Suit alleges that JCAHO’s misrepresentation of opioid risks contributed to West Virginia’s opioid crisis.
On November 2, 2017, four cities in West Virginia teamed up to file suit against The Joint Commission over the organization’s handling of pain management standards. The move follows more than a decade of public sparring over the role that the organization may have played in the worsening opioid epidemic.
The lawsuit details a laundry list of allegations. It claims that The Joint Commission, formerly known as JCAHO – partnered with Purdue Pharma, manufacturer of Oxycontin, to set pain management standards that “grossly misrepresented the addictive qualities of opioids and fostered dangerous pain control practices” which fostered a culture of providing inappropriate prescriptions of opioids to patients and resulted in “disastrous adverse consequences” for patients and families.
According to the claim, JCAHO ignored the CDC recommendations on opioid prescribing and its policies continue to spread a “misinformation campaign” about the safety of opioids. Because The Joint Commission certifies 99% of health care organizations in the Unites States, and because its certifications are “critical” to healthcare organization operations, the lawsuit alleges that healthcare organizations are highly influenced by these standards.
The lawsuit goes on to detail the development of JCAHO’s pain management standards, beginning with policies in 2001 stating that patients “have the right to appropriate assessment and management of pain” and that pain must be “considered the ‘fifth’ vital sign in the hospital’s care of patients.” The lawsuit notes how JCAHO partnered with the National Pharmaceutical Council, and how JCAHO continued collaborating with Purdue Pharma even after Purdue had been issued a warning from the FDA that Purdue’s advertisements were minimizing risks associated with OxyContin. Even after Purdue Pharma pled guilty to criminal allegations of misleading the public about OxyContin’s addictive properties, the lawsuit noted how JCAHO – which changed its name to The Joint Commission – continued to push the requirement that pain be considered “The Fifth Vital Sign.” The lawsuit even included a picture of the front page of the November 2011 edition of “The Source” – a Joint Commission publication – with a headline stating “The Fifth ‘Vital Sign’”.
Rather than creating standards to prevent or curtail the opioid crisis, the lawsuit alleges that JCAHO added to the problems.
The lawsuit seeks compensation for the funding that the West Virginia towns have had to spend to combat the opioid crisis. It cited West Virginia court opinions noting that West Virginia has the highest rate of fatal drug overdoses in the nation – of which 86% involved opioids. While JCAHO has reported income of $60 million per year, the lawsuit alleges that JCAHO has continued to prosper while the West Virginia communities are floundering because of economic damages related to increased costs associated with health care, insurance, first responders, crimes, criminal vagrancy, and public safety. Had JCAHO not issued and enforced inappropriate pain management standards, the lawsuit alleges that the towns would not have had to incur these costs.
The lawsuit seeks more than $75,000 in damages and also seeks class action status.
Background
The West Virginia lawsuit comes after years of similar clashes and critique within healthcare. So much so that The Joint Commission issued a written policy statement in April of 2016 in which David W. Baker, MD, MPH, Executive Vice President of Healthcare Quality Evaluation at The Joint Commission, attempted to address the controversy head on.
“In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame,” The Joint Commission’s statement begins. “Often, The Joint Commission’s pain standards take that blame. We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.”
Baker goes on to synopsize the Pain Management Standards in a way that is both simple and non specific. The foundational principles of The Joint Commission’s pain standards, says Baker, are that hospitals (1) educate all licensed independent practitioners on assessing and managing pain, (2) respect the patient’s right to pain management and (3) assess and manage the patient’s pain.
In the 2016 statement, Baker sought to distance The Joint Commission from the claim that pain should be treated as the fifth vital sign. “The original 2001 Joint Commission standards did not state that pain needed to be treated like a vital sign,” writes Baker. “The only time that The Joint Commission standards referenced the fifth vital sign was when The Joint Commission provided examples of what some organizations were doing to assess patient pain. In 2002, The Joint Commission addressed the problems in the use of the 5th vital sign concept by describing the unintended consequences of this approach to pain management and described how organizations had subsequently modified their processes.”
According to Baker, the idea that these standards in any way caused a sharp uptick in opioid prescriptions is “completely contradicted by data.” As evidence he points to statistics from The National Institute on Drug Abuse. One chart in particular shows the number of opioid prescriptions filled at commercial pharmacies in the United States from 1991 to 2013. While the graph shows a disconcerting increase in prescriptions over time, the curve doesn’t show a sharp uptick after 2001. “If there was an uptick in the rate of increase in opioid use, it appears to have occurred around 1997-1998,” writes Baker. That would have been two years prior to release of the pain care standards.
These statistics will doubtless be critical to the West Virginia case as they are central to the plantiff’s claims. “The [opioid]epidemic is not a coincidence,” states the complaint. “It is in part the result of Pain Management Standards issued in 2001 and recklessly maintained and enforced to this day by Defendant JCAHO that led to a sharp increase in prescriptions for opioids.”
In a JAMA letter from July, 2017, Dr. David Baker was more sanguine, writing: “The Joint Commission should have examined ways to address the opioid epidemic earlier, and the organization should learn from this experience. Past criticism of the pain standards may have caused some reluctance to tackle the emerging opioid epidemic.”
The plaintiff’s claim that The Joint Commission teamed up with Oxycontin manufacturer Purdue Pharma on educational strategies has a more complicated history, and the lines have been drawn for years. In a July 2017 letter to JAMA, Drs. Neeraj Chhabra, MD and Jerrold B. Leikin made the claim that Purdue Pharma was one of two companies that provided funding for The Joint Commission’s pain management educational programs. Baker’s response in JAMA that same month unequivocally denied this claim, stating that the only organization to provide funding for The Joint Commission’s pain standards was the Robert Wood Johnson Foundation.
However, according to reporting by The New Yorker in 2013, “Purdue helped fund a ‘pain-management educational program’ organized by The Joint Commission; a related agreement allowed Purdue to disseminate educational materials on pain management, and this, in the words of the report, “may have facilitated its access to hospitals to promote OxyContin.” This finding dates back to a 2003 investigation by The U.S. Government Accountability Office called OxyContin Abuse and Diversion and Efforts to Address the Problem.
This suit summary doesn’t mince words, calling out The Joint Commission’s “reckless and negligent indifference to the horrors of addiction,” their “profitable co-option by the opioid industry,” and finally their “arrogant and intransigent refusal, despite an epidemic of human suffering, to modify or enforce its Pain Management Standards in a way that would reduce the risks of addiction.”
Doubtless this 15-year history will resurface as this case progresses. And if it appears before a jury, the results could be unprecedented.
13 Comments
At long last, Perdue is being held accountable for the opioid epidemic (not forgetting the massive FDA fine for the same thing). The JCHAO or Joint Commission played a pivotal role in allowing Perdue to broadcast its message of pushing the use of narcotics over reasonable doses of regular non-narcotic pain meds plus the emphasis to patients that they have to tolerate some degree of pain with injury. These two entities definitely colluded to emphasize the use of narcotics, along with the push to stop patients from having ANY pain at ANY time. The human condition cannot produce a pain-free state in injury or even in many illnesses. The fifth vital sign? Bah, how can anything that cannot be seen, felt, or detected be a ‘vital sign’? There is so much craziness in this that I remain astounded that good physicians could have been taken in by it!
While I applaud the cities in my home state for their attempt to bring some accountability to the industry for the current epidemic, I don’t think they have gone far enough. Personally I would like to see every Hospital/Health System Administrator who swallowed the JCAHO cool aid by the gallon bowing to the dual Gods of accreditation and Press Ganey scores while balancing their non-profit(really?) spreadsheets on the backs of EP’s and other providers just struggling to get through a shift without a complaint from a 12/10 abdominal pain patient sitting on a cart talking on their cell phones eating McDonald’s, (Chick-fil-a, Hardee’s). I left the Pvt/commercial ED 13 1/2 years ago to do Urgent Care Medicine where we’ve done almost zero narcotics since the start and have NO tolerance for chronic controlled substance use. I have never looked back. It feels nice to have actually been ahead of the curve on something. I wish them luck with their suits and pray that we all can find a solution going forward.
In my 34 years as a practicing EM Physician I personally saw this happening and on a personal level was completely disgusted with the way the whole issue of pain management was taken away from those in the trenches who saw this abuse occurring on a daily basis!
Patient satisfaction scores in the ED which were tied into our Hospital Administrators bonuses were in a way managed by our drug addicts!
I still remember our entire Dept having to attend a mandatory meeting on “Pain Sensitivity Management “ where we were instructed in being more liberal in prescribing Narcotis as we could not cure or harm an addict by giving him or her a few pills to tide them over till they saw their Private MD!!
This article makes me wonder as to who funded the study that at one time we had to administer antibiotics to a Pneumonia patient within 4 hours of walking in to the ED!!
I would love to see this become a class action lawsuit. AAEM and ACEP please support this!
Oh, its not just JACHO. JACHO and CMS are just tools easily manipulated by the likes of Purdue Pharmaceutical and Press-Ganey. Getting garbage data to determine reimbursement and bonuses. Brilliant. You can also thank those hospital administrators, CEOs of hospital groups so eager to one up their competitors, so willing to doctor the data before the merger. They who did quite well for themselves while they bullied ED physicians to tow the line or be fired, or your group will lose the contract.
This is what corruption looks like on a massive scale.
This is our tobacco moment. Shameful.
Our professional organizations, our physician leaders, they all failed us ,and the public as well. We stopped being patient advocates and simply became part of a sales force. I have be saying this for years and have paid dearly for doing so. Not very satisfying to say ” told you so” now when i see the track marks on teenagers and tell a family member that here loved one is yet another victim to this insanity.
During any court proceedings, can we ensure that there is no coffee or beverages at the desks of the lawyers to prevent any infections?
I just have one question… anyone who has an answer, please join.
“Why does the JC exist? Do we really need such a thing?”
Such a silly question: JC exists so they can make money off the working people.
Before they made pain the 5th VS, I too could see this epidemic coming down the pike and have “paid” a bit for it my self, for not following the rules and or the flow. Oh well. At least I refused to participate in creating addicts, without making people that needed pain relief suffer. It is called an “educated decision”. We used to make those type of decisions. Now, we just follow the algorithms or rules, or not.
This issue is not just JCAH or CMS. I fault our professional organizations even more for not speaking up for what is right, though they hear it from a couple of us. I fault citizens for allowing lobbies to legislate every industry. Those professional organizations and those citizens are us. Each one of us, looking to blame someone else instead of taking responsibility ourselves. No one caring enough to rock the boat. And for that, we get a bunch of dead kids.
This is our industry. It is past time to engage and demand active bedside clinical people do the research (without being paid based on the results) and make the decisions regarding clinical care. No lobbies, no MBA’s, no salesmen.
I did not know about this relationship between the JC and Purdue Pharmacy and am very happy to be informed (although it is scandalous in its implications, of course!). I have gone on for years about how we were told that we weren’t treating pain adequately, and all the rest of it – the required CMEs in pain sensitivity, the bad press about insensitive physicians, etc. etc. – and of course it (opiate addiction) has come back to haunt us as a profession – and most importantly, has led to tremendous suffering in our communities and a “national crisis”. I cannot tell you how many times I have said “no” to the requests and demands for narcotics. Cursed at, yelled at, given “the finger”, demeaned… an uproar in the ED that makes me look bad to administration. But, as a physician and a person, I don’t support opiate abuse – those are my ethics and my morality. Congratulations to all those physicians who have bucked the trend to give everyone Vicodin!! While there are certainly some overly generous bad apples in our profession, we physicians are the ones who should be the ones making these decisions based on our education and clinical experience!
I, also, have been a practicing ER physician for quite a few decades that has become fed up with how those who have absolutely no skin in the game somehow been able to position themselves to dictate how we, as the educated professionals we are supposed to be, get sucked into the money-sucking vortex that the medical industrial complex has become–and that includes some in our own profession that are part of the overreaching policy-implementing committees. There are many examples–and pain management and the use of antibiotics for pneumonia within 4 hrs of any possibility of pneumonia being described on a chest X-ray are only two of them as have been mentioned. How about nitroglycerin and aspirin being given ‘within a certain time frame’ for chest pain? How many chest pains are really heart attacks? One hospital I worked in was actually having the nurses give every patient with chest pain nitroglycerin and aspirin with the complaint of chest pain ‘in order to fit the time frame’–despite any ED MD order or lack thereof. Really? Pregnant women and 10 yr olds included. Or this claim that every possible neurological deficiency being claimed as a ‘stroke alert’ with ‘automatic stat CT scans’ and consideration of thrombolytics ‘within a set time frame’ despite any history. All of this being claimed by the hospital administration that ‘if we don’t do it this way, we don’t get paid’.
While I think that I am as thorough and as fast in the ED as I can practically be, I even have a problem with the claim that ‘faster is better’–as now has become the mantra of ‘the industry’. I practice in the state of Texas which has enacted substantial tort reform laws in the past 10 yrs–and, in that time, I have only been mentioned in one malpractice lawsuit. However, in that lawsuit which involved three others in the same case of a patient returning to the ED for the same complaint, the expert witness kept claiming all sorts of problems with ‘not enough information in the charts to make the diagnosis, not enough history taken to make the diagnosis, not enough, not enough, not enough’–and, at no time, did the hospital administration nor my own ER corporation representatives ever come in to claim ‘Well, at least the patient was seen and disposed of quickly…..’
I have a colleague of mine that I think has hit the nail on the head with how this issue got started several years ago when nurses started asking ‘Why are the hospital administrators in our recent meetings now calling our patients customers instead of patients?’ That colleague responded ‘If you can call them customers, corporations have control. If you call them patients, doctors have control’. Maybe it is time for us to take our profession back……
I am almost gleeful about the intelligent action on the part of these West Virginia counties. I shall use this as President of the MO chapter of AAEM to try to persuade Missouri Attorney General Josh Hawley to have Missouri join in. To my view, this issue is highly analogous to how the states went after the cigarette companies and got a huge settlement. States are having to spend $$ to buy naloxone for EMS crews, and I’d bet that many of the vials expire un-used. Plus there is the training cost. Etc etc I think if you are reading this you get my direction. GMG
While I hope this all goes to a class action lawsuit in order to let the paper-pushers realize their implementations have consequences, also, I would also hope that Press-Ganey gets added to the lawsuit. After all, it is the Press-Ganey questionnaire that provides the feedback loop to administration that endorses overuse of narcotic medications tied to how patients ‘appear satisfied with their pain management’. I’ve seen where Press-Ganey is going to change that feedback question from ‘how well was your pain managed’ to ‘how well did anyone discuss your pain management with you’–as if that will resolve it and as if to ignore the point that part of this problem is how much these overreaching policy-implementing committees infringe upon the very discretionary judgment that I believe should be within the sole purview of the practitioner having to deal with the case at hand. I’ve seen where this lawsuit is asking a rather nominal amount of monetary compensation from the Joint Commission because if its ‘non-profit’ status and relatively small worth in dollars (measured in just a ‘few million’) compared to other institutions. However, I’ve read that Press-Ganey was recently sold to a Swiss investment firm for over 2.9 billion dollars. What actually is Press-Ganey ‘selling’ to make it worth so much? Well, since part of its ‘value’ is in providing the feedback loop that administrators use to hand over the head of actual practitioners in imposing the Joint Commission ‘policies’, I think that Press-Ganey also should be added to this lawsuit. It’s time that they are as accountable to their actions in medical ‘decisions’ as practitioners taking care of the patients are…..