Immediate pathology report release to patients – Is the 21st Century CURES Act worse than the disease?
By Lorraine L. Rosamilia, MD, FAAD
Staff Dermatologist, Geisinger Health System
Aug. 25, 2021
Vol. 3, No. 34
The 21st Century Cures Act, signed into federal law in 2016, was enacted to optimize medical product development and advance patient access to medical innovations. Notable for inclusion of patient perspectives in its provisions, the Act was then given to the Office of the National Coordinator for Health Information Technology (ONC), which was tasked with easing the regulatory burden of utilizing and accessing the electronic health record (EHR). The ONC Final Rule was released in 2020 with a grace period for implementation ending April 2021, requiring that providers and health systems prevent “information blocking,” meaning that patients must have free portable electronic access to their entire health record. (1)
As dermatologists, the most germane portion of this mandate includes sharing pathology results with patients in the EHR as soon as they are available. There are several exceptions to the rule, including Preventing Harm, determined by the ordering provider but strictly outlined as severe physical harm with no sanctioned loophole to summarily delay result release for all patients so that the provider may first interpret the data before the patient receives it. Thus far, the Office of the Inspector General has not delineated the provider penalties for noncompliance with the rules.
Now that we have the rules down, let’s try to understand them and anticipate as well as mitigate the potential benefits and harms of their implementation. Some key questions come to mind:
How could this legislation be a good thing?
The ability for patients to own their medical data, securely access and maintain it in their portable devices, and provide time and health care worker economy for data transfer, are good technology advances and patient-centered care.
How is this different from OpenNotes? It wasn’t as bad as we thought it was going to be, right?
The Cures Act piggybacks on the advent of “open notes” around 2010, in which patients may access their verbatim visit records in the EHR, typically through a patient portal; an innovation that was already in place (but not mandatory) across many health systems over the past decade. (OpenNotes© (one word) is a component of the Research Section of the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, and the source of initial (and ongoing) study on providing electronic open notes directly to patients.) Further, the amendments to the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in 2014 allowed release of real-time laboratory and imaging results directly to patients. (2, 3) Until now, these patient access points did not include pathology reports and were not required to be immediately released. Surveys of patient response to OpenNotes implementation noted that they are “rarely troubled by what they read” and “find note reading important for their health management.” (4) Clinician assessment of OpenNotes over time reflects acceptance of the practice, where “most endorsed the idea of sharing notes and believed the practice could be helpful for engaging patients more actively in their care.” (5) Whereas, a radiology study reported that patient preference for receiving diagnostic reports depended on the level of test result abnormality, with most preferring immediate access versus a 3-day delay for near-normal findings; when results were indeterminate or abnormal, fewer patients wanted real-time access. (6)
What challenges do we anticipate with these rules in place?
The physician-patient exchange of history, results, and advice hinges on clear communication, trust, and timing. External derailment of any of those components confers a breach of our perceived professional judgement and fragmented clinical care. The feared consequence of the rules is that patients may read the pathology verbiage, especially if it includes a malignancy diagnosis and particularly when it is unexpected (i.e., a pink melanoma), and frantically call the dermatologist’s office, perhaps even before said dermatologist has even opened let alone reviewed the report. The patient might also note the pathologist’s name and contact that office. Maybe the dermatologist would like to first compile all information before generating a management plan, for example to contact the pathologist or wait for a pending consult or send-out test. Perchance the patient does not want to know the results before the physician calls but is given an email or alert on his/her device to open it. We then fear the stepwise Googling of “parakeratosis,” “adipocyte rimming,” and “where the heck is the lateral antitragus?” Subliminally, will the pathology reports soon include less diagnostic verbiage, truncated microscopic descriptions, and fewer items in the differential diagnoses? The psychology of this process seems to detract from the goal of smooth and effective care and the privilege of methodical clinical documentation and discussion without the possible paranoia of wondering who’s reading it.
How do we mitigate these challenges?
Firstly, our discussions with patients in the room about the biopsy differential, the method by which they would prefer to receive results, and how the patient should optimally contact you are paramount but also are likely things most of us already do. We should also try to understand the logistics and workflow of our own patient portal, as the way in which the patient is alerted, the alert language, and the report format influence the patient’s next steps. You may be able to serve on a committee that designs or monitors this flow at your workplace or speak to your legal team to determine how they deem the EMR compliant with the rules. Perhaps even a psychologist could serve on the committee to analyze metered language and flow. For instance, the patient’s notification of results could be manually activated when the patient wants to open it instead of a phone alert automatically opening the report with merely a fine print warning that “your doctor may not yet have reviewed the results, and the results could be upsetting.” OpenNotes has been less onerous than I predict these rules will be, in my opinion, because it is not a “result” that the patient is immediately urged to open; patients have to open the portal EMR and purposefully view their visit documentation at their discretion.
Access other Academy resources on the new information blocking rule.
What education and advocacy efforts exist on our behalf as these rules are implemented?
The American Medical Association (AMA) passed a resolution in June 2021 calling for changes to these rules to allow for delay of pathology results, advocating to the Office for Civil Rights (OCR) to revise the “harm” exception to include psychological distress. (7) In early August 2021, the American Academy of Dermatology Association (AADA) met with senior officials at the ONC also to revise its definition of “harm,” sharing examples of emotional strain of receiving results without clinical context (thank you, AADA!). (8) Further, the state of California enacted a prior law requiring lag time for clinicians to contact patients before they receive results of a malignancy diagnosis. (9) All of these efforts circle back to the physician being the leader of the clinical dynamic and facilitator of the best therapy plan for each patient, hopefully unifying our specialty’s approach to the rules and creating a forum for us to comment on opportunities and pitfalls with its implementation.
Losing control of our clinical time scares us — a lot. My first editorial for this publication touched on that theme addressing the overflow of patients referred to our specialty. (10) The Cures Act reminds us that some health mandates strip us of protection of managing the shape of good communication with said patients. Our time and relationships in the room with them, our clinical interpretations and insights, and the shared management of their diseases are likely still the reasons we love medicine. Therefore, as the rules are reality, we hope the indispensable advocacy of organized medicine and our clinical insight within our offices and institutions will be heard, and then “access” and “portability” won’t scare us or the patients anymore.
Point to remember: The ONC rule for direct pathology result release to patients has gone live as of April 2021 and carries with it a complicated patient communication experiment. Our national organizations are advocating for the rule’s most appropriate implementation, requiring further study of its flow, its legal penalties, and most importantly, the net effect on patients.
Our Editor’s Viewpoint
Warren R. Heymann, MD, FAAD
As a clinician and our group’s dermatopathologist, I (along with many others) faced the 21st Century Cures Act with angst and trepidation. While I appreciate the advantages of transparency and disclosure of all medical data, we went to medical school for a reason — to provide compassionate care, enveloped in providing information in the right context. Yes, we now have a disclaimer on our pathology reports (similar to the statement in Dr. Rosamilia’s commentary). As it has now been four months since the implementation of the act, I am pleased to say that not a single patient has contacted me to discuss their biopsy report prior to having been informed of the result by the requesting dermatologist. Perhaps this is because they are not aware that they have this access — more likely it is a function of our telling them that they will be hearing from us when the report is available. I am hopeful that the act will be modified as Dr. Rosamilia suggests. It should serve as a reminder, however, that with open access, patients may not be too pleased to read that they are morbidly obese or non-compliant. Think before you write. You are likely to have a happier patient with an elevated BMI who could better adhere to the recommendations offered.
Walker J, et al. OpenNotes after 7 years: patient experiences with ongoing access to their clinicians' outpatient visit notes. J Med Internet Res. 2019;21(5):e13876
Desroches CM, et al. The views and experiences of clinicians sharing medical record notes with patients. JAMA Netw Open. 2020;3(3):e201753
Johnson AJ, et al. Access to radiologic reports via a patient portal: clinical simulations to investigate patient preferences. J Am Coll Radiol. 2012;9(4):256-63
Email Blast: AAD Advocacy Update, August 6, 2021
https://www.nashp.org/wp-content/uploads/2010/02/ElectronicLabResultsExchangePolicy.pdf: California Health and Safety code 123148(f)
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