Countdown to Information Blocking Rule in Progress

Organizations and providers express concerns about potential impact.

Nearly two weeks ago the Office of Management and Budget (OMB) began reviewing a proposed rule from the Office of the National Coordinator (ONC) for Health Information Technology that could have a significant impact on entities involved in "data blocking." So far, nothing has emerged, but the eyes of industry players are closely watching for news as the clock ticks.

While the "21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program" covers a lot of ground, the information blocking portion of the mandate is the most controversial. The Act authorizes fines of $1 million from the Office of Inspector General (OIG) for each case of information blocking. The rule under review is expected to define exceptions; curiosity about that language has some industry representatives sitting on the edge of their seats.

The Problem
 

While nearly everyone agrees that data sharing is essential and intentional information blocking is harmful, a lot of grey territory exists between those two positions. Two industry organizations demonstrate measures of cooperation to support the exchange of information.

"The Electronic Health Record Association, our member companies, and non-member companies that have adopted the EHR Developer Code of Conduct strongly oppose information blocking," said the HIMSS  Electronic Health Records Association (EHRA) in a statement to HealthLeaders. ERHA is a trade association of Electronic Health Record (EHR) companies, addressing national efforts to create interoperable EHRs in hospital and ambulatory care settings. EHRA points out its position is clearly stated in the Code: “Given our strong support for interoperability, adherents to the Code do not engage in data blocking.”

"Information blocking is a very real issue facing our health care ecosystem today," said Kelly Thompson, CEO of Strategic Health Information Exchange Collaborative (SHIEC), national, non-profit Health Information Exchange organization, in a statement to HealthLeaders. "SHIEC supports efforts to advance the sharing of health information. When further information is available, SHIEC will review the details and make thoughtful recommendations. One recommendation may include establishing a threshold for compliance based on active, good faith participation with a Health Information Exchange." 

It's Complicated
 

There doesn't seem to be agreement among industry players about what constitutes data blocking and the degree of severity involved. And, sometimes issues that result in blocked information are beyond the control of an entity involved.

"Data blocking is a bit like a mythical creature," says Marc Probst, vice president and CIO of Intermountain Healthcare. "I think they [HHS] are stretching it a bit when they talk about some of the things that have happened around data blocking, but, be that as it may, they're likely to encourage more sharing of data. And, I think that's a good thing. So if the term 'data blocking' needs to be used to encourage people to share, not just across provider organizations, but the pharmaceutical, life sciences, and other medical device industries, then that's good. I think that will be a good outcome from the ruling. But I don't yet know what the outcome is going to be."

HealthLeaders also reached out to the College of Healthcare Information Management Executives (CHIME), the professional organization for chief information officers and other senior healthcare IT leaders. While the organization did not provide a direct comment or statement, they pointed to passages in multiple letters written to the U.S. Department of Health and Human Services (HHS) that provide insight into some their concerns and highlight the complications providers encounter related to the information blocking issue.

In a September 10, 2018, letter written to Seema Verma, administrator for the Centers for Medicare and Medicaid Services (CMS), CHIME made the following points: [Editor's note: these comments were made in reference to a different anticipated ruling: “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program,” published on July 27th.]

• "Increasingly we are hearing from members about exorbitant fees associated with establishing interfaces and we seek clarification around how CMS will treat providers from an information blocking standpoint who are unable to afford all of the costs. We do not believe a provider should be deemed to be blocking information if the reason is rooted in the cost of establishing an interface."
   
• "In addition to concerns with costs, providers continue to worry that CMS will deem them to be data blockers if they refuse to connect to an API they consider unsecure. The cybersecurity issues are proliferating daily and risks to patient safety and privacy pose a significant threat to our industry."

Desperately Seeking Clarity
 

Specific definitions are essential, say many of those potentially impacted by this ruling. EHRA provides further insight.

"We look forward to the opportunity to review the proposed clarifications to the information blocking definitions and work with OIG and ONC to minimize ambiguity of these definition," EHRA said in its statement. "Unambiguous definitions are essential to effective and minimally disruptive implementation. EHRA’s November 2017 letter to the Senate HELP Committee provides a perspective on critical aspects that we believe the proposed rule should address."

Ultimately, Everyone Desires Patient Value
 

Once OMB releases the ruling, it appears more questions are likely. Yet most agree that working toward a common goal serves a greater purpose.

"As the information blocking rule progresses, SHIEC will look for guidance on things such as reporting mechanisms, investigation processes, standards, thresholds, violations, definitions, and implementation timeframes," said Thompson. "It will be important to consider existing, related requirements placed upon the regulated industry."

The SHIEC CEO continues, "As SHIEC has most recently worked on the sharing of health information in planning and response to Hurricane Florence and through national efforts of the Patient Centered Data Home, it is evermore clear that individuals should have their information when and where they need it. Information blocking emphatically holds no place in such devastating disasters when individuals need their health information. SHIEC looks forward to serving as a resource and a partner for policymakers as they advance the rule."

While the American Hospital Association is waiting to see the ruling before providing a comment, representatives pointed out the document should be posted on the Federal Register. Tick tock…