Long-Term Opioids Worsen Outcomes After Back Fusions
Long-term opioid therapy for patients who’ve had lumbar fusion for degenerative disk disease may lead to poor outcomes, suggests a new study. Researchers found injured workers prescribed opioids for more than a year after the surgery had lower return-to-work rates, higher medical costs, and more psychiatric comorbidities than those not on chronic opioid therapy (COT).
For the study of more than 1,000 injured workers who had undergone lumbar fusion surgery, researchers from several institutions teamed with workers’ comp administrators. Analysts from Case Western Reserve School of Medicine, the New Hampshire NeuroSpine Institute, and University Hospitals Case Medical Center Department of Orthopedics in Cleveland teamed with officials from the Ohio Bureau of Workers’ Compensation. The study evaluated risk factors among those on chronic opioid therapy compared them with a group that had only a temporary supply of opioids.
“The COT group experienced markedly worse outcomes after fusion,” the study said. “The overall poor outcomes of this study could suggest a more limited role for discogenic fusion among patients receiving workers’ comp.”
The increase in the use of opioids for non-cancer pain has risen significantly in the last decade, the authors noted. The increase has been associated with high rates of substance abuse disorders, hospital admissions, and overdose deaths.
While opioids may be effective for low back pain in the short term, there is little evidence that they are effective long term. There is also evidence that long-term high dose opioids may lead to opioid-induced hyperalgesia, or abnormal pain sensitivity.
“The clinically-distinct workers’ comp population is noted to have high rates of COT and early opioid therapy for acute low back pain in a workers’ comp setting has already been associated with increased disability,” the authors wrote. “Our study investigated opioid analgesic utilization among 1,002 Ohio workers’ comp subjects who underwent lumbar fusion for degenerative disk disease and discogenic low back pain from 1993-2013.”
The study population was divided into two groups. Those receiving opioids more than one year after the initial six-week period following the fusion — 575 patients — were identified as the COT group. The remaining 427 were the temporary opioid group.
Within three years after the fusion surgeries, the COT group received an average of 1,083.4 days of opioids, a 72.3 percent morphine equivalent daily opioid load, and 49 opioid prescriptions, most of which were Schedule II drugs.
The authors noted the COT group’s worse outcomes were “highlighted by an 11.0 percent return-to-work rate and nearly $28,000 higher medical costs paid by the Ohio Bureau of Workers’ Compensation per subject compared to the temporary opioid therapy group.” They also noted “a 43.5 percent overall rate of clinically-diagnosed psychiatric comorbidity — 68.4 percent of which was diagnosed after fusion, a 16.7 percent rate of failed back syndrome, and a 27.7 percent rate of additional lumbar surgery.”
“The overall poor outcomes of this study could suggest a more limited role for discogenic fusion among patients receiving workers’ comp.”
Specifically, three years after the surgery, those in the COT group were out of work an average of 37.3 days more than the other group, had a 27.4 percent lower return-to-work rate, a 20 percent increased rate of new onset psychiatric disorders, 12.7 percent higher rate of failed back syndrome, a 7.4 percent increased rate of total permanent disability payments, and a 16.2 percent higher rate of additional surgery.
Approximately 32 percent of the workers’ comp population is prescribed opioids, according to the researchers. Those receiving the medications for acute low back pain were found to have higher rates of disability and more surgery, as well as COT.
The authors also identified risk factors associated with COT vs. temporary opioid therapy.
“The strongest predictor of COT after fusion was receiving COT before fusion,” the study said. “Seventy-nine-point-6 percent of subjects on preoperative COT ended up on COT after fusion. Both increasing duration of opioid use and increasing net opioid load within the year before fusion were positively associated with higher rates of postoperative COT.”
The COT group was given opioid analgesics an average 22.4 more days than the temporary opioid therapy group during the year before the fusion surgery. They also filled an average of 1.2 more opioid prescriptions, which the authors said equated to 217.9 additional morphine equivalents and 7.4 morphine equivalent higher daily opioid load than the temporary group.
The chronic opioid group also had an average 76.6 more days out of work before fusion, a 5.9 percent higher rate of psychiatric disorders, a 13.3 percent higher rate of being out of work more than 12 weeks. They also had a 5.4 percent higher rate of psychotherapy utilization, a 10.1 percent increased rate of undergoing discography, a 7.3 percent lower rate of utilizing chiropractic care, a 6.5 percent higher rate of legal representation, and a 3.8 percent higher rate of spondylosis, or spinal degeneration.
Workers’ comp patients in other states may show different results than what the researchers found in Ohio. Legislative regulations, treatment guidelines, and other factors could generate different findings. Also, differences in preoperative variables between the two groups, as well as “significant differences in surgical methods” could have affected the findings.
However, “the high rates of psychiatric disease after fusion and the strong impact depression had on rates of COT may indicate a possible impact of better screening and treatment for psychiatric disease before lumbar fusion,” the study suggests. “Also, the significantly greater utilization of psychotherapy after fusion among both groups may suggest worsening psychological health after fusion within our study population.”
Treating the Whole Person
Recent research from Gallup and Healthways Inc. shows what claims payers already know: The percentage of obese Americans continues to increase. In their May 2015 report, Gallup and Healthways stated that the nation’s obesity rate rose again in 2014, reaching 27.7 percent, up from 27.1 percent in 2013.
Even more unsettling — and perhaps surprising to some — is that research indicates changes in diet and exercise are not enough to reverse the trend.
What’s needed, according to the studies, is a more holistic engagement that boosts a person’s sense of purpose and strengthens their community and social relationships; even their financial health.
Professionals that help injured workers address biopsychosocial issues say they agree with that assessment. They also say it is increasingly a factor in their work with employers and other workers’ compensation and disability claims payers.
Biopsychosocial issues refer to psychosocial factors impacting a person’s medical problems, said Michael Coupland, CEO and network medical director at Integrated Medical Case Solutions Group, which provides biopsychosocial assessments and interventions.
Most biopsychosocial approaches take into account that factors such as emotions, behaviors, social environments and culture all impact human medical conditions and performance.
Services addressing biopsychosocial problems are being applied more often when medical treatment alone fails to mend injured workers. They can help with depression, pain medication misuse and obesity, which can delay or even thwart successful return to work.
About 75 percent of the workers’ comp and disability claimants referred to his group are obese or morbidly obese, IMCS’s Coupland said. They are referred by claims payers, treating physicians, self-insured employers and others.
“They are the people that tend to have psychosocial factors that are delaying their recovery,” Coupland said.
IMCS Group specialists offer their patients cognitive-behavioral techniques for taking control of their health and wellness, Coupland said. The techniques include meditation, mindfulness and biofeedback.
Those practices can help, for example, with decreasing muscle discomfort so recovering workers are able to go for walks and reap the benefits of exercise.
Darrell Bruga, founder and CEO, LifeTEAM Health, agrees with the Gallup and Healthways findings that factors such as social interactions, financial well-being and a sense of purpose must be addressed.
Bruga said many of the injured and disabled workers his company sees are obese, although his organization does not directly treat obesity. LifeTEAM professionals provide services for reducing psychosocial and return-to-work obstacles.
Interventions that help people develop a sense of purpose, achieve financial well-being and develop community interactions “are exactly the sort of things we are focused on in helping people re-engage,” Bruga said.
“It makes sense that if you are having challenges from a psychosocial standpoint in life as a whole, that is certainly going to impact your well-being and potentially your body composition,” he said.
But it’s important to recognize that returning to work is part of the solution — it can help meet the needs the researchers outline because work is social and it also improves peoples’ financial position, Bruga added.
“It makes sense that if you are having challenges from a psychosocial standpoint in life as a whole, that is certainly going to impact your well-being and potentially your body composition.” — Darrell Bruga, founder and CEO, LifeTEAM Health
Bruga will speak on mitigating psychosocial risk factors with biopsychosocial measures during the National Workers’ Compensation and Disability Conference® & Expo to be held at Mandalay Bay in Las Vegas November 11-13.
Dr. John T. Harbaugh, occupational medicine physician director at Southern California Permanente, will join Bruga and share results from helping his organization’s injured employees overcome psychosocial risks with a biopsychosocial strategy.
What’s important to keep in mind in managing the biopsychosocial aspect of work injury and return-to-work is that any injury creates stress for both the employer and the employee. The mere fact that a once-productive employee is leaving work creates a host of issues.
“There is a stigma to going out of work. Nobody wants to go out on leave,” said Rebecca Moya, a behavioral health manager with Sun Life Financial.
“So if we can battle that, have employers manage that piece in a more empathetic, supportive and understanding way, that’s one less hurdle that insurers or benefit analysts or vocational rehabilitation consultants have to jump over to get there,” Moya said.
There is also psychological trauma that lives within a worker who associates pain and injury with their workplace.
“It’s hard to revisit and go back to that place,” Moya said.
“We’ve worked with employers to ask, ‘Are there other sites? Is it possible to have this person work at a different site?’ Because they’re ready to come back — it’s just that the emotional and psychological aspect of returning to the site of their injury is very challenging,” she said.
There are also the injuries to self-esteem and the sense of self-worth that a physical injury can bring about.
Even without obesity or some other comorbidity dogging them, a worker who faithfully performed a task for decades can suffer a loss of confidence or suffer depression when a work injury means they will never be as strong or able again.
“That’s hard for people. They don’t always want to go back and do something different. Even with accommodations, it’s hard for people to accept that’s going to be the way things are going to be going forward,” Moya said.
Overcoming those fears and that damage to self-esteem means focusing on the positive, Moya said.
“If an analyst starts off a relationship with an injured worker with a positive, ‘We’re going to work on your abilities, not your disabilities, and we are going to get you back to work,’ then people are really receptive to that.
“It’s all about the foundation you lay at the start of a claim,” Moya said.
IMCS Group’s Coupland agrees that helping people return to work and reclaim their sense of purpose is a key piece of the well-being issue that the Gallup and Healthways researchers raise.
“We get so much of our purpose from work,” Coupland said.
Data Drives Down Skepticism
Growing acceptance of paying for biopsychosocial approaches to wellness is being helped along by a significant shift that occurred in 2009, Coupland added.
Health providers in psychology gained the ability to provide health and behavior treatments under Current Procedural Terminology codes for physical medicine rather than having to provide them as treatments under psychiatric codes, he said.
Now, workers’ comp payers are much more accepting of the treatments, Coupland said.
Even so, some workers’ comp claims payers are skeptical about a concept calling for treating the “whole person” and are still reluctant to pay for providing injured workers with biopsychosocial treatment approaches.
But increasingly, sophisticated claims payers are funding such programs and their numbers will continue to rise, said Debra Levy, senior VP of workers’ comp product management and national workers’ comp practice leader for York Risk Services Group.
Payers funding those programs are doing so because their data shows a positive return on investment, Levy said.
“The earlier you can recognize those are factors and offer solutions or guided care … you see a positive impact as opposed to throwing away money,” she said.
A Wake up Call for Any Company That Touches Food
It’s not easy to be in the food industry these days.
First, there is tougher regulation. On August 30, 2015, the Food Safety Modernization Act (FSMA) required companies to file planning paperwork for Preventive Controls for Human Food. The final FSMA rules take effect on August 30, 2016.
Next, increases in food recalls, some deadly, are on the rise. In early September, 9,000 cases of frozen corn were pulled from shelves after a listeria scare. A few days later, a salmonella outbreak in cucumbers imported from Mexico resulted in one death, while sickening hundreds of consumers nationwide.
Courts are getting tougher, too, as owners/executives in particularly egregious cases involving consumer deaths have been prosecuted criminally, with one receiving a recommendation for a life sentence.
Finally, advances in science – including whole-genome sequencing technology, which maps DNA of microbes to more easily pinpoint precisely where contamination occurs – can expose every player in the supply chain to potential losses and lawsuits.
“Few companies have the balance sheet or brand loyalty to survive a serious recall. Outbreaks, new regulations, prosecutions and science have made purchasing product recall and contamination insurance literally an act of survival for companies of all ages and sizes,” said Jane McCarthy, Senior Vice President of Global Crisis Management at Liberty International Underwriters (LIU), who has over 30 years of industry experience.
Working with growers, processors, manufacturers, importers, shippers, packagers, distributors, wholesalers or retailers, LIU’s policy provides indemnity to pay for losses a company might incur from a recall, including logistic expenses, lost income and access to crisis management and public relations consultants.
Legislation tightens on food-related companies
Passed in 2011, the FSMA gives the Food and Drug Administration a far more proactive weapon in the war on tainted food, as the focus shifts to prevention combined with the FDA’s newfound authority to close businesses that aren’t complying with FSMA rules and regulations.
In addition to the August 30, 2015 deadline for filing paperwork for preventive controls, as part of the law, all companies need to be registered if they do anything with food in the United States, or a company is a foreign entity bringing food into the U.S.
“It’s the law and every regulation and benchmark has to be met,” McCarthy said. “The FDA will shut someone down if they don’t think a company is handling a food product properly. With these new rules and regulations, the whole industry has to change.”
With LIU’s product contamination policy, companies have 24/7 access to pre-loss consultancy through red24, one of the world’s leading security consultants and global crisis management consultancies. For example, they’ll work with clients to best prepare them to meet the FDA’s 48-hour response deadline should a food contamination or product recall incident occur.
Costly outbreaks on the rise
According to a Wall Street Journal article, food recalls from 2012 to 2014 increased more than five times compared to the total number of recalls from the prior eight years combined. The Journal also reported that foodborne illness is often never formally reported, so about 48 million Americans, or one in six, get sick each year from food. The CDC estimates 128,000 hospitalizations and 3,000 deaths from tainted food.
Food contaminations happen in two main categories: allergens (peanuts, etc.) and pathogens (bacteria). There were four listeria outbreaks in 2014 alone, compared with one in each year from 2011 to 2013. Listeria is a particularly tricky and virulent pathogen that continues to survive and blossom, even in refrigerated environments. Listeria does not impact the appearance, taste or smell of food it invades, so a company in the food industry can only confirm contamination through testing or, unfortunately, once a customer becomes ill.
“Listeria is one of the worst nightmares. Not only is it deadly, but once it gets into a plant, it’s very difficult to eradicate,” said industry veteran Meg Sutton, LIU’s Senior Claim Officer. “It sneaks into drains and crevices that you thought were clean. Attempts to clean those drains and crevices, if done improperly, can result in aerosolizing the listeria and spreading it throughout the facility. In some cases, companies are forced to shut down the plant for extended periods of time, resulting in significant business interruption and loss of revenue.”
Courts get tough on deadly cases
With the increase and severity of food contamination recalls rising, the courts are getting tougher too. The food industry was rocked last month by a recommended life sentence for the ex-CEO of a peanut manufacturing company following a multiple-felony conviction for knowingly selling tainted peanut butter that ended up killing nine people.
“The judge ended up sentencing him to 28 years in federal prison, still the harshest penalty ever in a case of food contamination. While our policy won’t cover your defense if you’ve committed a crime, the penalty is another wake up call for the food industry that executives at the highest levels will be held accountable,” McCarthy said.
Science boosts detection, transparency
By using today’s scientific methods to trace back to the source (grocery store, restaurant, wholesaler, etc.), experts can determine the production facility or farm that originated the food or food additive. They can swab the facility for DNA matches and pinpoint the contamination.
Considering those four prime drivers, it’s not surprising that interest in food product recall and contamination coverage from companies of all sizes is gaining momentum.
“We don’t want them to just buy our insurance,” McCarthy said. “We want them to be better for it with us as their partner by making sure they have the right coverage in place and improving their business from a health, safety and compliance standpoint.”
Liberty International Underwriters is the marketing name for the broker-distributed specialty lines business operations of Liberty Mutual Insurance. Certain coverage may be provided by a surplus lines insurer. Surplus lines insurers do not generally participate in state guaranty funds and insureds are therefore not protected by such funds. This literature is a summary only and does not include all terms, conditions, or exclusions of the coverage described. Please refer to the actual policy issued for complete details of coverage and exclusions.
This article was produced by the R&I Brand Studio, a unit of the advertising department of Risk & Insurance, in collaboration with Liberty International Underwriters. The editorial staff of Risk & Insurance had no role in its preparation.