Questions and Answers from Cures Act Roundtable

Best addressed at the institutional level and how your pathology practice—and ordering clinicians-- may want to engage in making any changes.

We encourage pathologists to engage with referring practices and organizations on how patients should be educated about their results. Pathologists could also come up with a script to respond to such calls by suggesting that the patient contact the referring clinician since the referring physician has more knowledge about what these results mean to this particular patient.

Currently, there are only proposed civil monetary penalties for health IT companies, Health Information Exchanges, and health information networks, not for providers. Healthcare providers are treated differently under the law and may be subject in the future to “appropriate disincentives”. HHS must engage in future rulemaking to establish these disincentives as directed by the Cures Act.

Consider how you would engage with your institution/ordering clinicians to handle these situations.

We encourage you to talk with the outreach facility about the federal mandate, how patient-specific exceptions could be applied, and how care coordination can best be achieved. Unfortunately, these are federal regulations that pathologists need to comply with.

We’re hearing anecdotally about these disclaimers and what patients can expect. Generally, this is done at the organizational level. We encourage you to talk with whoever governs the patient portal to ensure you know what the disclaimers are, and what patients are being told.

Thank you for sharing your experience. Others have asked about adding disclaimers on path reports aimed at earning patients about potentially sensitive content.

Tests for which counseling is required: Some states require that patients be counseled about the results of tests before they can be released to patients (e.g., HIV and other sexually transmitted infection results, genetic results) In cases where patients do not return to get counseled about the result but then access their patient portal, it is not clear how this would be interpreted by the ONC.

Unexpected results that trigger state regulatory prohibitions: Tests that look for broad diagnoses, such as microbiology studies as well as pathology and genetic studies, may return unexpected results that get sent to the patient portal when state law would have required counseling. For example, a culture of synovial fluid from the knee of an adolescent may return an unexpected gonococcal infection.

Without systematic delays on these types of results, laboratories and healthcare organizations will find themselves either in violation of the information blocking rule or of their own state laws.

We understand this and believe there could be real psychological harm. We encourage you to talk with your hospital about how patient-specific exceptions could be applied, and how care coordination can best be achieved. Unfortunately, these are federal regulations that pathologists need to comply with and ONC believes the benefits outweigh the harm.

We understand this and believe there could be real psychological harm. Finalized results must be made available, but –if applicable here--preliminary results do not need to be released. Also, in these cases, there may be the possibility of case-by-case exceptions.

We recognize that these new rules can put pathologists in these difficult situations. Some organizations are developing communications to address this, including by the referring physician. We encourage pathologists to engage with referring practices and organizations on how patients should be educated about their results. Pathologists could also come up with a script to respond to such calls by suggesting that the patient contact the referring clinician since the referring physician has more knowledge about what these results mean to this particular patient.

There are some state regulations that supersede the Cures Act rules. Indeed, California’s rules allow for limited delay, especially in the case of malignancy, for example. We recommend that you check with your institution and their legal counsel as to whether they have made a determination on whether/how to address conflicts between state and federal rules and regulations.

We understand this and believe there could be real psychological harm. Some organizations are developing communications to address this, including by the referring physician. We encourage pathologists to engage with referring practices and organizations on how patients should be educated about their results. No blanket exceptions are allowed but we encourage you to talk with the ordering clinicians about how patient-specific exceptions could be applied, and how care coordination can best be achieved. Unfortunately, these are federal regulations that pathologists need to comply with.

This is not a requirement of the Cures Act rules but it is possible since patients might see lab/pathology results prior to the ordering clinician(surgeon) having a chance to review, ordering clinicians might look for some workarounds. We encourage you to talk with your organization about risk management issues associated with any workaround like this, and/or whether there are any automated solutions available for such notification.

This is not a requirement of the Cures Act rules but it is possible since patients might see lab/pathology results prior to the ordering clinician having a chance to review, ordering clinicians might look for some workarounds. We encourage you to talk with your organization about risk management issues associated with any workaround like this, and/or whether there are any automated solutions available for such notification.

ONC is not currently allowing any blanket exceptions—so we cannot say that, for example, that “all transplant patient reports with donor information can be blocked.” We’d all agree this should be allowed, and this adds to our examples where we advocate to ONC that the rule needs to be more nuanced.

No, the Cures Act rules do not change the way you release results. If you have previously sent results to the referring clinician, you should continue to do so and the results will be shared with the patient through the referring clinician’s EHR.

We agree more engagement is ideal. Our planned second webinar in June will be more in the discussion format. Please join us for that.

We encourage you to see federal and state regulations about this. In short, the rule does not require private AP laboratories to have patient portals; rather, the results should be released through the ordering clinician’s EHR or directly in the patient portal for direct patient testing. Current reporting from LIS to the ordering systems with reasonable turnaround time should satisfy the requirements without a need to change or add data elements.

We agree and are advocating—along with the AMA and other groups-- for ONC to allow for limited blanket exceptions to the rule for specific situations, including the ones you mention.

There are some state regulations that supersede the Cures Act rules. We are not aware of Michigan’s specific requirements. We recommend that you check with your institution and their legal counsel as to whether they have made a determination on whether/how to address conflicts between state and federal rules and regulations.

Our interpretation is that the whole report should be released. The ONC’s definitions of “laboratory narrative” and a “pathology narrative” are somewhat confusing, but the intent of the rule is that patients have access to all of their health information.

Yes.

We encourage you to talk with your system’s legal and compliance teams about policies to support pathologists’ role in supporting patients’ right to have their information available so quickly.