is rendered.  Are there cases that end up in a gray area?  Of course.  But those cases require more professional judgment than painstaking review of thousands of pages of medical records. 

Mr. Jones should have interviewed more than one doctor.  Dr. Grodan should have chosen his words a bit more judiciously.  If we step back, consider multiple view points, and remove the hyperbole, we’re likely to find a tenable solution to this simple economic issue. 

Michael
On Twitter @PRIUM1

Let the People Decide! Prescription Drugs and the Democratic Process

From what I can gather, 43 states have some form of Prescription Drug Monitoring Program (PDMP) up and running.  An additional 6 states have authorized such a program, but the systems are not yet functional or the concept hasn't yet been adequately funded.  That leaves a single state lagging behind all the rest: Missouri. 

Last year's legislative session saw Representative Kevin Engler introduce legislation that would create a PDMP.  The bill never came to a vote in the Missouri State Senate thanks to an 8 hour filibuster from Senator Rob Schaaf, a trained physician whose concern about patient privacy over patient safety made his state a bit of a laughing stock among those serious about combating prescription drug misuse.  (See PDMPs: NY Sets the Standard, MO Lags Behind).

Senator Schaaf is back this legislative session and has a new idea for how best to reconcile the competing ideals of privacy and safety: punt.  The good Senator apparently isn't comfortable with the idea of legislative representation, so his Senate Bill 146 calls for a state-wide referendum on the issue.  If the people of the Show Me State don't want to become the nation's capital for prescription drug abuse, well that's going to be on their heads... not on Senator Schaaf's. 

The more I think about it, though, the more I'm convinced he's on to something.  Perhaps things in most states would work better if state legislators got out of the way and let the people decide how the system should work.  In reality, this is impractical given the thousands of nuances and technicalities involved.  But for fundamental issues - like ones involving trade-offs between basic, but competing ideals - turning to the people might not be a bad idea.

Let's just hope, if SB 146 passes, that the people of Missouri do the right thing.

Michael
On Twitter @PRIUM1

Another Sad Story: Prescription Therapy Gone Awry

The front page of the Sunday New York Times yesterday featured the sad story of Richard Fee, a bright, talented baseball player who, as the title of the article states, Drowned in a Stream of Prescriptions.  His particular addiction was Adderall, an amphetamine-based medication used for the treatment of ADHD, a diagnosis which was questionable at best in Richard’s case. 

The story resonated with me, though, because of its implied indictment of our collective approach to any form of care delivery that might take more than a five minute office visit or a thirty minute trip to the operating room.  In particular, I saw themes throughout the article indicative of our culture of overtreatment and overreliance on prescription medication.  We’re dealing with more than just an opioid problem.  We’re dealing with more than just a chronic pain problem.  The fundamental model of care delivery is broken.

Below, I’ve taken several quotes from the Times article and simply removed the name of the drug and the diagnoses.  Ask yourself: How many injured workers do you know that fit the descriptions below?

“Through the remainder of 2010, in appointments with Dr. Ellison that usually lasted under five minutes, Richard returned for refills… Records indicate that he received only what was consistently coded as ‘pharmacological management’ – the official term for quick appraisals of medication effects – and none of the more conventional talk-based therapy that experts generally consider an important component… of treatment.”

“His [prescriptions] were always for the fast-acting variety, rather than the extended-release formula that is less prone to abuse.”

“Virginia is one of 43 states with a formal Prescription Drug Monitoring Program… Although pharmacies are required to enter all prescriptions for controlled substances into the system, Virginia law does not require doctors to consult it.” 

“’The doctor wouldn’t give me anything that’s bad for me,’ Mr. Fee recalled his son saying… ‘I’m not buying it on the street corner.’”

“He had it in his mind that because it came from a doctor, it was OK.” 

DeAnsin Parker, a clinical neuropsychologist in New York: “Diagnoses are made just this quickly, and medication is filled just this quickly.  And the lack of therapy is really sad.  Doctors are saying, ‘Just take the meds and see if they help.’”

Richard Fee eventually took his own life, unable to deal with his addiction and its consequences. 

We must do everything we can to stop addiction before it starts, provide alternative non-pharmacological therapy wherever we can, and help safely wean those already addicted to medications that are doing more harm than good.  This won’t be easy and it won’t be cheap.  But we have to do it anyway.

Michael   
On Twitter @PRIUM1

Borders and Biology: Should a Physician's Licensure Matter?

Can someone explain to me how the physiology of a human being that lives in one state can differ so dramatically from human beings in other states?  As some physicians and state regulators would have us believe, a doctor lacking licensure in a given state simply cannot understand the unique circumstances faced by patients in that state.  Biology, it seems, recognizes state borders. 

Take, for instance, the treating physician that recently refused to make any changes in her patient's drug regimen (which included the usual suspects - an opioid, a muscle relaxant, a sleep aid, etc... all for a twisted knee from 15 years ago).  Her reasoning for not making changes?  Despite the evidence presented and the collegial nature of the conversation, she stated that she was offended that the PRIUM reviewer wasn't licensed to practice medicine in her state.  Our apologies, doctor.  By all means, carry on with your medically unnecessary treatment. 

Take the state of Illinois, where the Department of Insurance can't get out of its own way regarding some rather simple principles of utilization review.  A bulletin from December appears to indicate UR physicians must be located within the state of Illinois... an unofficial response to inquiry indicates this doesn't apply to work comp... a follow up bulletin this month indicates that UR activities can't be "offshored", but doesn't provide any guidance as to the definition of offshoring, what constitutes UR activities, or whether it applies to work comp.  Glad we cleared that up. 

In a workcompcentral article on this topic, I noted the risk inherent in requiring UR doctors to be licensed and domiciled within the state from which the request was generated.  Doctors in the same geographic area are much more likely to have trained together and may even be tied to one another's referral patterns.  UR loses its independence and objectivity when conflicts of interest arise between reviewing and treating physicians that may have personal relationships or economic ties to one another.

But that's a more nuanced argument than is necessary here.  The simple reality is that state licensure is a red herring - an excuse used by treating physicians when they're called out (however collegially) by a peer regarding medically unnecessary, and in some cases dangerous, treatment. 

I'm tired of it.  State legislators and regulators need to recognize that the injured workers in any given state will be better served by the input and oversight of the very best doctors... even if those doctors aren't the worker's treating physician... and even if they're not licensed in that state. 

Michael
On Twitter @PRIUM1

Comprehensive View of the Opioid Epidemic

I ran across two great pieces of writing today, one a journal article and the other an opinion piece.  Both highlight how we got here and how hard it's going to be to dig out.  Not exactly encouraging, but as I've said before... anyone that tells you they've solve the opioid epidemic in our society should be looked upon with great skepticism.  This is hard. 

The journal article comes from the Pain Physician Journal and is titled Opioid Epidemic in the United States.  While there are no work comp specific statistics to be found, the paper is the most comprehensive overview of the opioid epidemic that I've read.  Essentially, it's a meta analysis of other studies done over the last several years.  I was left with a better appreciation of the breadth and depth of the problem at hand. 

The second piece, published this past week by Dr. Jen Gunter entitled The FDA's New Restrictions on Hydrocodone are Unlikely to Solve Any Problem, is a very honest and candid assessment of the obstacles we face as a health care system and as a society in stemming the tide of opioid abuse.  She points out the clinical, social, and financial drivers of the problem.  While the financial drivers are different in work comp, the clinical and social factors are the same.  Doctors are not sufficiently assessing depression, anxiety and other co-morbid conditions prior to the very first script.  Clinicians are not adequately exploring conservative therapies before turning to pharmacological solutions.  We know the story.

The hardest part to read was her conclusion:
"Requiring a new written prescription for hydrocodone every 30 days probably won’t change too much. Some doctors, to avoid the hassle, might refer a little sooner to pain programs (which will be good, if such a program is available) or to a surgeon (in general less good for chronic pain, but always available). Some doctors may refuse to start opioids (good for some patients and bad for others), but many doctors will probably just leave written prescriptions with their receptionists for their patients to pick up. In summary, the American problem with opioids and chronic pain will remain unchanged."

I hope she's not right, though I fear she might be.  We need more than simple restrictions on hydrocodone scripts to get this public health issue under control.

Michael
On Twitter @PRIUM1

New Opioid Guidelines: Well Done Washington

Washington State's Department of Labor & Industries (L&I) has issued new, and quite comprehensive, guidelines for prescribing opioids to treat injured workers.  Yes, Washington is a monopolistic state.  Yes, I've been critical in the past of certain L&I measures that gained widespread praise, but fell short when one looked closely at the details.  But the new guidelines represent a bold, clinically-focused, evidence-based, administratively-tight step that will lead to material changes in opioid use for the state.  The document is dense and covers a lot of ground: the prevalence of opioid use, the impact of the drugs - both clinically and socially, the appropriate uses of the drugs by stage of injury, and best practices regarding discontinuation.  Not enough room here to cover everything, but here are a few highlights:

Let's start with my favorite sentence in the entire 20 page document: "If opioids are to be prescribed beyond 12 weeks post-injury or post-surgery, the provider must have received prior authorization from the department."  (By the way, the bold font for "must" is not my doing... L&I wrote it that way).  Further, in order to receive such prior authorization, several important conditions must be documented, including:
- Clinically meaningful improvement in function (greater than or equal to 30%) has been established with opioid use in the acute or subacute phase.
- Failure of trials of reasonable alternatives to opioids.
- Signed treatment agreement (pain contract).
- A time limited treatment plan, addressing whether chronic opioid therapy is likely to improve the worker's vocational recovery.
- Consultation with a pain management specialist if the worker's dose is above 120 mg per day MED.

Good stuff.  If every state, every carrier, every employer enforced (or, perhaps were allowed to enforce) such guidelines, we could eliminate a significant portion of the opioid problem in comp. 

One concern (and I'd be happy to get some input here, particularly from Washington readers): Is L&I prepared for the administrative burden of the prior authorization process they've created here?  While taking a slightly different form, Texas has effectively created a similar requirement (through its closed formularly rules).  We've performed sufficient analysis and looked at enough cases in Texas to know that enforcing a pre-auth requirement takes a lot of resources, a lot of planning, and (optimally) a remediation period to address chronic opioid therapy on legacy claims.  Washington appears to plan to "flip a switch" on July 1, 2013.   I hope they're ready.

Michael
On Twitter @PRIUM1

Payer Access to Prescription Drug Information

CWCI has published a research piece suggesting that 3rd party payer access to the CURES database (Controlled Substance Utilization Review and Evaluation System) - California's Prescription Drug Monitoring program - could create material cost savings for the California work comp system.

California is on the verge of pulling the plug on CURES.  Despite significant evidence from across the nation that Prescription Drug Monitoring Programs (PDMPs) are critical to fighting the inappropriate utilization of opioids, California has yet to commit to the $3.7 million in annual funding necessary to keep the system online.  If funding doesn't materialize before this summer, the database will go offline in July. 

So why should a state with a massive budget deficit throw $3.7 million at a database?  Perhaps because it would save 15X that number if the database was accessible and usable by 3rd party payers.  The analysis from CWCI is characterized as conservative, but still suggests potential savings (ranging from 3% to 7%, depending on the complexity of the claim) of nearly $60 million simply through the elimination of fraud and abuse by 3rd party payers having access to critical data not currently available to them.

Before the chorus of "privacy concerns" erupts, keep in mind that CWCI is merely suggesting that payers be granted access to data regarding services and therapies for which they are most likely already paying.  The aggregation of the data by prescriber and by pharmacy offers insight into inappropriate and/or unsafe activities such doctor shopping, pharmacy shopping, drug-drug interactions, etc. and can serve as a powerful tool that an individual payer can use to help manage care more effectively. 

Pain management guidelines don't appear to be working (that's a post for another time) and the study found that 41% of work comp claims end up with at least one opioid script, with >20% of injured workers receiving at least 7 opioid scripts over a 24 month period.

That's a lot of drugs.  And a $3.7 million database with a potential for a $60 million return sounds like a good investment to me.

Michael
On Twitter @PRIUM1

Generic Opana: An Unwelcome Addition

Good news for investors of Impax Labs (NASDAQ: IPXL) turns out to be bad news for lots of other people, including injured workers and their families. 

After a well publicized settlement back in 2010 with Endo, makers of the brand name version of Opana ER, Impax has begun shipping generic oxymorphone hydrochloride extended release tablets as of January 4, 2013. 

Upside: As we all know, generics are cheaper.

Downsides:

1) The new formulation is not tamper-resistant.  This actually creates two potential consequences: a) physicians who are aware of the fact that the new generic is non-tamper resistant may be less likely to prescribe it, therefore dampening the typical post-patent-expiration price drop of the drug; b) physicians who are not aware of the non-tamper resistant formulation - or choose to ignore its significance - will write scripts for the new generic, thus introducing a more dangerous and abuse-prone drug into the injured worker's treatment plan (and into the injured worker's home, I might add, where others may abuse or divert the drug). 

2) The post-patent-expiration price drop can be a deceiving phenomenon for a work comp claim.  Yes, the drug spend may go down.  But is the patient improving?  Does the introduction of the cheap generic opioid increase or decrease the likelihood of a positive clinical outcome?  What additional medical expenses will result from the introduction of the generic opioid (side effects, exacerbation of co-morbid conditions, risk of dependence/addiction, etc)? 

Cheap generics can be just as dangerous as expensive brands - don't take your eye off the ball.

Michael
On Twitter @PRIUM1