Congress must put an end to the emerging practice of “information blocking” by purveyors of electronic health record systems, American Society of Clinical Oncology urged at a Capitol Hill briefing.
At the briefing Sept. 15, ASCO said that some EHR companies are erecting obstacles that prevent health care providers from sharing data contained in patient health records.
ASCO is at the heart of this Big Data controversy because it is developing the CancerLinQ database. If oncology practices are precluded from sharing data—as they increasingly are—CancerLinQ will become unworkable.
“This is tragic, because the success of CancerLinQ and any data-sharing platform, is from being able to draw out information from all individuals that are affected, not just a few of them,” Robin Zon, a medical oncologist with Michiana Hematology Oncology, one of the first 15 practices that will participate in CancerLinQ, said at the ASCO briefing.
“The bottom line is, that if data-sharing is not achievable, then vital insights will be lost. I think our patients deserve better.”
Clifford Hudis, a breast cancer expert at Memorial Sloan Kettering Cancer Center, a past president of ASCO, and a member of the board of governors of CancerLinQ, said Congress has the power to fix the problem.
“It is common for adjacent facilities using the same health care records to have no ability to transmit them, because their customized installations change the way data fields are recorded, so one has to bring 500 pages of chart in one hospital’s record system, take it across the street and scan it back in to the same vendor’s product in another facility,” Hudis said.
The lack of “interoperability” across EHR systems stems from a fundamental flaw.
Since the federal government mandated the transition to electronic medical records in the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, a handful of powerful players emerged throughout medicine.
The problem becomes all the more complex because the data being collected by this handful of players throughout medicine are extraordinarily valuable. While interoperability is often discussed, the EHR providers are broken into two groups:
- First and foremost, there is Epic, the largest provider of health record systems.
- The second group is everybody else. Smaller players have formed a consortium called CommonWell Health Alliance that’s developing the interfaces that would allow systems to communicate with each other.
While no one owns up to information blocking, oncologists say the practice is on the rise.
“What does information blocking really mean?” Zon said at the ASCO briefing. “As you can imagine, there are EHRs that are competitors in the marketplace. And they don’t allow each other’s systems to talk with each other.
“So what’s happening as a provider—and we’re hearing this across all specialties, not just oncology, and across the nation—some of these EHR systems are requiring a transaction fee to import and to export the information.
“There are other EHR systems and vendors that are flat-out refusing or making it prohibitively expensive to make the systems communicate with each other.
“And then, most recently, I heard a report that there was a vendor [that] by contract has disallowed anybody who is using their system from sharing their information with a data system that is not their own.”
Asked to name the EHR vendors who contractually block release of information to entities that use the systems supplied by competing vendors, ASCO officials declined to provide specifics.
“ASCO is a membership organization and it is our policy that we not comment on vendors that may have a business relationship with our members,” Apoorva Stull, policy communications manager, said in an email.
Anecdotal Evidence
Zon’s allegations echo a recent report by the HHS Office of the National Coordinator for Health Information Technology, which catalogued anecdotal reports of information blocking. These practices include:
- Contract terms, policies, or other business or organizational practices that restrict individuals’ access to their electronic health information or restrict the exchange or use of that information for treatment and other permitted purposes.
- Charging prices or fees (such as for data exchange, portability, and interfaces) that make exchanging and using electronic health information cost prohibitive.
- Developing or implementing health IT in non-standard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information, especially when relevant interoperability standards have been adopted by the Secretary.
- Developing or implementing health IT in ways that are likely to “lock in” users or electronic health information; lead to fraud, waste, or abuse; or impede innovations and advancements in health information exchange and health IT-enabled care delivery.
Misunderstanding of privacy laws also presents an obstacle, ONC said in the report.
“Some providers or other persons or entities may mistakenly or even intentionally misinterpret or misrepresent state privacy laws as prohibiting the sharing (disclosure) of electronic PHI—either with individuals directly or with other health care providers that an individual has designated—in circumstances when federal and state law permit such disclosure,” the report states.
ASCO isn’t alone in facing the challenge of aggregating data. The American Society of Radiation Oncology and the Radiation Oncology Institute recently finished a one-year demonstration project focused on prostate cancer. Altogether, 30 centers were selected to participate, but 11 of them withdrew because of legal and administrative concerns. Another five sites found that they couldn’t transfer data. The remaining sites—14 of them—were able to compile data on 430 patients. Some of this required manual data entry.
ROI officials said to The Cancer Letter that they are evaluating these results and preparing to publish them.
Under the Carpet
Maneuvering in this little-understood corner of medicine occurs outside public view, guided by secret plans, shielded by confidentiality agreements between EHR vendors and healthcare providers, and further obscured by the overwhelming complexity of technology and business structures.
An image Winston Churchill used to describe power struggles in the Kremlin can arguably be used to describe the war that now rages at the informatics underlayment of oncology.
It is akin to a battle of bulldogs under a carpet: “An outsider only hears the growling, and when he sees the bones fly out from beneath, it is obvious who won.”
Some movements of the carpet can be observed on Capitol Hill.
The sprawling 21st Century Cures legislation passed by the House this summer includes a section on interoperability that affects information blocking, and now the Senate is about to take up the legislation.
Though ASCO is one of the fighting bulldogs, at the congressional briefing Sept. 15, the society strategically pulled back one of the carpet’s corners, exposing a fragment of the battlefield.
In a statement, the society said information blocking is on the rise.
“I think that the proposal that payment be linked to this is potentially useful, but part of the concern here is that it’s not the clinicians that determine the interoperability, it’s the vendors that they’re purchasing their electronic records from, and those folks have less stake in the alternative payment models than the clinicians, and what we don’t want to do is to add burden to clinicians which in some form or fashion gets passed onto the entire marketplace,” Hudis said. “I think there might be an idea in there that might be pursued, but it’s not that simple.”
In addition to supporting the provisions in the 21st Century Cures Act, ASCO urges Congress to take the following additional steps:
- Congress should enact legislation as quickly as possible to ensure widespread interoperability is achieved. The legislation should include clear direction and mandates on the elimination of unjustified information blocking.
- Congress should pass legislation to remove barriers to interoperability, especially information blocking. The legislation should include aggressive deadlines for implementation.
- Policymakers should ensure that cancer patients, oncologists and other oncology providers do not bear the costs of achieving interoperable electronic health records and of companies refraining from information blocking. Patients and health care providers should not have to subsidize the cost of ensuring that electronic health records are interoperable.
- Federal officials should work with ASCO and other stakeholders to ensure that healthcare providers have the information necessary to be prudent purchasers and users of health information technology systems. Officials should work with ASCO and other stakeholders to help educate health care providers regarding contractual provisions, information blocking and other activities that are counterproductive to the national interest of promoting widespread interoperability.
The webcast of ASCO’s briefing is posted here.
ASCO is developing CancerLinQ in collaboration with SAP SE (Systems, Applications & Products in Data Processing), a German multinational software corporation that makes enterprise software to manage business operations and customer relations.
ASCO’s work on CancerLinQ began in 2010, with an estimated budget of $80 million for the first five years. The funds are raised from philanthropy, ASCO’s revenues, its foundation, advocacy organizations, and pharmaceutical companies (The Cancer Letter, Feb. 20, 2015; Jan. 23, 2015; Nov. 22, 2013).
Key players in the field of providing EHRs include Epic Systems, Cerner, Eclipsys Corp., MEDITECH, McKesson Corp., and Flatiron. Players seeking to aggregate oncology data across EMRs include software companies Syapse and IBM Watson, the cancer centers consortium ORIEN, and Intermountain Precision Genomics (The Cancer Letter, July 10, 2015; March 13, 2015; Feb. 27, 2015; March 30, 2014).
New Silos?
While ASCO’s analysis of the problem is viewed as on-target, not everyone agrees that congressional involvement is the answer or that EHR vendors would be able to fix the problems.
“I completely agree with ASCO that healthcare data exchange standards need to be legislated,” said John McIlwain, chairman of the board and president of Velos, a company that makes research software widely used by cancer centers. “However, EMR vendors are not the only accountable constituency. Providers and payers are also often not incentivized to share data. What’s more, all constituencies have to be concerned about HIPAA compliance. Until there are standards and laws that foster robust, safe, inexpensive data exchange, the problem will continue.”
Electronic medical records were forced onto the US health care system before data standards could be developed, and ensuring interoperability of EHRs—even when they are supported by the same vendor—is no small task, said Stanley Huff, chief medical informatics officer at Intermountain Healthcare, who also serves as chair of the board of Health Level Seven International, a standards developing organization seeking to provide a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services.
“The interoperability parts of the 21st Century Cures are very naive,” said Huff, a clinical professor of biomedical informatics at the University of Utah School of Medicine.
The House bill suggests that the flow of data is being impeded and that enforcement has the ability to eliminate these impediments. In reality, data sharing is complex and expensive.
“It makes it sound like if we find the bad guys, the problem will be solved,” Huff said to The Cancer Letter. “The real solution is to invest in standards, and development of standards is a voluntary undertaking.”
Huff said he has been told about contractual clauses in which EHR providers restrict the flow of information, but has never seen them.
“What I have never seen and don’t find credible is that any software vendor would have it in the contract that data cannot be shared,” Huff said. “They are prohibiting their own income if they do that. They have no motivation to block information to another system. They have motivation to share.”
Transfer of data is expensive and hard to do, and therefore fees for providing this service are appropriate.
“Until we get to better standards, it’s hard to create these interfaces,” Huff said. Even two hospitals using the EHR systems that are produced by the same vendor have to overcome significant technical problems.
“To exchange with another system they have to change it from local code to standard code, and that takes time and money,” Huff said. “If two institutions are regularly exchanging data, the cost of the interface can be spread out over many transfers and therefore is inexpensive. However, if the exchange is one of a few, the cost can be very high.”
Huff estimates the construction cost of an interface at roughly $20,000.
In some situations, the incentives line up against sharing data, Huff said. “I can believe that there are health care providers who would be reluctant to share data with direct competitors in the same market,” he said. “They would be nervous about another provider stealing their patients.”
The situation mentioned by Hudis—where medical records travel from institution to institution in PDF format and are scanned in—is quite common. “That’s how it is,” said Huff. “They haven’t created interface so they have to use the fax or PDF. They can create an interface.”
Moving charts is difficult enough, but charts are just a part of the picture. Lab data are different from drug data and both differ from the diagnosis data.
“The real barriers are need for better standards and the need for monetary incentives to want to exchange data, and standards are created by volunteer organizations, and the pace at which we do this is the pace of volunteering time,” Huff said.
If one is to believe the group of EHR vendors, the technical component of the problem of interoperability is being resolved,
“CommonWell Health Alliance is working to improve information exchange across disparate systems by creating real-world interoperability services that are currently being deployed nationwide,” Jitin Asnaani, Executive Director of CommonWell Health Alliance said to The Cancer Letter.
“Our services remove the need for multiple interfaces in order to exchange health data–which can be costly and inefficient,” Asnaani said. “All members of CommonWell—including EHR market leaders in acute, ambulatory, oncology, imaging, perinatal, population health and post-acute care—support the belief that provider access to health data must be built into health information technologies at a reasonable cost for use by a broad range of health care providers and the populations and people they serve.”
That said, Epic is not a member of CommonWell.
A Safety Issue
“While much progress has been made in exchanging structured demographic information, critical information needed by oncologists, such as staging, treatment plans, pathology, and radiology are still exchanged by fax machine,” said Jonathan Hirsch, president of Syapse, a company that integrates oncology data from EHRs with genomic data to enable precision medicine. “Extracting structured oncology data from one EHR is difficult enough, but doing so from multiple customized EHR systems and integrated the subsequent patient data requires a herculean effort.
“At its core, this is a patient safety issue. Print-fax-scan and other unstructured medical record transmission mechanisms hinder the ability to coordinate care across the many clinicians who treat a patient during their cancer care journey.
“Health IT vendors, oncologists, and professional societies need to come together and agree on a core set of oncology data elements that can be made accessible by every EHR to any other software system. This will greatly accelerate the sorts of care coordination, clinical decision support, quality improvement, and research programs that ASCO, Syapse, and others are implementing.”
The House version of 21st Century Cures required that EHRs meet the following criteria to be considered interoperable:
- Secure Transfer—The technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable State or Federal law.
- Complete Access to Health Information—The technology allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law without special effort by the requestor of such health information.
- No Information Blocking—The technology is not configured, set up, or implemented to information block.
The legislation specifically prohibits vendors, health care providers, and operators of health information exchanges and data registries from engaging in information blocking. Prohibited practices include imposing unreasonable fees and introduction of contractual language to restrict an authorized exchange.
