On March 9, 2020, the Office of the National Coordinator for Health Information Technology (ONC), under U.S. Dept of Health and Human Services (HHS) issued its final rules on healthcare interoperability and medical record ownership and access. These rules, titled the Cures Act Final Rules, align with complementary rules proposed by the Center for Medicare and Medicaid Services (CMS) and were initially resisted by some industry associations and at least on major health record system provider because of the rules' onerous implementation deadline and vague parameters. The rules are designed to stimulate a more consumer-centered healthcare system by giving healthcare consumers the information they need to get the right care from the right provider at a price they can fit into their budget.
In an announcement published March 9, 2020, HHS declared that “these rules finally deliver on giving patients true access to their healthcare data to make informed healthcare decisions and better manage their care. Putting patients in charge of their health records is a key piece of giving patients more control in healthcare, and patient control is at the center of the administration’s work toward a value-based healthcare system.” The ONC is hosting a webinar series starting on Wednesday afternoon, Mar. 11 to explain the rules. The registration site can be reached by clicking here. For a high-level summary of the rules’ impact on developers prepared by electronic healthcare record company (EHR) Cerner, click here to visit prominent industry blog HISTalk.
Seema Verma, administrator of the Center for Medicare and Medicaid Services (CMS) is quoted in the announcement saying, “The days of patients being kept in the dark are over. In today’s digital age, our health system’s data sharing capacity shouldn’t be mired in the stone age. Unfortunately, data silos continue to fragment care, burden patients and provider and drive up costs through repeat tests.” She goes on to address industry concerns about privacy by adding, “We are holding payers to a higher standard while protecting patient privacy through secure access to their health information. Patients can expect improved quality and better outcomes at a lower cost.”
With the explicit intent to stimulate industry innovation and a more competitive healthcare marketplace, the ONC final rule also requires electronic health records to provide the clinical data necessary, including core data classes and elements, to promote new business models of care. Implementation of the new rules is to begin on Jan. 1, 2021 and full compliance is required by 2022.
Reflecting widespread industry concern about the rules and the ONC's process for finalizing them, a number of prominent providers, associations and industry partners lobbied for changes that did not make their way to the final rules. In a letter secured by CNBC to HHS secretary Alex Azar stating their opposition to the new rules, these organizations expressed concerns about patient privacy and the challenge of complying with the broad scope of the new rules in such a short timeframe. Technology companies like Apple, Alphabet and Microsoft took the opposite stance.
In its coverage of the rulemaking and the industry’s response, CNBC noted that some health IT experts had noted that the “letter has not been signed by some of the largest health systems in the Epic ecosystem.” David Brailer, the first National Health Information Technology Coordinator, appointed by George W. Bush is quoted saying, “Their absence represents a thundering silence. Many health systems are quietly discussing how the data access and data fluidity actually benefits them in the long run.
Here at Loyale Healthcare, we couldn’t agree more. And while we respect the healthcare system signers of the letter opposing the new rules, it has become increasingly clear to us that the status quo is not sustainable. It’s true that the ONC’s new rules represent a shift in the foundation of the U.S. health system’s operating model. It’s also true that market conditions - driven by consumer demand and, in some instances, outrage - has lost its patience with business as usual.
Not surprisingly, the industry’s early response to the new rules has been mixed, with stakeholders and EHR vendors releasing statements both for and against. According to an EHR Intelligence article, Epic which initially apposed the new rules for the reasons listed above, tempered its position with a statement that they would “read (the rule) carefully to understand its impact before making judgements.” Cerner, another EHR system, reiterated its support, with CEO Brant Shafer stating that, “Fundamentally, we believe healthcare is too important to stay the same.” Mr. Shafer went on to say that “Consumers should have the right to access the healthcare information their providers have about them and dictate where they want it to go.”
Organizations expressing negative opinions about the rules include the American Hospital Association (AHA) which may be considering legal action against the rules; and the American Health Information Management Association (AHIMA), whose CEO, Wylecia Wiggs Harris, expressed disappointment that “the ONC did not heed stakeholder calls to issue an interim final rule.”
We’ve written extensively about the barriers presented to patients by the current system of care delivery in the United States. Barriers whose significance cannot be overstated. This is especially true in our area of expertise, patient financial engagement. As many as one half of Americans are avoiding or delaying care because they’re worried about their ability to afford it. Lacking access to the most fundamental information used in every other financial transaction in their lives - namely cost, quality and payment options - patients have been forced to make decisions without knowledge. Too often, those decisions result in poor health and/or financial outcomes.
At Loyale, we’re fortunate to work with a number of healthcare systems who, like the systems mentioned above, “are discussing how data access and data fluidity actually benefits them in the long run.” Importantly, our clients are moving beyond discussions into execution, developing initiatives to aggregate data so it’s more useful for them and their patients. Looking ahead, it’s hard to imagine any other kind of future for healthcare.