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, on its progress establishing information blocking regulations that are required under the 21st Century Cures Act.
The proposal (SA 3732), authored by Senators Sheldon Whitehouse (D-RI) and Bill Cassidy (R-LA), serves as another push, on the part of lawmakers and healthcare stakeholders, for Congress to publish the rule.
As previously reported by Healthcare Informatics, earlier this month, in a strongly worded letter to National Coordinator Donald Rucker, M.D., several healthcare and health IT industry groups expressed frustration with the Office of the National Coordinator for Health IT’s lack of progress in publishing information blocking regulations, as required in the Cures Act.
“It has been 601 days since the 21st Century Cures Act was signed into law. Every day that the administration delays implementation of these critical provisions places patients at risk of harm,” the letter stated. Stakeholders including Health IT Now, Research!America, Oracle, the American Medical Informatics Association (AMIA), the American Academy of Family Physicians, Cambia Health Solutions and Claim Your Health Data Coalition signed the letter dated August 6.
The rule’s release has been delayed several times; in May, the federal government released its unified agenda for the spring, and included was a proposed rule titled, “Health Information Technology: Certification and Interoperability Enhancements,” with a date of September 2018 for the rule’s release. And during an Aug. 8 episode of the Pulse Check podcast from Politico, Rucker said that the rule is "deep in the federal clearance process."
Indeed, some of the core health IT components of the Cures legislation, which was signed into law in December 2016, as read in the “Title IV—Delivery” section, 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.
As part of the Cures Act’s definition of interoperability, the legislation says there must be no information blocking as defined in section 3022(a). And, information blocking is defined in the law as, with respect to a health information technology developer, exchange, or network, business, technical, or organizational practices that, “except as required by law or specified by the Secretary, interferes with, prevents, or materially discourages access, exchange, or use of electronic health information; and the developer, exchange, or network knows, or should know, are likely to interfere with or prevent or materially discourage the access, exchange, or use of electronic health information.” And with respect to a healthcare provider, “such provider knows that such practice is unreasonable and is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information.”
The Cures Act doesn’t come without consequence or penalty, either: regarding information blocking, developers, exchanges, and networks found to have engaged in data blocking and who have submitted a false attestation would be subject to civil monetary penalties not to exceed $1 million per violation.
Following the signed amendment this week from Sens. Whitehouse and Cassidy, Health IT Now Senior Director of Government Affairs Catherine Pugh showed support on behalf of her organization, with the following statement:
"Information blocking represents a senseless barrier to true interoperability and a continued threat to patient safety that must be addressed. Bipartisan majorities in Congress recognized this when they rightly added key information blocking provisions to the 21st Century Cures Act but, more than 600 days after its enactment, we are still waiting on these rules of the road to be released.”
Pugh added, “We have met with countless officials in the Trump administration who share our commitment to combating the perils of information blocking and we believe they are acting in good faith to release these rules promptly but, in the meantime, it is fitting that Congress would put oversight measures in place to ensure that the intent of 21st Century Cures is followed and that the administration upholds its end of the bargain. Health IT Now thanks Senators Whitehouse and Cassidy for their leadership on this amendment and urges its inclusion in the final spending bill."