CEO SUMMARY: A new federal requirement requires labs to make test results available to patients beginning this month. What is unknown is how patients will respond to the opportunity to see their lab test results. The effective date for this new requirement was October 6. It is expected that patients with chronic conditions will have the greatest motivation to regularly access and retain their lab test results. However, at this point, labs don’t know what proportion of patients will request access to their lab test results.
THIS MONTH, a new federal law became effective that requires clinical labs and pathology groups to give patients access to their lab test results just five days after their physicians have seen them. Mandated by the federal Health Insurance Portability and Accountability Act (HIPAA), this requirement took effect on October 6.
One big question mark is how many patients may want to see their laboratory test results. “Will labs see a tidal wave of patient interest or will only a handful of patients want access to their lab results?” asked Greg Kennedy, Director of Information Technology for ClearPath Diagnostics in Syracuse, New York.
“That’s the question every clinical lab is asking today,” noted Patricia Brown, Marketing Director for Lifepoint Informatics, a healthcare IT company in Glen Rock, New Jersey. “Patient engagement always has been a challenge for physicians and all providers.
“Labs will now begin to see which patients are accessing their test results,” she said. “Typically, a patient must enroll with the lab as a necessary step to gain access to their lab results. How many patients will do so is an open question at the moment.
“It is believed that patients with chronic diseases will have the greatest motivation to view and save their lab test results,” continued Brown. “How to best encourage patients to become more engaged in their own well-being is an issue that frustrates physicians. In fact, this issue is linked to the issue of how the healthcare system can motivate patients to take ownership of their health.”
Watching Patient Response
Kennedy agreed, adding, “Here at ClearPath, we don’t know if we’re going to get two requests a week or two thousand requests a week from patients wanting to view their lab test results. In either case, we have to be compliant.”
ClearPath is a pathology group that serves the Northeast. To comply with the new requirement, it installed a patient access portal from Lifepoint. “By the deadline of October 6, we were delivering lab test results to patients who requested them,” stated Kennedy. “Under existing New York State law, labs are not allowed to give patients access to their test results. So, conforming to this new federal requirement is a big change for us.
Patient Portal Strategy
“The decision to implement a patient portal to meet the new federal requirement simplifies the process any clinical lab or pathology lab would follow to make test results available to patients,” explained Kennedy. “Mailing results would be time consuming and expensive. Thus, our ability to post results online within our portal is a positive step for ClearPath.”
A patient wishing to see his or her lab test results must first make that request to ClearPath, he commented. “If the patient has Internet access, our team directs the patient to our website for access to the Lifepoint-powered portal. There, the patient can create the account needed to gain access to lab test results.
“If the patient does not have Internet access, we have a manual process to authenticate the request and deliver hardcopy results,” he added. “The online process is similar to that of a number of other experiences that people have online. For example, just as with online banking, our patient visits the portal, answers a few questions, and creates an account. It’s fast and simple.
Manual Process Available
“Not only do we want to comply with the regulations, but we need the patient to have safety and security,” he added. “Thus the patient’s answers to several questions are used to confirm identify. Next, the patient is sent an authentication number by email that he or she uses to visit the portal, to log in, and to view results.”
Federal regulations dictate the timing of release. Physicians see the lab results first. Following a delay that could be as much as 30 days, the lab test results are then available to patients, according to the Federal Register, which published the regulations on February 6.
ClearPath Diagnostics will make the results available to the patient after the ordering provider has had time to review them, Kennedy said.
HHS Says New Rule Boosts Patients’ Rights
IN FEBRUARY, the federal Department of Health and Human Services issued rules to allow patients (or an individual designated by a patient) to have direct access to the patient’s complete laboratory test reports.
At the time, former HHS Secretary Kathleen Sebelius stated, “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans.”
The rule amends the Clinical Laboratory Improvement Amendments of 1988 to allow laboratories to give a patient, or a person designated by the patient, his or her “personal representative,” access to the patient’s completed test reports on the patient’s or patient’s personal representa- tive’s request, HHS said.
Technically, three agencies within HHS issued the rule: the Centers for Medicare & Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the Office for Civil Rights (OCR), which enforces the HIPAA privacy rules. The final rule is available for review at the Federal Register site (https://www.federalregister.gov).
The title of the rule is “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports; A Rule by the Health and Human Services Department and the Centers for Medicare & Medicaid Services on 02/06/2014.”