Leaders at the Alexandria, Va.-based AMGA are urging the senior officials at the Office of the National Coordinator for Health Information Technology to address an unanticipated development that has emerged out of the ONC’s recently implemented rule around “information-blocking.” In fact, what’s happening, as physicians in AMGA-member groups have been sharing with the association, is that patients are in many cases receiving information on the results coming out of diagnostic tests before their physicians can explain the meaning of those results, leading to confusion and distress.
As a press release posted to the AMGA’s website on July 26 explained it, “AMGA today offered recommendations to improve information blocking requirements to help strengthen and support the doctor-patient relationship in a letter to the U. S. Department of Health and Human Services Office of the National Coordinator (ONC) for Health Information Technology. The changes that AMGA is recommending furthers ONC’s transparency goals while also ensuring that patients receive any concerning laboratory and other results in a thoughtful, compassionate way. Under ONC rules that took effect earlier this year, healthcare providers generally are required to provide patients with immediate access to their electronic health information. Patients expect timely access to test results, and AMGA supports the underlying intent of the rules. Based on our members’ experience, however, the stringent requirements on how quickly clinicians must provide access to the laboratory and other results are causing patient harm and distress, as patients are receiving results via patient portals and other technology and not through a conversation with their clinician. AMGA recommends that healthcare providers be allowed more time to electronically release test results so that they can reach out to patients about sensitive findings and answer questions.”
A letter dated July 27 and carrying the signature of Jerry Penso, M.D., AMGA’s president and CEO, and addressed to National Coordinator for Health Information Technology Micky Tripathi, Ph.D., began thus: “Dear Dr. Tripathi: The Office of the National Coordinator for Health Information Technology (ONC) on April 5 implemented rules on “information blocking” that generally require healthcare providers to provide patients with access to their electronic health information (EHI) immediately. On behalf of AMGA and its members, I am writing to provide you with an update on the initial effects of these new requirements. Our members are reporting this ‘immediate resulting’ requirement is causing patient harm by releasing clinical data to patients before their physicians can review and interpret the results.”
In the letter, Dr. Penso went on to share two key recommendations: first, “ONC should expand the definition of harm to account for emotional distress”; and second, “Providers should be able to hold select results for 24 to 72 hours to deliver them in a more compassionate way.”
As the letter went on to note, “AMGA and its members support the concept of providing timely access to results and other information to patients. Due to concerns that physicians were delaying the release of information and results, many of our members tie physician compensation to the timely release of information to patients. How quickly physicians and care teams inform patients of their laboratory result or other findings factors into how our medical group and health system members evaluate the performance of their physicians and other clinicians. In some cases, those providers who are consistently late in releasing or providing results to their patients face financial penalties. The information blocking regulations, however, go beyond supporting the concept of sharing information and instead are adding confusion to the doctor-patient relationship. AMGA members report concerning and disturbing instances where immediate resulting has caused patient harm. Examples include:
> A patient portal automatically alerted a patient of a Huntington’s disease diagnosis.
> A patient learned of a miscarriage via a phone alert before the physician had reviewed the results.
> Patients are routinely receiving pathology reports that either confirm a cancer diagnosis, or, absent a conversation with their doctors, lead them to believe they have cancer.
> Patients are receiving positive test results for infectious diseases, including HIV.
These examples demonstrate the immediate need for ONC to revise the regulations. AMGA is pleased to offer recommendations to amend the definition of patient harm so the regulations support transparency and information sharing, while also ensuring patients receive results in context and as part of a care plan.”
“AMGA strongly supports information sharing and the need for patients to have quick access to test results and other clinical findings,” Dr. Penso said. “The problem with ‘immediate resulting’ is that patients are learning about cancer diagnoses or other serious conditions from a computer, not a person. The rules unintentionally are favoring speed over compassion.”
And, the press release noted, “AMGA recommends that rather than require patients be immediately alerted when laboratory or other clinical findings are entered into a patient record, clinicians have the option to delay their automatic release for 24 to 72 hours to allow providers the opportunity to discuss the results and answer any questions. A conversation between the clinician and the patient can help prevent needless confusion about abnormal results. The regulations currently allow for a delay in the release of results if there is a potential for patient harm. The rules, however, define harm in purely physical terms. AMGA recommends that the delay be permitted to help prevent or mitigate emotional and mental stress and harm.”
‘First do not harm’ is not just a slogan, but an underlying principle,” Penso said in his statement in the press release. “We live in a fast-paced world, and patients expect to have information at their fingertips. As healthcare providers, we can provide that information quickly, but sometimes it needs to be delivered with added context, expertise, and something a computer can’t provide, compassion and understanding.”
This week, Healthcare Innovation Editor-in-Chief Mark Hagland spoke with Darryl Drevna, AMGA’s senior director of policy affairs, about the letter and its origin. Below are excerpts from that interview.
How did the senior leaders at AMGA decide to write a letter to National Coordinator Tripathi?
We’ve been hearing from our membership over the past couple of weeks about how ONC’s new requirements are actually affecting people on the ground. And everyone’s in favor of transparency and making sure patients have access to test results and their data. But we’re finding that these requirements are creating a lot of confusion and distress among patients, because they’re getting results they don’t understand, or getting frankly really bad news through a patient portal or an alert on their phone. They want to hear from people. Our group members’ practicing physicians are compassionate people, and they want to do the best they can for their patients. And it’s totally an unintended consequence of the desire to make sure patients receive their important information.
How should the language of the rules be changed?
There are a few things that ONC can do to help make sure this doesn’t happen. The first is to expand the definition of patient harm, to allow for a delay in the immediate release of results if they think there will be harm. The rule doesn’t not allow for emotional distress. But if you expand the definition to allow the provider to put a brief hold, to prevent distress or harm, we think that that’s still a reasonable thing to do, to get patients their results in a reasonable period of time—we’re talking about twenty-four to seventy-two hours—just enough time to be able to get on the phone with the patient and have that conversation, so that they can explain what exactly is going on and what their care plan is. And to be fair, these are conversations happening on the front end, but it’s one thing to explain what a test result might mean before you conduct a test, and actually receiving results afterwards. And then in terms of the timeframe, twenty-four to seventy-two hours—we think it will accommodate test results that might come in, say, on a Friday afternoon, where it would be happening over a weekend. So it’s creating some confusion and frustration for patients and for our members. Instead of helping to support care coordination and clear communication, it’s creating confusion that nobody wants.
What will be the process for changing this?
They could issue guidance to clarify the language of the rule; I think that would be well-received. If that wasn’t sufficient, they could open up the regulation and open it up for comments and get additional feedback and do it that way.
Do you have any other thoughts on this?
I think this is something that caught everyone a little bit by surprise. You hear a lot about unintended consequences [of new regulations]. I think everyone was on board with the idea that patients should get their data really quickly; it was just that people are getting results that they shouldn’t be getting through technology. And there are situations where, say, you have some lab work done and the results on paper might show abnormal, but you have a conversation with your physician—you might need a bit more context from an actual physician rather than Dr. Google, that provides a whole lot of comfort for patients.
