The Cures Act and transparency in medicine
James Xie MD, Jorge Galvez MD and Ellen Wang MD
There are several articles in the October issue of Anesthesia & Analgesia about Open Notes, transparency in medicine, and the Cures Act. Over the next 2 weeks we’ll review some of these articles. We first discussed and reviewed this in the March 14th PAAD. Because that review laid out a lot of the fundamentals I’m reposting it today. Indeed, before that posting I had never heard of the Cures Act or the Open Notes movement and suspect that many of you hadn’t heard of it either. In March I asked 3 experts on these topics, James Xie MD, Ellen Wang MD, and Jorge Galvez MD from SPA’s IT committee to write a PAAD to explain what this is all about. Because it is so fundamental and foundational I am reposting it today. Additionally, the SPA education committee will present a formal series of lectures on these topics at a forthcoming SPA meeting. Myron Yaster MD
Original Article:
Priya Ramaswamy, David T. Chin, David Robinowitz; Open Anesthesia Records: Guidance for Anesthesia Providers on Implementing the Cures Act. ASA Monitor 2021; 85:e3–e4 doi: https://doi.org/10.1097/01.ASM.0000733900.18773.a4
Title: A year after Cures Act implementation: how are open anesthesia records affecting pediatric anesthesiologists?
The 21st Century Cures Act was passed and signed into law in 2016. The majority of the act focuses on “expediting discovery, delivery and development of new cures and treatments,” but one component - the “Final Rule” - defines interoperability of electronic health records and specifically prohibits “information blocking” of health records from patients. The goal was to make medical records as transparent and accessible as possible, through electronic portals at no additional cost to patients. It’s now 2022 - what has happened since the law passed?
This Final Rule went live in April 2021 after a delay from the originally intended October 2020 date. Its rules are slated to be enforced in October 2022 and if healthcare providers are found to be non-compliant, they may be subject to fines. Consequently, this topic has been keeping many CMIOs and clinical informaticians busy in the last few years. Already, there have been almost 300 information blocking claims logged in the past year that the Office of the National Coordinator is required to investigate (1). If there are healthcare providers that are doing anything (intentionally or not) that “interferes with, prevents, or materially discourages access to, exchange of, or use of Electronic Health Information” - then they will be running afoul of the Cures Act Final Rule.
In the anesthesiology community, there has been less discussion on the topic than perhaps there should be. Our clinical care documentation has often remained separate and sometimes less transparent to even our own healthcare colleagues. There have been technical barriers with sharing a complete version of the anesthetic record to patients and external physicians. However, the Cures Act will likely change the landscape of how our anesthetic encounters appear to our patients, families, and colleagues. Our pediatric anesthesiology colleague Dr. David Robinowitz along with Dr. Priya Ramaswamy and Dr. David Chin at UCSF outlined in their article in the ASA Monitor last year a guide for how anesthesia providers should think about how open anesthesia records will affect our specialty.
Almost a full year has gone by and for many anesthesiologists, it may feel like not much has changed. However, as the authors aptly note, we are in uncharted territory and many of us are still learning along the way. An early experience that was described by Naftalovich and colleagues was an incident in which a patient became very anxious as a result of seeing the procedure notes associated with her anesthetic care (2). As it turned out, only the procedure notes were shared, thus providing an incomplete picture of what had occurred through the course of this patient’s case.
In navigating all of this, it is important to remember that the entirety of a patient’s medical record already belongs to the patient - only now there are expectations around the timeliness of release of data. Whereas previously patients had to undergo an onerous process of requesting via Medical Records, immediate release of most records is the expected “new normal”.
For pediatric anesthesiologists, there are some unique considerations that many healthcare institutions and providers have now encountered that we will briefly highlight. Part of what makes our subspecialty unique is that we are not only taking care of a child, but also the family/guardians of the child too.
Timing of Data Release: In the perioperative period, when a pediatric patient is undergoing anesthesia, the patient’s guardians remain awake and anxious during this time. As a result, if notes, labs, and imaging studies are being released in real time, the guardians may access and view these results at a time when there may not be an available healthcare provider to discuss the results with the family. Anecdotally, this has led to panicked phone calls into the OR when a family member noticed abnormal arterial blood gas lab results coming back during their child’s operation. Thus, many institutions have put in place short delays (for example until the anesthesia encounter is closed or the patient is discharged) on releasing these portions of the chart. Unfortunately, there is currently no consensus on what delay is appropriate and within the spirit of the Cures Act’s ban on information blocking (ONC's Cures Act Final Rule (healthit.gov)).
Pediatric Pain Medicine: Another unique situation that arises is in the domain of pediatric pain medicine. Since pain medicine does not fall under the strict criteria of psychiatry encounters, pain medicine notes are not exempt from the information blocking rule. Traditionally, pain medicine notes often contain detailed and extensive summaries of a patient’s mental health and psychosocial factors that may be influencing their pain management. Furthermore, sensitive but not confidential information such as foster status, family stressors, and patient/family-care team tensions would not be considered confidential in notes, and thus would be subject to being shared with patients/families. Due to this change, some pain medicine colleagues have described that they have had to shift some of their communication about patients to external (i.e. not in the patient’s chart) secure communication systems (e.g. EHR secure messaging systems). This inability to separate out communication of sensitive information between healthcare teams has led to fragmentation of care notes and additional documentation/communication burden for pain medicine providers.
Adolescent Confidentiality: For our adolescent patients, this issue is complicated by confidentiality laws that vary by state. Regardless of your resident state, certain parts of the adolescent’s chart should not be viewable by their guardians unless the adolescent consents to it. As it turns out, a majority of adolescent patient portal accounts are accessible by their guardians (3). Although we do not know with certainty whether adolescents are consenting to this, whether this behavior is due to suboptimal registration workflows for adolescent portal accounts, or whether guardians are surreptitiously accessing their child’s portal account, the end result is still of concern. Some institutions have attempted to correct the situation of guardian-accessible accounts (4), but this type of effort is still a work in progress. In the long run, ensuring sensitive/confidential information stays that way for adolescent patients is crucial to maintaining their trust in the healthcare system. For anesthesia providers specifically, keep in mind that the anesthesia pre-evaluation is part of our clinical documentation that will be released via the patient portal. Will information about smoking or substance abuse get populated into this note? Will the post-pubescent adolescent female’s pregnancy test get pulled in automatically?
Parental Confidentiality: In pediatric hospitals, newborns often have a lot of maternal data pulled into their chart that is highly revealing about their birth history. For example, maternal STI status, medical history, and medication history are relevant pieces of information for newborn babies, but may not be things that a parent would want the child to have access to knowing when they’re older and have the option to view their own chart. Are there ways for providers to refer to the maternal record without saving it all in the child’s chart? How do we respect maternal privacy while still providing necessary information for the care of the infant?
While the concept of open notes in medicine has been well-received by our ambulatory colleagues, leading to greater connection between healthcare providers and their patients (5), anesthesiologists are still in the process of working out how open notes can best be used in the acute care and perioperative setting. It behooves anesthesiologists - and even more so for pediatric anesthesiologists - to join the discussion and help shape this evolving standard to a mature state. We have outlined some common scenarios that pediatric anesthesiologists might run into and hope that this generates more discussion and thoughtfulness with your local institution’s clinical informatics teams and CIO/CMIOs.
References:
https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers
Rotem Naftalovich, Andrew John Iskander, Patrick Joseph Discepola, Aaron Avraham Schweitzer, Jean Daniel Eloy; Patient Anxiety Caused by the Cures Act. Anesthesiology 2021; 135:373–374 doi: https://doi.org/10.1097/ALN.0000000000003847
Ip W, Yang S, Parker J, et al. Assessment of Prevalence of Adolescent Patient Portal Account Access by Guardians. JAMA Netw Open. 2021;4(9):e2124733. doi:10.1001/jamanetworkopen.2021.24733
Xie J, McPherson T, Powell A, et al. Ensuring adolescent patient portal confidentiality in the age of the cures act final rule. J Adolesc Health. 2021;69(6):933-939.
Bell SK, Mejilla R, Anselmo M, et al. When doctors share visit notes with patients: a study of patient and doctor perceptions of documentation errors, safety opportunities and the patient–doctor relationship. BMJ Quality & Safety 2017;26: 262-270.