SB 922 and the Cures Act: Practical guidance for managing sensitive test results in EHR systems

BY Jordan T. Vogel, Esq., and Phuong D. Nguyen, Esq., Brown & Fortunato, P.C.

Last year, we wrote about the information blocking provisions of the 21^st Century Cures Act (“Cures Act”) and an available three-day exception to the Cures Act’s immediate electronic release requirements applicable to certain test results under Texas Senate Bill 922 (“SB 922”). To build on these concepts, this article addresses the scope of SB 922 and practical guidance for implementing electronic health record (“EHR”) systems that take advantage of the Cures Act’s exception for information blocking required by law.

Brief Recap of the Cures Act and SB 922

The Cures Act prohibits the practice of “information blocking,” which is defined as a practice, except as required by law, that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information. In practice, the Cures Act obligates providers to immediately release electronic health information to patients except under limited circumstances, or as required by law. Unfortunately, the Cures Act’s requirement to immediately release electronic health information, including test results, created circumstances where patients received test results with serious health implications without the benefit of provider counseling or interpretation.

 

To address this situation, the Texas Legislature enacted SB 922. SB 922 created a brief three-day window for providers to withhold “sensitive test results” to allow providers the opportunity to contact patients to discuss certain test results before the EHR system automatically released them. As long as a provider withholds test results consistent with SB 922, the provider avoids potential violations of the Cures Act and its related penalties. On the flip side, where a provider withholds test results outside the scope of SB 922, the provider is subject to the Cures Act and risks violating federal information blocking rules. Therefore, it is important for providers to “get in the weeds” and understand the scope of SB 922.

 

“Sensitive test results”

The scope of SB 922 is limited to “sensitive test results” – defined as a “pathology report or radiology report that has a reasonable likelihood of showing a finding of malignancy” or a “test result that may reveal a genetic marker.” A test result must be withheld for three days after the test is final if it meets the definition of “sensitive test results.”

 

Given this, providers must ensure that they are only withholding test results that meet the definition of “sensitive test results.” The possibility of overinclusion is real as a test result that might ordinarily be considered sensitive might not meet the definition provided in SB 922.

 

Pathology report or radiology report with a reasonable likelihood of showing a finding of malignancy

To determine whether a test result would qualify as a sensitive test result, providers must first ask whether a pathology or radiology report has a reasonable likelihood of showing a finding of malignancy. The statute does not define the term “malignancy.” Under ordinary use, malignancy tends to refer to cancerous cell growth or tumor capable of invading nearby tissue. So, for instance while a sensitive test result under SB 922 likely includes tests used in the diagnosis or detection of cancer, tests for sexually transmitted diseases may not qualify as sensitive test results under SB 922 because such test results, although serious, are not typically directed at finding malignancy. Until the term is better defined, providers should use their professional medical judgement in determining which tests are reasonably likely to show a finding of malignancy.

 

Test result that may reveal a genetic marker

The second class of test results that may be considered a “sensitive test result” is more easily understood. Put simply, if a test result may reveal a genetic marker, such as a molecular (DNA‑based) genetic test result or a tumor genomic profiling test result, such test results must be withheld for three days after a test result is final. In contrast, test results that do not reveal a genetic marker, like laboratory, microbiological, and functional test results, are not “sensitive test results,” and should be disclosed pursuant to the Cures Act.

 

Implementing SB 922

Given the limited scope of SB 922, providers must classify tests precisely to avoid improperly withholding non‑covered results. We recommend that providers take the following steps to ensure the proper classification of test results under SB 922:

 

1. Determine (a) what pathology or radiology reports the provider orders that can show a finding of a malignancy, and (b) what tests the provider orders that may reveal a genetic marker. For any tests that cannot be classified in one of these two categories, the provider’s EHR system should be configured to immediately release the test results when they are final, absent extenuating circumstances that allow withholding under the Cures Act.
2. For pathology and radiology reports that can show a finding of a malignancy, EHR systems should be configured to withhold the result for three days after the date the result is finalized.
3. For tests that may reveal a genetic marker, EHR systems should be configured to automatically withhold test results for three days after a test result is final.

 

Besides the proper classification of test results, providers should also consider the following recommendations aimed at aligning a provider’s operations with the intention of SB 922:

1. Pathology, radiology, and genetic test results should be subject to prompt review to ensure adequate time for patient outreach before the results are released by the EHR system. Organizations should assign responsibility for outreach clearly, whether to the ordering provider, a covering clinician, or a care coordination team, and may want to consider implementing scripts or templates for consistent communication.
2. Staff should be trained and know why certain results are delayed, how to handle calls from patients who ask about missing or delayed results, and how to document outreach attempts. During pre‑test counseling, clinicians may explain that certain results may be communicated by phone before they appear in the portal.
3. Providers should monitor compliance with the law and refine their implemented processes. Implementation of the 72-hour withholding period may reveal bottlenecks, like delays in reviewing reports, inadequate documentation, or inconsistent classification of test types. Periodic audits will help identify where improvements are needed.

 

Conclusion

While SB 922 gives providers options on how to convey sensitive news to patients in these circumstances, clear policies and safeguards are critical to ensure that providers satisfy the requirements of SB 922 and remain compliant with the Cures’ Act.