by adgrooms on January 30, 2020

In our last post, we looked at the how proposed interoperability rules were getting some pushback. We have also written a post about proposed interoperability rules in the past that are a different set of rules. So, there are two different sets of rules from two different agencies. This prompted some questions for us about the differences. Why two different rules? Will they work together? Who is involved?

The rules originate from the 21st century cures act, signed into law in December of 2016. It requires department of Health and Human Services (HHS) to "establish a goal, develop a strategy, and make recommendations to reduce regulatory or administrative burdens relating to the use of electronic health records (EHR)." Specifically, the departments in the HHS umbrella that are enacting the rules are the Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) were directed in the bill to take action on interoperability.

The ONC rule addresses "conditions and maintenance of certification requirements for health information technology (health IT) developers". The certification requires that IT developers don't engage in information blocking and make their systems able to send and receive information "without special effort". Information blockers may be publicly named in an effort to end the practice. It proposes patients be able to access their health data via secure APIs at no extra cost. ONC is also coordinating with private entities to set up TEFCA (Trusted Exchange Framework and Common Agreement) that is supposed to connect providers, health plans, individuals, and other health neworks into a nationwide network.

The CMS Rule addresses interoperability by requiring insurers to allow patients on Medicare Advantage, Medicaid, the Children's Health Insurance Program, and Affordable Care Act health plans immediate access to claims. It also also requires access to diagnoses, procedures, tests and providers that a patient has seen. It proposes that payers and providers join a trusted exchange network so that they can send patient information nationwide an allow patients to move between plans more easily. CMS can also penalize information blockers through fines and publicly naming the blockers. The CMS rules propose using standardised language that the ONC is proposing for their certification of healthcare IT.

CMS and ONC address different aspects of healthcare, but they aim to align in advancing interoperability by looking at the technical and industry problems together. CMS is looking to give more power to patients to control their data while ONC is working on the standards and connectivity issues.

The information of the rules and the organization of the government entities are complex. This is our best attempt to get a basic understanding of the workings of interoperability from a regulatory viewpoint. While advancing interoperability is needed in healthcare, sometimes regulations have unintended negative consequences. The best approach for institutions and healthcare technology stakeholders is to be knowledgeable on the proposed rules and get involved in the process. These rules will have a lasting impact on the healthcare system.