By VINCE KURAITIS and DAVID C. KIBBE, MD

Last Friday ONC (the Office of the National Coordinator for Health IT) released a long-awaited Report On Health Information Blocking. The ONC blog capsulizes the report:

Health information blocking occurs when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information. Our report examines the known extent of information blocking, provides criteria for identifying and distinguishing it from other barriers to interoperability, and describes steps the federal government and the private sector can take to deter this conduct.

We were struck with two major reactions to the ONC Info Blocking Report:

• It’s a solid double: it does a credible job of recognizing that the major problems of interoperability and blocking are not technical or due to a lack of standards, but rather due to business practices and business models. The report also proposes a baseline of potential solutions.
• It’s not a home run: the report misses the opportunity to describe a comprehensive approach to combat information blocking.

In turn, we offer seven recommendations to strengthen the report:

1. Place Greater Weight on Patient Safety and Public Policy Concerns
2. Lower the Burden of Proof For Information Blocking
3. Put Criminal Penalties On the Table
4. Broaden the Scope of Tactics for Addressing Information Blocking
5. Emphasize Federal Purchasing Power — Not Regulatory Power — to Address Information Blocking
6. Place Less Weight on the Interests of EHR vendors
7. Name Names, Shine the Light

A Solid Double: Credible Job Of Describing The Problem And Proposing Solutions

The ONC report is an admission, once and for all, that the major problems of interoperability and blocking are much more attributable to business practices than to lack of technology and standards:

…most allegations of information blocking involve business practices and other conduct that interferes with the exchange of electronic health information despite the availability of standards and certified health IT capabilities that enable this information to be shared. (Info Blocking Report, p. 29)

The report is bringing sorely needed attention to the long standing problem of information blocking by EHR vendors and their customers. It has quickly been picked up by many healthcare news outlets and is also penetrating broader national media, including The Wall Street Journal, PC World, and Politico. ONC’s report also lays a good foundation of suggestions to begin to address information blocking:

While we will quibble with some of the details in the recommendations, overall they’re pretty solid.

Not a Home Run: The ONC Report Misses the Opportunity to Describe a Comprehensive Approach to Information Blocking

The Info Blocking Report was created as the response to a Congressional request. Congress’ specific request stated:

This detailed report should also include a comprehensive strategy on how to address the information blocking issue. (emphasis added, Info Blocking Report p. 5)

This request is akin to Congress lobbing a slow softball pitch to ONC:

“Tell us how information blocking occurs, the extent of the problem, and the mechanisms and resources needed to fix the problem”.

Congress’ request could have been taken as a swing-for-the-fence invitation to propose a truly comprehensive strategy. We’ll offer seven recommendations for the next time ONC is up at bat.

1) Place Greater Weight on Patient Safety and Public Policy Concerns

This is an admittedly subjective reaction to ONC’s report, but we ask “Where’s the outrage?!” We’re talking about people’s lives here, not just an abstract analytic or technical problem. The overall tone of the report is extremely matter-of-fact, formal and defensive. An occasional lapse into humanity would greatly strengthen the potential impact on readers. Even members of Congress are people who can be reached through emotional appeals, not just logic.

2) Lower the Burden of Proof for Information Blocking

The ONC report suggests an unnecessarily high burden of proof — that a vendor or provider must “knowingly or unreasonably interfere” with information exchanges. ONC proposes a three part test:

1. Interference
2. Knowledge
3. No Reasonable Justification

ONC acknowledges how difficult it is to prove information blocking based on its definition:

Identifying and confirming specific instances of information blocking is a difficult and highly fact-specific task. (Info Blocking Report, p. 19)

We agree, but are puzzled why ONC then proposes such a high burden of proof. Meeting ONC’s 3 part test likely would require strong evidence, e.g., emails or voice recordings to prove vendor or provider knowledge of interference. How did ONC decide on this high burden of proof? We don’t see anything in the Congressional request requiring this narrow interpretation. What would work better? We suggest a much lower bar for proof, e.g., developing a standard that would require establishing “interference” and then putting the burden of proof back onto vendors and/or providers to explain why this might be reasonable in specific circumstances.

3) Put Criminal Penalties On the Table

To the extent that Feds could show “knowing and unreasonable” information blocking, why not also create an option for criminal penalties for EHR vendors and providers? Now that would be a deterrent! How would you and the public react to an EHR vendor or provider email that read “We are not going to interoperate with vendor X or Provider Y. Period. I don’t care if it puts patient’s lives at risk.” We think most people would be outraged…beyond the point where sanctions or civil penalties are sufficient when patients’ lives are put at risk.

4) Broaden the Scope of Tactics for Addressing Information Blocking

The Info Blocking Report dwells on the “death penalty” option of decertification of an EHR. It explains why this drastic, last resort solution option is problematic:

First, terminating a certification may cause widespread and in many cases severe consequences for innocent parties….

Second, expanding the scope of the ONC HIT Certification Program to encompass information blocking would be challenging and require expanding the current approach. (Info Blocking Report, p. 30)

We agree the decertification option is severe, but the Info Blocking Report incorrectly implies an all-or-nothing dichotomy. It’s like saying “We could penalize burglars by cutting off their legs, but that seems unnecessarily harsh. Therefore, we don’t have any good options to do deter or punish burglary.”

As to point number two — OK, it’s hard, we get it. But remember that Congress asked you and invited you to propose a comprehensive approach. Saying it’s “challenging” doesn’t cut it.

There are many other options for deterring and/or penalizing information blocking:

Fines. Nowhere does the Info Blocking Report suggest or discuss fines as a potential penalty for vendors or providers. Why not?

Audits. CMS has the power to audit providers who have been paid Meaningful Use bonuses and to claw back the money if the rules have been broken. Why can’t it audit the health IT vendors to whom those bonuses have been passed through? It is possible to investigate reports of information blocking, and ONC admits that it has done some of that. In fact, more than some, quite a lot. Why punish the providers but not the vendors?

Cease and Desist Orders. It seems entirely plausible and within reach that ONC and CMS could establish that a pattern of behavior on the part of particular vendor constitutes information blocking. A cease and desist order giving the vendor a reasonable period to remediate that behavior could be issued; follow up might establish in the worst cases that de-certification is a reasonable penalty.

5) Emphasize Federal Purchasing Power — Not Regulatory Power — to Address Information Blocking

The ONC Report focuses almost exclusively on regulatory options to address the info blocking problem. Through funding and regulation of Medicare and Medicaid, the Federal government pays for roughly half of all health care costs in the US. A focus on leveraging Federal purchasing power offers several huge advantages:

• CMS itself will have authority to explore many options, therefore minimizing the need for Congressional action to address information blocking. Congressional action at best would take time and at worst would never happen.
• Emphasizing Federal purchasing power is much more politically savvy and has potential for bipartisan support. What’s the potential for enacting a comprehensive regulatory scheme in a Congress where both the House and Senate are controlled by Republicans?
• CMS is the big dog in the health care marketplace. Many other private sector payers will follow its lead.

In fairness to the authors, one of the recommendations reads:

Work with CMS to Coordinate Health Care Payment Incentives and Leverage Other Market Drivers to Reward Interoperability and Exchange and Discourage Information Blocking (Information Blocking Report, pp. 27-28)

…but this recommendation covers 3 paragraphs of a 38 page report. We believe it should be a centerpiece in a comprehensive plan to address information blocking.

6) Place Less Weight on the Interests of EHR vendors

The HITECH Act recognizes the need to protect the legitimate economic interests of providers, developers, and other market participants.”(Info Blocking Report, p. 14)

True, but vendors have received almost $30B through HITCECH funds to buy their software. That’s a pretty strong concession to vendor interests right there!. How about delivering the goods? EHR vendor stock prices have increased dramatically since the enactment of HITECH. While it’s debatable whether vendors are the root cause of the problem, there’s no question they hold many of the tools to implement the solutions. We are not suggesting any type of conspiracy theory between the EHR vendors and ONC . We both know many of the people at ONC and see them as conscientious, ethical and well intentioned.

7) Name Names, Shine the Light

The Report does not mention vendors by name. This is a missed opportunity. Shining a public light on violators would be one way of bringing attention to the issues and forcing vendors and providers to be publicly accountable for their actions.

Summary and Conclusion

We recognize that ONC has been under a lot of criticism lately. At one level, it’s not surprising that the overall tone of the report is matter-of-fact, defensive, and overly analytical.

At its root, information sharing is not a technical or technological problem: the standards for data sharing are there, in place, ready to be used.

We encourage ONC to swing-for-the-fence in comprehensively addressing information blocking. It’s the right thing to do.

photo credit: Lowell Connects for HR via photopin (license)