U.S. hospitals and physician practices — still coping with the logistic and financial pressures of managing care during the Covid-19 pandemic — now must quickly ramp up efforts to meet information-blocking compliance requirements that are slated to go into effect in only a few weeks.
As of late September, rules currently in place would set a November 2 deadline for the industry to achieve compliance with key provisions of the 21st Century Cures Act. However, federal agencies are reviewing a potential rule that would push back the deadline to a later date, giving the industry more time to achieve compliance.
Even if it’s delayed, the industry will face challenges, as well as additional costs, in eventually meeting the requirements that the new regulations spell out.
Originally released in March by the Office of the National Coordinator for Health Information Technology (ONC), the rules seek to ensure that healthcare information flows freely to patients and between patients, providers, and other stakeholders.
Because of the public health emergency posed by Covid-19, ONC extended the implementation timeline to six months after the final rules were published in the Federal Register, and then offered enforcement discretion for an additional three months for certain parts of the rule. Nonetheless, awareness of the impending deadline has caught many provider organizations by surprise, with most departments scrambling to support adaptations to patient care during the pandemic rather than focusing on the new ONC rule. The regulation is wide-ranging, with provisions also relating to health information networks, health information exchanges and developers of certified health IT.
The rules are intended to further efforts to advance interoperability. Federal efforts to encourage data liquidity have ramped up in recent years — for example, the longstanding EHR Incentive Program was renamed the Promoting Interoperability (PI) Program. And before the Covid-19 pandemic, health care payers were encouraging providers to improve information exchange, said Leigh Burchell, vice president for government affairs and public policy at Allscripts, a health information technology company. Facilitating data exchange holds promise for eliminating duplicative work and is a key requirement for realizing the benefits of price transparency and consumer engagement, payers believe.
The 21st Century Cures Act sets out a formal definition of information blocking and raises the specter of punishment for providers who block it. Section 4004 of the Cures Act specifies practices that could constitute information blocking, such as those that restrict authorized access, exchange, or use of information for treatment. It also would penalize those that implement health IT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging or using EHI or that hamper the movement of information sets or in transitioning between health IT systems.
The rules going into effect on November 2 aim to require clinical data sharing, specifically in eight types of clinical notes outlined in the United States Core Data for Interoperability (USCDI). These include consultation notes, discharge summary notes, history and physical, imaging narratives, laboratory report narratives, pathology report narratives, procedure notes, and progress notes. The end result will be technical infrastructure that supports a much broader set of clinical data elements than is normally exchanged today.
Compliance with the new rules won’t be easy, contended Chelsea Wyatt, a principal at the Chartis Group, a health care consulting firm. Responsibility for compliance extends far beyond IT to include health information management, clinical care, and more. In discussion with CIOs served by the Chartis Group, Wyatt has heard that they anticipate cost for compliance to run from $500,000 to $1.5 million over the next few years to fund strategic changes, education, and workflow adjustments, in addition to other expenses.
The new rule does not specify the penalty for providers for failure to comply with information blocking, according to an analysis by The Advisory Board. But while “ONC didn’t establish a mechanism for information blocking disincentives, remember that providers must agree to ‘prevention of information blocking’ in order to meet PI reporting requirements,” the consultancy’s analysis noted. The Department of Health and Human Services has indicated that it intends to issue a proposed regulation to outline a potential penalty structure for the long list of provider types included in the regulation.
Technology vendors and health information exchange entities will need to eliminate information blocking aspects of their products and business practices and also do significant development work to incorporate the expanded definitions reflected in the ONC rule within their products, and would face hefty civil monetary penalties for non-compliance.
Records vendors and their trade group, the Electronic Health Records Association, are working with federal agencies to hash out the impacts of the program, especially as providers expand into new areas, such as telehealth, which will further increase the need — and complexity — in achieving interoperability.
The elimination of barriers to information exchange that should follow the implementation of this rule will better enable allow patients to manage their own care through increased access to their own data. And while compliance will take effort and expense upfront, it will save the nation’s health care system money in the long run when patients are empowered to choose the provider that best meets their needs, including financial concerns, and move their data accordingly, Burchell contends.
“This is leading to a major shift in how providers need to think about and operationalize health information exchange, and they need to be thinking now about how to make this complicated regulation work in their organization,” she concluded.