Ebola’s Impact on the Health Care Industry
Now that a second nurse at Texas Presbyterian Hospital in Dallas has been infected with the Ebola virus, the risk to U.S. health care workers has been thrown into the limelight.
“Health care workers are at more risk than any other worker,” said Ron Leopold, M.D., health outcomes practice leader for Willis North America. “But I think there is an overwhelming tendency for all of us and the national media to overblow the risk.”
The virus is highly contagious, but only through direct contact with an infected person. “That’s a very small number of health care workers in this country,” he said. “Being alerted to what’s going on but not alarmed is critical.”
“Being alerted to what’s going on but not alarmed is critical.” — Dr. Ron Leopold, health outcomes practice leader, Willis North America
However, as more doctors, nurses and other clinical staff are exposed to the virus, the potential spread of Ebola on U.S. soil could pose a considerable workers’ comp risk for the health care industry.
“What if doctors treating patients in the U.S. are exposed? For every doctor, you have multiple staff working beneath them. That could have a quick and dramatic effect on personnel at the hospital and the financial consequence would be large,” said Pete Reilly, health care practice leader at retail broker William Gallagher Associates.
In the case of nurses Nina Pham and Amber Joy Vinson, who both cared for Liberian Ebola patient Thomas Duncan at Texas Health Presbyterian Hospital in Dallas and subsequently contracted the disease, illness clearly arose out of the course and scope of employment.
Arguments could be made that breaches in safety protocol led to their exposure, placing fault on the nurses and precluding coverage. But given the CDC’s admission of mishandling its approach to Ebola safety training and not offering enough assistance to the hospital, that rationale may not stand up.
At a hearing of the House Subcommittee on Oversight and Investigations, CDC director Thomas Frieden even said, “While we do not yet know exactly how these transmissions occurred, they demonstrate the need to strengthen the procedures for infection-control protocols which allowed for exposure to the virus.”
Several of the nurses’ co-workers also said that they followed CDC guidelines and wore full hazmat gear while caring for Duncan.
“There are details about every case that would come to bear, but it all depends on the carrier, the policy and other things we can’t address until a scenario is presented,” said Eric Justin, M.D., chief medical officer at Lockton Cos.
Workers’ comp carrier and large health systems, which are typically self-insured, simply don’t have enough information to determine coverage at this point.
It’s tough to understand what all the risks are at this point.”– Dr. Eric Justin, chief medical officer, Lockton Cos.
“It’s a small numbers problem. It’s tough to understand what all the risks are at this point,” Justin said.
Even if few health care workers become infected, the impact on workers’ comp could be significant for any individual hospital because of the high costs associated with caring for a patient in isolation.
“You may not have to close or quarantine your emergency room, but certainly you’ve had to quadruple your order for some type of vaccine or other medications,” Reilly said. Additional expenses may be incurred for hazmat suits, the proper disposal of those suits, additional steps needed for disinfection of hospital rooms and equipment, and even public relations messaging that may be necessary to reassure the public that a facility is safe.
“Normal business services may be 50 percent more expense in this type of situation because you have to go through additional steps to comply with CDC protocol,” Reilly said.
It’s up to hospital risk managers to plan for the admission of Ebola patient, however unlikely, to ensure staff is up to date on safety protocols.
The transmission of the disease on U.S. soil has sparked renewed vigor from the CDC, including clearer and more rigorous guidelines for the proper wear and removal of protective gear, and a plan to send larger, more experienced teams of experts to any hospital caring for an Ebola patient.
Initially, the CDC indicated that any hospital in the U.S. should have the essentials to treat Ebola on their own. The experiences of Emory Hospital in Atlanta and then Texas Presbyterian prove that assumption to be naïve and unsafe.
“In a very short time, mostly due to the situation in Dallas, we’re learning [about the virus] rather rapidly, and one sign of that learning is that the CDC announced that they will start to be much more assertive about providing not just teams to go wherever an Ebola case is confirmed, but larger teams that are experienced not just with working with Ebola but also training others to work with the isolation gear and decontamination procedures,” Justin said.
Most doctors and nurses are aware of the guidelines issued by the CDC and OSHA regarding protective gear, but many have likely not practiced them since early days of job training.
“Even people with experience are finding, ‘This isn’t so easy,’” Justin said. “They’re becoming aware of the need to actually practice them.”
Current CDC protocol also calls for any worker to be observed while removing protective gowns, masks and gloves to ensure that everything is done correctly.
Justin called this “buddy system approach” a necessary methodological step, which allows observers to both step in in a critical moment to correct a problem, and also record information to suggest process changes in the future.
The CDC has also backtracked on earlier assertions that any hospital can handle an isolation patient.
Future cases will most likely end up in one of the four larger, specialized centers that house their own biocontainment units, including Nebraska Medical Center in Omaha, the National Institutes of Health in Bethseda, Md., and St. Patrick Hospital in Missoula, Mont., along with Emory Hospital.
Health care risk managers should make sure to keep third party service providers informed about Ebola response plans and safety procedures.
The experience at Emory, the first U.S hospital to receive an Ebola patient, revealed shortcomings in the U.S.’s plan to manage the virus.
Several third-party vendors working with the hospital balked at the idea of dealing with any potentially infected materials.
Their waste removal company, for example, refused to haul away the high volume of waste generated by someone afflicted by the disease. A transport company would not take blood samples a few blocks away to be tested.
“People on the waste management side are a step or two removed from the clinical setting, so I can see why they’d be concerned,” Justin said. “The best thing to do to allay those anxieties is to have discussions between infection control and those companies, and also let them know of the procedures available.”
Having these third-party vendors on board not only help care for an infectious patient run more smoothly, but also mitigates the risk of a contracted worker making claims of negligence against a hospital.
“As part of your disaster recovery plan, you should be checking with those vendors and making sure they are going to respond,” said Deana Allen, SVP at Willis North America’s national health care practice. “These are the critical services we’ll need.”
Zohydro Draws Ire of Docs, WC Payers
On Sept. 28, 2,000 members and supporters of the Fed Up! Coalition marched on Washington, D.C. in the hope of getting the federal government to pay more attention to the opioid epidemic currently thriving in the U.S.
The Fed Up! Coalition is an umbrella group of medical professionals, addiction treatment experts and consumer groups who oppose the FDA’s actions when it comes to releasing and marketing opioid painkillers.
“Between 1999 and 2011, 175,000 Americans have died of opioid overdoses. That’s 145,000 from painkillers, and 30,000 from heroin,” said Andrew Kolodny, M.D., president of the advocacy group Physicians for Responsible Opioid Prescribing. “And we haven’t heard one word from the president. He’s not seeing that his agencies are working in a coordinated fashion to make the crisis worse. He’s even cut spending on addiction treatment.”
The latest installment in the conflict is the FDA’s approval of Zohydro ER in October of last year. The extended release drug that contains at least double the amount of hydrocodone found in Vicodin was approved despite an 11-2 vote by the FDA advisory committee to keep it off the market. It also lacks abuse deterrent features such as an anti-crushing design.
It will take several years to determine what kind of impact a powerful painkiller like Zohydro will have on workers’ compensation care, but the reaction to the FDA’s apparently lenient approval process demonstrated increased awareness of opioid addiction in the U.S. and renewed efforts to stem the flow in new drugs into the market.
“Had the FDA been doing its job in the late ’90s, we wouldn’t have this epidemic.”— Dr. Andrew Kolodny, president, Physicians for Responsible Opioid Prescribing
“Approval of Zohydro was just one very bad decision in a long line of bad decisions by the FDA all clearly putting the interest of industry ahead of public health,” Kolodny said.
That long line of bad decisions began, according to Kolodny, with the approval of Oxycontin in 1995 and decision by its manufacturer, Purdue Pharma, to market the drug as a treatment for common chronic conditions like low back pain. Such highly addictive drugs should only be indicated for end of life care as a comfort measure, or for short periods of severe acute pain, he said.
“I don’t think any of these types of opioids have a particular purpose for anyone other than the very end stages of life, for comfort measures only. And even then, I don’t think this should be released without abuse deterrent technology,” said Sherri Hickey, director of medical management for Safety National. “When you increase the dosage, there comes a point when the drug no longer relieves pain and will actually cause pain. We’ll see an increase in this condition – hyper-algesia – when Zohydro hits the market here.”
“Had the FDA been doing its job in the late ‘90s, we wouldn’t have this epidemic,” Kolodny said. “Even had they started to do their job in early 2000s, if they had narrowed the indication on the label, so drug companies couldn’t market them for chronic pain, the epidemic never would have gotten as bad. Not only didn’t they do that, they changed the rules to make it easier for drug companies to get new opioids on the market. They opened the spigot. The FDA also spent 10 years blocking up-scheduling of hydrocodone combination products.”
Kolodny and Hickey both say Zohydro’s impact on the market has so far been minimal, possibly due to the bad press surrounding it. Hickey said Safety National has only one patient out of the thousands in its system taking the painkiller.
The FDA defended their position in an article published in the Journal of The American Medical Association, stating that criticisms of Zohydro really applied to extended-release opioids as a whole and would require broader policy changes to address. It said, for example, that abuse-deterrent features have not been validated by enough solid evidence to justify including such technology in the manufacture of Zohydro.
It made the determination that “Zohydro ER met the current safety and efficacy standard for approval,” and cited other efforts it had made “improve the safe use of the class,” including working toward “better and more comprehensive abuse-deterrent formulations available across the class of opioids” and tightening safety labeling to “clarify the intended patient population.”
It also claimed that fears surrounding Zohydro are overblown, citing the low levels at which it has been prescribed. In July 2014, the article said, Zohydro “represented 0.23 percent of the 1.6 million ER/LA opioid analgesic prescriptions and .02 percent of the nearly 18 million prescriptions dispensed for all opioid analgesics during the month.” The FDA encouraged critics to broaden their focus to “the more than 100 other opioid products on the market – the known drugs that have caused serious public health consequences for more than a decade.”
As of April, two states – Vermont and Massachusetts – issued rules specific to Zohydro, requiring physicians to consult state prescription drug monitoring programs, screen patients for abuse risk and document medical need before turning to the drug. If such practices can indeed spread to other high strength opioids, the FDA may get the message that healthcare providers and workers’ comp payers are indeed fed up.
Court Decision Renders Side Agreements Unenforceable
California employers scored a victory on Sept. 23 with a decision by a New York Appellate Court finding side agreements attached to workers’ comp policies unenforceable unless properly filed on time with the state’s Department of Insurance and Workers’ Compensation Insurance Rating Bureau (WCIRB).
California law states that mandatory workers’ comp policies must be submitted to the Department of Insurance. In 2011, the Department banned side agreements sent to insureds well after their policies had taken effect that were not properly filed with the insurance commissioner. Side agreements were deemed enforceable only when filed along with the policy at the time of issue.
“[Employers] had already hired the people and paid the premium and spent a large sum to start the workers’ comp program,” said Nick Roxborough, co-managing partner of Los Angeles-based Roxborough, Pomerance, Nye & Adreani, which specializes in representing employers in workers’ compensation premium disputes. By the time employers received side agreements attached to their policies, “very few people read them, and even if you did there was nothing you could do about them.”
In the case of Monarch Consulting Inc. v. National Union Fire Insurance Co. (a subsidiary of AIG), the court denied the insurer’s petition to compel settlement of disputes through arbitration in its home state of New York, which it sought based on a side agreement clause. Given the insured’s location in California, the mandate presented a significant logistical and financial hardship.
Appellate court Judge Karla Moskowitz wrote in her opinion, “in light of the strong policy under California law… the side agreements, along with arbitration clauses contained in them, are not enforceable because the insurer failed to file them with the WCIRB and the California Department of Insurance. Thus the petitions to compel arbitration are dismissed and the cross petitions to stay arbitration are granted.”
Carriers have mandated arbitration as a method to control disputes over mishandled claims, forcing policyholders to travel to them to present their argument to a panel appointed by the carriers. Arbitration cases are also confidential and non-discoverable, making the process akin to a “secret society,” Roxborough said. Prior to this decision, the mandates also allowed carriers to apply their own state’s laws and regulations to the cases.
“You must not think your agreement is very fair if you don’t want the [insurance] commissioner to know what you’re charging.”— Nick Roxborough, co-managing partner, Roxborough, Pomerance,
Nye & Adreani
“New York doesn’t want California courts interpreting New York workers’ comp policies. No state wants some other state applying different laws to their policies,” he said.
According to Roxborough, side agreements by insurers arose in part to circumnavigate a decision in a 1999 California court of appeals case that found the State Compensation Insurance Fund (SCIF) guilty of “dishonest, deceptive, oppressive, fraudulent, unfair, and destructive conduct” by denying requests to review claims files.
The published court opinion bound carriers to keep a “covenant of good faith and fair dealing” with their policyholders. Side agreements, including arbitration clauses, allowed them to introduce terms and conditions favorable to them with little or no resistance.
In addition to mandatory arbitration clauses, side agreements also typically contain conditions for medical bill review, which Roxborough called “huge profit centers for insurance companies.” In many cases, medical bill review only reduces bills down to the level of the state physician fee schedule, which doesn’t generate significant savings for insureds. They can also add on extra fees for nurse case managers and other extra services.
The New York appellate court decision would render these components unenforceable as well.
“AIG is forced to appeal because this affects hundreds of thousands of side agreement deductible policies that they’ve written,” Roxborough said. “There are carriers who have sued based on these agreements. If as a matter of law the agreement is unenforceable, the lawsuits go away.”
“If you think your contract is fair, file it with the government,” he said. “That’s what the law requires. You must not think your agreement is very fair if you don’t want the commissioner to know what you’re charging. There’s a reason they don’t want to file.”