Diagnostic imaging centers and hospital radiology departments are trying to understand, in light of the new Federal Information Blocking Rule, when to release radiology reports to patients and whether those reports should become immediately available to patients once finalized. It's useful to consider the response to somewhat similar legislation enacted in Pennsylvania and how imaging providers have responded.
The Patient Test Result Information Act (Act 112) was enacted by the Pennsylvania General Assembly in 2018 but not enforced until the end of 2019. The law requires direct notice to patients of “significant” abnormalities on imaging studies, meaning those findings “which would cause a reasonably prudent person to seek additional or follow-up medical care within three months”. Diagnostic imaging facilities are required to directly notify outpatients within 20 days of the imaging study about significant imaging abnormalities. Pennsylvania imaging centers are not required to send a copy of the radiology report itself or to even describe the specific significant abnormality to the patient. Rather, the legislation mandates the use of specific language in the notice stating: "You are receiving this notice as a result of a determination by your diagnostic imaging service that further discussions of your test results are warranted and would be beneficial to you. The complete results of your test or tests have been or will be sent to the health care practitioner that ordered the test or tests. It is recommended that you contact your health care practitioner to discuss your results as soon as possible."
In a featured perspective article in the Journal of the American College of Radiology, three radiologists who practice in the Commonwealth of Pennsylvania described the practical implementation challenges resulting from compliance with Act 112. The authors noted that what is considered a significant abnormality could be minor - such as a possible rib fracture - or it could be more ominous, such as lung cancer. But a patient receiving the notice has no way of knowing the importance of the "abnormal" finding. The anxiety these letters have produced in patients residing in Pennsylvania is unsurprising.
As the implementation of Act 112 began, Pennsylvania imaging facilities began facing complaints from physicians who ordered imaging studies for their patients, particularly ordering doctors were contacted by anxious patients about results of imaging studies before these physicians had a chance to review the radiology report. The authors noted, "[i]mposing a moratorium for when the letter is sent out can potentially alleviate some of these issues by giving the ordering provider more time to review the radiology report. However, this may still be an issue as Act 112 requires the letter to be sent within 20 days. It may be difficult for ordering providers in all practice settings to always be able to review imaging reports for patients under their care within 20 days, particularly in the modern practice paradigm where they are forced to see more patients in less time."
This raises the question of whether the Information Blocking Rule will mandate patients having immediate access to radiology reports through secure patients portals or through other means.
Based on guidance from the Office of the National Coordinator (ONC) for Health Information Technology, it appears that imaging centers and hospital radiology departments will likely need to opt for immediate patient access to those reports if delays in providing tests results are considered unreasonable and likely to interfere with access, exchange, or use of electronic health information. FAQs published by ONC state that policies to embargo the release of test results could be considered "interference" for purposes of information blocking, and they recommend that a patient should be able to access their test results "in parallel to the availability of the test results to the ordering clinician."
Unquestionably, the good intentions of the Pennsylvania test results legislation combined with the expected requirements of the Information Blocking Rule have created a "perfect storm" for imaging facilities and the physicians who order diagnostic tests in that state.