21st Century Cures Act – Landmark legislation for healthcare
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is perhaps one of the most important pieces of healthcare legislation to date. The Cures Act contains a wide range of provisions, including authorizing funding for public health programs and medical research, accelerating drug and device development, advancing health IT interoperability, addressing information blocking, and improving patient access to health data. In 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) enacted the Cures Act through two separate regulations directed towards both payers and providers in order to address the need for patients to be able to access their own health data.
CMS and ONC regulations to improve patient access to health information
The CMS Interoperability and Patient Access final rule for payers requires that they make the following available to patients:
- Clinical data that payers maintain, formatted to the United States Core Data for Interoperability (USCDI) v1 standards; and,
- Claims information through a Fast Healthcare Interoperability Resources (FHIR)-based Application Programming Interface (API).
These requirements apply to health data with a date of service on or after January 1, 2016. While these requirements were initially scheduled to go into effect on January 1, 2021, enforcement has been delayed until July 1, 2021 due to the COVID-19 pandemic.
The ONC’s Cures Act rule discourages practices from participating in information blocking, or, in other words, interfering with patient access to, as well as exchange or use of, electronic health information. Information blocking includes actions such as delaying the response to a patient’s request for health data, charging unnecessary and unsubstantiated fees for data access, or requiring written consent before sharing patient health data for treatment purposes. The compliance date for providers to implement a FHIR-based API for patient access has been delayed until April, 5 2021; however, providers were to have granted unobstructed access to patient health data as of November 2, 2020.
Challenges for payers, providers, and patients
Implementing the CMS rule may be challenging for payers unaccustomed to providing the breadth and depth of information required. In addition, it may be difficult for those unfamiliar with implementing patient access APIs, not to mention the time and resources that will be required to support this new technology and respond to patient queries.
Providers must also supply patients with a more complete picture of their medical records. As a result, patients, now equipped with more health information, may come to the clinician with additional questions, necessitating more time and effort to furnish appropriate answers. There are exceptions in the ONC rule for reasonable and necessary activities to protect privacy, security, or potential harm. Nevertheless, providers will need to be mindful of whether or not a refusal to fill a request could be deemed information blocking.
While more of the data in their healthcare record must now be made available to patients, there are no requirements that the information be made understandable to patients. Patients want to be able to verify their records for accuracy, track results from past procedures, and review financial data. With these new regulations, they will also need help making sense of their data. Powerful data normalization tools to help translate complex clinical and administrative terminologies to more “patient-friendly” language will help support productive communications between patients, payers, and providers. How and when such solutions are developed and implemented will greatly impact the efficacy of the above-mentioned rules.
For more background on the Cures Act, download IMO’s white papers, Interoperability, information blocking, and the coming data tsunami and The 21st Century Cures Act in the age of COVID-19.