Archive for April, 2014

An Opioid Call To Arms

Wednesday, April 30th, 2014

In October, 2013, the Food and Drug Administration (FDA) allowed the opiate Zohydro ER to come on the market despite its own Advisory Panel voting 11-2 against it because it was not tamper resistant. Twenty-nine state Attorneys General petitioned the FDA to reverse its decision, but the FDA declined to do so, saying that the drug is safe and effective if used as directed.
We chronicled Massachusetts Governor Deval Patrick’s Quixote to the Windmill charge as he attempted to ban the sale of the drug in the state. The windmill won when US District Judge Rya W. Zobel overturned the state’s ban. Shortly thereafter, just days before his ban was due to expire, Governor Patrick remounted Rocinante and made a less Quixotic charge: he followed the lead of governors in other states by imposing sweeping restrictions on how Massachusetts doctors prescribe the powerful pain killer, the first pure opiate.
The restrictions, which Zohydro ER’s maker, Zogenix, calls “draconian” and “unjstified,” require that doctors:

  • Evaluate a patient’s substance abuse history and other current medications;
  • Provide a “letter of medical necessity” to the pharmacy;
  • Enter a “pain management treatment agreement” with the patient; and,
  • Use the state’s online Prescription Monitoring Program, which tracks prescriptions of controlled substances, before prescribing drugs like Zohydro that are extended-release medications containing only hydrocodone and do not come in an “abuse-deterrent form.”

Zogenix is fighting back. On Monday, the San Diego-based company filed a federal lawsuit arguing that the Massachusetts new restrictions impose “draconian” mandates on doctors and “amount to an effective ban of the drug” that is unconstitutional.
The Suit asks that the Court vacate any restrictions imposed on the sale of Zohydro ER.
Governor Patrick says that his problem with Zohydro ER is that it does not come with “abuse deterrent” packaging. Zogenix responds with three assertions:

  • The active ingredient in Zohydro ER, hydrocodone bitartrate, is no more potent than most other opioids;
  • There are more than 30 extended-release opioids on the market, and only one has an FDA-approved label indicating it has abuse deterrent properties; and,
  • No product on the market today addresses the most prevalent form of abuse, taking an excessive number of tablets or capsules.

Yesterday, things got even hotter in the Bay State when drug abuse prevention groups, state lawmakers and organized labor leaders rallied outside the statehouse on Beacon Hill demanding even more restrictions.
The rally drew more than 150 demonstrators who, in addition to the call for greater restrictions, urged Congress and federal officials to reverse the FDA’s approval of Zohydro ER.
Those who attended the WCRI’s annual conference in Boston in April will recall the stemwinding luncheon speech of Steve Tolman, former Massachusetts state Senator and now President of the Massachusetts AFL-CIO. Tolman, who ardently and passionately does all he can to combat drug abuse in the Commonwealth, was in rare form at yesterday’s rally.
“We don’t need any more opiates! We don’t need any more addiction,” he shouted to the crowd. “Yes, we know that people need pain medication, but they need the right type of medication. And it needs to be monitored.”
Massachusetts Senate President Therese Murray promised the demonstrators that the legislature will take action and is now working on a comprehensive bill dealing with all aspects of addiction, from education to prevention to treatment.
But, with the exception of theft, the only way people get opioids is by doctors prescribing them, and, right now, doctors are cautious and, in some ways, befuddled. They know there’s a big opioid problem, which has prompted Governor Patrick to declare a state of emergency, but they don’t want government invading their patient examination rooms. Nonetheless, shortly after the Governor announced his restrictions, the Massachusetts Board of Registration passed emergency regulations adopting them.
Moreover, in this week’s New England Journal of Medicine, Doctors Yngvild Olsen and Joshua M. Sharfstein present a thoughtful op-ed focused on Zohydro ER and the greater issue of the intersection of chronic pain and pain management medication. They write:

Chronic pain, which affects tens of millions of people in the United States, is associated with functional loss and disability, reduced quality of life, high health care costs, and premature death. U.S. physicians are now more likely to recognize and treat chronic pain than they have been historically, with the number of prescriptions written for opioids having increased 10-fold since 1990.

Over the same period, however, the rate of overdose deaths in the United States has more than tripled. This is not a coincidence. Many doctors have prescribed opioids for chronic pain without following best practices, understanding the risk for the development of substance-use disorders, or recognizing the red flags that can emerge in clinical practice. There is now evidence from states including our own, Maryland, that some individuals whose path to addiction may have started with a prescription for pain are progressing to heroin.

It is becoming crystal clear that re-educating doctors regarding opioid usage is central to any attempt to fix this problem.
It is also clear that this crisis is not about Zohydro ER, although the drug may prove a catalyst for change. Rather, we are witnessing a growing countrywide realization that we are slipping into a public health crisis unlike anything we have ever seen.
In the workers comp field, there is a glimmer of hope. Progressive Medical and PMSI yesterday reported a slight drop in the number of opioid prescriptions written, as well as the costs of those prescriptions in 2013. Other PBMs are reporting similar moderate declines. But that is workers comp, the tiny caboose on the great big health-care train.
This issue demands more than the piecemeal approach it now is getting. Lives, careers and families are being destroyed, while too many constituencies operate alone, unable to achieve any kind of a cohesive and comprehensive solution. It is time for the FDA, the AMA, the US Congress and Big Phama to come together in serious purpose to address this public health emergency, which is rapidly spiraling out of control.
If not, more of America’s humanity will just continue to wither and die. We are better than that.

Coingate: The Gift That Keeps On Giving

Tuesday, April 29th, 2014

Imagine, for a moment, that you hold the lofty position of Inspector General for a major midwest US state. Imagine further that down the road and around the corner, before you time, way back in 2005 gross malfeasance and criminal activity happened in your state’s Bureau of Workers’ Compensation (BWC). And people went to jail. All told, there were nineteen criminal convictions, including several prominent Republican politicians. Your governor at the time, a member of the state’s most distinguished political family of the 20th century, a family that includes one member who became both President and Chief Justice of the US Supreme Court, pleaded “no-contest” to criminal charges of misdemeanor ethics violations.
Your name is Randall Meyer, and you inherit this mess in Ohio. You inherit it, because nine years ago, a political lifetime in the past, your office was charged with investigating the whole thing and producing a report that would explain what happened, along with how and why, as well as what the state and Bureau have done to prevent such a sorry affair from ever happening again.
The whole thing came about, because even farther back, in 1998, the BWC gave Thomas Noe, a major Republican fundraiser and professional coin dealer, $50 million to invest in rare coins, an investment with, essentially, no liquidity. And that is probably why no other state in the nation pursued such an investment with its workers comp surplus.
The concept wasn’t complicated: Noe and his partners took the state’s $50 million and, applying their professional experience, bought rare coins, which they then tried to sell at a profit. Sound risky?
In 1999, Keith Elliot, the BWC’s manager of internal audits, picked up the corner of the rare coin rug and tried to see what was growing underneath, because of “the unique nature of the investment.” He asked uncomfortable questions, was able to put a few minor controls in place and was essentially stonewalled by the Bureau’s leaders.
Time passed. Six years, actually. Finally, the whole thing blew up in April, 2005, when Mike Wilkinson and James Drew, of the Toledo Blade, published a long piece on Noe, his business and the, till then, history of what came to be known as “Coingate.”
The scandal was mothers milk to investigative journalists. As so often happens in these situations, the Blade grabbed hold and would not let go. It infuriated comfortable politicians and, in the process, performed huge public service for Ohio. For that service the Blade and its investigative journalism team won more than a dozen national, state and local awards, including being a Pulitzer Finalist for Public Service.
We at the Insider also drank deeply of Coingate’s milk, writing about it numerous times. How could we not?
But, back to you, Randall Meyer, Ohio Inspector General. Last week, you issued your office’s final report on Coingate – and, really, the only reason you released the redacted cat from the bag was because the Toledo Blade sued you to do it.
One would think that a report coming nine years after the investigation began and six years after the last prosecution would be juicy, indeed. But such is not the case. Your report was a mere chronology of events, not much of an investigation. You report that, “As the task force investigation was completed prior to the current inspector general assuming this office, there were no resources utilized to reinvestigate an already completed matter.” So, the Report did not include any investigative records, such as witness interviews. You didn’t even interview Mr. Coingate, himself, Tom Noe.
You did cause a bit of trouble for yourself, however, when you wrote in the Report that Noe’s ex-wife, Bernadette Restivo, was one of those against whom the BWC won civil judgements. The lady reacted strongly to that, and the day after you released the report, you had to change it to take her out of it.
We used to sing a song in my college folk group called The Cat Came Back, a cute little ditty about a cat that would find its way back to the back porch regardless of where you sent it, even outer space. I’m reminded of that song every time I hear something new about Ohio and Coingate. Even now, despite its experience with investing in rare coins, the BWC has decided that safe stocks and bonds still aren’t enough. Nope. On Sunday, the Toledo Blade’s Jim Provance, picking up on a story originally reported by WorkCompCentral’s Peter Mantius, reported that the BWC has invested another $50 million (that’s its limit on investments) “in a Wisconsin health-care real estate fund headed by a major national Republican donor and money-raiser, Jon Hammes.”
I can hardly wait.

Workers Memorial Day 2014

Monday, April 28th, 2014

April 28 is Workers Memorial Day, a day dedicated to remembering those who have suffered and died on the job and renewing the fight for safe workplaces.
Find an event near you
Profile of Worker Safety & Health in the US (PDF)
Fact sheet in English (PDF) and Spanish (PDF)
Other commemorations / resources
Workers Memorial Day – Because Going to Work Shouldn’t Be a Grave Mistake!!
International Day of Mourning
Presidential Proclamation — Workers Memorial Day, 2014
National Council for Occupational Safety and Health?
Lucky to Be Alive on Workers’ Memorial Day
Workers’ Memorial Day 2014: Chemicals, New Hazards, Falls

Health Wonk Review & roundup of other notable news

Friday, April 25th, 2014

Biweekly roundup of health wonkery – Louise Norris posts Ways the ACA Could Be Improved Edition of the Health Wonk Review at Colorado Health Insurance Insider, a robust roundup of links and opinions from some of the best health wonks on the web. It could also be titled the “hopeful signs of spring” edition – check out the great local photos.
Reminder: April 28Workers Memorial Day is coming up. April 28 is dedicated to, remind us that every death, injury, or illness on the job represents a human tragedy. For a toolkit or list of events, see the AFL-CIO Workers Memorial Day site. Yesterday was the one-year anniversary of Bangladesh’s Rana Plaza factory which killed 1,129 garment workers. The New York Times looks at the past year’s battle for a safer Bangladesh.
Spine Surgery – CBS News features an important story on the increase in spinal fusion surgeries: Tapping into controversial back surgeries. CBS examined the number of spinal fusions each doctor in the country billed to Medicare from 2011-2012, finding that 5% of spine surgeons performed 40% of riskier fusion surgeries. The data analysis was the starting point to a deeper investigation raising questions about disparities in treatment and whether many such procedures are performed unnecessarily. “The data shows that a small group of doctors performed these procedures far more frequently than their peers. While the national average was 46 surgeries over the two year period, some did more than 460. While the average spine surgeon performed them on 7 percent of patients they saw, some did so on 35 percent.” They also offer a database to look up a surgeon,
Terrorism backstop – As the renewal of terrorism insurance winds its way through the legislative process, the industry is fairly unified in reaffirmation of the importance of renewal. The current bill is slated for expiration on Dec, 31. A newly released 2014 Terrorism Risk Insurance Report by Marsh makes the case for renewal, stating that the law offers a stable underpinning to ensure availability and affordability of coverage. Last year’s Boston Marathon bombing sparked demand among smaller and midsized firms — and also raised the issue of a need for clarity about just what constitutes a terror event.
CA Opioid Guidelines – Joe Paduda posts a detailed take on the strengths and weaknesses of California’s new Opioid Guidelines. His opinion? Underwhelming.
Claims – Dave DePaolo has a post on Mental Claims & Boundaries, in which he looks at a PTSD claim that is being contested in Florida.
OpioidsLab-based Urine Drug Monitoring, Interventions Improve Outcomes for Injured Workers on Chronic Opioid Therapy – Clinical interventions performed in conjunction with laboratory quantitative drug testing and monitoring reduced injured workers utilization of high risk medications, according to a clinical study released by Progressive Medical/PMSI and Millennium Laboratories. The study showed a decrease in all measures of utilization, driven primarily by opioids (32%) and benzodiazepines (51%), as well as a 26% reduction in total utilization of all medications, regardless of drug class.
Quick takes

Just for fun

Where’s Aristotle When ABC Needs Him?

Friday, April 18th, 2014

This morning, ABC’s Good Morning America shone its media arclight on Cathy Caswell as she spun the great big wheel on The Price is Right, not once, but twice. But while doing so Ms. Caswell was drawing $3000 per month in workers comp indemnity payments, according to ABC. And she was collecting those payments because of a shoulder injury, which prevented her from standing, running, reaching or grasping, as reported by ABC’s eagle-eyed Cecilia Vega. Vega “reported” that Caswell was one of “the countless people accused of faking an injury” to the tune of “hundreds of millions of dollars.”
The report then cut to some fraud words of wisdom from private eye, “master of disguise” (not my words; they’re Vega’s), Bob Keane who fancies himself cut from the James Bond cloth. Keane claimed that if you’re committing fraud the only way to avoid being caught by him is “by completely staying in your house for three to five years,” because if you venture outside he’s going to “get you.”
By using phrases like “countless people” and “hundreds of millions of dollars” ABC implies that Ms. Caswell is merely the tip of a very big iceberg. Frankly, I think Ms. Vega skipped Philosophy 101 – Aristotelian Logic. You know, the part about faulty inductive arguments going from the particular to the general? But I digress.
We all know that there are people who commit workers comp fraud. In fact, some of them are workers who fake injuries or malinger trying to milk the system. But the fraud committed by workers is dwarfed by that of many others in the system.
Consider Devon Lynn Kile and her husband Michael Petronella. In 2010, while Ms. Kile sought to appear on the Bravo TV series “The Real Housewives of Orange County,” the couple gained a different kind of notoriety when federal authorities, after raided their three roofing businesses as part of a two year probe, charged them with 31 felony counts involving tens of millions of dollars of underreported workers comp premiums. Petronella went to jail for 10 years, and Kile was sentenced to 10 years probation and ordered to make $2.8 million in restitution.
There are many dimensions to fraud in the workers comp system. While many people think of fraud primarily as a problem involving employees, in dollar terms most fraud is committed by other players in the system. There are opportunities for wrong-doing in virtually every financial transaction within a system that generates multiple billions of dollars every year.
Just to be clear, fraud can be committed by, yes, employees, but also by employers (see Devon Kile), attorneys, medical providers, claim adjusters, insurance agents and even investment firms (see the “Coingate” scandal in Ohio).
Despite the many opportunities for fraud in the comp system, outright fraud is relatively rare. The vast majority of transactions within the comp system, involving all of the above players, are carried out with integrity and good faith. Nonetheless, vigilance is always necessary to ensure that comp dollars are spent prudently and wisely.
ABC has scheduled an expanded report on Ms. Caswell, et al, this evening on its World News Tonight program. It should make for some interesting, if infuriating, entertainment, faulty logic and all.

Fresh Health Wonk Review posted at Healthcare Lighthouse

Friday, April 11th, 2014

Check out the freshly posted Health Wonk Review – The April Fools’ Edition at Healthcare Lighthouse. Think we’re a little late on the date? Nope. Host Billy Wynne says the spirit of April Fools’ lives on as the blogosphere’s smartest health wonks gather to correct foolish notions and misconceptions floating around in certain pockets of our national dialogue.
Billy has been contributing to Health Wonk Review for some time now but this is his first time at bat in hosting, so be sure to give him a a visit. While you are visiting this edition, take a minute to explore other resources at Healthcare Lighthouse beyond the blog. Billy is the CEO and founder – he has gathered an impressive advisory board.

Zohydro ER Vs. Deval Patrick: The Latest Gunfight at the OK Corral

Wednesday, April 9th, 2014

The U.S. Food and Drug Administration (FDA) has acknowledged that prescription drug overdoses are now the leading cause of injury-related death in America, surpassing auto accidents. Couple that with the Agency’s approval last October of Zohydro ER, the first pure opiate painkiller, and you begin to understand why many lawmakers are left scratching their heads. More than half the states’ attorneys general have asked the FDA to withdraw approval of the drug. But the Agency is unrepentant. FDA Commissioner Margaret Hamburg told the Senate that the drug is a safe and effective option for patients with excruciating pain.
In late March, a stymied Governor Deval Patrick took the highly unusual step of banning the sale in Massachusetts of the controversial opioid made by California-based Zogenix, Inc. Many in the Massachusetts legislature as well as a number of workers compensation claims professionals thought it was the best thing any governor had ever done, a bold step to protect the citizenry.
Only it’s not as simple as that. It’s turning out that, however well-intentioned Governor Patrick may be, he probably can’t ban the sale of the drug, after all. Yesterday, US District Court Judge Rya W. Zobel told state lawyers that by Monday she wanted to see a lot more research that would buttress the Governor’s ban. Nonetheless, she said that she would more than likely grant a preliminary injunction on behalf of Zogenix that would allow Zohydro ER’s sale in Massachusetts. Said Zobel, “I think, frankly, the governor is out of line on this.”
According to Patrick, his issue with Zohydro ER is that it is not in “an abuse-resistant form,” meaning that it is not crush-resistant. Consequently, addicts (or anyone else who has the drug, for that matter,) can crush it and snort it or inject it.
Why would anyone want to do that instead of simply washing it down with a sip of water? Because in its pill form Zohydro ER is an “extended release” medication. That’s what the ER stands for. In fact, Zohydro’s full legal name is Zohydro ER (hydrocodone bitartrate) Extended Release Capsules. Crushing and snorting or injecting simply bazookas the whole dose at one time, which can be a deadly proposition.
Zogenix’s President, Steven J. Farr, attended yesterday’s hearing and, afterwards, took pains to let everyone know that Zohydro ER is safer than other hydrocodone drugs because it does not contain Acetaminophen, which can cause liver damage and failure with prolonged, high-dose usage. Farr did not mention that Zohydro ER contains up to five times the hydrocodone found in Vicodin. He did say that the company is in early stage development of abuse-deterrent formulations of the drug. That gave cold comfort to the Governor.
Whatever happens, it is hard to believe that Governor Patrick, a very smart lawyer, actually thinks he’s on firm legal footing here, although outside the courthouse that’s exactly what he said. As Judge Zobel pointed out (and she was decidedly irate that Patrick banned the drug without ever talking with Zogenix), Patrick cannot blame the Massachusetts opioid epidemic on Zohydro ER because the drug has yet to be dispensed in the state. She urged lawyers for the state and Zogenix to meet before the hearing scheduled for Monday, but she told everyone that Zogenix “probably will prevail.”
I have a few thoughts about this little mess:
First, it is not the fault of Zogenix that we have an opioid epidemic in Massachusetts or anywhere else. Yes, there’s an epidemic, but drug makers didn’t cause it. Irresponsible physicians, doctors who consider the Hippocratic Oath to be a mere suggestion, have placed their patients on the slippery slope to hell by prescribing over and over again strong and addictive narcotics for conditions for which those narcotics were never intended.
Second, the vast majority of physicians would never knowingly over-prescribe any medication. They have not forgotten that Oath and why they went to medical school. The ones I know resent and cannot understand the over-prescribers.
Third, although I wish it had built crush-resistance into Zohydro ER from the beginning, Zogenix did nothing wrong here. In fact, the Zogenix complaint notes: “When FDA approved Zohydro, it considered but rejected the idea of requiring the drug to utilize abuse-deterrent technology.” The company did everything it was supposed to do in gaining FDA approval. And that isn’t easy. One of the more difficult tasks in the universe is to get FDA approval for a new drug. The camel through the eye of the needle doesn’t even begin to describe the process. It takes many years and boatloads of money. So, you can understand that after all those years and money devoted to bringing this drug to market, to have it summarily banned is a bit hard to take.
Fourth, there are many people who suffer with agonizing pain. Think end-stage cancer. Those human beings need and deserve the best pain amelioration they can get, and the goal of the pharmaceutical industry, in addition to making money, is to give them that relief.
Finally, ending the opioid epidemic will require political courage and a much more highly-regulated process to oversee and assure that the relatively few ethically-challenged, weak-kneed and overly greedy physicians who now abuse their privilege are forced to change their bad behavior and follow that “do no harm” rule. If it weren’t for them, there would be no epidemic.

Wearable technologies: the next frontier in workplace safety

Wednesday, April 9th, 2014

The use of health monitors and fitness trackers have exploded in recent years — but expect the next frontier in wearable technologies to be in the workplace. The implications for worker safety and productivity are promising. While Google first introduced its revolutionary Glass to consumers, the current marketing direction is aimed at custom work applications.
One example of this is Patrick Jackson, a firefighter in North Carolina’s Rocky Mountain fire department: This Firefighter Built His Own Google Glass App And It’s Saving Lives.
Jackson is also a member of the Google Glass Explorer program and has developed an app that displays incoming emergency dispatches, shows maps of where incidents are, nearest fire hydrants, and even building plans. You can see a brief demo of Glass at work in the short clip, below. In addition, “Jackson is also working on a CPR assist app for Glass, measuring the speed of compressions, and whether you need to speed up or slow down based on sensors that detect head movement. He’s teaming with a Michigan startup called team (evermed) during his days off from the department, where he spends 10 days per month working grueling 24-hour shifts.”

The article also suggest another work safety application in DriveSafe, a Google Glass app that uses infrared sensors to detect when you doze off and to issue alarms to wake you and direct you to the next rest area.
PC World takes a look at other potential workplace applications for smartglasses , noting that, “The future of smartglasses will be realized by a factory worker operating a 3000-pound stamp press, not a gamer stomping on virtual-reality bad guys. Face computers will be all about scanning bar codes on cardboard boxes, not scanning tourist attractions for augmented reality overlays.” They present a variety of work scenarios, from hands free scanning and troubleshooting to safety applications.
FierceCIO explores the topic further in Making wearables a good fit for workplace safety. They discuss potential safety applications and suggest that gaining optimal value from wearable devices will require IT departments to innovate with software applications, data management and administrative protocols and policies.
We’re really just at the threshold of wearables in the workplace. To see more of the opportunities, this excellent Deloitte University Press primer by Shehryar Khan and Evangeline Marzec on Wearables is helpful in exploring the potential of everything from productivity, training and worker safety:

“Wearables’ value comes from introducing technology into previously prohibitive environments–where safety, logistics, or even etiquette have constrained traditional technology solutions. Wearables can be the first seamless way to enable workers with digital information–especially where hands-free utility offers a clear advantage. For example, using wearables, workers in harsh environmental conditions can access data without removing gloves or create records without having to commit data to memory and then moving to a sheltered workstation.”

Wearables are not without their HR and IT challenges. Susan Kuchinskas explores some of these issues in Forbes: How To Prepare Your Business For Wearable Technology. Also see:The Wearable Technology Revolution: Is your workplace prepared?

Bi-weekly Risk Roundup

Thursday, April 3rd, 2014

Nancy Germond hosts a new edition of Cavalcade of Risk #205 at her blog. Check it out. You can also follow Nancy at Twitter: @insurancewriter