Using electronic source data in clinical trials can be difficult because of the interoperability between data capture systems and the aversion to change among sponsors and investigators who are used to doing things a certain way. But what if some vendors and health systems purposely block information from being shared? Congress has expressed concerns about this practice in the past, and a recent study says that information blocking is still considered routine among some vendors and health systems.

In April 2015, the Office of the National Coordinator for Health Information Technology (ONC) of the U.S. Department of Health and Human Services (HHS) submitted a report to Congress on health information blocking. In this report, the ONC says that information blocking occurs when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information.1 The definition requires that three requirements be met:

1. Interference. Information blocking requires some act or course of conduct that “interferes with the ability of authorized persons or entities to access, exchange, or use electronic health information.” This interference, the report says, can take many forms, from “express policies that prohibit sharing information to more subtle business, technical, or organizational practices that make doing so more costly or difficult.”
2. Knowledge. The decision to engage in information blocking must be made knowingly, the report says. “An individual or entity does not engage in information blocking unless it knows (or should know under the circumstances) that its conduct is likely to interfere with the exchange or use of electronic health information.”1
3. No reasonable justification. Accusations of information blocking are serious and should be reserved for conduct that is objectively unreasonable in light of public policy, the report says. “Public policy must be balanced to advance important interests, including furthering the availability of electronic health information as needed for authorized and important purposes; protecting and promoting patient safety; maintaining the privacy and security of electronic health information; and protecting the legitimate economic interests and incentives of providers, developers, and other market participants to innovate and compete in ways that ultimately enhance technology, healthcare, and consumer health and welfare.”1

In its investigation for the report, ONC received unsolicited reports of potential information blocking. It also reviewed public records and testimony, industry analyses, trade and public news media, and other sources, in addition to holding stakeholder meetings, having in-person discussions, and making phone calls. Most of the complaints involved electronic health record (EHR) developers, many of whom charge fees that make it “cost-prohibitive for most customers to send, receive, or export electronic health information stored in electronic health records, or to establish interfaces that enable such information to be exchanged with other providers, persons, or entities.” Fees could be charged each time a user sends, receives, or searches for a patient’s electronic health information. The developers also could charge high prices to establish certain common types of interfaces, such as connections to local labs and hospitals.

Many providers also complain about the costs of extracting data from their EHR systems for their own use or to move to a different EHR technology,” the report says.1

ONC was able to confirm a “wide variation” in the fees that developers charged for their services. Although some of the variation could be found in the differences among the developers, such as their different technology architectures and service models, ONC did not feel the differences could adequately explain the variations of fees among the EHR developers. “There are indications that at least some developers may be engaging in opportunistic pricing practices or charging prices that are designed to deter connectivity or exchange with competing technologies or services.”

Not only were some EHR developers charging high fees to establish interfaces, some developers were refusing to establish them at all. “Some of these developers cite security concerns and business justifications for these practices, while others provide no justification or, in some cases, appear to acknowledge a strong preference not to exchange information using federally adopted standards and to instead drive more users to exchange information using proprietary platforms and services.”1

Healthcare providers also were accused of information blocking practices, primarily to control referrals and enhance market dominance. The providers often cited security or privacy concerns, even though privacy rules actually permitted the exchange of electronic information that was in question. Some providers even coordinated with EHR developers to restrict exchange with unaffiliated providers. “For example, a developer may have the requisite trust relationships and technological capabilities to exchange secure messages using the federal direct standard with a large network of providers. But the developer and provider may implement this capability so as to restrict the exchange of information to physicians who are members of the provider’s care network.”1

To limit information blocking, ONC says there needed to be a “comprehensive approach, consisting of both targeted actions to deter and remedy information blocking as well as broader strategies that address the larger context in which information blocking occurs.” Some of the targeted actions included strengthening in-the-field surveillance of health IT certified by ONC, constraining standards and implementing specifications, and promoting greater transparency in certified health IT products and services.

Has anything changed?

An article published in March 2017 argues that it is critical to find out how often information blocking happens and what forms it takes.2 Also, how effective are policy responses to information blocking?

A challenge is to find financial incentives that promote the engagement and support of health information exchange (HIE), say authors Julia Adler-Milstein and Eric Pfeifer, both from the University of Michigan Schools of Information and Public Health in Ann Arbor. “Providers have expressed concern about the loss of patients and associated revenue that could result from sharing data with competitor organizations and more generally express uncertainty about the return on investment from prioritizing HIE ahead of other investments.” EHR vendors can make money by charging their fees and also may benefit if they make “cross-vendor connectivity difficult because it may increase the likelihood that providers select their product.”2

For their research, the investigators conducted a national survey of leaders of HIE efforts “who work to enable HIE across provider organizations.” Adler-Milstein and Pfeifer asked the HIE leaders about the frequency of information blocking, its specific forms, and the effectiveness of various policy strategies to address it. Although some EHR vendors had complained that the characterization of them blocking information is not accurate, this study points to a different scenario. Sixty individuals responded to the survey, a 57% response rate. Half of the respondents reported that EHR vendors routinely engaged in information blocking, with 33% saying they blocked occasionally. Twenty-five percent of respondents reported that hospitals and health systems routinely did so, and 34% saying they did so occasionally. Among EHR vendors, the most common forms of information blocking were deploying products with limited interoperability, charging high HIE fees related to cost, and making third-party access to standardized data difficult. Among hospitals and health systems, the most common forms were coercing providers to adopt particular EHR or HIE technology, controlling patient flow by selectively sharing patient health information, and using the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as a barrier to patient information sharing when it is not.2

The respondents told the researchers that they perceived that information-blocking practices by EHR vendors were motivated by a desire to maximize short-term revenue along with a motivation to increase the likelihood that providers will select their EHR instead of a competitor’s EHR. Among hospitals and health systems, the most frequent perceived motivation also was related to improving revenue, namely to strengthen their competitive position in the market, followed by accommodating more important internal priorities than HIE.

The respondents also weighed in on what policy strategies would help to curb information blocking. They predicted three strategies would be equally effective to curb information blocking by EHR vendors: prohibiting gag clauses and encouraging public reporting and comparisons of vendors and products; stronger demonstrations of product interoperability “in the field”; and establishing stronger state and/or national infrastructures, policies, and standards for core aspects of information exchange. The strategy most thought to be “very effective” would be to make information blocking illegal.

To help curb information blocking for hospitals and health systems, respondents said the top two policy strategies were stronger Centers for Medicare & Medicaid Services (CMS) incentives for care coordination and/or risk-based contracts, and public reporting or other efforts to increase transparency of provider business practices. The respondents thought that making information blocking illegal would be very effective for hospitals and health systems, too.2

Adler-Milstein and Pfeifer pose the question of whether vendor and provider motivations reinforce each other. A hospital or health system seeking to control market share would be happier with an EHR vendor that charges high prices for HIE with other vendors because “both stakeholders benefit from the resulting scenario where affiliated providers choose to adopt the vendor’s product.” This dynamic may also help explain why providers purchase EHRs that do not readily enable HIE, the researchers say. “Vendors are incentivized to claim that their products readily enable HIE when they do not, and providers are not incentivized to perform due diligence to assess the true information-sharing capabilities of the system and negotiate acceptable HIE-related fees before purchase. If true, it will be critical to pursue a policy response that targets vendors and providers.”2

Regardless of which strategies policymakers pursue, information blocking should remain high on their priority list, the researchers say. “When information is not able to flow across provider organizations, there are direct implications for the quality of patient care: Missing information impairs clinical decision-making in ways that result in care that is unsafe, is duplicative, and fails to meet evidence-based guidelines. More broadly, when information cannot be shared across the care continuum, it impedes current reform efforts to move toward a person-centered, high-performing health care system.” Patients also are less able to switch providers and are therefore limited in their choice of providers; this decreases competition among health care providers. “Finally, information blocking prevents advances in biomedical and public health research, which require the ability to access information from many sources in order to identify public health risks, develop new treatments, and enable precision medicine.”

21st Century Cures Act

In December 2016, President Obama signed a new law, the 21st Century Cures Act, which directly addresses the practice of information blocking. The Act defines information blocking as: a) a practice likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information; and b) if conducted by a health information technology (HIT) developer, exchange, or network and the entity knows or should know that the practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information; or c) if conducted by a provider and the provider knows that the practice is unreasonable and likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information.3

In addition, it defines practices that may constitute information blocking as: a) restricting authorized access, exchange, or use of information under applicable state or federal laws for treatment and other permitted purposes including transitions between certified HIT, b) implementing health information technology in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using electronic health information, and c) implementing health information technology in ways that are likely to restrict the access, exchange, or use of electronic health information with respect to exporting complete information sets or in transitioning between HIT systems, or that lead to fraud, waste, or abuse or impede innovations and advancements in health information access, exchange, and use including care delivery enabled by health information technology.3   

The Act requires that the HHS secretary identify “reasonable and necessary” activities that do not constitute information blocking. Providers will not be held accountable if their vendors fail to ensure that they are not blocking information. The Act allows the Inspector General to investigate claims of information blocking. Developers, networks, and exchanges found to have engaged in information blocking by the Inspector General can be subject to a civil monetary penalty not to exceed $1 million per violation. Healthcare providers will be subject to disincentives under the applicable federal law.3

“At the very least, it is likely that the new Cures information blocking provisions will pose challenges to vendors and developers for the next couple of years,” writes David Kibbe, on The Health Care Blog. “The law’s language is remarkably broad and, in my opinion, purposely comprehensive.”4 Kibbe is the founding president and chief executive officer of DirectTrust, a collaborative non-profit association of 124 health IT and health care provider organizations.

It is in the best interest of EHR developers and vendors to work with physicians, hospitals, and with interoperability standards groups like DirectTrust, Kibbe says. “There are legitimate reasons for restricting access to health care information in electronic formats, including security measures and identity assurances needed to protect the privacy of that information. The vendors need to articulate these carefully and with the interest of their customers and their customers’ patients—not their own profits—clearly in mind.”

Physicians and clinicians also must do what is reasonable to “better knit together the fabric of the entire health care system so that care is better and costs are lower,” Kibbe writes. “That is our duty under the new laws. Quite simply, we cannot make good progress toward meeting these goals without the collaboration of the major EHR vendors, their customers, and the public.”

References

1. Report to Congress: Report on Health Information Blocking. Office of the National Coordinator for Health Information Technology. April 2015. Available at https://www.healthit.gov/sites/default/files/reports/info_blocking_040915.pdf. Accessed June 29, 2017.
2. Adler-Milstein J, Pfeifer E. Information Blocking: Is it occurring and what policy strategies can address it? Milbank Q 2017;95:117-135. Available at http://onlinelibrary.wiley.com/doi/10.1111/1468-0009.12247/full. Accessed June 29, 2017.
3. 21st Century Cures: Health IT and HIM provisions. AHIMA. Available at http://bok.ahima.org/doc?oid=302012#.WVVybYqQyLI. Accessed June 29, 2017.
4. Kibbe D. Information blocking under attack: The challenges facing EHR developers and vendors. The Health Care Blog. May 28, 2017. Available at http://thehealthcareblog.com/blog/2017/05/28/information-blocking-under-attack-the-challenges-facing-ehr-developers-and-vendors/. Accessed June 29, 2017.
   

By Sue Coons, MA

This article was reprinted from Research Practitioner, Volume 18, Number 3, July-August 2017. Subscribe >>