2019 is a year of unprecedented regulatory releases and activity by federal healthcare agencies. eHealth Initiative (eHI) responded to two of the year's most significant proposed rules related to interoperability and information blocking on Thursday, May 30. Key issues highlighted in eHI’s CMS and ONC responses include:

Overarching ONC and CMS Issues

• Agency Coordination – Practical, thoughtful agency coordination between ONC and CMS on implementing programs related to these proposed rules is needed.
   
• Promoting Patient Access to and Control over Health Information – eHI expresses support for the ONC and CMS strategy to anchor their proposed rule around fostering innovation that promotes patient access to and control over their health information. eHI emphasizes that patient self-efficacy is critical in value-based payment and patient engagement/education is fundamental to that success.
   
• Patient Matching RFI – eHI supports the intent expressed in the proposed rules to identify additional opportunities in the patient matching space and explore ways that ONC and CMS can lead and contribute to coordination efforts with respect to patient matching. eHI also offers its perspectives and support on patient matching issues such as:
  • Matching solutions involving patients;
  • Adoption of well-tested demographic data standards to improve patient matching; and
  • Working with industry and experts to identify other regularly collected demographic data elements that could be incorporated into the US Core Data for Interoperability (USCDI) to support patient matching.

ONC Specific Issues

• Scope of Electronic Health Information - Given that the electronic health information definitions will form the basis for both action and penalty in our healthcare system, eHI urges ONC to further define and appropriately focus and specify the electronic health information definition for the final rule.  
   
• Conditions and Maintenance of Certification (APIs) - eHI commends ONC for selecting an innovative and flexible suite of standards and associated resources, including HL7® Fast Healthcare Interoperability Resources (FHIR®).

As with the proposed information blocking provisions, eHI urges caution given our concerns about complex and costly compliance, documentation, patient education and healthcare stakeholder risk issues related to the proposed API provisions. All parties will need to undertake significant steps to implement APIs and all stakeholders will need to work together to ensure a measured, secure, informed and realistic approach to this transition.

eHI also registers concern regarding the proposed rules’ API provisions and the associated app and attestation process, which could present risk to both providers and patients. Specifically, according to the ONC proposed rule:

APIs should require a “yes” attestation by the app that patients are provided meaningful notice and control over how their protected health information (PHI) is used to connect to the API.

eHI believes that this traditional "click yes to continue" model likely isn't enough to communicate to the patient the risk managing that data might have or to give confidence to providers concerned that patients understand the risks and benefits of this data use. Healthcare providers and others should be assured that patients comprehend the risk prior to using their data in apps and in choosing using the API.

We urge ONC to evaluate for future certification criteria, ways in which certified health IT can gather and store information specific to a patients’ understanding of the use of the data, drawing as appropriate on elements of the Model Privacy Notice created by ONC.

• Information Blocking - eHI urges a review of the very broad definitions of health care actors related to information blocking, particularly health information networks and health information exchanges. We also register caution and concern about complex and costly compliance and documentation related to the proposed information blocking provisions.  eHI expresses its willingness as a leading, multi-stakeholder national HIE resource to work with ONC on HIE issues as they evolve and grow within ONC program purview.

CMS Specific Issues

• Patient Access Through APIs (Open API Proposal for MA, Medicaid, CHIP, and QHP Issuers in FFEs) - eHI registers caution and concern about complex and costly compliance, documentation, patient education and healthcare stakeholder risk and liability issues related to the proposed API provisions. Significant steps to implement APIs will be required and all parties will need to work together to ensure a measured, secure, informed and realistic approach to this transition.

Cited as particularly aggressive are the API implementation and data availability timeframes - January 1, 2020 for MA plans and QHP issuers in FFEs, July 1, 2020 for Medicaid FFS, Medicaid managed care plans and CHIP managed care entities.

For more information, please see eHI’s detailed ONC and CMS comments attached below.