EHR Companies Want Big Changes to ONC Proposed Rule, Innovation Barriers

The proposed interoperability rule from the Office of the National Coordinator for Health Information Technology (ONC) lacks clarity and disrupts the flow of developers, according to the Electronic Health Record Association (EHRA), the trade group that represents leading EHR vendors.

EHRA submitted its thoughts yesterday, as the public comment period for the ONC and Centers for Medicare & Medicaid Services (CMS) proposals drew to a close. Now, the agencies will review the comments and work to finalize the rules, which are slated to go into effect in early 2020.

EHRA is composed of 30 member companies, including EHR giants Cerner, Epic and Allscripts. The alliance aims to enhance the usability of EHRs, accelerate their adoption, advance interoperability and improve healthcare outcomes through the use of technology.

In recent years, EHR companies and physicians and other clinicians have often clashed. Doctors have claimed that EHR systems were designed more for billing than care, leading to inefficient workflows and more time spent on documentation. But EHR vendors have pointed to unrelated factors as the reason for physician burden, sometimes pointing to evidence that EHRs have improved healthcare.

Comments for ONC Rule

• Innovation Barriers

The proposed ONC rule could inadvertently disrupt natural market forces, EHRA argued. This could lead to a less inclusive environment where only some developers survive, forcing them to focus on regulatory compliance, Application programming interface (API) creation and pursuing patents. The members noted that the rule will deter new developers from entering the space if their work will be exposed immediately to other parties.

Being limited to charge fees beyond cost recovery could devalue the work of developers, increase recordkeeping burden and disincentivize efforts to improve efficiency, EHRA members wrote. They noted that ONC needs to engage with EHR developers to facilitate data exchange. The agency should also consult with registries and stakeholders who contribute to the costs that providers pay to exchange information.

“The breadth of the proposed rule and the complexities woven throughout — along with the numerous interdependencies and occasional conflicts with other federal or state programs and well-intended but confusing or not thoroughly explored implications of some of the proposals — create a regulatory burden,” EHRA members wrote.

• Unrealistic Timeline

A survey taken by EHRA found that members believe the rule “severely underestimates the development time required for its many components.”

EHRA proposed two criteria that could be priority areas reasonable for the timeframes:

• Updates to electronic prescribing
• U.S. Core Data for Interoperability (USCDI) APIs, which are health data classes and elements for nationwide, interoperable health information exchange.

Other criteria would need to be deferred to a longer timeline.

Members are also concerned with how the timeframe will conflict with other CMS and ONC programmatic requirements.

• Ambiguous Language Could Challenge Planning and Compliance

Vague language could lead to severe risks to stakeholders, especially if certain penalties run as much as $1 million per incident.

EHRA suggested three things to avoid room for interpretation:

• ONC should address all of the ambiguity in the final rule. EHRA suggests a second round of public comment to aid in further clarification. They wrote that the industry needs more examples in the final rule to provide for accurate interpretation. EHRA members said they would then need the opportunity to provide feedback on the additional examples before the structure is finalized.
• The establishment of an ongoing process for clarification. EHRA members want to anonymously request guidance from ONC or OIG on whether certain practices implicate information blocking. They noted that the guidance should be public, so stakeholders can benefit from the information.
• The establishment of a time period of enforcement for discretion. Doing this will allow the guidance to be propagated and for claims to be investigated in an educational manner without financial penalties.

Comments for CMS Rule

• APIs

In the feedback provided to CMS from EHRA, members wrote that they support referencing the use of common standards for payer-to-payer exchange that can also be used for provider-to-provider and provider-to-patient exchanges, based on the USCDI.

EHRA argued that building on a common USCDI could enhance the EHRs’ ability to consistently share the same data across a variety of stakeholders.

• Conditions of Participation

EHR companies support the proposal to improve care coordination and interoperability through the Conditions of Participation for Medicare- and Medicaid-participating hospitals, which requires electronic notifications when a patient is admitted, discharged or transferred. EHRA recommended requiring the inclusion of emergency departments.

EHRA requested that CMS give clarification on how a hospital’s participation would be measured if they use a third party and don’t know whether a notification reaches a participation. The agency should also clarify hospital expectations when a patient does not have a primary care provider and there is no known recipient of the notification during admission, discharge or transfer.

• Care Continuum

EHR companies agree with CMS that post-acute, behavioral health and critical access hospital care settings lag in EHR adoption compared to those who participate in Meaningful Use.

EHRA expressed concern about the feasibility of adopting and using the data segmentation standards from the proposed rule revising ONC 2015 Edition Certification. Members claimed that the timeline needs to be considered, as the adoption of the proposal is not feasible in the short term.

EHRA also recommended aligning program requirements to reduce client burden.

• Additional CMS Comments

EHR companies support the efforts to enhance interoperability and said they believe that the Center for Medicare and Medicaid Innovation could help. It would be more effective to notify experts early on, they said, to be more inclusive and enable greater program participation and success.

EHRA argued that a key component of accurate patient matching is sharing best practices on education and processes that show the need for organizations to invest in improving registration processes.

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