By Tony Schueth, Editor-in-Chief
, and Michael Burger, Senior Consultant
Alleged information blocking by vendors of electronic health records (EHRs) continues to be a hot topic in Washington. It first arose as part of the broader conversation about the need for interoperability in the health information technology (healthIT) space. Now it appears to be taking on a life of its own: the focus of a new draft congressional bill, the recently released Report to Congress on Health Information Blocking from the Office of the National Coordinator for Health Information Technology (ONC), meaningful use (MU) draft stage 3 certification processes and a discussion topic at the May meeting of the Health Information Technology Policy Committee (HITPC).
Taken individually, these events are interesting. Taken together, they add up to a trend that is likely to be around for some time and bears close scrutiny. Point-of-Care Partners (POCP) is monitoring this issue, and here is where it stands at the moment.
Proposed legislation. Rep. Michael Burgess, MD, recently released a draft bill, Ensuring Interoperability of Qualified Electronic Health Records. Language from the finalized bill will become part of the 21st Century Cures initiative, which the powerful House Energy and Commerce (E&C) Committee of which Burgess is a member will use as a vehicle to develop ways to accelerate the discovery, development and delivery of promising new treatments to patients.
The Burgess bill does several things. It specifies that an EHR can be considered interoperable if it provides open access, complete access to health data and does not block access to other qualified EHRs. Those criteria would be fleshed out by a 12-member, congressionally appointed charter organization yet another federal advisory committee that would supercede existing ones. It would recommend EHR interoperability measures to ONC and submit a report in 2017 on interoperability progress. The legislation also allows for vendors to be decertified by the Department of Health and Human Services if they are unable to meet the interoperability criteria.
Whats missing here is anything related to the likely cost to make this happen. Its technically possible, but not inexpensive. That is why EHR vendors should be interested in the Burgess bill: it could have a potentially bigger impact on product planning than meaningful use. The bill also is important as yet another symbol of congressional disillusion with the progress of EHRs and healthIT in the face of the $44 billion already paid as incentives to eligible providers. It also is a harbinger of things to come as it probably will not be the only bill of its kind to hit the Hill in coming months. This kind of issue will likely resonate with powerful constituent groups, so lawmakers are likely to pile on to better position themselves in upcoming elections.
We expect Burgess will submit finalized language this summer, following analysis of stakeholder comments submitted earlier this spring. The E&C Committee is very powerful, so it is possible that the 21st Century Cures initiative will have some traction. In addition to his seat on that committee, Burgess is one of the few physicians in Congress and a member of the Republican Doctors Caucus. As a result, we anticipate healthIT will continue to be of interest to him.
ONC Report to Congress. ONC recently released its Report to Congress on Health Information Blocking, which responds to a Congressional request that was included as part of a spending bill to keep the government running for the first three quarters of 2015 (aka the CRomnibus). The legislation directs ONC to assess the extent of health information blocking and recommend a comprehensive strategy to address it.
The Report begins with a balanced and thoughtful analysis of the issue, acknowledging that many actions that prevent information from being exchanged may be inadvertent, resulting primarily from economic, technological and practical challenges that have long prevented widespread and effective information sharing. Information blocking is defined as occurring when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information.
Not surprisingly, the Report is sharply critical of EHR vendors. It alleges that certain vendors create a climate ripe for information blocking through business practices and pricing. It contends the information blocking phenomenon largely is due to business practices of certain EHR developers [who] refuse to establish interfaces with certain technologies or entities, or will only do so on terms so onerous that they amount to a refusal for all practical purposes. This seems harsh, especially since it is based mostly on anecdotal evidence. Little actual data could be obtained because ONC does not have the authority to require vendors and others to produce such information.
What is missing is a counterweighting explanation of why such business practices might occur. The answer is that there is insufficient justification for information sharing relative to the costs of creating the interface. This is the central issue. For example, the report cites an instance in which an integrated delivery network (IDN) restricts the ability to exchange secure messages among only providers who are members of its care network. However, in doing so, the IDN is protecting its business interests (and in turn managing costs) by using technology to ensure that referrals stay in network. It is not that the EHR vendor and IDN collude to block information. In reality, there is no economic incentive to refer patients out of network; the IDN simply is taking advantage of a smartly designed piece of software that enables an ability to address a business need.
There are also pricing issues. Prices for interfaces could be considered comparatively high, but compared to what? Interfaces between any disparate computer software are complex, with many potential points of failure. EHR software is no different. And interfaces often represent the single most costly feature for EHR vendors to support. Interfaces are priced relative to what they cost to build and maintain; of course, margin is built in. The answer proposed by ONC is free or low-cost application interfaces (APIs). We believe further study is needed to address a number of issues, including the use of standards, governance, privacy and security. What protections for vendors and users are needed if API developers cease supporting their software or substantially increase prices? What processes will be put in place to ensure that an API functions correctly to ensure patient safety?
MU stage 3 certification. Information blocking is a topic for comment in the MU stage 3 certification rule. It asks for examples of information blocking and ideas for criteria and processes for decertifying EHRs of vendors who engage in the practice. We expect stakeholder feedback on this issue to be incorporated in the final rule.
HITPC. The CRomnibus also directs the HITPC to submit a report on the state of interoperability to the House and Senate Committees on Appropriations and the appropriate authorizing committees before the end of 2015. The report is to cover the technical, operational and financial barriers to interoperability, the role of certification in advancing or hindering interoperability across various providers, as well as identification of any other barriers. As part of the report development, information blocking was a topic of discussion at a recent HITPC meeting. According to news reports, a HITPC work group declined to endorse the information-blocking restrictions in ONC’s MU stage 3 certification standards, calling for additional study of this complex issue. It also concluded that EHR decertification, as proposed in Burgess’ draft bill and discussed in ONCs Report to Congress, would place an undue burden on providers and patients (not to mention vendors).
So, whats the answer? Its clear that information blocking is a hot potato that is not going to be dropped anytime soon.
Its easy to point the finger at EHR vendors and claim they are engaging in opportunistic pricing practices, which generally are not illegal. Its not as easy to target IDNs and force them to share information about patients when theyve invested millions to keep such data within their walled garden. Its also easy to point the finger at Congress and the government for creating legislation and multiple (and potentially overlapping) programs that would regulate and perhaps stifle, as some suggest the business of healthIT and health information exchange.
At the heart of the matter is that healthIT is a business. HealthIT responds to market-based demand. The transition from quantity-based reimbursement to quality-based reimbursement will create business reasons to share patient data better outcomes, reduced costs and elimination of duplicative testing. At that point, a $20,000 interface moves from nice to have to a valuable business tool. Health care is not a normal market it is composed of very different entities that dont necessarily respond to traditional market drivers. Truth be told, the health care system sometimes does not work in favor of consumers (providers and patients) and requires oversight to work more effectively. Striking an effective balance across traditional drivers, market realities, user needs and government oversight will be vital.
We also need to have some up-front harmonization among the requirements for any new healthIT legislation and those for existing federal programs, advisory committees and related processes. There already has been pushback from the Brookings Institution about the Burgess bill, which essentially says that more congressional action is not the answer to stimulate innovation and eliminate barriers to better healthIT and better health care.
Nonetheless, congressional action is where the ball rests at the moment. ONCs Report essentially punted the ball back to the Hill. Dr. Burgess should introduce his revised language soon. The HITPC has to draft its Report to Congress following near-term deliberations. It will then be up to Congress to decide what to do next. POCP is monitoring the action, so let us know if we can provide further details.