- The Biden administration on Tuesday finalized penalties for health IT companies found blocking the electronic flow of health information, freeing regulators to start investigating the backlog of information blocking complaints.
- The HHS Office of Inspector General final rule enacts statutory penalties created by the 21st Century Cures Act, including fines of up to $1 million per information blocking violation.
- Regulators have yet to codify information blocking penalties for providers, a separate rule that’s been held up amid enforcement complexity and is now expected to be published this fall.
The Office of the National Coordinator in 2020 finalized long-awaited regulations requiring providers, health information exchanges and health IT developers certified by ONC to share data with patients and with each other. The rules resulted in more hospitals electronically sharing health information, though data exchange is still patchy across the U.S., which complicates quality of patient care between care sites.
Regulators also in 2020 proposed new civil monetary penalties for health IT vendors and networks to enforce that rule, which are now final.
Having a stick in place to enforce compliance three years after the original rule is expected to more firmly move the needle on interoperability in U.S. healthcare.
“The industry has been awaiting this rule and we anticipate that it will be one more step in ensuring that electronic health information is flowing in support of patient care,” ONC head Micky Tripathi told Healthcare Dive in a statement.
Violators can face fines of up to $1 million, but regulators will determine the exact amount based on factors including the nature and extent of the information blocking, and the harm that resulted from it, such as how many patients were affected.
The OIG rule also outlines priorities in investigating and punishing information blocking claims. The department expects to get more complaints than it can investigate, Andrew Vanlandingham, OIG’s health IT policy lead, said in a tweet on Tuesday.
As a result, investigations will focus on cases of information blocking that had the potential to cause patient harm, impacted providers’ ability to care for patients, went on for a long time, caused federal healthcare programs to lose money or were performed knowingly.
The OIG also said it might prioritize investigations based on the volume of claims alleged against a single actor.
“Our enforcement priorities will inform our decisions about which information blocking allegations to pursue, but these priorities are not dispositive. Each allegation will present unique facts and circumstances that must be assessed individually,” the 130-page final rule reads.
“We can and do expect to investigate allegations of other information blocking conduct not covered by the priorities ... And as we gain more experience with investigating information blocking, we will reassess our priorities accordingly,” regulators noted.
Some comments on the proposed rule suggested the OIG should turn to less punitive measures than monetary penalties, like educating actors found guilty of information blocking or issuing corrective action plans. Regulators said “at this point” they don’t anticipate using alternatives to fines, though the OIG will have a self-disclosure protocol to allow for lower penalties.
The OIG said it could also refer allegations to other agencies, including the ONC and the HHS Office for Civil Rights, that have other authorities to issue corrective action plans or additional fines.
“As we gain more experience investigating and imposing [civil monetary penalties] for information blocking, we may further consider alternative enforcement approaches,” the rule reads.
Since April 2021, the ONC has received more than 700 possible claims of information blocking, but regulators have been unable to start investigating the allegations without a final rule around enforcement.
Now, the OIG could begin enforcement as soon as this summer. The final rule will go fully into effect 60 days after it is published in the Federal Register.
The wide majority of information blocking allegations have been levied against healthcare providers, which still don’t face any penalties for information blocking.
The timeline to finalize a regulation that would establish disincentives for providers has been pushed back multiple times. However, once the penalties are established, enforcement will fall under the just-released OIG rule, according to the ONC.
Regulators have run up against a slew of difficulties in crafting a rule that could stand up to industry scrutiny, Tripathi told Healthcare Dive late last year.