On April 1, the CAP met with the Office of the National Coordinator for Health Information Technology (ONC) chief clinical and chief medical officers to discuss implementation challenges regarding the new Cures Act information blocking and interoperability regulations. CAP Council of Government and Professional Affairs (CGPA) Chair Jonathan Myles, MD, FCAP; and CGPA Vice-Chair Joe Saad, MD, FCAP; and Pathology Electronic Reporting (PERT) Committee Chair Mary Elizabeth Edgerton, MD, PhD, FCAP; Informatics Committee Chair James Harrison, MD, FCAP, and Vice-Chair Alexis Carter, MD, FCAP asked for further clarification regarding the new regulations and outlined the potential harms to patients, burdens on pathologists, and laboratories.

During the meeting, the CAP acknowledged that providing patients with direct access to their pathology reports may have some advantages. However, challenges and potential safety issues exist for patients with the current regulation requiring immediate release to a patient portal of finalized pathologist and laboratory results. Only case-by-case exceptions are allowed; no blanket exceptions are allowed. When implementing this particular regulation, the CAP advocated that the ONC should consider a broader ability for pathologists and ordering physicians to make exceptions to the immediate release requirement.

The CAP does not think that ONC intends for patients to receive uncoordinated or confusing information. The CAP urged ONC to consider allowing a delay for the opportunity for involved clinicians to create an integrated response before patient communication. The CAP did clarify that this may not be the case for all diagnostic test results, but rather, for more complex diagnostic tests, which could be misconstrued without proper context. Those tests that require patient counseling should be allowed to have a blanket delay of release.

The CAP updated its fact sheet summarizing key provisions and answering pathologists’ questions on regulation regarding sharing test results with patients that is set to take effect on April 5.

Download the CAP’s fact sheet on the regulations

In November 2020, the Department of Health and Human Services (HHS) pushed back the deadline for the regulations, which include information blocking, citing implementation concerns during the coronavirus pandemic. The rules will change how many physicians, including pathologists, pass along and receive electronic health information.