I've been in more than a few meetings with payers discussing the problems with opioids when someone wonders aloud, "Why aren't some of these patients suing their doctors?"
Turns out, they are doing just that... in increasing numbers.
A study of malpractice claims over the last 30 years presented at the 2014 Annual Meeting of the American Society of Anesthesiologists concludes that the number of claims related to chronic pain management is increasing far out of proportion to the growth in the number of pain management practitioners. Further, the analysis shows the prescription medications are playing a significant role.
As a proportion of anesthesia malpractice claims, those claims related to pain management rose from 3% in 1980 to 18% in 2012. Medication management claims increased from 2% to 17% of anesthesiology malpractice claims.
Perhaps more alarming: in the 1980s, death was the cited reason for a claim 6% of the time and severe injury for another 6% (the rest of the claims related to temporary and/or minor injuries). After 2000, death was cited in 19% of claims and severe injury in 28%. That's nearly half of all chronic pain malpractice claims.
Not only are chronic pain malpractice claims becoming more frequent, but the resulting injuries are becoming much more severe.
What to do?
I'm not a lawyer, but it strikes me that payers should probably be having conversations about provider network strategy and sticky things like subrogation, right? Where does work comp leave off and med mal pick up? When a payer has done all they can legally do to provide safe care for an injured worker and the doctor continues to prescribe absurd levels of opioids... what are the options when that injured worker doesn't wake up one morning?
Michael
On Twitter @PRIUM1
Tuesday, October 21, 2014
Monday, October 20, 2014
A Name You Should Know: Jack Conway
David Armstrong has written a piece on Bloomberg.com that should be required reading. Not only does it recap the overarching legal strategies currently being pursued by various municipalities against manufacturers of painkillers, but it dives keep into Kentucky's battle - by far the longest and potentially most successful suit thus far.
Recall that in 2007, Purdue Pharma paid a $634 million fine in connection with inappropriate marketing of Oxycontin. Of that fine, $160 million was specifically earmarked to reimburse the federal government and state governments for damages suffered by the Medicaid program. Kentucky's share of that fine was to be $500,000.
Kentucky said "no thanks" and filed its own lawsuit.
Seven years later, we're as close as we've ever been to a trial and it's more likely than not that we'll see this trial play out at "ground zero" (Pike County prosecutor Rick Bartley's phrase, not mine) of the opioid epidemic. For Purdue, whose chief financial officer is on record as saying that this could be a billion dollar case and would have a "crippling effect on Purdue's operations and jeopardize Purdue's long-term viability," this is nothing less than a "save the company" moment.
On the opposite side of the courtroom will be Kentucky Attorney General Jack Conway, a rising political star in the state. He lost the 2010 US Senate Race to Rand Paul, but remains an up and comer in the Democratic party in Kentucky. This is one of those cases in which an Attorney General can set himself up for future political wins. And beyond that, I think he genuinely wants to do the right thing here. And the right thing, according to Mr. Conway, is to hold Purdue accountable. I met Mr. Conway and got to talk with him for a few minutes at last year's National Prescription Drug Abuse Summit in Atlanta. He's the real deal. He cares about the issue of prescription drug misuse and abuse.
The most interesting take-away from the article: Purdue hired an outside consultant to assess the likelihood of getting a fair trial in Kentucky. The findings?
Recall that in 2007, Purdue Pharma paid a $634 million fine in connection with inappropriate marketing of Oxycontin. Of that fine, $160 million was specifically earmarked to reimburse the federal government and state governments for damages suffered by the Medicaid program. Kentucky's share of that fine was to be $500,000.
Kentucky said "no thanks" and filed its own lawsuit.
Seven years later, we're as close as we've ever been to a trial and it's more likely than not that we'll see this trial play out at "ground zero" (Pike County prosecutor Rick Bartley's phrase, not mine) of the opioid epidemic. For Purdue, whose chief financial officer is on record as saying that this could be a billion dollar case and would have a "crippling effect on Purdue's operations and jeopardize Purdue's long-term viability," this is nothing less than a "save the company" moment.
On the opposite side of the courtroom will be Kentucky Attorney General Jack Conway, a rising political star in the state. He lost the 2010 US Senate Race to Rand Paul, but remains an up and comer in the Democratic party in Kentucky. This is one of those cases in which an Attorney General can set himself up for future political wins. And beyond that, I think he genuinely wants to do the right thing here. And the right thing, according to Mr. Conway, is to hold Purdue accountable. I met Mr. Conway and got to talk with him for a few minutes at last year's National Prescription Drug Abuse Summit in Atlanta. He's the real deal. He cares about the issue of prescription drug misuse and abuse.
The most interesting take-away from the article: Purdue hired an outside consultant to assess the likelihood of getting a fair trial in Kentucky. The findings?
- 40% of Pike County residents knew someone who had run into criminal trouble because of an Oxycontin addiction;
- 33% knew someone who overdosed to was otherwise seriously hurt by the drug;
- 29% knew someone who had died;
- 90% agreed that Oxycontin had a "devastating effect" on the community.
I'm not a legal expert. I don't know if Purdue can get a fair trial in Pike County or not. But either way, it sounds to me like there's going to be a fight - and a very public and very ugly fight at that.
Michael
On Twitter @PRIUM1
On Twitter @PRIUM1
Thursday, October 16, 2014
Guidelines: How to Make Them Matter
There has been a lot of talk in the last couple of weeks about medical treatment guidelines. North Carolina, Tennessee, Arizona, and several other states are looking into adoption of guidelines.
There is a lot of discussion about "evidence-based" vs. "consensus-based" guidelines as well. While I'm an outspoken proponent of the evidence-based variety, I recognize that local political conditions can make adoption of such 3rd party guidelines difficult. Politics is a poor excuse - states can benefit significantly not only from the credibility of 3rd party guidelines, but also from the fact that providers of such guidelines work constantly to ensure those guidelines reflect the most contemporary view of the medical evidence. Consensus-based guidelines (where a state medical director or agency gathers a bunch of stakeholders and they all decide what's best for injured workers in a given state) tend to be static - they age... and they tend not to age well. They also tend to be subject to influence from outside parties with vested economic interests (see Louisiana as an example).
But the debate between the two competing approaches to guidelines is actually a sideshow, a distraction that prevents regulators from focusing on what matters most: enforcement.
When reading proposed or adopted treatment guidelines for a given state, make sure you explore the extent to which you can successfully challenge treatment that falls outside of the guidelines. For instance, let's say a medical treatment guideline states that prescribing opioid analgesics in excess of 50 mg MED daily is not recommended (as the ACOEM guidelines suggest). And assume you have a case where the doctor is prescribing 250 mg MED daily... and that doctor has been unresponsive to requests for discussion regarding the case and has not provided the rationale for why he's prescribing outside of the evidence based guidelines. Question: Now what?
There are states that have good answers to this question.
In Texas, if those opioids are N drugs, the answer is required pre-authorization based on a 3rd party guideline (Official Disability Guidelines) and a utilization review process that is statutorily supported and has clearly defined dispute resolution mechanisms.
I was encouraged to read that in Tennessee, the goal is to ensure that any adoption of treatment guidelines is consistent with existing utilization review regulations (which include the ability for a payer to subject any schedule II-IV medication used for the purposes of pain management for more than 90 days to utilization review).
Those are guidelines with enforcement mechanisms. If the adoption of guidelines doesn't come with enforcement mechanisms, they're still worth having (because good doctors will still be responsive to guidelines). But those guidelines won't be as valuable as they could be if appropriate enforcement mechanisms are in place (because not-so-good doctors will ignore contemporary medical evidence and continue to administer sub-optimal treatment until the payer stops paying for it).
Michael
On Twitter @PRIUM1
There is a lot of discussion about "evidence-based" vs. "consensus-based" guidelines as well. While I'm an outspoken proponent of the evidence-based variety, I recognize that local political conditions can make adoption of such 3rd party guidelines difficult. Politics is a poor excuse - states can benefit significantly not only from the credibility of 3rd party guidelines, but also from the fact that providers of such guidelines work constantly to ensure those guidelines reflect the most contemporary view of the medical evidence. Consensus-based guidelines (where a state medical director or agency gathers a bunch of stakeholders and they all decide what's best for injured workers in a given state) tend to be static - they age... and they tend not to age well. They also tend to be subject to influence from outside parties with vested economic interests (see Louisiana as an example).
But the debate between the two competing approaches to guidelines is actually a sideshow, a distraction that prevents regulators from focusing on what matters most: enforcement.
When reading proposed or adopted treatment guidelines for a given state, make sure you explore the extent to which you can successfully challenge treatment that falls outside of the guidelines. For instance, let's say a medical treatment guideline states that prescribing opioid analgesics in excess of 50 mg MED daily is not recommended (as the ACOEM guidelines suggest). And assume you have a case where the doctor is prescribing 250 mg MED daily... and that doctor has been unresponsive to requests for discussion regarding the case and has not provided the rationale for why he's prescribing outside of the evidence based guidelines. Question: Now what?
There are states that have good answers to this question.
In Texas, if those opioids are N drugs, the answer is required pre-authorization based on a 3rd party guideline (Official Disability Guidelines) and a utilization review process that is statutorily supported and has clearly defined dispute resolution mechanisms.
I was encouraged to read that in Tennessee, the goal is to ensure that any adoption of treatment guidelines is consistent with existing utilization review regulations (which include the ability for a payer to subject any schedule II-IV medication used for the purposes of pain management for more than 90 days to utilization review).
Those are guidelines with enforcement mechanisms. If the adoption of guidelines doesn't come with enforcement mechanisms, they're still worth having (because good doctors will still be responsive to guidelines). But those guidelines won't be as valuable as they could be if appropriate enforcement mechanisms are in place (because not-so-good doctors will ignore contemporary medical evidence and continue to administer sub-optimal treatment until the payer stops paying for it).
Michael
On Twitter @PRIUM1
Friday, October 10, 2014
What's Old is New Again: The Real Opioid Wars
Addiction is not a new phenomenon. Opioid analgesics aren't new either. And as we fight our current war against the man-made epidemic of opioid misuse and abuse, let's not forget that actual wars have been fought over opium. The Chinese and the British, in fact, fought two wars in the 19th century that hinged, at least in part, on the alarming growth in the number of opium addicts in China. In fact, the first Opium War started when the Chinese government seized 20,000 chests of opium (or about 2.7 million pounds) belonging to the British East India Company. The opium had been grown in India and transported to China by British traders who were making lots of money selling it to Chinese merchants. (As an aside, the treaty that ended this war resulted in the cessation of Hong Kong to the British in 1841... the beginning of the political drama still playing out in Hong Kong to this very day).
Opium isn't new to the US either (see photo below). In the early 20th century, opium addiction had become a sufficiently important public health issue that the Harrison Act of 1914 required doctors and pharmacists that prescribed and dispensed opium to register with the government and pay taxes on the sale of opium. Nine years later in 1923, the US Treasury Department's Narcotics Division banned the sale of opium and other narcotics altogether (creating a vibrant black market for drugs that still thrives today).
Our public health and regulatory response to today's crisis is more nuanced and more measured than in the early 20th century, as it should be. Opioid analgesics absolutely have a role to play in contemporary treatment of pain. The challenge today remains how to balance the real needs of people in pain with the public health crisis that is the opioid epidemic. But we've been here before and we'll figure it out.
Don't think history repeats itself? Here's a "selfie"... 1920s style.
Have a great weekend.
Michael
On Twitter @PRIUM1
Opium isn't new to the US either (see photo below). In the early 20th century, opium addiction had become a sufficiently important public health issue that the Harrison Act of 1914 required doctors and pharmacists that prescribed and dispensed opium to register with the government and pay taxes on the sale of opium. Nine years later in 1923, the US Treasury Department's Narcotics Division banned the sale of opium and other narcotics altogether (creating a vibrant black market for drugs that still thrives today).
Our public health and regulatory response to today's crisis is more nuanced and more measured than in the early 20th century, as it should be. Opioid analgesics absolutely have a role to play in contemporary treatment of pain. The challenge today remains how to balance the real needs of people in pain with the public health crisis that is the opioid epidemic. But we've been here before and we'll figure it out.
Don't think history repeats itself? Here's a "selfie"... 1920s style.
Have a great weekend.
Michael
On Twitter @PRIUM1
Thursday, October 9, 2014
California: Predictions and Politics
The latest study from CWCI suggests that implementation of a Texas-like or Washington-like formulary could produce substantial savings in the CA work comp system on the order of $124-$420 million. I was extremely impressed with the detailed methodology CWCI developed. Not only did they dig into the formularies at the NDC level and build the analysis from the bottom up, Alex Swedlow and team also created a model that incorporates the effects of drug substitution in light of formulary implementation. And it's not an overly simplistic approach, either. They use the Medispan GPI number to assess the likelihood of substitution for drugs not included on the formulary. The reader of this report learns more than just dollars and cents in CA; some of the key take-aways relate to the vast differences between the TX and WA approaches. Bottom line: the report is educational and insightful and should be required reading.
There's just one major variable the report doesn't include: politics.
That's not a shot at CWCI - that's not their role, their mandate, or their mission. But I couldn't help look at the numbers and think, "there's no way a closed formulary concept survives a fight in Sacramento." I'm always encouraging people to avoid cynicism and here I am dishing it out. But it's hard to imagine a politically diverse state like CA (was that diplomatic enough?) implementing something remotely close to what Texas did (a much more politically homogeneous state) or what Washington did (a monopolistic work comp system). Keep in mind that even in Texas, the legislation that called for the creation of a closed formulary was signed into law in 2005. Full implementation of that closed formulary finally occurred in 2013. That's 8 years of regulatory wrangling in a state where less than 10 percent of injured workers are represented by attorneys and employers need not bother with work comp at all if they so choose.
On the other hand, we learned this morning from the Oregon Workers' Compensation Premium Rate Ranking Summary that California is the most expensive state in the country. While there has always been a lot of debate about the methodology of this annual report, perhaps it's enough to create the burning platform CA so desperately needs to get a handle on medical costs.
Michael
On Twitter @PRIUM1
There's just one major variable the report doesn't include: politics.
That's not a shot at CWCI - that's not their role, their mandate, or their mission. But I couldn't help look at the numbers and think, "there's no way a closed formulary concept survives a fight in Sacramento." I'm always encouraging people to avoid cynicism and here I am dishing it out. But it's hard to imagine a politically diverse state like CA (was that diplomatic enough?) implementing something remotely close to what Texas did (a much more politically homogeneous state) or what Washington did (a monopolistic work comp system). Keep in mind that even in Texas, the legislation that called for the creation of a closed formulary was signed into law in 2005. Full implementation of that closed formulary finally occurred in 2013. That's 8 years of regulatory wrangling in a state where less than 10 percent of injured workers are represented by attorneys and employers need not bother with work comp at all if they so choose.
On the other hand, we learned this morning from the Oregon Workers' Compensation Premium Rate Ranking Summary that California is the most expensive state in the country. While there has always been a lot of debate about the methodology of this annual report, perhaps it's enough to create the burning platform CA so desperately needs to get a handle on medical costs.
Michael
On Twitter @PRIUM1
Tuesday, September 30, 2014
A World Without Work Comp
"I was carrying a steel pipe at work and it brushed up against an electrical wire. When I woke up, I saw that everything was gone, and I just started crying... I've been begging for money in this same spot for 20 years. All I can do is try to get my bread every day until God decides to take me home."
(If you don't follow Humans of New York on Facebook, you're missing something in your life. This amazing project has gone from the streets of New York to a worldwide photo documentary of the highs and lows of human existence. If you're looking for a little perspective, this is a great source.)
This particular picture and quote was taken in Mexico City some time Monday afternoon. On the one hand, it made me sad for this man and his circumstances. On the other hand, it caused me to reflect on the positives of our workers' compensation system in the US. Frankly, it's not hard to criticize the system. But there's also a lot good that occurs and I'm grateful to know that should I ever brush a steel pipe against an electrical wire while on the job, my prospects would likely be better than this gentleman's.
To paraphrase Churchill's thoughts on democracy: "Workers' compensation is the worst form of protection for injured employees... except for all those other forms which have been tried."
Michael
On Twitter @PRIUM1
On Twitter @PRIUM1
Friday, September 26, 2014
Hard Choices: Mental Illness vs. Medications
The recently released report and follow up webinar from the Workers' Compensation Research Institute (WCRI) shines more light on the complicated world of chronic pain. (Full disclosure: PRIUM is a WCRI Core Funder... and proud of it). WCRI doesn't take policy positions, they work hard to inject data and academic rigor into policy debates without taking a stance one way or the other. As if often the case, however, the data in this report appears to speak for itself.
The report measures the utilization of modalities that should be used to support chronic pain patients in the healing process. Physical therapy is the most common (moving from 87% of injured workers in chronic pain to 88%). Still more work to do here - why are 12% still not getting PT? - but that statistic isn't particularly alarming.
Only 25% of injured workers in chronic pain are being monitored for compliance with drug therapy regimens. From our vantage point, this statistic is slightly misleading. We see pockets of extremely high and inappropriate utilization of drug testing among some physicians and virtually zero testing among others. The net statistic is 25%, but we see a tale of two extremes in this area. Again, this is our view from PRIUM - admittedly skewed by our focus on complex claims.
Finally, the dismal news. Only 5% of injured workers in chronic pain go through psychological evaluation and only 4% receive psychological treatment of any kind.
We know why this is. Adjusters: Raise your hand if you're willing to let a potential psych diagnosis get within 10 miles of any of the claims on your desk. Seeing no hands raised, let's address the issue as candidly as possible.
On many long term complex claims, you are left with two bad choices: continue the meds or deal with the psych. This is the proverbial "rock" and "hard place." And years of training and bad experiences have left the work comp community with a clear answer to this quandary - under no circumstances are we to explore the psych. Just pay for the meds, cross your fingers, and hope...
A favorite aphorism from one my business school professors comes to mind: "Hope... is not a strategy."
So what's the strategy? I don't have all the answers, but here are a couple of ideas:
First, keep in mind that some modalities, like cognitive behavioral therapy (CBT), which are often used in support of the weaning process, do not necessitate or lead to psych diagnoses. These are supportive and therapeutic modalities, not diagnostic. And they can be billed under physical medicine CPT codes. So don't freak out when you see a CBT recommendation.
Second, many treatment options require a psych eval to assess whether the option is viable for the injured worker. Things like spinal cord stimulator trials, inpatient detox, and surgery often require (via medical treatment guidelines) a psych eval. This can be complicated and you should consult with your supervisor and/or defense counsel on a case by case basis, but we've seen positive clinical outcomes as a result of a claims organization's willingness to choose the right clinical path, even if a psych eval has to be done first.
Finally, recognize the brutal fact that on some cases, the only way to reach resolution, the only way to for the injured worker to truly heal, is to deal with the underlying psychological issues faced by that person. Note that according to the CDC, more than 60% of us experienced some kind of childhood trauma or abuse (verbal, physical, psychological, sexual, etc.) We are a society of broken people. Workplace injuries can trigger, exacerbate, or prolong our struggles with inner demons that have nothing to do with our non-specific low back pain.
I'm not declaring you should take on psych without regard to the potential consequences. I'm simply suggesting that the first step to solving a problem is recognizing we have one. And the second step is to have a real dialogue about the nature of that problem.
Michael
On Twitter @PRIUM1
The report measures the utilization of modalities that should be used to support chronic pain patients in the healing process. Physical therapy is the most common (moving from 87% of injured workers in chronic pain to 88%). Still more work to do here - why are 12% still not getting PT? - but that statistic isn't particularly alarming.
Only 25% of injured workers in chronic pain are being monitored for compliance with drug therapy regimens. From our vantage point, this statistic is slightly misleading. We see pockets of extremely high and inappropriate utilization of drug testing among some physicians and virtually zero testing among others. The net statistic is 25%, but we see a tale of two extremes in this area. Again, this is our view from PRIUM - admittedly skewed by our focus on complex claims.
Finally, the dismal news. Only 5% of injured workers in chronic pain go through psychological evaluation and only 4% receive psychological treatment of any kind.
We know why this is. Adjusters: Raise your hand if you're willing to let a potential psych diagnosis get within 10 miles of any of the claims on your desk. Seeing no hands raised, let's address the issue as candidly as possible.
On many long term complex claims, you are left with two bad choices: continue the meds or deal with the psych. This is the proverbial "rock" and "hard place." And years of training and bad experiences have left the work comp community with a clear answer to this quandary - under no circumstances are we to explore the psych. Just pay for the meds, cross your fingers, and hope...
A favorite aphorism from one my business school professors comes to mind: "Hope... is not a strategy."
So what's the strategy? I don't have all the answers, but here are a couple of ideas:
First, keep in mind that some modalities, like cognitive behavioral therapy (CBT), which are often used in support of the weaning process, do not necessitate or lead to psych diagnoses. These are supportive and therapeutic modalities, not diagnostic. And they can be billed under physical medicine CPT codes. So don't freak out when you see a CBT recommendation.
Second, many treatment options require a psych eval to assess whether the option is viable for the injured worker. Things like spinal cord stimulator trials, inpatient detox, and surgery often require (via medical treatment guidelines) a psych eval. This can be complicated and you should consult with your supervisor and/or defense counsel on a case by case basis, but we've seen positive clinical outcomes as a result of a claims organization's willingness to choose the right clinical path, even if a psych eval has to be done first.
Finally, recognize the brutal fact that on some cases, the only way to reach resolution, the only way to for the injured worker to truly heal, is to deal with the underlying psychological issues faced by that person. Note that according to the CDC, more than 60% of us experienced some kind of childhood trauma or abuse (verbal, physical, psychological, sexual, etc.) We are a society of broken people. Workplace injuries can trigger, exacerbate, or prolong our struggles with inner demons that have nothing to do with our non-specific low back pain.
I'm not declaring you should take on psych without regard to the potential consequences. I'm simply suggesting that the first step to solving a problem is recognizing we have one. And the second step is to have a real dialogue about the nature of that problem.
Michael
On Twitter @PRIUM1
Wednesday, September 24, 2014
Calls for FDA Commissioner to Step Down Over Opioids
Anti-addiction advocates have sent a letter to Secretary of Health and Human Services Sylvia Burwell calling for FDA Commissioner Margaret Hamburg to step down. The letter itself is worth reading.
I was in the audience at the National Prescription Drug Abuse Summit here in Atlanta back in April when Dr. Hamburg attempted to address some of the decisions the agency has made. I can understand the tension created by the need to balance public health with the FDA's role of approving medications on which million upon millions of R&D dollars have been expended. My view: it's not that she doesn't get it, it's that she's erring on the wrong side of the issue. Public health concerns should be the primary lens through which her agency assesses new pain medications and that's simply not the case right now.
The letter is signed by many organizations, most notably Physicians for Responsible Opioid Prescribing (PROP). This organization has worked tirelessly to push back against the tide of prescription drug misuse and abuse and the regulatory system that enables it. If you haven't seen or taken advantage of their education materials, you absolutely should. Every person in medical and claims management can learn something about opioid abuse here: PROP web site.
While I don't think Commissioner Hamburg will step down, the press coverage of the letter shines a spotlight on the issue and calls into question the behavior of the key federal regulatory agency responsible for approving new pain medications. I think this will help push us toward a more comprehensive and responsible view of opioid prescribing.
Michael
On Twitter @PRIUM1
On Twitter @PRIUM1
Monday, September 22, 2014
Unfunded Mandates and Patient Safety
Last week, several New Jersey state legislators convened a press conference to announce a legislative package intended to stem the tide of opioid and heroin overdoses in the Garden State. And quite a package it turned out to be: 21 bills are included, covering everything from mandatory insurance coverage for behavioral health to the use of naloxone to prevent overdoses. There appears to be enough in the package that everyone has something they like... and everyone has something they don't like. Should make for interesting politics.
One key piece of legislation in the package caught my eye.
The bill requires the mandatory registration and use of the Prescription Monitoring Program (PMP) among New Jersey physicians. Everyone likes the concept of the PMP, but the Medical Society of New Jersey has an issue with requiring doctors to consult the database prior to writing prescriptions. Should this bill pass, New Jersey would join Oklahoma, Kentucky, New York, Tennessee, and Massachusetts as the only states that require doctors to consult the database prior to writing prescriptions for pain management medications. If New Jersey legislators are smart, they'll include provisions (like Oklahoma did) creating exemptions for hospice and other end-of-life care situations. Additionally, they'll prohibit lawsuits against physicians for not checking the database. While a patient can't sue a doctor for not checking the database, the doctor would still be in violation of the law and subject to sanctions, punishment, etc.
Doctors often refer to such requirements as an "unfunded mandate." By that, they mean additional requirements are being placed on them with no additional remuneration. But this is fundamentally about patient safety. Are the pre-surgical verification steps outlined by JCAHO an "unfunded mandate"? What about the commonly expected best practice of physicians washing their hands between patients? These are things we do in the healthcare community to protect patients, physicians, and other stakeholders from the unintended consequences of care delivery. I can't understand how that logic doesn't extend to opioid prescribing.
New Jersey is headed in the right direction. I hope they don't screw it up.
Michael
On Twitter @PRIUM1
One key piece of legislation in the package caught my eye.
The bill requires the mandatory registration and use of the Prescription Monitoring Program (PMP) among New Jersey physicians. Everyone likes the concept of the PMP, but the Medical Society of New Jersey has an issue with requiring doctors to consult the database prior to writing prescriptions. Should this bill pass, New Jersey would join Oklahoma, Kentucky, New York, Tennessee, and Massachusetts as the only states that require doctors to consult the database prior to writing prescriptions for pain management medications. If New Jersey legislators are smart, they'll include provisions (like Oklahoma did) creating exemptions for hospice and other end-of-life care situations. Additionally, they'll prohibit lawsuits against physicians for not checking the database. While a patient can't sue a doctor for not checking the database, the doctor would still be in violation of the law and subject to sanctions, punishment, etc.
Doctors often refer to such requirements as an "unfunded mandate." By that, they mean additional requirements are being placed on them with no additional remuneration. But this is fundamentally about patient safety. Are the pre-surgical verification steps outlined by JCAHO an "unfunded mandate"? What about the commonly expected best practice of physicians washing their hands between patients? These are things we do in the healthcare community to protect patients, physicians, and other stakeholders from the unintended consequences of care delivery. I can't understand how that logic doesn't extend to opioid prescribing.
New Jersey is headed in the right direction. I hope they don't screw it up.
Michael
On Twitter @PRIUM1
Wednesday, September 10, 2014
Medical Marijuana is NOT the Answer to the Opioid Problem
At least not yet. But the conclusion being drawn by many a reporter in our industry would have you believe otherwise. "Fewer Opioid Related Deaths in States with Medical Marijuana" read one headline.
A study published in the Journal of the American Medical Association at the end of August is causing a lot of confusion in our space. The abstract of the study (which is, unfortunately, all that most reporters seem to have read) states the following: "States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate... compared with states without medical cannabis laws." One has to crack the cover and actually read the study to understand this conclusion results from a multi-variate linear regression model that compares behavior of individual states that have medical cannabis laws to what the behavior might have been in that state without such laws. I have absolutely no issue with the the methodology or the related conclusion. I'm a data geek and I love a good linear regression model as much as the next guy.
But on page 3 of the study, you quickly learn that the actual observed historical data tells the opposite story. States with medical cannabis laws exhibit a consistently higher opioid overdose mortality rate vs. states without such laws. Marcus Bachhuber, the lead author of the study, points out that its hard to compare states to each other and much more statistically relevant and reliable to compare states to themselves (what does California look like vs. what we would expect California to look like without a medical marijuana law?) This is a perfectly valid academic exercise, but not one from which we should be drawing policy conclusions. Dr. Bachhuber himself writes in the study, "In summary, although we found a lower mean annual rate of opioid analgesic mortality in states with medical cannabis laws [again, according to the linear regression model, not the observed historical data], a direct causal link cannot be established."
Kudos to Ben Miller at WorkCompCentral, who actually read the entire study and presented a balanced view of the issue in his article yesterday. I was interviewed for and quoted in the article and stated the case much like I'm stating it here. I was impressed that Ben was willing to dig beyond abstract and take his story in a direction he may not have originally intended. We need more reporters like him in our industry.
Bottom line: Medical marijuana laws cannot be said to lead to a reduction in opioid overdose deaths.
Michael
On Twitter @PRIUM1
A study published in the Journal of the American Medical Association at the end of August is causing a lot of confusion in our space. The abstract of the study (which is, unfortunately, all that most reporters seem to have read) states the following: "States with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate... compared with states without medical cannabis laws." One has to crack the cover and actually read the study to understand this conclusion results from a multi-variate linear regression model that compares behavior of individual states that have medical cannabis laws to what the behavior might have been in that state without such laws. I have absolutely no issue with the the methodology or the related conclusion. I'm a data geek and I love a good linear regression model as much as the next guy.
But on page 3 of the study, you quickly learn that the actual observed historical data tells the opposite story. States with medical cannabis laws exhibit a consistently higher opioid overdose mortality rate vs. states without such laws. Marcus Bachhuber, the lead author of the study, points out that its hard to compare states to each other and much more statistically relevant and reliable to compare states to themselves (what does California look like vs. what we would expect California to look like without a medical marijuana law?) This is a perfectly valid academic exercise, but not one from which we should be drawing policy conclusions. Dr. Bachhuber himself writes in the study, "In summary, although we found a lower mean annual rate of opioid analgesic mortality in states with medical cannabis laws [again, according to the linear regression model, not the observed historical data], a direct causal link cannot be established."
Kudos to Ben Miller at WorkCompCentral, who actually read the entire study and presented a balanced view of the issue in his article yesterday. I was interviewed for and quoted in the article and stated the case much like I'm stating it here. I was impressed that Ben was willing to dig beyond abstract and take his story in a direction he may not have originally intended. We need more reporters like him in our industry.
Bottom line: Medical marijuana laws cannot be said to lead to a reduction in opioid overdose deaths.
Michael
On Twitter @PRIUM1
Friday, September 5, 2014
What's Actually Happening at the Pharmacy?
A lot, it turns out. The local retail pharmacy represents another front, and a complicated one at that, in the battle against prescription drug misuse and abuse. And you need to be aware of what some injured workers are facing when they take their prescriptions to the pharmacy.
Pharmacists are asking doctors questions about medical necessity... and doctors don't like that. "They [pharmacists] call us sometimes and if (a prescription) is medically necessary," says Dr. Rafael Miguel, an anesthesiologist in Tampa. "Well, if I write a prescription and it's got my DEA number and my signature on it, what do you think, I'm joking around?"
No, no one thinks this is a joke. But pharmacists, insurance adjusters, case managers, other physicians, public health workers, and many others think you might be lacking key clinical knowledge regarding the appropriateness of certain prescriptions (yes, even doctors can be under-educated). We don't think it's funny, we think it's tragic.
Then again, are pharmacists the right ones to be asking this question? I have neither the clinical knowledge nor the courage to weigh in on that, but it's a question with which the healthcare industry is currently wrestling. There is new tension in the traditionally high functioning relationship between doctors, pharmacists, and patients and pain killers are at the center of that tension.
For pharmacists and doctors reading this, nothing new here. But for insurance industry personnel, it's important for you to get up to speed on the details of what's happening in the midst of an ordinary pharmacy visit. We're revisiting some fundamental questions about the roles and responsibilities of various clinical constituencies. I'm confident the pendulum (currently swinging at different rates in different directions in different places) will eventually come to rest where it should.
In the meantime, be on the look out for injured workers caught in the crossfire.
Michael
On Twitter @PRIUM1
Pharmacists are asking doctors questions about medical necessity... and doctors don't like that. "They [pharmacists] call us sometimes and if (a prescription) is medically necessary," says Dr. Rafael Miguel, an anesthesiologist in Tampa. "Well, if I write a prescription and it's got my DEA number and my signature on it, what do you think, I'm joking around?"
No, no one thinks this is a joke. But pharmacists, insurance adjusters, case managers, other physicians, public health workers, and many others think you might be lacking key clinical knowledge regarding the appropriateness of certain prescriptions (yes, even doctors can be under-educated). We don't think it's funny, we think it's tragic.
Then again, are pharmacists the right ones to be asking this question? I have neither the clinical knowledge nor the courage to weigh in on that, but it's a question with which the healthcare industry is currently wrestling. There is new tension in the traditionally high functioning relationship between doctors, pharmacists, and patients and pain killers are at the center of that tension.
For pharmacists and doctors reading this, nothing new here. But for insurance industry personnel, it's important for you to get up to speed on the details of what's happening in the midst of an ordinary pharmacy visit. We're revisiting some fundamental questions about the roles and responsibilities of various clinical constituencies. I'm confident the pendulum (currently swinging at different rates in different directions in different places) will eventually come to rest where it should.
In the meantime, be on the look out for injured workers caught in the crossfire.
Michael
On Twitter @PRIUM1
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
On Twitter @PRIUM1
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
On Twitter @PRIUM1
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.
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.
Hopefully this national media attention will get things moving in Missouri... and convince Sen. Schaaf to change his position.
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:
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
On Twitter @PRIUM1
On Twitter @PRIUM1
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
On Twitter @PRIUM1
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
On Twitter @PRIUM1
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
-- 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.
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.
Thursday, July 10, 2014
Senate Bill 526 overwhelmingly passed the
Missouri Senate on February 13, (26-7). Not exactly a predictable outcome based on what we know about Missouri.
The bill calls for the development of a database of
work comp claims that could be accessed by employers when hiring job candidates. It will next be
considered by the state House, and if passed the database would be implemented
on July 1, 2015.
Creating a database of work comp
claims could potentially allow employers to assess in a
pre-employment screening process whether their prospective employee has
submitted work comp claims. It’s not the same as asking your age or your
marital status that could potentially be used to discriminate, but that past
history could certainly influence an employer’s willingness to hire you. I’m
all for transparency in the hiring process so you can make a well-informed
decision on a very expensive process.
Here's the odd part: if Missouri is willing to
create this database, why are they
unwilling to create a PDMP (prescription drug monitoring program) that could
yield very important information about an individual’s entire drug regimen
that has potential life and death consequences? The primary obstacle to the PDMP in Missouri has been state senator Rob Shaaf, who has argued that "letting the government have your very personal and sensitive medical information on a government database, it's just wrong and Big Brother shouldn't have that effect on our lives." He voted in favor of SB 526, perhaps because the bill includes a provision that requires employee consent for an employer to search the database. Nonetheless, the database will be contain sensitive information on Missouri citizens, will be run by the government, and will have a much wider potential audience (all employers) than a PDMP (clinicians and law enforcement).
Saturday, July 5, 2014
I like David DePaolo. A lot. He is a voice of reason in our industry and I've enjoyed his musings, both personal and professional, for years.
But on the issue of urine drug monitoring, I think he's off the mark. On the one hand, I'm coming at this from an admittedly self-interested perspective (PRIUM is a wholly owned subsidiary of Ameritox), but on the other hand, the context and conclusions of David's recent post on drug monitoring beg for someone to clear up the confusion.
What did he miss? Nowhere in his piece did he mention that:
Michael
On Twitter @PRIUM1
But on the issue of urine drug monitoring, I think he's off the mark. On the one hand, I'm coming at this from an admittedly self-interested perspective (PRIUM is a wholly owned subsidiary of Ameritox), but on the other hand, the context and conclusions of David's recent post on drug monitoring beg for someone to clear up the confusion.
What did he miss? Nowhere in his piece did he mention that:
- People are dying. Overdose deaths from prescription opioids now outpace deaths from traffic accidents and have tripled since 1990;
- The CDC has identified the opioid crisis as an epidemic, a term the CDC does not use lightly;
- More than 12 million people reported using prescription painkillers nonmedically in 2010;
- Urine drug monitoring technology is relatively new. David's quote from the CWCI data that suggests 192X growth in spend on urine drug monitoring in CA doesn't recognize the point at which the health care community sat on the adoption curve for this technology in 2004. Nor does it recognize that we still didn't realize the enormity of the opioid crisis in 2004. And don't tell me we knew in 2004 how bad this was going to get. I came into this industry in 2010 and spent my first two years here at PRIUM trying to convince payers there was an opioid problem in the first place.
- There's a distinction between point-of-care testing in a doctor's office and reference lab testing. Failing to make this distinction leads the reader to conclude that all inappropriate behavior rests with reference labs and fails to recognize that some physician practices are by themselves driving inappropriate utilization. Physicians who partner with experienced and capable reference labs that understand payers' perspectives and expectations can help align stakeholders (injured worker, physician, lab, and payer).
- There are guidelines for the appropriate use of urine drug monitoring and these guidelines are based on risk stratification of the patient. We follow these guidelines. We help payers follow these guidelines. Testing beyond the guidelines is as inappropriate as not testing patients that should be tested.
- Even in light of these guidelines, WCRI data tells us that less than 25% of injured workers on long term opioid therapy are being tested at all. David states "we know [the guidelines] are specific case recommendations particular to a certain set of medical facts, not to be applied universally." Agreed. Perhaps David doesn't realize how many injured workers fit that "certain set of medical facts." A lot more than he apparently realizes.
- Not all companies offer direct financial incentives to physicians. He lumps an entire industry together and does so just a couple of paragraphs after he details that Millennium's practices were found by a jury to be illegal and that all counterclaims against Ameritox were dismissed. Perhaps David missed the most important take-away: there's at least one company trying to do it right.
Michael
On Twitter @PRIUM1
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
On Twitter @PRIUM1
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
On Twitter @PRIUM1
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