Anne Paxton
September 2019—Laboratory pharmacists are a rare breed. When Monique Dodd, PharmD, PhC, MLS(ASCP), spoke at the Executive War College this year, she joked that a third of the laboratory pharmacists in the country might be in the audience. “Within my family, if I mention that I’m a pharmacist who works in the lab, usually that is where the discussion ends because I get a very confused look,” she said. But because collaboration between the laboratory and pharmacy is, in a way, a “prescription for disruption”—and that’s a good thing—it should be more widely employed, in Dr. Dodd’s view. Laboratory-pharmacy collaboration, she said, can be helpful to labs that want to use their data to control and treat high-cost, high-risk health conditions like opioid use disorder.
Dr. Dodd is the manager of enterprise clinical solutions at TriCore Reference Laboratories in Albuquerque, where she works with the diagnostic optimization team to design targeted interventions driven by the data the laboratory produces. In her talk, she described how TriCore laboratory data for people with opioid use disorder are helping to improve screening, identification, and management of this population. It’s a process that involves moving beyond the limits of traditional “Laboratory 1.0” systems thinking (focusing on laboratory testing and utilization and efficient and accurate results) to “Laboratory 2.0” (focusing on measured outcomes and demonstrating the laboratory’s value clinically and financially).
“Laboratory 1.0 is our foundation, our core; it’s what we do best,” she said. But Laboratory 2.0 allows the lab to think in terms of a broader mission: providing clinical insights to support population health management.
The Centers for Medicare and Medicaid Services is using PAMA to squeeze a $4.1 billion savings from laboratory reimbursement over five years (2018–2022), Dr. Dodd noted, and it’s reasonable to ask why the laboratory is in the CMS’ crosshairs. But she encouraged the audience to also think a little differently about the opportunity to save: “Perhaps PAMA is a good pressure because it’s forcing us to change our thought processes.” And it’s useful to ask how much impact laboratories themselves can have on cost saving. “That, I think, is up to us at this point,” Dr. Dodd said.
“We are at a strategic inflection point due to PAMA. As a laboratory, we have some decisions to make. We can either sell, we can partner, or we can do the best we can; we can try to maintain.” The third route is the one TriCore chose, and for a laboratory it means: “How can we find new ways to invigorate our business strategy by redetermining what our value is?” Dr. Dodd believes the answer hinges on how laboratories can use data to develop a new business strategy—one that might “bend the cost curve of health care or the cost curve within a particular hospital or clinic.”
TriCore has tried to change its perspective to see what it shares with pharmacy. “We are both fee for service. For the pharmacy, it’s script in/prescription out, just as in the laboratory we have the order in and results out. In the lab we are trying to focus on what we can improve—the preanalytical and postanalytical phases.” On the postanalytical end, with laboratories having to move from volume to value, Dr. Dodd said, they need to ask what their customers, whether physicians or health systems, truly need. “What is valuable to them?”
The laboratory is in a position to provide that value, she said, by leveraging laboratory data to produce population surveillance insights. “Whether you are a small clinic or a big laboratory, you have data on the patients within your community. So start to look at what patterns you are seeing, what risks you can identify with some of these patients.” In this way, laboratories can have an impact on total costs of care. “Or at least that is something we would like to show in our outcomes,” she added.
One of the risks in health care is that patients are not getting the lab tests they need. “We have care guidelines out there, most of the time laboratory based. But how often are these patients getting the labs they need? We can begin looking at that.” For example, “With ICD-10 diagnosis codes, we know that a particular patient has diabetes. Can I see that they have their HbA1c and microalbumin testing alongside the other data?”
Many labs feel they are stuck at Laboratory 1.0, but they can make progress if they advance part way, Dr. Dodd said. “To eventually get to Laboratory 2.0, we can move to Laboratory 1.5” as an interim step. “It’s somewhere in the middle where we ask our customers what they consider valuable and we are measuring the outcomes of our interventions. We have all of this data that we can begin to create different patterns with, different scenarios with. But what would help our customers in their day-to-day job? That is the question we are trying to answer in Laboratory 2.0.”
Pharmacists have been providing answers to this question in the clinic and hospital settings for several years, Dr. Dodd said. She quoted a California physician’s description of how the provision of pharmacy data can aid physician practice. This physician said: “Overall, if by the time I saw a patient they had been prescreened or processed, and behind the scenes somebody in pharmacy had run the CURES report [California’s Controlled Substance Utilization Review and Evaluation System] and had arranged for the interval of tox screens . . . [and] were aware of any escalations in terms of early refill, if that information was available, and I didn’t have to worry about it, that’d be helpful.” In their efforts to use their data to help their customers, labs can draw on what pharmacists do now as a model, Dr. Dodd said.
[dropcap]T[/dropcap]oday, the Centers for Disease Control and Prevention reports that much of the opioid dependence is caused by prescription drugs like oxycodone alone, not illegal drugs, and prescription drugs are often diverted. Can the lab help identify people whose drug use has taken this direction? “We don’t necessarily have information to identify the high-risk patients who are using illicit drugs unless they come in for testing,” Dr. Dodd said. But because 65 percent of opioid overdose deaths are related to prescription drugs, “perhaps we can start there.”
Based on CDC guidelines, these patients should be screened at least annually, and according to CMS guidelines, they should be screened two to four times yearly depending on risk stratification, Dr. Dodd pointed out. “If we are working with a managed care organization or payer group, we can say, ‘Can we help identify your high-risk patients, because we saw your patient come to the ED and it was coded as a potential overdose or opioid poisoning? This patient is now categorized as high risk. If we can give you this information, you can determine if the patient needs to be screened, or in some cases screened more often. Then we can put these patients in a category for you and you can have your care coordinators reach out to them.’”
TriCore’s current screening report covers everything that was detected with an immunoassay for a single patient. For one TriCore patient, for example, amphetamine was detected, as well as oxycodone and fentanyl. But the patient had been prescribed only oxycodone. “The physician called and said, ‘Wow, I don’t know where to go from here. I know that it’s reflexed to the confirmatory test, so I’m going to wait for those results in two or three days. But do you have any advice as to where I should go?’”
The laboratory declined to provide guidance until the confirmatory report, which found that the patient was taking a lot more than oxycodone. “The physician talked with the patient, who was honest and said they took heroin, it was laced with fentanyl, and they also took meth, but they also said, ‘I am taking my prescription so I’m compliant, right?’ This is an issue,” Dr. Dodd said. The physician has to explain that providers can consider the presence of illicit drugs or the absence of prescribed drugs in a patient to be a breach of contract by the patient.
But from the laboratory’s standpoint, “It’s great that we have this information—it’s valuable. The number one issue for physicians is, ‘How do I interpret results like this? If I have to call the lab every time to make sense of valuable information in front of me, that is a lot of time wasted—then there’s 15 minutes with the patient and I’m having to make phone calls not only with the lab but also the insurance company.’”
To rein in this waste of time at TriCore, the Laboratory 1.0 approach has been, instead of having 10-plus screening panels, to condense them into what are called hybrid pain management compliance panels to help the physician narrow down what their question is. Currently TriCore has a statewide initiative with physicians to move from these hybrid panels to more cost-efficient and clinically effective ones. “If it’s a new patient, then we have a new patient screening panel. The other panels are for chronic pain management and substance abuse.”
TriCore’s Laboratory 1.5 step in its evolution goes further, to an enhanced result report (Fig. 1). With this, the laboratory determines at order which valid prescriptions are presented for which opioids, then goes straight to confirmatory testing. “If my patient is taking oxycodone or another opioid, why screen for it? You already know what compound you’re looking for and expecting, so let’s go straight to the confirmatory. We’re just going to eliminate the immunoassay,” Dr. Dodd said. Other panels are set up to answer a few different questions: Is the patient in treatment? Is the treatment for opioid abuse? And do they have benzodiazepines on board as well?
Some laboratories have already moved to the enhanced interpretive report that TriCore has developed, Dr. Dodd said. “They paved the path and we’re in discussions with them. There are other labs that don’t have this report yet, and we are trying to pave a path for them.”
As TriCore implements its new panels, it is working with physicians to ask what information they need. “The physician is required to enter the prescription information up front, but will the physician do so? Maybe not. If they do and the hydrocodone they’ve prescribed is not detected, well, that’s additional information up front that we didn’t have before. And we can either say the results are consistent or inconsistent with what they’ve been prescribing. Then they can walk into the patient’s room and the next process can begin.”
This is an example of the laboratory using longitudinal data on its way to Laboratory 2.0, she said. “We have the results, the consistency or inconsistency, the ICD-10 information, the laboratory screening information to see if they’re getting screened every six months or every year, and we can begin to put a picture together for the payer or the physician group.”
As the largest clinical laboratory in New Mexico, TriCore has a strength: its wide footprint, Dr. Dodd pointed out. “The patients who usually come to us are from all across the state, so we can begin to put quite a few years of data behind each of these patients and we can offer this information to the clinicians. We can now identify our high-risk patients—whether they have had an ED visit in the past, whether they have been inconsistent—and then we can help the payer or the physicians help that patient get access to care.”
[dropcap]T[/dropcap]riCore’s Laboratory 2.0 effort, focusing the report on value and attributed outcomes, is still in development, Dr. Dodd said. “We are playing around with information to see what it might look like.” In the example she displayed for her audience at the Executive War College, an “Additional Drug Use” table based on the confirmatory testing (Fig. 2), the laboratory lists what the patient was prescribed down the left side, then across the top, the drugs for which the patient was found to be positive. “It shows, if they were prescribed oxycodone, how many times the patients were actually positive for morphine as well, or for benzodiazepines as well.”
“We’re a provider,” Dr. Dodd said. “If we have this information for 99.9 percent of our patients, we can expand that to say here is your list of patients who are high risk.” That is the low-hanging fruit, she said, and “For a lot of physicians, we don’t need to go beyond that.” But a pharmacist’s clinical perspective can be helpful if the laboratory wishes to pursue the data further, she noted. For the patient in Fig. 2, “We have prescription morphine. We go to heroin, which has 6-MAM as a major metabolite. Of these patients taking morphine, 16.5 percent were also positive for this heroin, but 6-MAM is not a prescribed drug. So if we were to develop an ‘illicit’ category, we would separate 6-MAM from the rest of the list. Not every heroin patient is also taking morphine, so this is where the IT and the pharmacist’s clinical expertise can come in handy in our discussions.”
The use of value-based analytical insights derived from clinical laboratory data can support risk stratification and identification of care gaps for opioid use disorder. Detecting a care gap is a major benefit of going through this process for patients treated with prescription opioids, Dr. Dodd said. “If a new patient is coming in and the physician orders a new patient screening, we can categorize that as a new patient for them. Then maybe every year after that, if that particular patient doesn’t come up in our annual drug testing, we’ll consider that there might be a care gap.”
Laboratories are positioned to provide a longitudinal history for patients who have multiple providers, and laboratories can identify high-risk patients in near real-time, Dr. Dodd said. Through a pharmacy-laboratory collaboration, clinical laboratories can enhance the value of their health data, providing insights into patients’ continuum of care and showing laboratories’ value beyond Laboratory 1.0.
“Big data is pretty intimidating. But it is a primary issue for laboratories,” she said, “and we all need to make sense of it.”
Anne Paxton is a writer and attorney in Seattle.