The rules in the 21st Century Cures Act (Cures Act) went into effect on April 5, 2021 with a limited definition of Electronic Health Information (EHI). On October 6, 2022, the Cures Act rule will expand to include all EHI. However, because penalties for clinicians will not go into effect until further rulemaking, pathologists and their institutions have time to implement protocols. To guide your compliance, we have centralized related resources from across the CAP.
The Cures Act Explained
The Cures Act aims to ensure that patients have timely access to their health information. The Cures Act rule requires all physicians to make their office notes, laboratory results, and other diagnostic reports available to patients as soon as the physician’s office receives an electronic copy. Decisions about delaying release of data is a decision of the ordering clinician in the context of their relationship with the patient. The rules have exceptions on a case-by-case basis for protecting patient privacy and security, but specifically does not allow for blanket exceptions. Read our Fact Sheet
The Cures Act is Different Than the CARES Act
Cures Act requirements are about patients accessing their healthcare information. The CARES Act includes reporting COVID-19 test results to the appropriate health department.
Impact on Pathologists
The implications for pathologists are test that results should be shared as soon as they are finalized—with the ordering clinician and/or through a patient portal for direct patient testing. Current reporting from laboratory information systems (LIS) to the ordering systems with reasonable turnaround time should satisfy the requirements without a need to change or add data elements. The expanded definition of EHI that takes effect on October 6, 2022 does not substantially change any expectations for pathologists.
Navigating the New 21st Century Cures Act
What do the new 21st Century Cures Act rules about making laboratory results immediately accessible to patients really mean for pathologists? There will likely be little change in how labs send results to EHR systems. However, there will be some new territory that pathologists and labs will have to navigate, and the CAP is working to help members better understand and prepare. Read the CAPToday article
Top Takeaways for Pathologists
- Most pathologists do not have to change the way they report. Continue to report finalized reports from the LIS to ordering systems—with reasonable turnaround time. No need to change or add data elements for this rule.
- Pathologists should not delay the release of laboratory and pathology results until the ordering clinician’s review. Decisions about delaying release of data is generally a decision of the ordering clinician in the context of their relationship with the patient. There are no blanket exceptions; only case-by-case exceptions for privacy, security reasons.
- The rules do not specify that pathologists must take phone calls from patients. It is the pathologists’ professional discretion on handling patient calls; for the most part, these calls cannot be billed within current payment policy.
- The rules, which started to go into effect April 5, 2021, initially had a restricted definition of EHI. However, after October 6, 2022, all EHI are subject to these rules. The definition of EHI is not limited by any particular technical functionality or standard. Penalties for clinicians will not go into effect until there is further rulemaking. Lack of penalties gives organizations time to implement workable protocols.
To guide your success managing Cures Act requirements, rely on these curated, centralized resources from across the CAP.
- Workaround So Patients Don't Panic Over EHR Bad News: CAP President Emily Volk, MD, FCAP, shares creative strategies some pathologists have adopted to address bad news in patients electronic health portals: They're trying to get the lab report's bad news to the treating physician first.
- Key Take-Aways for Compliance—The 21st Century Cures Act Roundtable: Read the questions and answers from the session and download the presentation deck.
- Intersecting with Patients: Actionable ideas and member experiences to manage pathologist-patient consults.
- How to Read Your Pathology Report: Easy-to-share materials and content pathologists can provide patients.
- The Case for Patient-Centered Pathology: Gain ideas and insights to implement personalized tumor boards and connect with patients.
- Talking with Clinicians: A focus on communication and infrastructure can spur more effective clinician-laboratory collaboration.
- Patients See Their Cancer Up-Close (Video): Go behind-the-scenes with Lija Joseph, MD, FCAP, to see how breast cancer patients benefited from time with the pathologist.