Industry group Health IT Now, a coalition of healthcare and technology companies, responded today to the Trump Administration's latest missed deadline for publication of a proposed information blocking rule as required under the 21st Century Cures law.
The proposed rule was sent by the Office of the National Coordinator for Health IT (ONC) to the Office of Management and Budget (OMB) on September 17, 2018, setting off a 90-day timeline for the agency to complete its review; a period which was now expired without publication of a proposed rule, according to Health IT Now.
The onus to publish the regulation falls on ONC, the health IT branch of the federal government that is tasked with carrying out specific duties that are required under the 21st Century Cures Act, which was signed into law in December 2016. Some of the core health IT components of the Cures legislation include encouraging interoperability of electronic health records (EHRs) and patient access to health data, discouraging information blocking, reducing physician documentation burden, as well as creating a reporting system on EHR usability.
The information blocking part of the law has gotten significant attention since many stakeholders believe that true interoperability will not be achieved if vendors and providers act to impede the flow of health data for proprietary reasons.
“Now, more than two years after 21st Century Cures was enacted, patients and providers are still without an information blocking rule - undermining the intent of the law,” Health IT Now officials stated.
ONC has delayed regulation around information blocking a few times already, previously stating that the rule would be released in April then revising its timeline to September, before finally submitting the rule to OMB on September 17th.
As previously reported by Healthcare Informatics Managing Editor Rajiv Leventhal, during an Aug. 8 episode of the Pulse Check podcast from Politico, National Coordinator for Health IT Donald Rucker, M.D., said that the rule is "deep in the federal clearance process." And even more recently, a bipartisan amendment to the U.S. Senate's Department of Defense and Labor, Health and Human Services, and Education Appropriations Act for Fiscal Year 2019 includes a requirement for the Trump administration to provide Congress with an update, by September 30.
“It is stunning that, more than two years after 21st Century Cures became law, we are still waiting on regulators to actually do what the law says,” HITN Executive Director Joel White said in a statement issued Monday. “Patients and providers have looked on with disappointment as the administration blows through one missed deadline after another for publicly releasing a proposed information blocking rule. It is time to say 'enough.' By continuing to slow walk these regulations, the administration is adding to uncertainty in the marketplace and is quickly reaching a point whereby it will be in obvious defiance of the spirit of the Cures law.”
White further stated, “Lawmakers who worked doggedly to get this landmark, bipartisan bill across the finish line should be incensed by the way that bureaucratic delays have weakened their signature achievement. This holiday season, the best gift that OMB could give consumers would be an expedited completion of its review and the public release of a robust information blocking rule. In the meantime, we are hopeful that industry stakeholders will not delay interoperability initiatives as a result of the ambiguity created by these continued delays.”
It is not the first time that the Health IT Now executive director has been publicly critical of the Trump administration for not yet publishing any regulation on information blocking. In an op-ed published September 8 in STAT, White wrote, “More than 600 days after the enactment of the Cures Act, not a single regulation has been issued on information blocking.” White added in frustration, “Health IT Now has met with countless officials in the Trump administration who share our commitment to combat information blocking. But those sentiments must be met with meaningful action.”