The State of Healthcare With the Cures Act Final Rule

Our industry and our lives were turned on their sides as we dropped everything to urgently respond to the COVID-19 pandemic. We’re still in the middle of a race to get providers personal protective equipment (PPE), scale telehealth, and ensure hospitals have the beds and ventilators to treat those with the most acute needs. Lots of priorities have shifted, lots of resources have been mustered. And while we must continue to respond to the pandemic, we also need to look ahead to “Our New World,” one where we see the virtualization of healthcare, the need to break down information and workflow barriers in how we deliver healthcare — whether legal, technical, or physical — and think about how patients play an increasing role in the healthcare system.

One game-changing element for patients has already been enabled with the recent passing of the Cures Act Final Rule.

The History of the 21st Century Cures Act & Meaningful Use

Earlier this year, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information (ONC) released the Cures Act Final Rule, which will require providers and health plans to provide their patients with access to their health information from a device or application of their choosing, including smartphones. The final rule will implement the technology provisions outlined in the 21st Century Cures Act, which President Barack Obama signed into law in 2016. Particularly, it requires common protocols to facilitate communication between patients and providers. It will also grant patients the right to electronically access all of their electronic health information, structured and/or unstructured, at no cost, for example, using a third-party app of their choice.

The HIPAA Privacy Rule and various iterations of “meaningful use” (MU) forced our industry to share more data with patients. Sharing clinical data directly with patients was a mind-blowing thought to many at the time, and a lot of work went into unlocking patient’s information. MU pushed providers to take the first steps in actively engaging patients in their healthcare: to become informed participant members of their own personal care team.

The MU mandates, though well-intended when introduced nearly 10 years ago, resulted in myriad patient-facing portals and websites. Patients are expected to use these patient portals and register, navigate, and consume their data to comprehensively understand their health. However, unless a patient receives their care from a single health system that maintains all their providers, labs, services, and programs in a single, fully integrated platform with a single patient portal (ahem, Epic MyChart), they cannot reasonably assemble a cohesive picture of their health — unless they happen to be experts at IT, clinical informatics, information security, and also have a lot of time on their hands.

The Cures Act tells us it is time for the next iteration.

Meeting the Needs of Today’s Consumer

The Cures Act builds an environment whereby a patient can choose their own technology tools to assemble a secure, comprehensive view of their health that the average Joe can access. It will be some time before we see an app for this, but imagine a patient scrolling through an integrated dashboard view of all their recent visits to various providers, or getting a notification when it’s time for a flu shot or appointment regardless of the facility. This user experience mirrors Kayak in the travel industry, or Mint, Intuit’s financial health app, in how the experience provides an overview, notifications, and tips for your financial health across all institutions. Ultimately, patients will have the greater transparency necessary to make truly informed healthcare decisions.

However, the demand for interoperability comes with significant changes in the healthcare landscape for providers, payers, health systems, and patients:

• Payers are required to adopt certified application programming interfaces (APIs) that the patient can securely access through technology of their choice, without help from the source system. The rules help ensure that the technology will be affordable for providers and health systems.
• Certified electronic health record (EHR) technology must support certain fast healthcare interoperability resources (FHIR, though FHIR has already made significant progress).
• Technology and service vendors cannot charge excessively for this interoperability.
• The final rule lays groundwork to prevent health IT developers from taking any actions or implementing any tools that will disrupt a patient’s access to their information or otherwise be a barrier to interoperability.

Secretary of Health and Human Services Alex Azar summed up the implications of the rule beyond the technology provisions as placing the patients back in control of their health: “These rules are the start of a new chapter in how patients experience American healthcare, opening up countless opportunities for them to improve their own health, find the providers that meet their needs, and drive quality through greater coordination.”

In terms of when these changes will take place, the rules are not expected to take effect until 2021 or 2022. CMS has given a general timeline for providers and health systems to adopt specific certifications and technology defined in the final rule, however, the timeline may be adjusted in response to the COVID-19 pandemic.

As CMS establishes new guidelines, we can hope that in the next year or two, we will accomplish the goal of having standardized, cost-efficient, secure ways to improve our providers’ workflows and patient care.

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