Premier submitted comments in response to the proposed rules from the Office of the National Coordinator for Health IT (ONC) on interoperability, information blocking, and the ONC Health IT Certification Program and from the Centers for Medicare & Medicaid Services (CMS) on patient access to data and interoperability. Together, these proposals would make sweeping changes to consumer and provider access to information.
In its comments, Premier expressed strong support for the overall direction of the proposed rules, which are aimed at achieving nationwide interoperability, adopting data and interoperability standards and increasing access to data. Premier expressed concerns, however, with the complexities and interdependencies of the proposed approaches. Premier urged the agencies to make changes to the proposed rules to:
- Ensure that providers have increased access and availability to data at the point of care and within workflow;
- Reduce regulatory and administrative data collection, documentation and reporting burdens, as well as related costs for providers;
- Extend the proposed implementation timelines, which are inadequate for the required operational, logistical, technical, technological and organizational changes;
- Clarify proposed terms and terminology that are overly broad, ambiguous and inconsistent, will be burdensome and extremely costly to implement and are ripe for (mis) interpretation;
- Reconcile potentially conflicting federal and state laws and regulations on privacy and security, including HIPAA and substance use confidentiality regulations (42 CFR); and
- Address the potential of unintended consequences, risks and potential liabilities faced by HIPAA-covered entities and business associates related to data access, exchange or sharing that occurs outside or beyond the scope of HIPAA.
Other highlights of Premier’s comments include:
- Revisions to hospital Conditions for Participation (CoPs) to require patient event notifications. Premier does not support adding interoperability requirements within the hospital CoPs. Premier recommended that CMS use existing policy levels to achieve event notifications and urged CMS to improve existing infrastructure to support health data exchange.
- Inclusion of price as part of the definition of electronic health information (EHI). Premier urged ONC and CMS to undertake a more systematic and evidenced-based approach to leverage prior and ongoing efforts as they consider price transparency. Premier does not support adding price information to the definition of EHI and urged ONC and CMS to work with payers to make price information accessible to patients and providers.
- EHR Reporting Program. Premier expressed concerns that ONC has not yet established this Program which was required by the 21st Century Cures Act to help provider make EHR acquisition and update decisions and we urged ONC to accelerate its development and implementation.