3D Printing Offers New Risk Challenges
As commercial 3D printing advances from occasional to routine use, the product liability landscape will shift around it. Defective and counterfeit product exposures, among others, will arise for all participants along the manufacturing continuum, industry experts said.
In an adverse incident, said Rob Gaus, product risk leader, Marsh, liability will be apportioned among participants in the manufacturing and distribution stream: product manufacturer, printer manufacturer, software designer, feedstock supplier, distributor (especially if it modifies the product) and retailer (if the manufacturer is not well capitalized). No case law exists yet.
In 3D printing, a computer sends the software containing a product design to one or more printers, which builds the product, layer by layer, from many kinds of materials — plastics, metals, drugs, paints and even human tissue.
David Carlson, U.S. manufacturing and automotive practice leader, Marsh, said 3D-printed products are treated the same as any other new operation that poses new risks.
Underwriters and brokers must first assess the company’s risk management profile and risk appetite. When production, research and development teams look at technology, “they should loop in risk management. Risk management should be part of the continuum, or the company could get into sticky situations.”
The emerging risks include unregulated manufacturing, said Mark Schonfeld, a partner at Burns & Levinson LLP in Boston specializing in business and intellectual property law.
If 3D printing enables production of, say, just 100 hip implants or 100 hearing aids, such work will generally take place outside of a traditional mass-production factory, which is subject to government regulation and inspection.
“Insurance companies like FDA oversight of manufacturing because it makes products safer and helps identify responsibility when things go wrong,” Schonfeld said.
To protect themselves and their clients, Schonfeld advises insurers to keep abreast of technological developments, consult with a creative and knowledgeable attorney about how to address liability exposure, and adjust existing policies to be fair to consumers and prevent injury to the insurance company.
3D printing also raises the risk of counterfeit products, said Peter Dion, line of business director-product liability, Zurich Insurance. The digital “recipe” in the software design, and is vulnerable to capture, he said.
Although there is no encryption mechanism for the software, one solution might be to transfer the digital file in pieces only as they are needed by the printer to prevent capture of the entire design signature, Dion said.
Manufacturers have always struggled with counterfeit products, but 3D printing magnifies the risks because it can slash the time from product development to market-ready product to a matter of hours and requires no molds or prototypes. “Hackers can take the proprietary blueprint or software, send it to a third-world country, and have the product ready for market tomorrow,” said Carlson. “That’s a business disruption issue. Counterfeiters can put a company out of business.”
Drug manufacturers may subvert counterfeiters by adding tracer elements and watermarks to their formulations, which protects their reputations, profits and public health. “If the counterfeiters get the recipe wrong, they might not produce high-quality drugs for public consumption,” Carlson said.
Other manufacturers can also use watermarks and digital rights management (DRM) software to prevent file sharing. Still, Carlson said, counterfeiting is an old problem. “Bad guys have always exploited new technologies for their personal gain.”
The materials used by manufacturers present a greater potential loss exposure than the 3D printer itself, said Dion, noting that it is just another piece of equipment, like a pencil or a lathe.
For example, if a 3D printer is used to replicate a cupcake, the manufacturer should be as careful of contaminants in the mix as traditional bakers need to be. “When 3D printer manufacturers purchase materials from suppliers, they need to perform due diligence on their supplier’s products also.”
Cyber Challenges Still Evolving
Some chief information security officers fail to see the value of standalone cyber-risk coverage, while some brokers give the impression that traditional policies cover many of the same risks.
These factors have contributed to surprisingly low recent take-up on standalone cyber coverage, according to Charles Cowan, counsel to law firm Drinker Biddle & Reath’s insurance transactional and regulatory team.
Cowan and Andrea Best, a partner with Drinker Biddle, addressed four emerging areas of cyber-related risk on May 19 in the Old Lloyd’s Library, built in 1928 and now in the basement at Lime Street. That very day, Lloyd’s announced its move into cyber coverage in Poland.
In the heavily wood-paneled atmosphere of the past, the speakers addressed four potential horsemen of the digital apocalypse.
Cyber-risk itself, drones, autonomous vehicles, and ride/car share all fall under the cyber umbrella and share a primary reliance on data that is largely not yet available, given the newness of the risks. The lack of data means that none of these risks is yet properly understood.
“First and foremost in cyber risk,” said Cowan, “is the need for data. Not a lot of reliable data exists about incidents and where future potential attacks might be, or of what size.”
Cowan added that little litigation has yet taken place to clarify the validity of exclusions. The wording of the standard war exclusion “requires a hostile act by a foreign Government,” he said, “without naming names.” The Sony hack, reportedly by the Government of North Korea, came to mind.
Following another hack that exposed some 80 million customer and employee records at Anthem Health Insurance, the company notified and conducted its correspondence with its customers on paper, Cowan said. (Target experienced further opportunist email hacking after advising its customers by email that the personal data of up to 70 million customers, including credit card numbers, had been stolen in late 2013.)
“For larger breaches, costs can be astronomical,” Cowan said, citing a three-year-old U.S. report that valued the average stolen record at about $180. Cowan, who had left Lloyd’s three weeks earlier, is now working with the Department of Homeland Security on garnering more timely information.
About 80 percent of commercial unmanned aerial systems, or drones, are used in agriculture. The U.S. economy might expect to earn $82 billion from the use and knock-on effects of drones by 2025, and the FAA is due to issue a set of standards in this as-yet largely unregulated area.
Liability issues abound: criminal activity, matters of privacy and trespass, nuisance and general danger, air traffic problems, misdirected payloads, and of course hacking. “Any system is hackable,” Cowan said.
The Institute of Electrical and Electronics Engineers forecasts that as many as 75 percent of all vehicles, some with removable steering wheels, are expected to be autonomous by 2030, Best said. Legislation in the U.S. is being enacted at the state level (five states plus Washington, D.C.), or has failed (12 states), or is not being considered at all.
Autonomous vehicles will require sensors for vehicle-to-vehicle communication, “but we’ll also have to have sensors on buildings, bridges, traffic lights and other objects we’ll have to navigate around,” Best said.
“The ultimate question, if this technology really takes off, and is so safe, is how much of an automobile insurance coverage market will there be left?” — Andrea Best, partner, Drinker Biddle & Reath
It is not yet clear who will need coverage. Manufacturers of the vehicles? Of component parts? Of the sensors? One known unknown is whether driver premiums for autonomous vehicles will fall, due to the lowered risk, or increase for traditional hands-on drivers.
“The ultimate question, if this technology really takes off, and is so safe, is how much of an automobile insurance coverage market will there be left?” Best asked.
Coverage challenges include the reliability and vulnerability of the technology, the adaptability of the driving public, and the hackability of the autonomous systems.
“These are probably just interim challenges,” Best said. “Given the level of investment, and how much of a push there is for (autonomous vehicles), these issues will fall away.”
The former will be familiar from transportation network companies such as Uber, which arrange one-time shared rides on short notice, and others that arrange transportation for a fee using online technology platforms.
The latter includes peer-to-peer car rentals organized by program administrators (such as RelayRides and Getaround) for short periods of time.
“Both services present new insurance coverage challenges,” Best said.
Ride-sharing is typically excluded from personal auto policies, creating coverage gaps. NAIC has issued a white paper to help state insurance regulators, and legislation is pending in more than 35 states. Similar coverage gaps exist in the car-sharing realm.
As if these four risks were not enough to digest, on the subject of emerging risks, in Best’s words, “we could have covered any number of topics and be here for hours.”
Mitigating Fraud, Waste, and Abuse of Opioid Medications
There’s a fine line between instances of fraud, waste, and abuse. One of the key differences is intent and knowledge. Fraud is knowingly and willfully defrauding a health care benefit program for personal gain or profit. Each of the parties to a claim has opportunity and motive to commit fraud. For example, an injured worker might fill a prescription for pain medication only to sell it to a third party for profit. A prescriber might knowingly write prescriptions for certain pain medications in order to receive a “kickback” by the manufacturer.
Waste is overuse of services and misuse of resources resulting in unnecessary costs, whereas abuse is practices that are inconsistent with professional standards of care, leading to avoidable costs. In both situations, the wrongdoer may not realize the effects of their actions. Examples of waste include under-utilization of generics, either because of an injured worker’s request for brand name medication, or the prescriber writing for such. Examples of abusive behavior are an injured worker requesting refills too soon, and a prescriber billing for services that were not medically necessary.
Actions that Interfere with Opioid Management
Early intervention of potential fraud, waste, and abuse situations is the best way to mitigate its effects. By considering the total pharmacotherapy program of an injured worker, prescribing behaviors of physicians, and pharmacy dispensing patterns, opportunities to intervene, control, and correct behaviors that are counterproductive to treatment and increase costs become possible. Certain behaviors in each community are indicative of potential fraud, waste, and abuse situations. Through their identification, early intervention can begin.
- Prescriber/Pharmacy Shopping – By going to different prescribers or pharmacies, an injured worker can acquire multiple prescriptions for opioids. They may be able to obtain “legitimate” prescriptions, as well as find those physicians who aren’t so diligent in their prescribing practices.
- Utilizing Pill Mills – Pain clinics or pill mills are typically cash-only facilities that bypass physical exams, medical records, and x-rays and prescribe pain medications to anyone—no questions asked.
- Beating the Urine Test – Injured workers can beat the urine drug test by using any of the multiple commercial products available in an attempt to mask results, or declaring religious/moral grounds as a refusal for taking the test. They may also take certain products known to deliver a false positive in order to show compliance. For example, using the over-the-counter Vicks® inhaler will show positive for amphetamines in an in-office test.
- Renting Pills – When prescribers demand an injured worker submit to pill counts (random or not), he or she must bring in their prescription bottles. Rent-a-pill operations allow an injured worker to pay a fee to rent the pills needed for this upcoming office visit.
- Forging or Altering Prescriptions –Today’s technology makes it easy to create and edit prescription pads. The phone number of the prescriber can be easily replaced with that of a friend for verification purposes. Injured workers can also take sheets from a prescription pad while at the physician’s office.
- Over-Prescribing of Controlled Substances – By prescribing high amounts and dosages of opioids, a physician quickly becomes a go-to physician for injured workers seeking opioids.
- Physician dispensing and compounded medication – By dispensing opioids from their office, a physician may benefit from the revenue generated by these medications, and may be prone to prescribe more of these medications for that reason. Additionally, a physician who prescribes compounded medications before a commercially available product is tried may have a financial relationship with a compounding pharmacy.
- Historical Non-Compliance – Physicians who have exhibited potentially high-risk behavior in the past (e.g., sanctions, outlier prescribing patterns compared to their peers, reluctance or refusal to engage in peer-to-peer outreach) are likely to continue aberrant behavior.
- Unnecessary Brand Utilization – Writing prescriptions for brand medication when a generic is available may be an indicator of potential fraud, waste, or abuse.
- Unnecessary Diagnostic Procedures or Surgeries – A physician may require or recommend tests or procedures that are not typical or necessary for the treatment of the injury, which can be wasteful.
- Billing for Services Not Provided – Since the injured worker is not financially responsible for his or her treatment, a physician may mistakenly, or knowingly, bill a payer for services not provided.
- Compounded Medications – Compounded medications are often very costly, more so than other treatments. A pharmacy that dispenses compounded medications may have a financial arrangement with a prescriber.
- Historical Non-Compliance – Like physicians, pharmacies with a history of non-compliance raise a red flag. In states with Prescription Drug Monitoring Programs (PDMPs), pharmacies who fail to consult this database prior to dispensing may be turning a blind eye to injured workers filling multiple prescriptions from multiple physicians.
- Excessive Dispensing of Controlled Substances – Dispensing of a high number of controlled substances could be a sign of aberrant behavior, either on behalf of the pharmacy itself or that injured workers have found this pharmacy to be lenient in its processes.
Clinical Tools for Opioid Management
Once identified, acting on the potential situations of fraud, waste, and abuse should leverage all key stakeholders. Intervention approaches include notifying claims professionals, sending letters to prescribing physicians, performing urine drug testing, reviewing full medical records with peer-to-peer outreach, and referring to payer special investigative unit (SIU) resources. A program that integrates clinical strategies to identify aberrant behavior, alert stakeholders of potential issues, act through intervention, and monitor progress with the injured worker, prescriber, and pharmacy communities can prevent and resolve fraud, waste, and abuse situations.
Proactive Opioid Management Mitigates Fraud, Waste, and Abuse
Opioids can be used safely when properly monitored and controlled. By taking proactive measures to reduce fraud, waste, and abuse of opioids, payers improve injured worker safety and obtain more control over medication expenses. A Pharmacy Benefit Manager (PBM) can offer payers an effective opioid utilization strategy to identify, alert, intervene upon, and monitor potential aberrant behavior, providing a path to brighter outcomes for all.