One new federal law forbids health IT vendors and providers from deliberately blocking information-sharing with competing EHR systems
Several years deep into its effort to get physicians and hospitals to use electronic health record (EHR) systems, the federal government has yet to come up with a way to improve interoperability—the ability of EHRs to interface and communicate with other systems.
Stage one and stage two Meaningful Use guidelines have failed to successfully address the barriers preventing interoperability. Of course, clinical laboratories and pathology groups encounter this problem daily. That’s because they must build interfaces between their laboratory information systems (LIS) and the EHRs of their client physicians. The cost of creating workable LIS-to-EHR interfaces continues to be a huge burden on medical laboratories and that is why they support improved interoperability. But labs also contribute to the lack of interoperability when they enact restrictions on how lab test data can be shared with other providers and competing labs who are serving the same physicians and patients.
House Passes Bill That Makes Intentional Information Blocking a Federal Crime
Interoperability and the lack thereof is such a big problem that the U.S. Congress was spurred to act. In July, 2015, the House passed H.R.6: The 21st Century Cures Act, in which section 3001 amends the Public Health Service Act (PHSA) to “establish requirements for interoperability and certification of health information technology. Practices that discourage the exchange of electronic health information are prohibited.”
H.R.6 is a follow up to H.R.2: The Medicare Access and CHIP Reauthorization Act of 2015, which the President signed into law in April. H.R.2 forbids EHR technology companies and healthcare providers that receive federal EHR incentive funds from deliberately blocking the sharing of information.
H.R.6 takes that violation a step further by making it a federal crime and outlining punitive actions. It came on the heels of a report delivered to Congress by Karen B. DeSalvo, MD, MPH, MSc, head of the Office of National Coordinator for Health Information Technology (ONC) and Acting Assistant Secretary of Health and Human Resources (HHS).
DeSalvo’s report cited deliberate roadblocks to information sharing erected by competing EHR software vendors, doctor and hospital networks, and clinical laboratories, even when the information was critical to patient care.
According to a New York Times report, DeSalvo provided the following examples of information blocking:
• A doctor may have to pay exorbitant fees to transfer information on patients from the medical record system of one vendor to that of another.
• A network of doctors and hospitals refuse to share electronic information on patients with providers outside their networks, even when the information is needed to treat patients and sharing the data is allowed by federal rules.
• Doctors obtain clinical laboratory services and health records technology from one company, which will not let them connect to a competing medical laboratory, even though the connection is technically feasible and the doctors are willing to pay for it.
One EHR Described As a “Closed Platform” for Interoperability
U.S. Rep. Phil Gingrey (R-Ga.), a physician, singled out the biggest EHR software provider in the nation during a July 2014 hearing of the House Energy and Commerce Committee. Gingery cited a Rand Corp. study that called Epic, the EHR system Epic Systems, Inc. of Verona, Wis., a “closed” platform that makes it “challenging and costly for hospitals” to interconnect with the clinical or billing software of other companies, noted a New York Times report.
Gingery pointed out that the federal program providing incentive payments for healthcare providers to install EHRs was intended to promote interoperability. Arguing that the government wasn’t getting its “money’s worth.” Gingery suggested that “It may be time for the committee to take a closer look at the practices of vendor companies in this space, given the possibility that fraud may be perpetrated on the American taxpayer.”
A month later Epic retained a Washington lobbyist to deal with Congress’ perception that its system lacks interoperability, noted a Modern Healthcare report.
Epic’s CEO Responds to Concerns about Information-Sharing
Judith Faulkner, Epic Founder/CEO, stated in a September 2014 New York Times interview that once her company realized a set of interoperability rules would not be forthcoming any time soon from the government, Epic started writing the code for the Care Everywhere platform for sharing information between patients and their providers, and between providers and other providers, regardless of whether they were on an Epic system or not.
Epic Vice President Peter DeVault contended in a May 2015 New York Times report, “We do not participate in any activities that could be described as information blocking. To our knowledge, these activities are very rare, if they exist at all.”
However, some competitors and healthcare providers disagree with Epic’s statement. They have criticized Epic for deliberately erecting significant barriers that impeded interoperability between the Epic EHR and competing systems.
Attorney Dan Haley, JD, is the Assistant General Counsel and Vice President of Government and Regulatory Affairs at Watertown, Massachusetts-based Athenahealth, a competing EHR vendor. He told the Times, “Some health IT vendors have business models that create real impediments to the sharing of medical information.”
Haley explained that this includes how some EHR vendors threaten clients with exorbitant costs and fees to make and maintain the connection to other systems. He noted that such costs can typically be as much as $1 million for a hospital to make the connection, $500,000 per year to maintain it, and $2 per medical record transmitted to hospital using a different EHR system.
H.R.6 Defines Information Blocking
If the 21st Century Cures Act passes the Senate as written, it would define “information blocking” as a federal offense noted the New York Times story. The bill also defines for the purpose of assessing penalties healthcare providers and HIT/EHR vendors who participate in information blocking.
In general, for the purposes of the bill, information blocking refers to the “access, use, and exchange” of qualified electronic health records that:
• prevent or materially discourage the access, exchange, or use of electronic health information; and/or,
• [when] the actor knows or should know [that he/she is] likely to interfere with the access, exchange, or use of electronic health information.
Additionally, the bill defines HIT technical/business/organizational practices that also engage in information blocking as:
• Contract terms, policies, or business or organizational practices that restrict authorized use under applicable State or Federal law of electronic health information or restrict the authorized exchange under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified EHR technologies.
• Charging unreasonable prices or fees (such as for health information exchange, portability, interfaces, and full export of health information) that make accessing, exchanging, or using electronic health information cost prohibitive.
• Developing or implementing health information technology in nonstandard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information, especially in cases in which relevant interoperability standards or methods to measure interoperability have been adopted by the Secretary.
• Developing or implementing health information technology in ways that are likely to lock in users or electronic health information, such as not allowing for the full export of health information; lead to fraud, waste, or abuse; or impede innovations and advancements in health information access, exchange, and use, including health information technology-enabled care delivery.
“Since 2009, we have spent $29 billion to encourage the adoption of electronic health records, but data is still fragmented,” U.S. Rep. Michael Burgess (R-TX-26) told the Times. “Vendors continue to impede the exchange of information.”
Path to EHR Decertification
H.R.6 also calls for the HHS Secretary to post a list of EHRs deemed in compliance with the methods relative to interoperability and those that are not by 2018. If vendors do not comply by 2019, they can be decertified. However, they would be able to apply for a five-year hardship exemption to avoid penalties under the MU program.
“The interoperability of health information between providers and labs is complicated and there is no simple solution,” Peter Ashkenaz, Director of Content and Media at the ONC, told Dark Daily. “Any solution is made more difficult by entities that engage in unreasonable practices—practices that interfere with the exchange or use of electronic health information, including blocking core clinical information for patient care, such as lab results. We do not believe that the federal government should tolerate those practices and are actively working with Congress to make sure they are addressed. Here at ONC, we have been focused on advancing the interoperability of laboratory information for many years, through standards initiatives, working closely with NIST and other federal agencies to support interoperability,” he added.
New Law May Bring Change, but EHR Interoperability May Take Years to Happen
All these steps may eventually make it easier, cheaper, and faster to establish interfaces between EHRs and other healthcare systems. If so, that would be welcomed by the nation’s clinical laboratories and pathology groups. However, experts believe that it will take several years for these reforms to actually bring about such changes in the healthcare marketplace.