In Press Briefing, Federal Health Officials Outline their Goals for Proposed Rules

Feb. 11, 2019
Following the release of two very significant new proposed rules on Monday morning by CMS and ONC, federal health officials answered questions from the press on those proposed rules

In a press briefing on Monday morning, Feb. 11, senior federal health policy officials shared with journalists their aims and intentions for the two proposed rules that they had just announced to the media, and which were covered in a news report published immediately afterwards by Healthcare Innovation Managing Editor Rajiv Leventhal. The press briefing, held by telephone, came during the first day of the annual HIMSS Conference, being held at the Orange County Convention Center in Orlando.

In the telephonic press briefing, Deputy Secretary of Health and Human Services Eric D. Hargan, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, and Donald Rucker, M.D., National Coordinator for Health IT, representing the Department of Health and Human Services, CMS, and the Office of the National Coordinator for Health IT, respectively, made brief opening statements, and then answered questions about the two proposed rules their agencies had just released moments before.

As announced Monday, morning, “The U.S. Department of Health and Human Services (HHS) today proposed new rules to support seamless and secure access, exchange, and use of electronic health information. The rules, issued by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), would increase choice and competition while fostering innovation that promotes patient access to and control over their health information. The proposed ONC rule would require that patient electronic access to this electronic health information (EHI) be made available at no cost.

“These proposed rules strive to bring the nation’s healthcare system one step closer to a point where patients and clinicians have the access they need to all of a patient’s health information, helping them in making better choices about care and treatment,” HHS Secretary Alex Azar said in a statement in the agency’s press release. “By outlining specific requirements about electronic health information, we will be able to help patients, their caregivers, and providers securely access and share health information. These steps forward for health IT are essential to building a healthcare system that pays for value rather than procedures, especially through empowering patients as consumers.”

Two separate but coordinated proposed rules were released Monday morning, one from CMS—CMS 9115-P—and one from ONC—RIN 0955-AA01. Those two agencies are both components of HHS.

As noted in the announcement, “CMS’ proposed changes to the healthcare delivery system support the MyHealthEData initiative and would increase the seamless flow of health information, reduce burden on patients and providers, and foster innovation by unleashing data for researchers and innovators. In 2018, CMS finalized regulations that use potential payment reductions for hospitals and clinicians to encourage providers to improve patient access to their electronic health information. For the first time, CMS is now proposing requirements that Medicaid, the Children’s Health Insurance Program, Medicare Advantage plans and Qualified Health Plans in the Federally-facilitated Exchanges must provide enrollees with immediate electronic access to medical claims and other health information electronically by 2020.” Further, “In support of patient-centered healthcare, CMS would also require these health care providers and plans to implement open data sharing technologies to support transitions of care as patients move between these plan types. By ensuring patients have easy access to their information, and that information follows them on their healthcare journey, we can reduce burden, and eliminate redundant procedures and testing thus giving clinicians the time to focus on improving care coordination and, ultimately, health outcomes.”

And CMS Administrator Verma said her statement in the press release, “Today’s announcement builds on CMS’ efforts to create a more interoperable healthcare system, which improves patient access, seamless data exchange, and enhanced care coordination. By requiring health insurers to share their information in an accessible, format by 2020, 125 million patients will have access to their health claims information electronically. This unprecedented step toward a healthcare future where patients are able to obtain and share their health data, securely and privately, with just a few clicks, is just the beginning of a digital data revolution that truly empowers American patients.”

Meanwhile, “The CMS rule also proposes to publicly report providers or hospitals that participate in “information blocking,” practices that unreasonably limit the availability, disclosure, and use of electronic health information undermine efforts to improve interoperability.  Making this information publicly available may incentivize providers and clinicians to refrain from such practices.”

At the same time, “ONC’s proposed rule promotes secure and more immediate access to health information for patients and their healthcare providers and new tools allowing for more choice in care and treatment. Specifically, the proposed rule calls on the healthcare industry to adopt standardized application programming interfaces (APIs), which will help allow individuals to securely and easily access structured and unstructured EHI formats using smartphones and other mobile devices. It also implements the information blocking provisions of the 21st Century Cures Act, including identifying reasonable and necessary activities that do not constitute information blocking. The proposed rule helps ensure that patients can electronically access their electronic health information at no cost. The proposed rule also asks for comments on pricing information that could be included as part of their EHI and would help the public see the prices they are paying for their healthcare.”

And the press release quoted Dr. Rucker as stating that, “By supporting secure access of electronic health information and strongly discouraging information blocking, the proposed rule supports the bi-partisan 21st Century Cures Act. The rule would support patients accessing and sharing their electronic health information, while giving them the tools to shop for and coordinate their own health care. We encourage everyone – patients, patient advocates, healthcare providers, health IT developers, health information networks, application innovators, and anyone else interested in the interoperability and transparency of health information – to share their comments on the proposed rule we posted today,” Dr. Rucker said.

In the press briefing Monday morning, Deputy Secretary Hargan, Administrator Verma, and National Coordinator Rucker offered further insights as to their agencies’ thinking in this process, and answered questions from the press.

“These proposals today contain a number of historic steps forward,” Hargan said. “Most importantly, we’ve proposed requirements that will allow individual patients to securely and easily access their health information, including through apps on their mobile phones.” He expressed strong support for the development of standards-based APIs, saying that “We believe that empowering patients with this access will… enable the private sector to develop an ecosystem of applications” that will support informed healthcare consumers. “Patients cannot act as consumers and rive value without easy access to their health data,” he said, and the release of these two new proposed rules furthers “part of HHS’s mission to improve the health of every American.”

In following up on Hargan’s comments with a statement of her own, Verma said, “I share your commitment to move towards a healthcare future where patients are able to obtain and access their healthcare information with just a few secure clicks. Together, these two ground-breaking rules will give [healthcare consumers] access to their data in a seamless format.” What’s more, she said, “Our nation is in the midst of the greatest healthcare challenge in perhaps our entire history. If nothing is done to curb our costs by 2021, we will be spending one in five dollars on healthcare.” She stated her firm belief that empowering healthcare consumers with their patient data could revolutionize the healthcare system, by encouraging them to investigate cost and quality information and to become more engaged in their patient care.

And Rucker told the press that “ONC has in our rule, highly synchronized with the CMS rule, we’re putting the technical underpinnings that were asked for in the 21st Century Cures Act, from Congress. We are requiring standards-based APIs as the underlying foundation of getting patients their medical record so that they control it, in a modern app, smartphone kind of way, and putting in a lot of elements to ensure security and privacy.” Information-blocking has been a target for federal healthcare officials, and has been “much talked about but not yet enforceable. We put in specific exceptions for privacy, security, patient harm, but more importantly, provides a reasonable set of pricing structures,” into the ONC proposed rule. “We’ve heard a lot of concerns that the interoperability is technically there, but that because of pricing concerns, the APIs are not effectively available. This proposed rule will stop that,” he said.

“In addition,” Dr. Rucker said, “this administration is extremely interested in transparency. There are two kinds of transparency to think about: one is transparency for the product—what are you getting when shopping? The other part is pricing information. And we have an RFI in our proposed rule. It turns out that getting pricing information transparent is very complicated and has a huge structure behind it. We’re exploring how to unlock that kind of information.”

The three federal healthcare officials then answered questions from the members of the press who were assembled by telephone.

In response to a question on the requirement for hospitals to notify other providers of discharges and transfers, and the potential cost impact involved in that requirement, Verma said, “The rule would go in effect in 2020, there is a regulatory impact element around cost impact. We also think that this is a very important step in terms of improving patient safety and quality,” based on the potential ability to avert duplicative tests, for example. “We think this can actually lead to reduced costs because of reduction of duplicative tests and because of more coordinated care,” she said.

When asked how federal healthcare officials would “expose bad actors,” as Verma had referred to it in her remarks, Verma said, “Verma: Providers have to attest to whether they’re blocking information or not under MIPS”—the Merit-based Incentive Payment Program. “We proposed this last year under MIPS and the hospital rule last year. There will be three questions that they will be required to answer around information blocking, and if they answer yes to any one of those, we will publishing that data.”

In response to a question from a reporter on how the rules, once implemented, might change life for Medicaid recipients and dual-eligibles (individuals eligible for both Medicare and Medicaid coverage), Verma said, “Depending on where the patient is, oftentimes, the patient might leave the doctor’s office with nothing other than a prescription. So we’re allowing the patient when they leave to get that information in an electronic format. Today, some providers might make information available through a patient portal. This allows the patient to aggregate all that data. Because it’s going to be in an API format, they can potentially aggregate data available in one place,” from multiple patient portals. “And 1,500 app developers are developing tools in this area,” she added. “We think this will increase patient engagement around tools—organizing medication information or information around preventive care visits; and they can simply give information to a new provider. Often, when patients go to a provider, they’ll ask what medications they’re on, have they had certain tests, and often, it’s hard for patients to remember that information. This aggregates that information. Physicians aren’t duplicating tests, and have information more easily.”