Although suing physicians and pharmacists over the opioid crisis is nothing new, up until now pharmacy benefit managers (PBMs) have been off the radar screen. But in February, a south Texas county included the three largest PBMs—CVS, Express Scripts, and OptumRx as well as some smaller ones operating in Texas—in a nationwide lawsuit focusing on the opioid epidemic because of their role in allowing access to prescription opioids.
PBMs set the rules that determine drug availability and how much patients have to pay out of pocket to get them. So why haven’t they been targeted until now?
Harry Nelson, managing partner, Nelson Hardiman, LLP, a healthcare law firm, says physicians have been targeted based on their role as prescribers and as frontline decision makers with the capability to avoid opioid overprescribing, dependency, and resulting harm. Similarly, pharmacists have been sued because of their roles as dispensers and their capacity to serve as the last safeguard before patients end up at risk from overprescribing.
“While PBMs play a critical role in drug’s pricing and availability, they are not expected to question physician’s therapeutic choices,” Nelson says. “They don’t have the same professional obligations that pharmacists do to avoid suboptimal dispensing choices. As unlicensed entities, they don’t hold individual licenses, as physicians and pharmacists do, so they are not held to the same standard. Their roles and responsibilities are less well-defined, so there is less basis to hold them responsible.”
Nonetheless, PBMs actually have a lot of power, says Christopher J. Metzler, PhD, JD, CEO, Gordium Healthcare, a multidisciplinary behavioral healthcare organization. They are the middlemen who operate between the doctor, patient, and pharmacy. They provide insurance contracts with pharmacies and can deny a claim’s payment. They have the most to gain from a prescription’s cost.
Given the number of governmental entities now bringing lawsuits, and the limited number of manufacturer and distributor targets, Lawrence Ingram, a partner in the law firm Freeborn & Peters' Litigation Practice Group, and a member of its Insurance and Reinsurance Industry Team, foresees every entity in the distribution chain eventually getting caught up in this type of litigation.
Similar lawsuits likely
In the Texas case, The Webb County lawsuit alleged that PBMs drove the opioid epidemic as a result of increasing profits from the drugs.
Nelson says since it doesn’t cost much to name a PBM as an additional party in litigation, he expects PBMs to increasingly be named in opioid-related lawsuits. “While it takes some creativity to do something new (like looking at PBMs) as a responsible party, my hunch is that other lawyers are likely to learn from this and will be interested in a potential additional source of settlement funds,” he says.
Metzler also expects more PBMs to be sued. “Lawyers who present a well-written and brutal set of discovery questions, review the prescription paper trail, and talk to pharmacies and patients will find a treasure trove of evidence to present to a jury,” he says.
So on what grounds could PBMs be sued? Nelson says PBMs may not hold licenses that impose obligations, but their contractual commitments as intermediaries between health plans and pharmacies provide a potential argument that they also owe responsibility to patients, who are arguably third-party beneficiaries of those contracts. In other words, health plans are contracting with PBMs for the benefit of patients, so PBMs have the responsibility to protect patients from harm. There may also be an argument that PBMs are in a better position than individual pharmacies because of their data access to red flag problematic prescribing practices.
Ingram says allegations would likely be that the PBMs somehow allowed a greater amount of these drug products to be permitted in communities than could be supported by legitimate medical needs.
As a novel legal theory, lawyers will have to explain in detail to the courts what PBMs are and how they operate. “Unless lawyers are able to do so and prove causation, this will be a very difficult road to travel,” Metzler says. “As in most novel legal theories, this is a test, the outcome of which is uncertain. It is up to lawyers to educate, persuade, and prove causation.”
In the future, Nelson says PBMs may put additional safeguards in place to scrutinize troubling practices that surface through data, such as potential indicia of excessive prescribing. For patients, getting access to opioids is likely to get even tougher, with another hurdle in the form of PBMs. This may also make opioids more expensive, as PBMs begin to factor in the additional costs and risks associated with opioid prescribing.
Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.