Healthcare groups are pushing HHS' Office of Inspector General to build a period of enforcement discretion into its proposal to impose financial penalties on information blockers.
Organizations will need time to ask questions and get clarification into regulations after a final rule is released, which will take longer than the standard 60-day period between when a rule is published and when it takes effect, they say. That's compounded by the COVID-19 pandemic, which has required many healthcare groups to pivot attention and resources toward the outbreak and away from other priorities.
OIG in April proposed a rule establishing civil money penalties for health information exchanges and health information technology software developers who engage in information blocking, with a maximum penalty of $1 million per violation. The rule wouldn't impose new information-blocking requirements; it would enforce regulations outlined in a final rule from HHS' Office of the National Coordinator for Health IT.
Organizations varied in how much time they wanted OIG to delay enforcement.
The American Medical Informatics Association asked OIG to delay enforcement for three to six months after the rule's effective date, while the Healthcare Information and Management Systems Society advocated for six months after. The American Hospital Association asked for a six-month delay from either publication of a final rule or the end of the COVID-19 public health emergency.
The College of Healthcare Information Management Executives recommended OIG delay enforcement of financial penalties until 2023 or the end of the COVID-19 emergency period.
Because of the connection to ONC regulations, one HIE—Midwest Health Connection—asked OIG to delay enforcement for six months after organizations are required to begin complying with ONC's information-blocking provisions.
"MHC in the process of updating its technological capabilities, policies and procedures to comply with the provisions of the ONC Cures Act final rule," wrote MHC, one of a few dozen groups that submitted comments to the agency. "MHC is doing so while acting as an important partner to the healthcare community and public health authorities in responding to the COVID-19 pandemic."
The Sequoia Project, an interoperability not-for-profit, did not recommend a specific time frame for when OIG should begin enforcement. However, it urged OIG to specify a fixed period after the rule's publication, and spend that period providing guidance into the final rule. The Sequoia Project also called for OIG to clarify how its enforcement date will intersect with ONC's compliance date for information blocking.
"There will be inevitable confusion and uncertainty as enforcement timing appears to be driven by the interrelated publication dates of two final rules, one not yet published from OIG and one already published from ONC," the Sequoia Project wrote.
OIG in its proposed rule said its enforcement would not begin earlier than the compliance date for ONC's information-blocking regulations.
ONC in April unveiled plans to delay enforcement of some components of its rule for three to six months because of the COVID-19 pandemic. CMS said it would give providers an additional six months to comply with rules to improve data sharing included in its interoperability rule, a companion to ONC's regulation.
While many groups asked OIG to delay enforcement of its rule, most also expressed support for the proposal and its potential to facilitate interoperability.
"OIG's work on information blocking is critical to the overall success of the program," HIMSS wrote. "Its proposed regulation is directionally appropriate, and many of our comments focus on OIG providing additional clarity."
How information blocking would be enforced for healthcare providers was a key area of confusion on which healthcare groups sought clarification.
OIG in its proposal acknowledged it doesn't have authority to impose financial penalties on providers, only HIEs and health IT software developers. If OIG determines a provider has engaged in information-blocking practices, the agency will refer it to the "appropriate agency for appropriate disincentives," according to the OIG's proposed rule.
Establishing the appropriate agency and disincentives for providers will require future notice and comment rulemaking from HHS, the OIG said.
"OIG will coordinate closely with other agencies within HHS to develop consultation and referral processes consistent with such rulemaking by the secretary," reads the OIG's proposed rule.
But healthcare groups requested OIG clarify what level of involvement it will have after referring a complaint about a provider, particularly given that additional rulemaking has not yet been complete. Groups also asked whether providers that share patient health information with other organizations—such as for care coordination programs—could be considered an HIE.
"Given the absence of follow-on rulemaking to date by the secretary, we are concerned as to how OIG will handle complaints of information blocking by providers until such subsequent rulemaking is completed," the American Health Information Management Association wrote.
That's something that should be sorted out before OIG begins enforcing its rule, wrote the American College of Cardiology.
It called for HHS agencies to take "immediate action" to supply providers with information on what processes and standards will be used to enforce information-blocking regulations for them.
"A delay in the publication of these processes will put providers at a distinct disadvantage and could result in inadvertent information blocking actions," the ACC wrote. "Once clarity on all components of the enforcement process exists, the ACC believes OIG should make every effort to align effective dates with ONC and CMS information blocking and interoperability provision effective dates where possible."