Some Healthcare Interoperability Rules Delayed Due to COVID

In March, MedPage Today published a story outlining two new interoperability rules issued by the Office of the National Coordinator (ONC) for Health Information Technology and the Centers for Medicare & Medicaid Services. Below we report on what has happened since.

In March, the Trump administration issued two final rules related to interoperability of healthcare records, with administration officials noting that making patient health records portable and accessible is especially critical during incidents such as the COVID-19 outbreak. And yet, the outbreak itself has delayed implementation of some of those same rules.

ONC issued a rule implementing the clinical interoperability provisions of the 21st Century Cures Act dealing with electronic health records (EHR), ONC head Don Rucker explained on a March 9 phone call with reporters. “Our rule requires hospitals and doctors to provide software access points — endpoints, if you will — to their [EHR] databases so that patients can download these records to their smartphones,” he said. “This download is entirely at the patient’s choice. It is done using modern security provisions and clear communications and choice about privacy.”

A second rule, issued by CMS, required health plans in Medicare Advantage, Medicaid, CHIP, and on the federal health insurance exchanges to share claims data electronically with patients, the Department of Health and Human Services said in a press release. The CMS rule required the Medicare, Medicaid, and federal health plans to implement apps allowing patients to easily retrieve healthcare claims and other information starting in January 2021, and also require plans to begin sharing patient data with other payers as needed beginning in January 2022.

The ONC rule’s provisions barring the blocking of healthcare information were to become effective on November 2. But because of the coronavirus, the ONC rule’s compliance date for the provisions banning information blocking was moved from the November date to April 5, 2021.

“We are hearing that while there is strong support for advancing patient access and clinician coordination through the provisions in the final rule, stakeholders also must manage the needs being experienced during the current pandemic,” Rucker said in a statement on October 29. “We are providing additional time to allow everyone in the health care ecosystem to focus on COVID-19 response.”

Implementation of the provision requiring developers to release their healthcare application programming interfaces (APIs) — the software tools Rucker referred to that allow different systems to more easily communicate — was pushed back to the end of 2022 from earlier in the year.

“Delaying the implementation of the information blocking rules was definitely a good idea, as many providers have been so focused on responding to the pandemic that they have not been able to dedicate the time and resources necessary to ensure compliance with the information blocking rules,” Randi Seigel, a partner at Manatt Health, a professional services firm in New York City, said in an email. “Many providers we work with are just beginning to focus on these rules and to develop implementation plans.”

Ben Moscovitch, manager of health information technology at the Pew Charitable Trusts here, said that “these rules take big steps forward to improve health data exchange” and that “once they are fully in effect, health data will be much more accessible to patients and clinicians alike.” One of the rules requires EHRs to have standard APIs.

“Patients will be able to more easily use personal devices like smartphones to aggregate their health records” from different providers onto their devices, Moscovitch said. Standardizing APIs will also help with clinical decision support tools — “to guide clinician decisions about what medication may be most appropriate for which patient, at what dose … and to track changes over time in a patient’s status,” he said.

The standard being used for the APIs is Fast Healthcare Interoperability Resources (FHIR). “The use of FHIR allows deviation based on how someone wants to implement it,” said Moscovitch. “So the ONC also referenced a way to implement the standard, called an implementation guide, which will result in … making it easier for different systems to use APIs to get information.”

The new provisions also address the issue of patients being able to transfer information from one provider to another, so providers know what tests and examinations have previously been performed. “One big barrier to having information at the point of care is inadequate patient matching,” said Moscovitch, referring to the idea of confirming that the patient in the exam room is actually the person whose records are in front of the provider. “That is traditionally done using demographic data like address, name, and date of birth, and what the ONC has done is expanded the data that can be used,” by establishing a data set known as the U.S. Core Data for Interoperability (USCDI).

The core data set adds the patient’s email address and prior home addresses, he said. “Having that information shared, along with better demographic data, can help them better match a record,” he said. The deadline for implementing the USCDI is October 2022.

The pandemic has made one thing very clear about sharing healthcare information, Moscovitch said. “Often public health is missing the critical information it needs to affect the public — for example, public health authorities may not receive patient phone number, which can make it difficult to conduct contact tracing when someone tests positive. Or they receive case reports via fax, and entering that information into a database can take days. So there is an opportunity to leverage these rules and take the next step on interoperability by applying a public health lens … by enforcing information blocking in a way that ensures that public health gets the data it needs. Congress provided robust authorities to ONC and the opportunity to leverage those authorities.”