The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.
The two agencies posted their respective final rules earlier this year, and their impact was noticeable on some firms’ returns on Wall Street. The rules were also at the time expected to boost the fortunes of those in the telehealth sector, which already has enjoyed a benefit from the pandemic.
In holding pattern over FDA’s pre-cert pilot
The ONC announcement said that the encoded changes are effective June 30 and noted that an additional deregulatory action is pending the U.S. FDA’s completion of its software pre-cert program. The office had proposed in its draft rule that any software as a medical device that is certified under the FDA pre-cert program might enjoy an exemption from some aspects of the ONC certification mandate. While some stakeholders expressed skepticism about such an exemption, the ONC said “there may be potential for recognition” of any such offerings via the FDA pre-cert program. The FDA had titled the pre-cert pilot in part, “2019 Test Plan,” suggesting that the pilot would wrap up by the end of the last calendar year – an ambition that was not realized.
The ONC posted a statement clarifying that it will exercise enforcement discretion in administering all new time-sensitive requirements that are captured in Title 45, Part 170 of its final rule. Enforcement will be delayed by an additional three months for any such requirements, a change the ONC said would nonetheless sustain “a trajectory that will advance patients’ access to their health information.”
One of the more potentially significant changes applies to the certification of application programming interfaces (APIs), which initially would have been in force six months after the final rule. That compliance deadline has been delayed for another three months, or until the end of 2020, given the March release of ONC’s final rule. The same time frames apply to certification that a product will not engender information blocking.
The rollout of standardized API functionality was scheduled for 24 months after publication of the final rule, a provision that also enjoys an additional three-month grace period. This likewise applies to updates per the U.S. Core Data for Interoperability, but initial testing plans are largely subject to the same compliance deadlines as seen in the March final rule.
CMS also announced a delay for the provisions of its rule, highlighting the conditions of participation related to the notification requirement for patient admission, discharge and transfer. This requirement, which provoked some controversy in the draft rule, will be suspended for six months beyond the deadline cited in the CMS final rule, yielding a compliance span of 12 months, or a new compliance date of March 2021.
The new compliance deadline for several provisions of the CMS rule will be delayed until July 1, 2021, including those pertaining to patient access and provider directory APIs, which were applicable to Medicare Advantage, Medicaid and the Children’s Health Insurance Program. This deadline initially was set at Jan. 1, 2021. The same initial and revised compliance deadlines apply also to the Patient Access API for qualified health plan issuers that take part in federally facilitated health insurance exchanges, but the agency noted that “other policies contained in the final rule will be implemented and enforced on schedule.”
CMS also noted that these changes are not subject to the notice and comment provisions of the Administrative Procedures Act (APA) due to federal government agency discretion. However, it also said that notice-and-comment would be impractical even if the agency did not enjoy such discretion. The ONC statement took a similar stand on the APA requirements.
Stakeholders varied in views on delays
Several organizations sounded off on the potential for delay in anticipation of the changed deadlines, including the Pew Charitable Trusts, which said in an April 2 letter that the new regulations “should be implemented without delay.”
Ben Moscovitch, Pew’s project director, health information technology policy, said the more widespread use of telehealth during the COVID-19 pandemic has increased the reliance of patients and health care professionals alike on telemedicine. He made the case that any further delay in the CMS and ONC timelines would impede crucial benefits to patients, as well as hinder “our ability to use this technology to address further disruptions in the health care system.”
Premier Healthcare Alliance Inc., of Charlotte, N.C., took a different position in an April 17 letter, which addressed several other considerations in addition to the CMS and ONC final rules. Blair Childs, Premier’s senior vice president of public affairs, recommended a delay in both the CMS and ONC final rules, but he declined to go into much detail.