Recently, the transparency provisions of the 21st-Century Cures Act have raised several questions and concerns for health care providers. Although passed in 2016, the Cures Act did not become effective until April 5, 2021. The first attestation of compliance is April 5, 2022. Below, we explore some of the most commonly asked questions regarding the Cures Act.
For Whom Does the Cures Act Apply?
The three categories of “actors” defined by the Office of National Coordinator for Health Information Technology (ONC) include: health care providers, the Health Information Network or Health Information Exchange, and Health IT Developer of Certified Health IT.
What are the Cures Act Requirements?
The Cures Act generally allows patients/families/guardians (collectively referred to as “patient”) to access, exchange, or use electronic health information (EHI).
At what point in the episode of care must EHI be made available to the patient?
Clinical notes and laboratory results pending confirmation are examples of data points that may not be appropriate to disclose or exchange with the patient until finalization. However, if that data is used to make health care decisions about an individual, then it would fall within the “designated record set” and therefore within the definition of EHI. To the extent that a data point falls within the definition of EHI, practices likely to interfere with legally permissible access, exchange, or use of that EHI may implicate the information blocking definition.
What materials are required to be accessible?
There are eight mandatory categories of clinical notes that must be made available to the patient:
- Consultation notes
- Discharge summary notes
- History and physical examination notes
- Imaging narratives
- Lab report narratives
- Pathology report narratives
- Procedure notes
- Progress notes
It’s important to keep in mind that the level of detail required in disclosed notes has not been finalized. It is likely true that the above categories can be manipulated for safety. For example, rules require the disclosure of EHI. However, the name of the nurse who wrote the progress note is not EHI. The name of the provider must be disclosed, but disclosing the names of those who took the X-ray, drew the patient’s blood, or hung the IV line is not necessary to convey the essence of the information to the patient. In short, the record revealed to the patient should be concise, accurate, and factual.
What are “blocking” provisions, and what are information blocking practices?
Blocking provisions impede or preclude a patient’s access to their EHI. However, there are many valid reasons for blocking a patient’s access to EHI listed as exemptions to the access requirements. Information blocking practices considered blocking include:
- Practices that restrict authorized access, exchange, or use under applicable state or federal law of information for treatment and other permitted purposes, including transitions among certified health information technologies (health IT)
- Implementing health IT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using EHI
- Implementing health IT in ways that are likely to restrict access, exchange, or use of EHI with respect to exporting complete information sets or in transitioning between health IT systems; or lead to fraud, waste, abuse, or impede innovations and advancements in health information access, exchange, and use, including care delivery enabled by health IT
How is the Cures Act enforced?
Enforcement of the information blocking regulations depends upon the individual or entity that is the subject of an enforcement action or actor. For health IT developers and health information networks/HIEs, the HHS Office of the Inspector General is presently engaged in rulemaking to establish enforcement dates. Currently, for health care providers, HHS must engage in future rulemaking to establish appropriate disincentives as directed by the Cures Act.
After April 5, 2021, any actor’s agreements, arrangements, or contracts are subject to and may implicate the information blocking regulations. All health care providers should review their contracts and agreements for health care portals and electronic medical records to ensure compliance with the Cures Act. Because many health care providers are not also IT experts, each vendor who supplies software or products that may affect EHI handling should submit a statement affirming or certifying the product’s compliance with the Cures Act.
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Download OmniSure’s FAQ Sheet
To read more about other important stipulations to the 21st Century Cures Act, please download OmniSure’s 21st-Century Cures Act Sheet. If you are still unclear of these new laws, OmniSure is here to help. Do not hesitate to reach out or call 800.942.4140 for support when situations or questions about your professional practice arise.
