Inside the Lab Industry: Direct Release of Patient Tests: It’s Now Legal, But Is It Consumer Friendly?

The first week in October is filled with significance. The U.S. Supreme Court began a new session, and the baseball playoffs kicked off, among other things. This year, a major change in health care delivery is joining those significant events. For the first time in decades, patients in the United States can receive their laboratory tests directly from a provider on demand. The change to the CLIA and HIPAA regulations by the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services superseded state laws or federal exemptions in 39 states that previously required such tests be vetted by a physician first before they’re turned over to a patient. Now, labs either have to mail or provide them online in a secure form within 30 days of a patient requesting any test results. Although the rule went into effect on April 7, labs were not compelled to fully comply until Oct. 6. How the change will affect the laboratory sector remains unclear, but not only are labs moving to comply with the rule change, some ancillary operators are trying to attempt to capitalize on the change as well. The sector “is moving in the direction of being more consumer friendly,” said Robert Gregory, chief business officer for Atlas Medical, a Calabasas, Calif.-based company that creates software applications for laboratories and other diagnostic testing facilities. Among its newest products is a patient portal that allows patients to access their records directly. It launched in the days running up to the rule change. Cinch, the new consumer-oriented labortory service recently launched by Spokane, Wash.-based PAML, had to make some changes to its Web site and interface in order to accommodate the new rule. “It was very coincidental,” said Shawn Whitcomb, PAML’s chief information officer, adding that the original plan was to launch the Cinch service well prior to the rollout of the new regulation. In response, PAML is making modifications to the Cinch service in order to accommodate the new regulation. Nonetheless, Whitcomb said that the change will in some ways complement Cinch’s approach, which focuses on personal testing, with several related services occurring at the patient’s home if they wish. Yet despite the nimbleness being displayed by companies such as Atlas to respond to a changing market, it appears many laboratories and affiliated organizations are still trying to catch up with the demands of patients, who not only want access to such data, but explanations of what they mean as well. Making Data Easier to Comprehend One of the biggest challenges facing labs in getting test results to patients is the fact that many may not be able to understand what the numbers actually mean. Interpretative data is available through some providers, but not in others. Oakland, Calif.-based Kaiser Permanente, for example, spent billions of dollars a decade ago to create an integrated electronic medical records system as well as a patient portal, and the effort shows. Since 2008, Kaiser has been offering lab results to patients in states whose laws permit them to do so. Kaiser patients are able to not only access their laboratory results, but the results are also accompanied by fairly concise explanations as to what the data mean (e.g., their blood sugar or cholesterol levels and how they correlate to their general health). Other large laboratories, such as Quest Diagnostics and Health Diagnostic Laboratory, have also provided extensive interpretations that accompany test results, but many smaller labs do not provide such services. Atlas, which works with labs of all sizes from local outreach programs to national players, now provides a patient module for them to view their test results. “Future versions will include data interpretation and trending for patients,” noted Gregory, which will include comparisons of their test results to what is considered an appropriate range for such a patient. That updated version will be made available later this year. And while Gregory noted there has been significant demand for the patient portal services, he declined to disclose how many laboratory clients are purchasing the product. Recent research, such as a 2009 study in the Journal of the American Medical Association, concluded that there were already communication issues regarding labs, clinicians, and their patients, with the latter not being informed of abnormal test results more than 7 percent of the time. Another study that was just published in the Journal of Medical Internet Research suggested that nearly two-thirds of patients with lower health literacy and numeracy skills could not correctly determine when their A1C test results for blood sugar were within a normal range. Meanwhile, the data provided by outside organizations can also be difficult for a consumer to interpret. Lab Tests Online, which has been operated for more than a decade by the trade organization the American Association for Clinical Chemistry (AACC) in collaboration with the American Society for Clinical Laboratory Science, the Clinical Laboratory Management Association, and other organizations, provides a wealth of information on hundreds of assays, including what they do, why they’re ordered, and how they work. The site provides a range of data for some tests but not for others. An AACC spokesperson said that as a result of the rule change, Lab Tests Online “has created several in-depth feature articles to help patients to better understand their lab report and results.” What the Future Holds Although Cinch is an example of the direct-to-consumer testing model, it appears to be in sync with the kind of easy-to-use interfaces that will make labs more competitive in an environment where clinicians can no longer stand between them and their tests. “Because your time matters” is the service’s slogan. Cinch currently offers more than 150 assays. Most are focused on personal health, but many of them are reflective of the kinds of tests patients typically receive during a physician visit, such as blood sugar, lipid panels, albumin levels, allergies, and thyroid function. Prices are posted up front. Patients have the option of visiting a PAML draw site, but they can also use a home kit that employs lancets similar to those used by diabetics to test their blood sugar. The sample can then be mailed in. Results are usually posted online within two to five days. PAML will soon launch a mobile phlebotomy service to have draws performed at a customer’s home or office. “The consumer is becoming more of the center of universe than the provider, and we recognize it more so than anything else,” Whitcomb said. PAML spent some significant advertising dollars to promote Cinch, including producing a television commercial that appeared on the personal screens of American Airlines travelers last July. It is also rolling out an extensive social media strategy, all aimed at patients rather than providers. Moreover, visitors to the Cinch Web site will soon be able to purchase gift cards friends and family members can redeem for tests. And while Whitcomb noted that the changes PAML had to make to the Cinch Web site to adhere to the new rules were extensive, they were not terribly complicated. “They’re not minor, but it is really about the flow and process, and how we position it with the patient, as well as the providers,” he said. Takeaway: The implementation of a new regulation intended to make it easier for patients to access their lab tests without their being vetted by a physician is challenging labs and their IT vendors in new ways.