Friday, July 18, 2014

Utilization Review: Tough Love is Best Practice

[A guest post from David Price, PRIUM's Compliance Counsel.  I'll direct any comments you might to have for response.]

“If you would persuade, you must appeal to interest rather than to intellect.”
                                                                                                            -- Benjamin Franklin

Promoting change is hard.  I feel like it’s particularly difficult in the sphere of workers’ compensation.  Between physicians, injured workers, payers, employers, and attorneys, there are multiple competing interests at stake, and policy makers are hesitant to change the existing laws and risk inviting backlash from the groups that don’t feel like they’re benefiting from the change.  The people that shape workers’ compensation law – whether they’re legislators, administrative officers, or judges -- want to promote the public good, but most importantly, they want to make sure that the system is fair.  They want to make sure that no one is getting cheated.  Once they feel like someone is getting cheated by the law, change suddenly becomes much easier.

When a new law is being discussed, there’s always a temptation for us to discuss only the aspects of the changes that benefit us – to only consider our side of the overall story.  What we say might be true, but it’s not always persuasive, particularly if we don’t discuss how the change will benefit other interested groups.  When we only talk about how the change benefits us, it’s no surprise when some of those other groups start to complain that the change is unfair… or when policy makers start to believe them.

Promoting good policy requires honesty, but more importantly, it requires effective honesty. 

I recently had the opportunity to attend the annual Tennessee Workers' Compensation Educational Conference.  This year, the conference was set up so that audience members could text their comments and questions to the speakers throughout each presentation.  This way, audience members could ask their questions while they were still fresh in their minds, and the speakers could finish their presentations without interruption and then come back to address the questions afterward.  As a bonus, because the comments were submitted anonymously, people weren't afraid to ask questions or offer their perspective on each issue.

For better or worse, there was a lot of honesty in the room.

Dr. Robert Snyder, the Medical Director of the DWC, discussed the DWC's plan to adopt treatment guidelines by 2016.  Additionally, several presenters made reference to Tennessee's current UR process, and there was some brief discussion of what the UR process would look like once the treatment guidelines were implemented.  

The comments from the audience, understandably enough, were more concerned with how UR could be used effectively to reduce medical costs.  Unfortunately, many of the comments were essentially expressions of outrage at the irresponsibility and attitude of entitlement of injured workers.  Commenters made a strong case for how UR (and by extension, the guidelines) could be a useful tool to beat drug-seeking claimants.  That may not have been the most effective form of honesty.

With legislators and workers' compensation judges in attendance, commenters touted UR and the guidelines as purely cost-reduction tools and, at one point, a presenter, in response to a question, made the suggestion that in 2016, adjusters, not UR physicians, should apply the new treatment guidelines, and that any request complying with the guidelines should not be subject to UR.  

The overall message was clear: the point of treatment guidelines is to reduce medical costs.  Since they’re really just a tool for the adjuster to use to “beat” the injured worker, maybe we should let the adjustor apply them directly, without getting a medical opinion.

If you ask any claimant's attorney, they'll tell you that all injured workers (or at least their clients) have a legitimate medical need for whatever treatment their doctors recommend, and that payors are just using treatment guidelines and UR as tools to get out of paying for treatment in order to save money.  UR and treatment guidelines are just tools to “beat” the injured workers -- at least, that’s how they tell the story.  Notably, their version frames UR and treatment guidelines as tools aimed solely at saving payors money.  They do this because they know that if they can show UR and treatment guidelines as being implemented solely to benefit the payor by harming the injured worker, it makes the whole process seem unfair.  Any policy maker with the slightest sense of empathy will try to find a way to undermine or limit application of the guidelines.

So here's where I say something that may be controversial:  The primary goal of UR and evidence-based treatment guidelines is to ensure proper treatment for the patient.  Cost reduction is a bonus -- a secondary effect.

Don't get me wrong: from the perspective of insurance carriers and self-insured employers, cost reduction is going to be the primary goal.  Most payers are for-profit entities, and their focus is (and should be) on reducing costs.  That said, policy makers have a different role.  Their focus should be on the public good, and if we continue to allow the debate to be framed as "patients' medical need vs. payers' bottom line," payors will lose every time.  If we talk about treatment guidelines as something that only benefits payers, we can expect to see those guidelines undermined at every opportunity.

We need to be careful in how we tell the story.

There is a very real public policy battle here, and not just in Tennessee.  In Louisiana, several courts have limited the application of the state's treatment guidelines.  In California, the infamous Dubon decision is being used by injured workers' attorneys as a means to attempt to escape the UR/IMR process.  Oklahoma has implemented a closed formulary based on the Official Disability Guidelines, but the state legislature has effectively limited application of the formulary based on date of injury.  (Only claims under the jurisdiction of the new Workers’ Compensation Commission – those claims with a date of injury of 2/1/14 or later – are subject to the closed formulary).  In multiple jurisdictions, we're seeing judges and other policy makers limit the opportunities to apply objective medical standards.  

Why?  The primary reason is a concern for due process.  At the risk of greatly over-simplifying the points raised in each of these instances, the general underlying concern is that the objective medical standards aren't really objective at all (or at least aren't being applied objectively), and so a "fair" determination of medical necessity can only come from a judge.

Now, in Tennessee, the DWC is planning to adopt treatment guidelines by 2016, but which guidelines will be adopted -- or how they will be utilized -- remains to be seen.  We can be certain that the way we talk about treatment guidelines and the UR process now will greatly affect the way the process is shaped as the guidelines are implemented, and whether or not policy makers see application of the guidelines as an "unfair" intrusion onto injured workers' right to due process.

We can be just as certain that when the guidelines are implemented, work comp and appellate judges will see a host of objections.  No doubt, many of those objections will echo the arguments that have been made in other jurisdictions.

If we talk about treatment guidelines as something designed to benefit only the payer -- and especially if we promote them as something that payers should be able to use without requiring a physician’s opinion (I don’t envy the attorney that has to defend a non-medically-trained adjusters determination that a physician’s recommended treatment isn’t medically necessary) -- we’re buying into a very dangerous story.  It’s the same story every injured worker’s attorney will tell in 2016 when the guidelines are applied.

To be honest, treatment guidelines do reduce overall medical costs, but that's not the whole story.  If that's how we allow the discussion to be framed, we can expect to see more limitations on when and how guidelines are applied -- in Tennessee and elsewhere.

The vital part that’s missing from that story is that, in reality, evidence-based treatment guidelines are designed to benefit injured workers, and that’s precisely what they do.

The reality is that injured workers usually don't know what treatment is appropriate; they only know what their doctors tell them.  The reality is that treating physicians are torn between their duty to help the patient recover as quickly as possible and the lingering financial incentive toward excessive treatment.  The very nature of the workers’ compensation system, and sometimes even the patients, can pressure physicians to treat in ways that contradict their best medical judgment.  At the same time, even the most honest and strong-willed treating physicians are hard-pressed to keep abreast of current medical evidence as they try to operate a successful practice, and many are particularly under-educated regarding the proper prescription of opioids for pain.  The reality is that evidence-based treatment guidelines provide an objective standard of care and, when used correctly, can protect the injured worker from improper treatment, overdose, and addiction.

That's the truth, and that's how we should tell the story.


Wednesday, July 2, 2014

CDC Reports: First Substantial Decline in Overdose Deaths in any State in the Last 10 Years

New reports from the CDC show that progress is possible in the fight against prescription drug misuse and abuse.  Highlights from each of two reports released yesterday:

From Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines:
States can take other actions that will affect prescribers. Developing or adopting existing guidelines for prescribing OPR and other controlled substances can establish local standards of care that might help bring prescribing rates more in line with current best practices. State Medicaid programs can manage pharmacy benefits so as to promote cautious, consistent use of OPR and benzodiazepines. In addition, a number of states have passed laws designed to address the most egregious prescribing excesses. Florida, for example, enacted pain clinic legislation in 2010 and prohibited dispensing by prescribers in 2011. It subsequently experienced a decline in rates of drug diversion (17) and a 52% decline in its oxycodone overdose death rate (18). Guidelines, insurance strategies, and laws are promising interventions that need further evaluation.

And from Decline in Drug Overdose Deaths After State Policy Changes, Florida 2010-2012:
This analysis showed that policy changes in Florida were followed by declines in the prescribing of drugs, especially those favored by Florida prescribing dispensers and pain clinics, as well as by declines in overdose deaths involving those drugs. Florida has reported that approximately 250 pain clinics were closed by 2013, and the number of high-volume oxycodone dispensing prescribers declined from 98 in 2010 to 13 in 2012 and zero in 2013 (2). Law enforcement agencies in Florida also reported that rates of drug diversion (i.e., channeling of prescription drugs to illicit markets) declined during 2010–2012 (6). Preliminary data for the first half of 2013 from the FMEC indicate a continued decline in oxycodone and alprazolam overdose deaths (4). These changes might represent the first documented substantial decline in drug overdose mortality in any state during the past 10 years.

Progress is possible.  Guidelines, insurance strategies, regulatory/legislative action, and common sense education are the keys to mitigating this epidemic.  The CDC reports yesterday put data behind what we already knew to be true.


Wednesday, June 11, 2014

A Better Approach to Chronic Pain Management

[A guest post from PRIUM's Medical Director, Dr. Pamella Thomas]

Maybe the discussion for specialists treating chronic pain should shift away from what law governs their treatment plans and toward what they should really be treating in chronic pain patients. 

The traditional biomedical model of chronic pain assumes chronic pain occurs because of deviations from normal and measurable biological (somatic) variables. In other words, there is always a direct causal relationship between a specific pathophysiological process and the presence and extent of a particular symptom.

Physicians are not, by and large, viewing the individual patient through the biopsychosocial model, which sees pain and disability as a complex interplay of biological, psychological and social factors that, when properly understood, can be assessed and managed. The operative word here is ‘managed’ as any other chronic disease would be managed, instead of trying to treat as you would an infection which is acute and can be cured with the correct medications. Treating chronic disease starts with objective measures of current status and function followed by a treatment plan to manage any distortions. Looking at these treatment records with the paucity of adequate clinical evaluation data and any objective supporting documentation, it is not surprising that continuing opioids is the only constant treatment plan. The patients are all "constant and stable"!

Some physicians unwittingly miss this distinction and do not educate the patient to set the right expectations.  This leads to failures, delayed recovery, and unnecessary disability and cost.  For example, neuropathic pain which traditionally was thought to develop in a primary peripheral nerve is now seen with recent investigation (using functional neuroimaging techniques) to have a large centralized nerve component (in conditions such as chronic low back pain, fibromyalgia, irritable bowel syndrome, and CRPS).

Pain psychopathology and physiology have to address the various components generating this pain. This may include cultural background, belief systems, relationships and interactions with the environment, including home, work, and social environments, as well as their interactions with the disability system and their health care providers.  All of these interactions contribute to the continuing pain when not recognized and managed according to evidence based guidelines.

This leads to neurobiological causes of persistent pain, when structural and functional CNS changes may amplify and maintain the experience and disability of certain pain conditions.  We know stressful stimuli can trigger potent analgesia, mediated by endogenous opioid systems in the CNS. The large prolonged levels of opioids being prescribed in these conditions are more than likely increasing pain from hyperalgesia, leading to intractable pain conditions.  These patients usually do better when weaned and adjuvant and/or co- analgesics are used along with integrated multimodal non-pharma therapy that addresses the pain triggers in the individual patient.  Along with patient education (emphasizing that pain is a perception that needs to be managed without opioids long term), this usually leads to a 'cure' and return to function.

If the treating physicians are following the science, then the point of governing law becomes moot. Instead, we focus on evidence based best practices.

Dr. Pamella Thomas 

Tuesday, May 27, 2014

The Demise of American Medicine: Lawsuits and Federal Legislation

I recently read two news items back to back, one regarding a lawsuit and the other a physician-written editorial in Forbes.  My coincidental consumption of these two items left me wondering about the fundamental practice of medicine in the 21st century.  

Much has been made in the last couple of days regarding the lawsuit filed by two California counties against five large drug makers for waging a "campaign of deception" to inappropriately promote use of potent painkillers like Oxycontin.  Tom Lynch provided an insightful overview of the suit, particularly in his emphasis on the lawsuit's intentional and powerful analogy to the tobacco fight of the last century. 

Irrespective of the lawsuit's legal standing and chances of success, I find the nature of the suit itself to be a sad commentary on the nature of the medical profession.  No one directly employed by any of these pharma companies ever wrote a single script for an opioid.  Physicians wrote the scripts.  Some were ill-informed (purposefully, the suit claims).  Some were improperly influenced (despite their better judgment, one can only assume).  And some openly championed the broader use of opioids as Key Opinion Leaders (KOLs), paid handsomely by the pharma companies to do so (leading, no doubt, to the aforementioned ill-informed group of physicians).      

Add to this Dr. Scott Gottlieb's piece in Forbes, "How American Doctors Lost Their Professional Autonomy."  He outlines the practical implications of the Sunshine Act, which requires doctors and pharma companies to disclose virtually every interaction they have with one another, from the ubiquitous giving away of simple pens to the $50,000 consulting fees paid to some doctors.  Gottlieb points out that this act is emblematic of a broader principle: "Underneath the imposition of the Sunshine Act is a far more troubling revelation: Washington has little faith in American physicians, and sees a need and a license to regulate just about every aspect of medical practice, even trinkets doctors receive.  There's a clear view that doctors can't be trusted to have any financial interactions with drug and device makers, no matter how small or simple these transactions."  He further cites the fundamental failure of professional medical societies to engage in any meaningful self-regulation, thus ceding that duty to the federal government.  Gottlieb calls this "the demise of American medicine."   

There are many, many more good doctors than bad.  But the bad doctors are certainly making it harder on the good ones to operate with the professional autonomy most doctors believe is required to deliver sound medical care.  

So where does that leave us?

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Thursday, May 22, 2014

Medical Marijuana: The Decision that Never Should Have Happened

Two of the biggest questions around the legalization of marijuana are: 1) whether or not the carrier or self-insured employer is going to have to pay for it; and 2) whether or not that payment violates federal law.

New Mexico just answered the first question for payers in their state.  The Court of Appeals just released its decision in the Vialpando v. Ben’s Automotive Services and Redwood Fire and Casualty case, in which they upheld the WCJ’s decision to require the carrier to reimburse the injured worker for his medical marijuana expense.

Under the New Mexico Workers’ Compensation Act, an employer is required to provide the injured worker “reasonable and necessary healthcare services from a health care provider.” Section 52-1-49(A)  The decision focuses on the definition of health care provider, and whether or not marijuana is a prescription drug or a service.  At no time does the court bring up the fact that the treatment with medical marijuana might not be medically necessary nor in line with evidence based medicine. 

New Mexico recently adopted medical treatment guidelines, and on July 1, 2013, the Official Disability Guidelines went into effect and all medical services rendered pursuant to the most current version of ODG is presumed reasonable and necessary. 

With respect to the use of medical marijuana, the Official Disability Guidelines state that medical marijuana is “not recommended for pain” treatment.  Therefore, it is unlikely that a health care provider in that state could consider it reasonable and necessary treatment.

Perhaps the issue of reimbursement, which could potentially violate federal law, could have been avoided altogether by making an evidence based medical argument first, and the legal/procedural argument next.  After all, we are ultimately talking about appropriate medical treatment, which is a clinical issue that should be discussed and determined by clinicians, not lawyers and judges.

Your thoughts?

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Monday, May 19, 2014

Great Data/Studies to Start Your Week

A paper published this week by Accident Fund Holdings and Johns Hopkins University on physician-dispensed medications offers incredible insight into the costs associated with doctors dispensing medications directly from the office to injured workers.  The work is particularly valuable not only because it's so thorough, but because it examines total cost of claims.  There are lots of great statistics here, but the one that jumped out at me: the average claim in the study for which there was never a physician-dispensed medication incurred total claim costs (medical + indemnity + other) of about $33,000.  The average cost incurred on a claim for which there was at least one physician-dispensed opioid?  Almost $57,000.  That's a 70% increase.  (With the analysis controlling for gender, age, acuity, etc.)  Wow.  

CWCI has published a research update on use of Schedule II and III medications in the CA work comp system.  The analysis is great, the results are not.  The use of both S-II and S-III opioids ticked up through the first half of 2013 from levels observed in 2012 (19.3% of all prescriptions were S-III, up from 19.0% in 2012... and 7.3% of all scripts were S-II, up from 7.2% in 2012).  Perhaps most notable is that CWCI estimates that nearly half of S-II opioids used in workers' compensation are for minor injuries, where medical evidence doesn't support the use of opioids (nor do the FDA labels on long-acting/extended-released opioids).  If we're spending approximately $1.5 billion on opioids in work comp and we estimate that $750 million of that is inappropriate... What does that mean for injured workers?  What does that mean for state workers' compensation systems?  What does that mean for the PBM industry?  What does that mean for your business?   The implications are significant.  

Finally, there was a piece last week that aired on NPR that should be required listening/reading for everyone in workers' compensation.  We've known for some time that low back injuries are frequent, surgeries (and subsequent surgeries) often don't appear to help, and that long term opioid use is a typical result.  We also have studies that suggest what injured workers with low back pain need to do: move!  Don't fear the pain. Get up and exercise.  This piece puts a human voice behind that logic.  Imagine if all injured workers with low back pain (even those who have suffered failed back surgeries) went through this program.  

Have a great week.

Thursday, May 15, 2014

What if it's the Opioids Causing the Pain?

Roberto Ceniceros wrote a great piece this week on R&I regarding opioid-induced hyperalgesia.  This is a phenomenon observed in some patients on long term opioid therapy in which the opioids actually increase the sensation of pain.

Among prescribers unaware or uneducated on the topic, the patient's legitimate report of increased pain can lead to increased dosage of opioid analgesics, which thus leads to increased pain.  This creates a vicious cycle that can lead to significant adverse effects, including dependence, addiction, and potentially death.

Dr. Marcos Iglesias, medical director for Midwest Employers Casualty, said, "A lot of claimants who are on high doses of opioids are still in a lot of pain.  A big reason for that is the opioids.  Once they are weaned off the opioids, they feel much better and their pain will actually decrease.  So ironically, one of the ways to help their pain is to take away their painkiller."

Add to this recent findings that weaning opioids, even high doses of opioids, in the outpatient environment is not only possible, but leads to decreases in pain scores, depression scores, etc. and we can begin to see the absolute necessity of questioning the medical appropriateness of high dose chronic opioid therapy.

The graphic below is from the CDC.  I wonder to what extent this cascade of negative clinical and social consequences started with an otherwise well-intentioned physician failing to notice signs of opioid-induced hyperalgesia.  

You didn't need any more evidence than you already had to question the medical necessity of long term opioid therapy.  Nonetheless, if you haven't already, it's time to focus on ensuring injured workers under your stewardship aren't being harmed by the very drugs intended to help them.