By: Margaret Louis Compton, MD & Renu Virk, MD

The purpose of the act is to provide widespread mandatory patient access to electronic health information (EHI) that would enable more patient control in healthcare. In addition, the legislation includes provisions designed to improve precision medicine and accelerate the process of drug and device development to bring new innovations and advances to patients who need them faster.

The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) both issued a final rule regarding health information access and interoperability. As per rule, interoperability means sharing and use of medical information via computers and online software. The rule is applicable to healthcare providers, healthcare networks and EHR vendors. The rule outlaws any kind of information blocking, which is defined as any practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of EHI. Institutions or individuals who participate in information blocking are liable for penalties, such as fines.

The Cures final rule, published by Health and Human Services (HHS) on May 1, 2020, mandated that patients be provided with widespread and immediate access to their own electronic health information (EHI) and specified eight types of patient data that must be made available to the patient free of charge. Laboratory and pathology report narratives are two of the eight types of patient data that needs to be immediately released. The other 6 patient data include 1) Consultation notes 2) Discharge summary notes, 3) History and physical access, 4) Imaging narrative 5) Procedure notes, 6) Progress notes.

The initial deadline for implementation of these changes (November 2, 2020) was extended to April 5, 2021, due to the COVID-19 pandemic.

There has been a lot of discussion about the potential consequences of this rule on current and future medical practice among physician community. On one hand, physicians have raised concerns about the implications of immediate release of EHI on patients’ well-being particularly pertaining to oncologic diagnosis. The other concern is that EHI contains lot of medical terms that patient will find difficult to comprehend and will inundate physician’s office with numerous questions. Additional concerns are related to privacy and security. To address some of these concerns, HHS has created eight exceptions to information blocking, including preventing harm; promoting the privacy of EHI; maintaining the security of EHI; recovering costs reasonably incurred; responding to requests that are infeasible; licensing of interoperability; maintaining and improving health IT performance; and limiting the content and manner of an actor’s response to EHI requests. On the other hand, providing immediate EHI access to patients have been shown to have advantages for patients as they get more engaged, feel more empowered in healthcare process, improving patient safety by decreasing risk of missed abnormal results and allowing them to more easily transfer their results between healthcare systems.

What are the implications of this rule for pathology? In the past, pathology results (including anatomic and clinical pathology) were being released to patients after the review by the ordering physician. It usually took 4-7 days depending on practice and hospital policies. Now patients will have immediate access to all pathology reports as soon as they are signed out by the pathologist. The most important concern that comes to everyone’s mind is impact of first time, particularly unexpected, oncologic diagnosis on patient’s well-being. Emotional harm due to oncologic diagnosis has already been excluded from list of exceptions. Moreover, exclusion is more at the discretion by ordering physician rather than pathologist at this time. All the exclusions are on case-basis and have to be documented each time exception is requested. Blanket exceptions (for example, blocking the release of all abnormal Pap tests) is specifically prohibited.

Other possible impact on pathology practice includes increased number of calls to pathologist’s office. The pathology community need strategies to handle patient calls to provide reasonable answers with empathy while realizing their limitations in further treatment planning, particularly that require multidisciplinary involvement. It would be prudent to encourage the patient to have initial conversation with their doctor who already have established relationship and connection with them. Pathology labs also need to address the issue of their laboratory’s policy on critical values/results and communications with ordering providers. One situation that is particularly relevant to cytopathology is provision of preliminary diagnosis vs. tissue adequacy at the time of rapid onsite evaluation as the results of onsite evaluation are part of final diagnosis. It will be important to keep in mind this fact while providing the onsite assessment.

While the 21st Century Cures Act final rule has the advantage of empowering patients and improving access to health information, there are a few possible downsides associated with immediate release of pathology reports into the patient portal. A lot of thoughts and concerns have been raised regarding the implications of immediate release of patient data, including heightened patient anxiety and increased administrative burden on physicians and laboratories due to a higher volume of patient questions.

To conclude, the Final rule is now in effect and compliance is mandatory. Physician and pathology community needs to adjust to this new situation with timely interdisciplinary communication as well as direct communication with patients while making appropriate adjustments with new challenges in the future as necessary.

21st Century Cures Act. Public Law 114–255. 114th Congress https://www.congress.gov/114/plaws/publ255/PLAW- 114publ255.pdf. Published December 13, 2016. Accessed March 16, 2021.
Final Rule Short Summary. American Medical Association.
https://cdn.ymaws.com/www.dcmsonline.org/resource/resmgr/files/covid19/onc_final_rule_short_summary. Published 2020. Accessed March 16, 2021.
The ONC Cures Act Final Rule. The Office of the National Coordinator For Health Information Technology.
https://www.healthit.gov/cures/sites/default/files/cures/2020-03/TheONCCuresActFinalRule.pdf. Accessed March 16, 2021.