CEO SUMMARY: Arizona’s new direct access testing law allows consumers and patients to have access to all laboratory tests without a physicians’ order. But one lab company decided not to offer all lab tests to consumers. Instead, executives at Sonora Quest Laboratories recognize that, for some health conditions that are complex to diagnose, it is inappropriate to allow consumers to use these lab tests to screen themselves. For these types of tests, SQL encourages consumers and patients to speak to its pathologists or their physicians.
ACCOMMODATING ARIZONA’S NEW DIRECT ACCESS TEST (DAT) LAW that allows patients to get any test without a physician’s order required the staff at Sonora Quest Laboratories (SQL) to make some difficult decisions about whether to offer to patients and consumers all clinical laboratory tests that it runs.
Before the law went into effect on July 3, SQL decided to limit the number of tests it offers patients on a direct access basis—in the best interests of patient care.
It’s an interesting decision for a clinical lab. In a business built on test volume, Sonora Quest does not offer consumers and patients access to all laboratory tests, even though the new DAT law permits such consumer access.
Selecting which specific tests it would offer consumers through its DAT program was done in a reasoned and thoughtful way and was intended to be in patients’ best interests, stated Robert Stern, MD, Medical Director of Sonora Quest Laboratories. By restricting access to some tests, the lab was, in effect, saying that giving access to all laboratory tests without a doctor’s order would be a disservice to patients.
“Many laboratory tests are not appropriate as screening tests,” emphasized Stern. “For that reason, we chose to offer what we believe is a responsible panel of tests.
“That is why, based on our best medical judgment, our DAT test menu includes those lab tests that we consider appropriate for a large number of patients and consumers to use.“Before this law was passed, Arizona had a direct access testing law that allowed consumers to order any of about 50 lab tests identified in the statute,” he said. “At the time this new law was proposed, we responded to a request for input from the bill’s sponsor. Our suggestion was that the bill’s sponsor consider expanding the list to about 100 tests rather than opening up the list to any lab test for direct access.
“We feel strongly that not every test is suitable for every patient in every situation,” emphasized Stern. “For that reason, we chose to offer what we believe is a responsible panel of tests.
“Some tests are good general health screening tests that shouldn’t lead a consumer too far astray,” he said. “Other tests are recommended as screening tests for a large segment of the population and some are recommended for individuals with chronic medical conditions who want to take an active role in managing their condition.
“By giving consumers access to a curated list of tests, we can point them in the right direction,” he added. “Our hope is to keep them from getting into too much trouble were they to order several lab tests and then wind up with results that could be difficult to interpret and could cause much anxiety.
Stern explained the science used to select tests for SQL’s Its My Lab ReQuest DAT menu. “Anyone who does laboratory testing and understands specificity, sensitivity, and predictive values knows that, if enough tests are done on a patient, there is a high probability of one or more of those results falling outside the reference range, even when the patient is perfectly healthy,” he stated. “That’s the nature of testing.
“We know that false positives can be the consequence of how clinical labs construct test ranges,” he continued. “For most lab tests, the reference ranges capture 95% of normal, healthy individuals.
“That means if a panel of 20 tests is done on a single patient, there is a 65% chance that at least one of those test results will be outside the reference range, even if there’s nothing wrong with the patient,” noted Stern.
“This is why we decided it would be in the best interests of the average consumer not to offer all lab tests that exist through our direct access testing program,” he commented. “By helping patients and con- sumers select lab tests that are appropriate, it keeps the potential for misinterpretation to a minimum.”
Given that decision, is Sonora Quest Laboratories worried that other labs will have a competitive advantage by offering all tests for direct access?
“No, this approach is part of the value proposition we offer to patients,” noted Stern. “I’m happy to have these conversations with patients because this is something about which I feel strongly. Further, most physicians and most clinical laboratory professionals would probably agree with me on this point.
New Revenue Stream
“This is independent of the question that some labs ask about the new revenue streams that can result from DAT,” he continued. “And the answer is, yes, absolutely, there is the potential for additional revenue from a DAT program.
“But Sonora Quest Laboratories is willing to forego potential revenue to do what it considers a more responsible job of helping patients and consumers manage their health, rather than simply offering them a product that will not always be appropriate.”
Sonora Quest is the largest clinical laboratory company in Arizona, serving an average of 24,000 patients a day and running 57 million tests per year. To accommodate the DAT law, it was necessary for Sonora Quest to make changes in lab operations and workflow. For example, along with the existing capability to deliver lab test results to physicians, it needed to implement a solution for reporting test results to consumers who ordered their own lab tests.
“Ordinarily when a physician orders a test, the system is built so lab test results for his or her patients are reported either directly into that physician’s electronic health record system, or by fax, or by other means they’ve selected,” observed Stern.
“That’s not what happens with direct-access testing,” he said. “Since DAT results are being reported without a physician’s signed order, the lab results must go to the patient and only to the patient.
“Arizona’s DAT law specifies that a physician or other provider doesn’t have liability for interpretation or action on those test results unless the doctor explicitly agrees to provide consultation to the patient,” commented Stern.
“Our goal was to keep that in the forefront because we want to ensure that DAT testing works for patients and that physicians are not surprised by results for tests they did not order,” he noted. “We didn’t want to drop lab test results on physicians when they didn’t expect them, didn’t want to see them, hadn’t asked for them, and didn’t want the liability for acting on a lab test that they hadn’t ordered.
“In fact, there seems to be some sensitivity about this issue among physicians here in Arizona,” Stern added. “They do not want to be liable for the results of direct access tests. We recognize that sensitivity and we didn’t want to possibly put ourselves between the patient and the physician.
“Thus, for example, a patient cannot send results from the patient portal to the doctor,” he said. “The only way for a patient to send direct-access lab test results to a physician is to hand carry them or mail them.
Better Processes Needed
“In planning to support our DAT program, we recognized that we did not have robust processes for sending results directly to patients,” he observed. “To address that problem, we developed a patient portal, which allows patients to retrieve their tests online.
“The beauty of the patient portal is that patients get the results of their direct access tests and can view the results of any prior lab test we’ve done for them since the portal’s inception,” explained Stern. “We can also send them results by email or postal mail if they prefer.
“There is another point to make about direct-access testing that is sometimes overlooked,” he stated. “There may be cases where the patient or the consumer did testing for certain infectious diseases. By law, the clinical laboratory is required to report that data to the state health agency. This is to allow public health authorities to do the appropriate follow-up when needed. And that lab test data has the patient’s name attached to facilitate follow up.”
One issue many labs encounter when working with patients’ test results is the ability to collect all lab test results so that the lab can use that data for population health management. DAT orders are segregated from all other results that are used in these reports. Another concern is whether keeping this data out of that pool of information that payers and others use to manage population health is potentially problematic.
That issue was important to Sonora Quest Laboratories. “How big the problem is will depend on how widespread direct access testing becomes,” said Stern.
“And I don’t think this is the end of the story because insurers are likely to want to have access to that data in some form, whether it’s patient-identified or de-identified data.
“Will insurers want to work with some of their patients to get access to that DAT test data?” asked Stern. “And if they do, how will the insurers request that access? We don’t want to be in the middle, but we are almost by default.
“Not only will the insurer be interested in using the data for population health management but the insurer might want to avoid duplicative testing,” he observed. “As we were developing the processes needed to offer direct access testing, we kept in mind the concept that both laboratory testing and healthcare management are part of a team sport.
“Although the DAT law allows the patient to be the quarterback in terms of determining who gets lab test results, it’s still important that patients share the results with their healthcare providers and we stress that point at multiple times in the process,” he said.
When the state legislature passed the new direct access testing law and the governor signed the bill earlier this year, there was extensive news coverage of this event throughout Arizona. That is one reason why there is plenty of consumer awareness about DAT in the Grand Canyon State.
These developments coincided with the greater number of patients who are either uninsured and pay cash for their lab tests or patients who have high-deductible health plans and may need to meet out-of-pocket requirements of between $5,000 and $10,000 per year. Because of these factors there are many healthcare experts watching to see if patients and consumers in Arizona will embrace DAT and generate large volumes of direct access tests.
Contact Laura Waldron at 480-998-2600 ext. 562 or firstname.lastname@example.org.
How Sonora Quest Laboratories Selects Tests It Considers Appropriate for its DAT Menu
THERE ARE A NUMBER OF LAB TESTS for diseases and conditions that are difficult even for physicians to interpret accurately, given the clinical presentation of a patient. For this reason, Sonora Quest Laboratories does not offer these types of lab tests on its menu for its direct-access testing program.
One example is testing for celiac disease. “Many Americans today are interested in going gluten free in part because they are worried about celiac disease,” stated Robert Stern, MD, Medical Director of Sonora Quest Laboratories in Tempe, Arizona. “That worry leads some to get celiac disease testing.
“It’s a huge area of interest in the population right now,” said Stern. “But the tests are difficult to interpret. Often I get calls from physicians who have ordered the tests and need help interpreting the results.
“The diagnosis is complex because the patient’s IGA level (blood level of immunoglobulin A) will affect what the other test results mean when identifying celiac disease,” he explained.
“To offer that test could have been a great moneymaker for the lab because so many people would have ordered it,” stated Stern. “But we recognize the potential clinical consequences if such a test could be ordered by patients without a physician’s order.
“Another example would be testing for Lyme disease, which is not endemic in Arizona,” observed Stern. “Therefore, if a consumer gets the test and has not traveled to an area where Lyme disease is endemic, then a positive result is almost certainly a false positive.
“Once that consumer gets a positive result, they think they’ve got a problem and start worrying about what to do next,” he added. “Usually that would trigger more lab testing and yet the initial test never should have been run in the first place.
“In laboratory medicine, it is called the ‘Ulysses Syndrome’ when a patient orders an inappropriate test, gets a result that he or she doesn’t know what to do with and then gets more testing,” he observed. “More lab testing leads to more results back.
“So, rather than helping to control healthcare costs, this kind of random or un-selected testing can drive up costs—even though lab tests as a percentage of overall healthcare spending is relatively low,” noted Stern.
“Remember, should a consumer order inappropriate tests and get results that require follow-up, additional lab testing would then be needed,” concluded Stern. “Add physician visits to this scenario and costs can run into serious money. That’s not good for anybody, particularly the patient who is now getting unnecessary lab tests and clinical care.”
DAT Means Collecting Money from Patients
IN ARIZONA, A DIRECT ACCESS TEST can be ordered by a consumer without a physician on the test request. For labs that offer DATs, this requires collecting payment from the consumer, typically when they have their specimen collected.
“At Sonora Quest Laboratories, we instituted changes in workflow in our 70 patient service centers to accommodate patients seeking direct access tests because these tests are handled a bit differently,” noted Robert Stern, MD, SQL’s Medical Director. “Patients who have physician orders usually pay with insurance and patients having direct access testing pay out-of-pocket.
“In fact, a patient ordering a direct-access test can’t use health insurance to pay for that test,” noted Stern. “Moreover, per the state law, the lab cannot bill that patient’s insurance company and the patient cannot submit a claim to have insurance pay for the DAT test. However, the patient can pay by using a flexible spending account or health savings account, if he or she has one. The Arizona statute makes the patient responsible for paying for every direct-access test.”
“Sonora Quest Laboratories researched the insurance payment issue,” stated Christina Noble, Vice President of Business Development. “Our policy for DAT requires the patient to pay 100% at the point of sale,” she said. “When patients come in with a DAT request, we ask that they pay 100% at that time.
“Additionally, we worked closely with those health insurers where we are in network to make them aware that Sonora Quest was offering direct access testing through our My Lab ReqQuest solution,” continued Noble. “We instituted a procedure to specifically brand our receipts for DAT tests ordered by any patients. That way, if an insurer receives a request from a member to be reimbursed, it would clearly see that the lab testing was for direct access testing.”