As healthcare leaders continue to digest two major proposals aimed at boosting interoperability and patient access, many are concerned that compliance with the rules, which could go into effect in 2020, will be expensive for providers and might stifle technology innovation.
Last month, ONC finally unveiled its 724-page information blocking rule (PDF), and CMS released a proposed rule (PDF) taking aim at data blocking.
CMS is proposing to require Medicare Advantage organizations, state Medicaid and CHIP fee-for-service programs, Medicaid managed care plans, CHIP managed care entities and QHP issuers in FFS programs to implement, test and monitor openly published FHIR-based APIs to make patient claims and other health information available to patients through third-party applications and developers.
The ONC rule, which was mandated by the 21st Century Cures Act, defines exceptions to data blocking and fines that may be associated with the practice. In its proposed rule, ONC is calling on the industry to adopt standardized APIs, specifically FHIR, to help allow individuals to securely and easily access structured electronic health information using smartphone applications.
The use of APIs is a key component in both the CMS and ONC rules, said Jeff Coughlin, senior director of federal and state affairs at the Healthcare Information and Management Systems Society (HIMSS) during a roundtable conference call with reporters on Thursday. “APIs are seen as a way to level the playing field to provide patients more control over their information,” he said.
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At the same time, the lack of standardization of APIs will make compliance with these proposed requirements a challenge, said Tom Leary, vice president of government relations at HIMSS, noting, in particular, the mandate to provide “patient access without special effort.”
“The closer we get to focusing on version 4 of FHIR, or version 5, if that is up when the rules are final, that’s going to be a key component,” he said.
Standards organization Health Level Seven (HL7) published Release 4 of its FHIR standard in January, marking the first release with normative content. Creating and publishing normative content is critical for allowing health IT developers to implement FHIR consistently and uniformly, according to HL7 officials. FHIR is a standards framework that leverages the latest web standards.
Providers concerned with cost, burden of compliance
HIMSS has not yet drafted its comments to ONC and CMS on the proposed rules, but HIMSS leaders have spent the past month “peeling back the onion” and getting feedback from HIMSS members, Coughlin said.
“One issue that has been raised is what we are looking at to meet all the proposed requirements, particularly in the ONC rule, and what is the compliance cost for providers to meet the requirements? With limited resources, across the developer community and the provider community, is meeting compliance going to stifle innovation?” Coughlin said.
Coughlin added, “We want to make sure there is still an opportunity for new market entrants to come into the field to think about how to share information. And the players who currently exist, are they going to spend an inordinately large of amount of time trying to comply and not be able to think for their own organization?”
Healthcare stakeholders are also concerned about an increased burden on providers to comply with the rules. “The burden issue is something that we have to think about with providers setting up new systems and setting up new interactions with entities they have not necessarily interacted with in the past,” Leary said.
“It’s a narrow tightrope the administration is walking here with trying to balance pushing Medicare and Medicaid providers down that path of value-based care and patient access to data without unduly burdening them,” he said.
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All sectors of the healthcare ecosystem will be impacted by these rules, Coughlin noted: “Between the two rules, CMS and ONC are trying to use every available policy lever to push interoperability and data exchange forward. We got a taste of what direction CMS was heading in when the MyHealtheData initiative was announced in 2018. This rule highlights the intention of the agency.”
During the call, Coughlin and Leary drilled down on significant aspects of the two rules and HIMSS members' concerns:
- Proposed budget cuts to ONC, OCR: Budget cuts to ONC and the Office for Civil Rights (OCR), as currently proposed in the Trump administration’s 2020 budget plan, could hinder the agencies’ efforts to enforce the information blocking rules. The proposed federal budget includes a 17% cut to ONC, from $60 million to $43 million, and a 25% cut to OCR’s budget. HIMSS members are concerned about the commitment of resources to ONC and OCR given the heavy lift of implementing and enforcing the rules, Coughlin said.
- Trump administration weighs publicizing negotiated rates: Buried in the ONC rule is a request for comment on the types of pricing information, including negotiated prices between providers and payers, that should be included as part of electronic health information regulated by the information blocking rule. The request for public comment lays the groundwork to potentially require hospitals and doctors to publish those negotiated prices, Leary said. “We’re trying to drill down and figure out if that’s an appropriate step to take,” he said. The move is in line with CMS’ focus on pricing transparency, he noted.
- Timelines: HIMSS has not called for an extension of the review period, as other industry associations have done, but HIMSS members are concerned about the timeline between when the final rule is published and when the rules go into effect and whether there will be sufficient time for organizations to come into compliance.
- Impact on hospitals and health systems: Under the CMS proposed rule, hospitals will be required to send admission, discharge, and transfer notifications as a condition of participation for Medicare and Medicaid, a requirement the American Hospital Association has publicly opposed. “That’s a major step,” Coughlin said. “Nearly all the provisions of the ONC rule impact providers and health systems in some way.”
- Impact on HIEs: The ONC rule did not include a second draft to TEFCA, the agency’s Trusted Exchange Framework and Common Agreement that aims to establish a framework and common agreement around data sharing. The CMS and ONC rules set a pathway for patients to gain access to their data directly with healthcare facilities. “What is the role of HIEs as we become more focused on the exchange between provider entities? It sets HIEs up for, maybe not soul-searching, but it is a shift,” Coughlin said.