This post was contributed by David S. Hirschorn, MD, who serves on the ACR Government Relations Commission-Federal Regulatory Committee and Informatics Commission
Policymakers continue to be interested in barriers and opportunities related to interoperability and heath information exchange. The American College of Radiology (ACR) Government Relations team has worked closely with ACR Informatics to help address these issues.
In 2013, the ACR Council passed a resolution (Res. 53) directing the College to explore legislative and regulatory mandates that would promote interoperability and exchange of patient data across disparate systems and providers.
Soon after the resolution, ACR successfully advocated for the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) to strengthen the interoperability requirements of the EHR exception/safe harbor from self-referral/anti-kickback prohibitions. The goal was to ensure that EHR technology donated at low cost to referring physicians could not be legally used to discourage referrals to competitors.
In 2015, ACR endorsed legislation to expand OIG’s authority to investigate and penalize anticompetitive “information blocking” practices by dominant providers and health IT vendors above and beyond the restrictions of self-referral and anti-kickback regulations. The language evolved into Section 4004 of the 21st Century Cures Act (Cures), which was signed into law in December 2016.
In March 2019, ACR provided feedback to the Networking and Information Technology Research and Development (NITRD) Program addressing high-level questions on medical device interoperability. The ACR discussed ways NITRD-participating agencies could collaborate with other actors to improve exchange between of FDA-regulated “medical devices” and EHR technology.
After an extended delay, CMS and ONC released proposed rules in March 2019 to implement, among other things, certain key aspects of the aforementioned information blocking provision mandated by Cures Section 4004. If implemented and enforced appropriately by HHS agencies, the information blocking provision could help reduce anticompetitive practices and other nontechnical barriers to data-sharing. Additionally, the proposed rules would expand the U.S. Core Data for Interoperability to include imaging narrative data, implement requirements for vendors and payers around API-enabled access to health information, and update the requirements of ONC’s health IT certification program. (CMS NPRM summary | ONC NPRM summaries)
The long-awaited CMS and ONC proposed rules, while encouraging, are not perfect. The ACR Government Relations Commission-Federal Regulatory Committee, Informatics Commission leaders, and individual volunteers are currently reviewing the details and providing input for ACR’s future comments.
- We encourage members interested in providing feedback to contact Michael Peters, ACR Director of Legislative and Regulatory Affairs, at email@example.com within the next few weeks.
- What barriers are you facing when it comes to interoperability and data sharing in your practice?
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