Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry

The Centers for Medicare & Medicaid Services (CMS) published a proposed rule on March 4 to help patients more easily access their complete health information in interoperable forms across programs that CMS administers (the Interoperability Rule). In the rule’s preamble, CMS lays out a vision of an environment in which a patient’s health information can move seamlessly between health plans, providers, and post-acute care settings. CMS observes that while adoption of electronic health records (EHRs) by healthcare providers has been significant, progress on interoperability needs to be accelerated. The Interoperability Rule fact sheet is available here. While there are several new proposals and requests for information in the 71-page document, this post provides an overview of two of the Interoperability Rule’s proposals.

Patient Access Through Application Programming Interfaces (API). CMS proposes to require Medicare Advantage plans and certain other programs to adopt and implement an “openly published” API that permits, at the direction of the patient, third-party software applications to retrieve a significant amount of clinical and payment information. In addition to Medicare Advantage plans, the rule would apply to Medicaid state agencies, Medicaid managed care plans, CHIP agencies, CHIP Managed Care entities, and issuers of qualified health plans in Federally-Facilitated Exchanges, except for standalone dental plans (Covered Programs).

The information to be made available through these Covered Programs’ API would consist of (1) data concerning adjudicated claims; and (2) clinical data, including laboratory results, if the Covered Program manages such data. This API would be publically accessible on a Covered Program’s website. CMS proposes requiring Covered Programs’ compliance with this requirement in2020.

Modify the Hospital Conditions of Participation (CoP). CMS proposes to modify the CoPs for hospitals, Critical Access Hospitals, and other hospital classifications to require these participating hospitals to send electronic patient event notifications upon a patient’s transition to another provider or care setting. The notification would include the patient’s basic personal information and diagnosis. Electronic patient event notifications from discharging providers to a receiving facility could improve care coordination by making a receiving provider aware of the care the patient has received elsewhere. The Interoperability Rule does not establish a defined timeframe for adopting these new CoPs, and instead requests suggestions regarding a reasonable timeline.

Requests for Information. In addition to the proposals, CMS is requesting specific feedback and commentary on how CMS can more broadly incentivize the adoption of interoperable health information technology systems for use in long-term and post-acute care settings, and the role of improving patient matching through data interoperability between health information technology systems.

The Interoperability Rule is complemented by a separate but aligned proposed rule (ONC Proposed Rule) issued by the US Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC). The ONC Proposed Rule would implement parts of the 21st Century Cures Act relating to (1) advancing interoperability; (2) supporting the access, exchange, and use of electronic health information; and (3) prohibiting information blocking. For educational resources on the ONC Proposed Rule, see the dedicated ONC webpage, which includes fact sheets, public webinar information, and comment submission instructions.

HHS states that the Interoperability Rule and ONC Proposed Rule address both technical and healthcare industry factors that create barriers to the interoperability of health information and these proposed rules are meant to align requirements for payors, healthcare providers, and health IT developers to help drive an interoperable health IT infrastructure across systems. If these proposed rules are finalized, it is likely that the changes will result in payors, healthcare providers, and health IT developers making significant investments in their health information technology to comply with the new requirements. Comments to both the Interoperability Rule and ONC Proposed Rule are due to CMS and ONC, respectively, by May 3, 2019.