HHS seeks authority to issue advisory opinions on information blocking

Currently, regulations prohibit the agency from giving healthcare organizations compliance advice about specific scenarios regarding info blocking.

The Biden administration has asked Congress to enact legislation that would give the Department of Health and Human Services the authority to provide organizations with “binding advisory opinions” about what constitutes information blocking.

HHS now lacks that authority under the information blocking rule, which is part of the 21st Century Cures Act.

The legislative request was made as part of the administration’s recent Fiscal Year 2023 budget proposal, according to a blog from the Office of the National Coordinator for Health IT.

Meanwhile, the HHS Office of the Inspector General is continuing work on a final rule outlining financial penalties and enforcement dates for health information exchanges and developers of certified health IT that violate prohibitions against blocking the sharing of vital healthcare information, an ONC spokesperson says.

"These ONC binding advisory opinions will offer the industry much-needed guidance and clarity on what is and what is not information blocking"

Robert Tennant, Vice President Federal Affairs, WEDI

The information blocking regulation authorizes the OIG to issue civil monetary penalties of as much as $1 million for each violation committed by exchanges or developers.

The proposed OIG rule is available on a regulatory update site.

Separately, HHS has not yet proposed “appropriate disincentives” for healthcare providers regarding information blocking, the spokesperson notes. “HHS Secretary [Xavier] Becerra has said closing the enforcement gap is a ‘top HHS priority,’ and we are working hard on this issue right now,” the spokesperson adds.

Providing clarifications

The information blocking rule, designed to prevent activities that impede the smooth flow of patient information among various entities to help ensure appropriate treatment, identifies reasonable and necessary activities that do not constitute information blocking, which are labeled as “exceptions.”

“Healthcare providers are really struggling with circumstances where it is reasonable to deny [information] access to third parties"

Adam Greene, partner at the law firm Davis Wright Tremaine

In the blog, Steven Posnack, deputy national coordinator for health IT, writes: “After five-plus years implementing the Cures Act, along with over two years of answering regulatory implementation questions and receiving stakeholder feedback, we believe that being able to issue binding advisory opinions for the information blocking regulations would be a substantial added benefit to the industry at large.”

HHS currently lacks the authority to issue a “definitive, binding answer to a discrete information blocking question in a way that would help [an organization] with compliance details relevant to its particular situation,” Posnack notes in the blog.

Reaction to proposal

The Workgroup for Electronic Data Interchange welcomed the administration’s legislative proposal.

Robert Tennant, WEDI

“WEDI applauds ONC for seeking legislative authority to issue binding advisory opinions, says Robert Tennant, WEDI’s vice president of federal affairs. “We believe providers generally are not looking to block information that serves to augment patient care.

“The issue of information blocking, however, is challenging and complex,” he adds. “With its varied and nuanced exceptions and its intersection with the HIPAA Privacy Rule that requires providers not to inappropriately disclose information, these ONC binding advisory opinions will offer the industry much-needed guidance and clarity on what is and what is not information blocking and will be extremely valuable as providers develop their data dissemination strategies.”

Adam Greene, a partner at the law firm Davis Wright Tremaine who specializes in healthcare regulatory issues, offers a similar assessment.

“Healthcare providers are really struggling with circumstances where it is reasonable to deny [information] access to third parties, but an exception is not applicable, especially with respect to particularly sensitive information,” he says. “Accordingly, receiving clarity through advisory opinions would be welcome.”

Greene says he appreciates ONC’s outreach efforts on the information blocking rule so far. “But I would like ONC to provide greater recognition of the fact that a practice is not information blocking under the statute and regulations unless the healthcare provider knows the practice is unreasonable.”

However, Kirk Nahra, partner and co-chair of the privacy and cybersecurity practice at the law firm WilmerHale, says advisory opinions would not have much impact. “These things tend to make sense in concept, but I have found that they don’t really do much (too specific) and take way too long,” he says.

Blog describes proposal

In his blog, Posnack describes the ONC’s legislative proposal.

“The requested new authority would give HHS the ability to issue a binding advisory opinion to advise whether, in HHS’ view, a specific practice would constitute information blocking, including whether an exception would or would not be met given the facts and circumstances. The advisory opinion would be binding on HHS. A requesting party that received a favorable advisory opinion would be protected from HHS penalties and disincentives for information blocking practices, so long as the specific practice(s) at issue were conducted in accordance with the facts submitted to HHS.”

The blog continues: “Further, we believe that the public availability of the facts and practice(s) associated with such advisory opinions would aid [organizations] by providing tangible compliance and non-compliance perspectives based on real-world requests.”

Claims contending information blocking are being filed with the government, but action against most alleged violators is on hold until rules are finalized.

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