Wednesday, August 27, 2014

The Rescheduling of Hydrocodone: Don't Get Too Excited

The Drug Enforcement Agency has published its final rule on HCPs - hydrocodone containing products - which will be rescheduled (from schedule III to schedule II) beginning on October 6.

The two areas that appear to be of greatest concern in the market regarding this move are:
1) The impact on pharmacies which will now be required to handle, store, and dispense these drugs with greater restrictions going forward, undoubtedly increasing costs for pharmacy operations; and
2) The impact on patient access.  Will patients in pain still be able to get these drugs?

On the first issue, we should all acknowledge the reality of retail pharmacy operations.  This will cause changes and those changes will lead to increased costs.  While I would argue the clinical and public health benefits of the rescheduling of HCPs outweigh those costs, I'm not running a retail pharmacy.  My hope is that these costs trend down over time as pharmacy operators adapt to the new routines required.

To the second issue regarding patient access, let's keep in mind that a rescheduling of a drug may not necessarily impact prescribing patterns.  Yes, schedule II drugs cannot be written for more than a 30 day supply and each prescription requires an office visit.  This will inconvenience some patients in chronic pain.  That said, there are "work arounds".  At the Georgia Workers' Compensation Education Conference here in Atlanta yesterday, I moderated a panel regarding medication usage for the treatment of chronic pain.  A suggestion was made that some doctors may just write two 30 days scripts with a "do not fill before" date on the second script.  Voila! 60 day supply.

Most troubling, though, is the sentiment I've heard from several workers' compensation professionals that goes something like "if a patient really wants the drug - and they will still want HCPs - they'll jump through whatever hoops necessary to get it."  On the one hand, I get it.  It's not as if cynicism in our industry doesn't have obvious and ubiquitous roots.  On the other hand, we cannot allow patient directed care to dictate appropriate treatment pathways for injured workers.  The rescheduling of HCPs should signal to physicians that the drugs are potentially more dangerous than we originally thought.  Doctors, not patients, should therefore be engaged in differential decision making.  If patients are going to be involved in that decision at all (and they certainly should be), the discussion should surround the significant risks and limited long term benefits of opioid use - not figuring out what hoops they have to jump through to continue getting it.    

Bottom line: The rescheduling of HCPs is more symbolic than anything else.  After 15 years of debate and discussion, the DEA, FDA, and clinical community have finally decided that virtually all opioid analgesics should be scheduled the same way (on schedule II, indicating high potential for abuse).

But don't expect to see a huge drop in HCP scripts in work comp.  Our expectations of what's possible are far too low for that to happen.   

Michael

Thursday, August 7, 2014

A Defense of New Opioid Guidelines

[Another guest post from Dr. Pamella Thomas, PRIUM's Medical Director.  Recently, another physician challenged both the science behind ACOEM's 50 mg MED threshold as well as its applicability to chronic pain cases. This was the response from Dr. Thomas.]

Dr. ----

Hope all is well.

I am a bit surprised that you would challenge the 50 mg morphine equivalent dose (MED) threshold supported in the updated ACOEM guidelines.  We are in a CDC-declared opioid epidemic.  People are dying needlessly.  It is difficult to dissent against ACOEM’s 50 MED threshold when the reported death rate is 3 to 5 times greater in patients prescribed 50 mg MEDs and above than in patients prescribed 49 mg MEDs and below.  For context the current CDC VitalSign report shows that, nationally, 46 opioid overdose deaths occur each day.

Furthermore the ACOEM guidelines are – contrary to your suggestion – both applicable to and directed toward chronic cases.  As the most recently updated standards for the practice of occupational medicine, ACOEM further reveals our developing understanding of opioid best-practices.  There is simply no credible evidence to support long term opioid use for chronic non-cancer pain.  Conversely a Cochrane review demonstrated that back pain patients taking opioids for more than a week, when compared with a similar cohort taking opioids for a week or less, were twice as likely not to return to work within a year.  A related review contradicted the practice of escalating doses.  High doses of opioids were shown to be no more effective than lower doses of opioids, supporting the intuitive notion that once opioid receptors are saturated, increasing the dose does not yield additionally beneficial results.  If you have not yet read the two studies used to confirm the new ACOEM morphine equivalent dose (MED) level, you should.

Another concerning issue that pain management physicians among others are not taking into account?  Up to 30% of patients can’t properly metabolize approximately 25% of drugs currently used clinically due to inherent pharmacogenetic deficiencies (Wang et al., 2009).  Drugs in this grouping include codeine, tramadol, oxycodone, hydrocodone and many synthetic and semisynthetic opioids which are not adequately metabolized by other CYP450 isoenzymes.  As result many patients are building up levels of the parent drug causing cascading effects such as hyperalgesia, which in turn often causes the treating physician to further increase dosage.  Dose escalation is often pursued instead of weaning without documenting either improved function or reduced pain.

Following a psychosocial evaluation, most patients feel better once weaning starts in conjunction with pain management and mind-body therapies (e.g. cognitive behavioral therapy, motivational interviewing, etc.).  However, only about 4-7% of patients are ever evaluated for these potential treatment options despite prolonged treatment and a history of attenuated improvement.  Similarly medically indicated evaluations for dependence and addiction or interventions for smoking cessation are often left unaddressed.

My feeling is that a number of clinicians still practice based on an outdated biomedical model instead of utilizing a growing body of evidence supporting a psychosocial model of pain and its correlation to impairment and disability.  It is ignored that psychologically and/or socially distressed people seek medical treatment for psychosocial conditions.  Due to this lack of recognition, many psychosocial conditions are being managed through inappropriate modalities and passed off as anatomically  diagnosed biomedical pain.  These inappropriate modalities (e.g. opioids, surgery, and interventional treatment) share complicit complications and side effects that further exacerbate long term disability and failed syndromes.

Consider that in October 2010, the CDC published a report indicating that over 60% of US children had suffered some form of traumatic abuse prior to the age of 18.  These same children grow up and enter the work force.  Some of them eventually file claims because of unresolved, unaddressed issues amplified by a work related injury, leaving the worker feeling victimized by a supervisor, a poor work environment, or low wages.  Injecting opioid treatment into this psychosocial complexity without addressing the underlying issues leads to long term disability and frequent social isolation due to unsympathetic family, friends, and coworkers.

I hope that this will help clarify why the decision was made that, when people are dying daily, we cannot apologize for taking action to ensure patient safety.  While we realize guidelines take time to be updated (MTUS is being rewritten currently), an epidemic exists at this moment which can be controlled by removing the cause.

We do not want to be downstream catching bodies but upstream saving lives.
Thank you for your understanding.


Dr. Thomas

Thursday, July 31, 2014

PDMPs: At Least Someone in Missouri is Paying Attention

Missouri is the last state in the union without an approved Prescription Drug Monitoring Program.  While that's inexcusable and embarrassing, it also has real consequences for the state.  Past legislative attempts to create a database have met with resistance from Dr. Robert Schaaf, a family practice physician and Missouri state senator.  The St. Louis Post Dispatch published an op-ed on the topic yesterday, which reads, in part:
"Sen. Schaaf, a family practice physician, said his opposition to the database is about freedom. The drug database would infringe on patients’ personal liberty, he says.
Of course, his opposition makes life easier for greedy doctors and unscrupulous pill-pushers, and more dangerous for drug addicts.
Dr. Schaaf is not opposed to all databases or impinging on the freedom of poor people. He voted in favor of legislation in 2011 that required the state Department of Social Services to set up a database to screen some welfare recipients for drug use.He also voted last session for a bill that would have required the state Division of Workers’ Compensation to develop and maintain a database allowing employers access to workers’ compensation records. 
So much for freedom, eh, Dr. Schaaf?"
Ouch.  
I've spoken to Senator Schaff directly on this topic and asked him to explain the inconsistency of his positions.  I'm not sure he understands the importance of the issue at hand.  
You can find a front page article from the NY Times on this here.
The St. Louis Post Dispatch op ed is here
My past critique of Sen. Schaaf is here and here
Hopefully this national media attention will get things moving in Missouri... and convince Sen. Schaaf to change his position.  
Michael 

Wednesday, July 30, 2014

H.R. 4709 Offers Little Help in the Fight Against Prescription Drug Abuse

If you want to bill that purports to mitigate prescription drug misuse and abuse, but actually has no hope of doing so - well, look no further than the 113th Congress.  Turns out they can be counted on for something.

Rep. Tom Marino (R-PA) is sponsoring H.R. 4709 which passed the House yesterday and now heads to the Senate.  The bill's purpose is to "improve enforcement efforts related to prescription drug diversion and abuse..."  It does so by amending the Controlled Substances Act (CSA) to more clearly define that certain drugs may represent an "imminent danger" to the public (though it doesn't name those medications, it just makes it possible to designate such medications) and to make it easier for the DEA to leverage the CSA to suspend certain medications that pose a substantial public health risk (though, of course, pharma companies are given the opportunity for remediation with the Attorney General before a drug is actually suspended).  The bill also calls for the Department of Health and Human Services to report back to Congress on law enforcement activities related to patient medication access and, in so doing, consult with every possible constituency and stakeholder on the planet (including tribal law enforcement agencies).

I wonder if anyone in Congress will ever have the courage to do what's actually needed.  Namely:

  • Take on the American Medical Association around the issue of mandatory physician education for pain management and opioid prescribing.  The AMA consistently argues such a measure would infringe upon the practice of medicine.  That ship has sailed.  The good doctors want this education and seek it out anyway.  Doctors who either aren't aware of the need for education or are willfully ignorant of best practices in opioid prescribing should be required to engage in such education before prescribing opioids.  
  • Provide more federal funding for state level Prescription Drug Monitoring Programs (PDMPs) and additional funding for a fully integrated, national PDMP database.  We're seeing regional efforts along these lines that are promising (see Ohio and Kentucky collaborating on PMIX), but more needs to be done in the areas of standardization, integration, data sharing, access, etc.  The federal dollars currently flowing to these initiatives are minuscule given the severity of the problem.  The Harold Rogers Prescription Drug Monitoring Program and the National All Schedules Prescription Electronic Reporting Act are both under-funded and under-utilized.  California legislators fought tooth and nail over $3 million to fund its CURES database and it's still woefully under-funded and under-utilized. The federal government's FY2015 HHS budget contains $10 million through the Substance Abuse and Mental Health Services to "help state substance abuse authorities develop comprehensive prevention approaches through collaboration with state partners and integration of health information exchange systems with strategic plans."  A) I don't know what that means; B) It's not enough.  
  • Leverage data and surveillance from the Medicare and Medicaid programs to identify and deal with high prescribers of opioid medications.  To be fair, the federal government is already working toward this.  See page 73 of the HHS budget overview.    
  • Take on the pharma companies through better Congressional oversight of the FDA approval process.  FDA is and should be an independent agency, but serious doubts have been cast regarding the agency's independence and consistency regarding approval of opioid analgesic formulations.  
More needs to be done.  More can be done.  HR 4709 has little chance of moving the needle.  

Michael 

Monday, July 28, 2014

Abuse Deterrent Opioids: Technology vs. Medical Necessity

Last week, the FDA approved Targiniq ER, an extended release / long acting opioid with abuse deterrent properties.  In this case, the Purdue Pharma medication contains naloxone, which blocks the euphoric effects of the oxycodone when the pill is crushed and snorted (or crushed, dissolved, and injected).

I've posted thoughts along these lines before, but I'd like to remind everyone that abuse deterrent opioids are an excellent solution to a limited set of misuse and abuse issues posed by prescription analgesics.

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).

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

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.


David

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.

Michael