More Comments Pour in on Feds’ Interoperability Rules; One Coalition Calls for ONC Proposal to be Rescinded

June 4, 2019
Stakeholders are concerned with the aggressive timelines outlined by ONC and CMS in their proposed rules

As stakeholder comments continue to pour in on ONC’s and CMS’ proposed interoperability rules, one group— Health Innovation Alliance (HIA)—is formally calling on ONC specifically to rescind its regulation.

The two proposals released in February—about 1,200 pages combined—look to further advance the nation’s healthcare interoperability progress. They represent great significance for health IT stakeholders, who will now be more under the microscope than ever before as it relates to their efforts in making sure that health information is seamlessly moving—while not restricting such efforts.

But the Health Innovation Alliance—formerly called Health IT now and representative of patient groups, providers, employers, insurers, and startup innovators—attests in a letter to federal officials that the information blocking exceptions to the proposed rule are so vague that "they will produce a market worse than today's status quo." The coalition further explains that the rule extends beyond the scope of the 21st Century Cures Act and runs counter to Congressional intent by granting ONC (the Office of the National Coordinator for Health IT) unprecedented new regulatory authority.

According to federal officials, the proposed ONC rule implements the information blocking provisions of the 2016 Cures Act, which defined information blocking as interfering with, preventing, or materially discouraging access, exchange, or use of electronic health information.

The new ONC rule proposes seven exceptions to the definition of information blocking. As it outlines, there are four specific healthcare “actors” regulated by the information blocking provision: providers, certified health IT developers, HIEs (health information exchanges) and HINs (health information networks). The seven proposed exceptions include: preventing harm; promoting the privacy of EHI; promoting the security of EHI; recovering the costs reasonable incurred; responding to requests that are infeasible; licensing of interoperability elements on reasonable and non-discriminatory terms; and maintaining and improving health IT performance.

HIA specifically wrote in its letter to ONC, “The categories –security, privacy, etc. –may be appropriate, but the lack of clarity and specificity, and sweeping and broad exceptions are troubling. Because the exceptions are so broad, we are deeply concerned that many of these exceptions will become organizational policy and ingrained practices. As a result, information blocking will persist.”

However, the letter did note that many of these issues can be addressed through clarification of the exceptions. For example, one of the troubling aspects of the proposed rule, per HIA, is that the broad definition of EHI paired with a broad definition of a health information network “could have chilling effects on innovation and significantly burden organizations that were not intended to fall under the information blocking provisions.”

As currently defined, according to HIA, “the rule would apply to social networks, such as Facebook, Twitter, Google; cloud-based service providers; community-based support organizations; and almost any system where electronic information is exchanged. It will also draw-in community-based support organizations who may hold health information, but whose main activity is not providing clinical services, such as Meals on Wheels, Area Agencies on Aging, and disease support groups.” As such, HIA recommends that ONC revise the definition for “health information network” to focus on actors that have EHI exchange authority, influence interoperability functionality, and are custodians of EHI data.

HIA also took issue with the ONC exception that allows actors to continue blocking information if complying with a request to access, exchange, or use EHI would impose a substantial burden on the actor that is unreasonable under the circumstances. The group wrote, “Because circumstances change, doctors, patients, and others must continuously seek clarity about whether their situation means blocking can continue. Such gaping loopholes to information blocking will become the norm, not the exception.”

In the end, HIA concludes that the rule "should be rescinded by HHS, reviewed, and divided into appropriately targeted rules so that the administration can revise the proposals and fashion new rules that promote innovation and eliminate information blocking consistent with Congressional intent."

Regarding the CMS (Centers for Medicare & Medicaid Services) rule, which is proposing to require health plans 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, HIA similarly wants the proposal to "be clarified and implementation timelines adjusted, so that payers and other actors can meaningfully accommodate the new requirements."

The letter to CMS noted, “Plans may require more time to make information available in a format that can be shared via API. Technology is constantly evolving, and technology used to store beneficiary data five years ago is vastly different than today. Given the amount of data payers hold, we urge CMS to take this into consideration when finalizing a timeline for this requirement. We are also concerned that the proposed requirement that plans make claims data available via API in one business day is also unrealistic.”

Similarly, in comments sent in to the government this week, the American Medical Informatics Association (AMIA) stated that while it supports the API proposals, the government’s timelines were too aggressive, given the state of standards development and adoption. For instance, CMS would have required the adoption of new data standards proposed by ONC as part of the U.S. Core Data for Interoperability by January 2020. But ONC is not expected to require certified health IT to generate such data until January 2021 at the earliest, AMIA noted.

To address these issues, AMIA recommended CMS establish a phased approach, beginning July 2020, to require payer data be made available to beneficiaries via open API. The first phase would include claims and encounter data; the second phase would include clinical data and lab results; and the third phase would include drug benefit, pharmacy directory, and formulary data. AMIA noted that CMS may want to consider the use of ONC’s Certification Program to align standards and implementation decisions across stakeholders who generate and use these datatypes.

“We applaud CMS for their proposals to improve beneficiary access to health plan data,” said Peter J. Embi, M.D., AMIA Board Chair, and President and CEO, Regenstrief Institute, Inc. “But we must install deliberate processes and sensible timelines to ensure these data are useful for beneficiaries.”

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