Doctors Caught in Middle of Battle Over Interoperability Rules

The battle over proposed new government rules on interoperability and information blocking escalated to a higher level on June 4 as all six previous national coordinators of health information technology joined the current national IT coordinator, Donald Rucker, MD, in calling for the adoption of the regulations, according to a post on Health Affairs Blog.

Meanwhile, a broad array of industry groups, including associations representing physician practice administrators, electronic health record (EHR) developers, insurance companies and other parties, presented critical comments to the government agencies that drafted the rules.

The Medical Group Management Association (MGMA), for example, said in its letter to Rucker, "We urge ONC [Office of the National Coordinator for Health IT] to avoid pushing physician practices too far, too fast. The risks of moving too quickly include additional administrative and financial burdens on practices, weaker privacy and security protections for sensitive health information, an increased level of physician burnout, and the potential of compromised patient care."

In contrast, the six former national coordinators — David Blumenthal, David Brailer, Karen DeSalvo, Robert Kolodner, Farzad Mostashari, and Vindell Washington — said in their Health Affairs Blog post that "we…unanimously believe that these rules have the potential to transform how information flows through our health care system, catalyzing broad innovation and engaging and empowering consumers."

Key Regulatory Provisions

The proposed rules, released in February by ONC and the Centers for Medicare & Medicaid Services (CMS), are designed to carry out the intent of the 21st Century Cures Act to promote interoperability among health IT systems, to prevent information blocking by providers and IT developers, and to make it easier for patients to access their health records.

The ONC rule would update the 2015 edition certification criteria for EHRs, requiring an expansion of standardized data elements in clinical summaries and the ability to use open application programming interfaces (API) based on an industry standard called Fast Health Interoperability Resources (FHIR). EHR developers would have to program the capability to electronically export all the information in their systems.

Information blocking features — which make it difficult or impossible to exchange data with other systems — would be prohibited, with penalties of up to $1 million per infraction. Additionally, healthcare providers who engage in information blocking would be liable for civil monetary penalties or "appropriate disincentives." The ONC rule lists seven exceptions to information blocking in areas such as privacy, security, and patient harm.

Under the CMS rule, starting in 2020, hospitals would be required to electronically inform physicians and other providers when their patients were admitted, discharged, or transferred. CMS would make this a condition of participation in Medicare.

CMS would also require private insurers who operate Medicare Advantage plans, Medicaid plans, Children's Health Insurance Program plans, and federal insurance marketplace plans to develop FHIR-based APIs to enable their members to download claims data related to their healthcare. Fee-for-service Medicare beneficiaries can already do this via specially built apps through CMS' Blue Button 2.0 API.

Strong Pushback

The EHR Association (EHRA), which represents the major EHR vendors, said in a blog post that it supports the goals of ONC's interoperability rule but that the regulation is too broad and goes beyond Congress' intent in the 21st Century Cures Act. "In particular, we have significant concerns regarding timelines, ambiguous language, disincentives for innovation and definitions related to information blocking," EHRA said in the post.

The Health Innovation Alliance, a lobbying group representing 75 healthcare, health insurance, and health technology organizations, including EHRA, said the interoperability rule is unworkable and needs to be revamped, according to FierceHealthcare. The College of Health Information Management Executives and the American Medical Information Association (AMIA) asked ONC for an interim final rule to allow more time to work out the issues with industry stakeholders.

While the ONC proposal has borne the brunt of the attacks, some associations have also questioned portions of CMS' proposed rule. For example, the AMIA warned the government to go slow in requiring federally funded health plans to use API interfaces to make claims data available to consumers. If there is a rigid deadline, it will be nearly impossible for all of the plans to meet it, the AMIA said in a statement.

In the face of all this opposition, Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Sen. Lamar Alexander (R-Tenn.) recently called for the Department of Health & Human Services (HHS) to consider delaying the implementation of the new interoperability rules. At a hearing on the topic, HELP committee senators suggested HHS adopt a more phased-in approach rather than implement hard deadlines, FierceHealthcare reported.

But the six former national coordinators stressed the importance of moving ahead with the rules as quickly as possible. They applauded the ban on the use of pricing to restrict patients' access to their health information; the promotion of APIs "to enable clinical data liquidity and convenient patient access to personal data"; the adoption of new data standards; the prohibitions on information blocking; and the requirement that hospitals electronically notify providers when any of their patients are admitted, discharged, or transferred.

MGMA Position

The MGMA's letter to Rucker described ONC's proposal as "extremely ambitious." The association said the ONC should consider "staging" the requirements to give practices and vendors sufficient time to develop and implement software solutions.

The ONC should also ensure that the rule doesn't increase administrative burdens on practices and that privacy and security are protected, the letter said. Additionally, instead of subjecting providers to information blocking penalties, the ONC should educate clinicians and patients about their rights and responsibilities with regard to health information exchange, according to MGMA.

No physician wants to block the exchange of information that could be helpful in treating patients, Rob Tennant, senior policy adviser to the MGMA, told Medscape Medical News. If some doctors don't exchange data with other providers, they either don't understand the rules or they're not able to send and receive information because of the technology costs involved, he said.

Asked about the administrative burden that MGMA says the ONC rule would impose, Tennant cited additional documentation requirements that practices would have to meet whenever they needed to justify exceptions to the rule for privacy, security, or patient harm. Any violation of such rules could incur monetary penalties, he added.

Another area that concerns MGMA, Tennant noted, is that many physicians have not yet upgraded to 2015 edition certified EHRs. This year, they must do so in order to meet the interoperability criteria of CMS' Merit-Based Incentive Payment System. If these certified EHRs must have API and other new capabilities, he said, small practices could face huge upgrade fees.

On top of all of that, Tennant said, "we still don't know the implications of this technology. There have been no pilots, and we have no real sense of how patients are going to react. So let's let the larger, more sophisticated groups go first, and let's learn from them. We may have to tweak the regulations, but let's not impose penalties on folks when we have no idea what the implications of this are."

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