HHS announces compliance flexibilities to ease the burden on the healthcare industry and focus resources on the pandemic.
On March 9, the U.S. Department of Health & Human Services (HHS) announced two final interoperability rules, hailed by many as a historic step to provide patients access to their own records. Progress toward that goal is being sidelined by COVID-19.
Late yesterday the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS), in conjunction with the HHS Office of Inspector General (OIG), announced that restrictions on some of the requirements will be eased, enabling the healthcare industry to focus vital resources on responding to the pandemic.
While the rules impact many aspects of hospital and health system operations, CMS regulations related to admission, discharge, and transfer (ADT) notification, is one of greatest concern. Yesterday's announcement indicates the deadline for compliance will move from six months after publication in the Federal Register to 12 months. The rules have yet to be published in the Federal Register; the expected publication date in May 1.
"Recognizing that hospitals, including psychiatric hospitals, and critical access hospitals, are on the front lines of the COVID-19 public health emergency, CMS is extending the implementation timeline for the admission, discharge, and transfer (ADT) notification Conditions of Participation (CoPs) by an additional six months," CMS says on its website.
Another relevant issue for hospitals and health systems is the ONC's Health IT Certification Program compliance. "To support that important work and the information sharing efforts we are already seeing, ONC intends to exercise enforcement discretion for three months at the end of certain ONC Health IT Certification Program compliance dates associated with the ONC Cures Act Final Rule to provide flexibility while ensuring the goals of the rule remain on track,” said Don Rucker, MD, National Coordinator for Health Information Technology. More details about dates and timeframes are available in an ONC Fact Sheet.
“Today’s action follows the extensive steps CMS has taken to ease burden on the healthcare industry as it fights COVID-19," said CMS Administrator Seema Verma in a statement. "Now more than ever, patients need secure access to their healthcare data. Hospitals should be doing everything in their power to ensure that patients get appropriate follow-up care. Nevertheless, in a pandemic of this magnitude, flexibility is paramount for a healthcare system under siege by COVID-19.”
Additional resources about yesterday's announcement are available through HHS:
While expressing full support of an enforcement delay for ONC interoperability rules impacting hospitals and providers during the pandemic, Matthew Michela, president and CEO of Boston-based Life Image and a member of The Sequoia Project, expressed concerns that delays should not apply to technology and other healthcare IT companies "who have an obligation to make their systems more interoperable." The Sequoia Project is a nonprofit organization focused on implementation of secure, interoperable nationwide health information exchange.
Tech and IT companies "are less impacted [by the pandemic] and should be required to complete their plans to meet the interoperability standards so that when the public health crisis is under control, hospitals can more quickly get back on track," says Michela. "We should not let this crisis be an excuse for technology companies to slow-walk their long-awaited movement toward better interoperability."
The pandemic itself is providing further evidence for the need for interoperability, Michela says. It "acutely magnifies the many clinical, operational, and infection risks associated with non-interoperability in healthcare. With data locked into proprietary silos, you can't access critical information in a timely and efficient manner or to do so requires manual intervention. You certainly don't want to rely on faxes, PDFs, CDs, and thumb drives during a massive emergency, or no clinical information at all, which happens way too often."
The ability to easily access images for diagnostic, acute care, treatment, and post-acute monitoring is the issues the interoperability rules are designed to address. "While many of the larger health systems have established digital connections with their primary referral sites," says Michela, "no large site is fully digital. Many smaller healthcare facilities, particularly those in rural communities, are also unfortunately not yet connected for digital transfer." To address this, he says that organizations should explore mature technology solutions that can "establish digital connections quickly and cost effectively without a lot of demand on IT staff."
“in a pandemic of this magnitude, flexibility is paramount for a healthcare system under siege by COVID-19.”
CMS Administrator Seema Verma
Mandy Roth is the innovations editor at HealthLeaders.
Deadlines for CMS regulations related to admission, discharge, and transfer (ADT) notification have been extended from six months to 12 months after the CMS final rule is published in the Federal Register.
Certain ONC Health IT Certification Program compliance dates have been extended by three months.
Member of The Sequoia Project expresses concerns that delays should not apply to technology and other healthcare IT companies.