As part of a large-scale government and industry effort get patients more engaged in their care and to ensure they have better access to their own health data, the government wants to allow labs to release test results directly to patients.
The proposed rule, sponsored by The Centers for Medicare & Medicaid Service and two other federal agencies, would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and require labs to release results directly to patients or their designated representatives upon request.
"What we're hoping this regulation will help achieve is for the healthcare system to become more responsive to patients in general, but at the same time give patients direct access to their information when they want it, Alice Leiter, director of health IT policy at the National Partnership for Women & Families, said in an interview.
"This direct access should strengthen the partnership between patients and clinicians, rather than leaving patients in the dark with respect to their own health information."
The move "empowers patients to become true partners in their healthcare decisions, promotes the transparency our system needs, and ultimately helps us use our healthcare dollars more wisely," Christine Bechtel, vice president of the non-profit women and families partnership and a member of the federal Health IT Policy Committee said in a statement.
At least one national lab, Quest Diagnositcs, is also in favor of the rule.
"Patient engagement in healthcare decision making is vital to promoting better health outcomes and reduced costs in our healthcare system," Surya N. Mohapatra, Quest's chairman and chief executive officer said in a statement. "HHS's proposed rule will help to empower patients to understand their health condition and discuss their healthcare options more constructively with their physicians."
Cost considerations
But it's not as simple as it sounds, Bernard Emkes, MD, medical director managed care services at St Vincent Health in Indianapolis, said in an interview. For starters, there's the question of whether labs have the right technology to meet the demand and what the rule would cost labs and, by extension, consumers.
"The lab has pretty good structures in place to get a lab results to my office. But they don't have anything in place to get a lab result to an individual patient's home phone number," Emkes said. "There's going to be a huge infrastructure cost for having the lab provide that directly to patients."
Leiter contends that the move would save money by reducing duplicate tests after results go missing and by improving quality of care.
"Any time we can empower patients with information and get them more active and involved in their care, the resulting stronger partnership between patients and their care team will in the end reduce costs. Patients who are engaged and getting the care they need and want means better management of healthcare and healthcare service and more effective and efficient patient care," she said.
Interpreting results
Another obvious issue with direct-to-patient lab results: Most test result reports are not designed for the layperson.
"A number without a contextual relationship and without some level of interpretation is totally worthless …Relaying data to a patient is totally unrelated to relaying information to a patient," Emkes said. "Data is 'Your A1C level is 11.' Information is 'Your A1C level is 11 and oh my God we've got to get on this right now and here's what we need to do.'"
Bechtel and Leiter both agree that patients need help interpreting and understanding lab results. In fact, Leiter said, the rule would support that goal, allowing patients to "loop back around to their care team so that patients and providers can work together on how to interpret and understand lab results."
Further, she added, the rule doesn't force patients to get their lab results directly—it just gives them the option to do so.
"The idea that people won't give patients information about themselves that's legally theirs because they think patients won't understand it is no reason to oppose this rule," she said. "We don't disagree that accompanying context, explanation, and education is preferable, but we also do not believe in the idea that patients fundamentally are not equipped to decide whether and when they want to go back to their doctor with questions. This is about allowing those who want to get informed to get informed, and then decide how to use the information they receive like they would any other information in daily life."
Missing, delayed, or incorrect test results are often blamed on a variety of factors: the number of different testing locations, the large number and variety of tests, and inconsistent reporting processes.
"This is primarily a workflow issue," Leiter said. "Especially in primary care settings, where doctors and their staff are incredibly busy, are managing multiple patients, and are often struggling to coordinate multiple dimensions of an individual's care, it can be difficult to be as responsive as patients want or need … Sometimes it just takes too long to wait for the mail or a call from your doctor or for the lab to deliver the results to the doctor—who then needs to interpret them and then have a staff member call the patient. It's not hard to see how things can fall through the cracks with that many steps."
Although Emkes says it is a doctor's duty to get test results to patients in a timely manner—when he was practicing he would call patients with results each night—he agrees that the process of communicating lab results is complex.
Doctors get results from a variety of sources—multiple labs and different hospitals and health systems, Emkes said. "And they're all in a different format and they're all in a different layout. It's really hard for me to pick up the abnormalities … because every one of those is formatted differently."
One solution to these problems can be found in health information exchanges, Emkes said.
Physicians who are members of the Indiana Health Information Exchange, for example, can choose how they want their lab results formatted and packaged, he said, making it easier to read, interpret, and deliver the findings to patients in a timely manner.
"I think we absolutely positively have to move toward more electronic connectivity," Emkes said.
But even the efficacy of health information technology is up for debate.
Not all patients whose doctors use electronic health record systems or patient portals have online access, Leiter said. "Patient portals are certainly a great way to deliver lab results and we hope we see more widespread use of them. But right now all patients deserve the ability to see their information in a timely manner."