CMS Proposes Rules on Information Blocking, Patient EHR Access

Ken Terry

February 12, 2019

The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) on February 11 rolled out complementary proposed rules to improve the interoperability of health IT systems, increase the access of patients to their electronic health information (EHI), and prevent information blocking.

For physicians, the proposed rules have several important ramifications.

To begin with, healthcare providers who engage in information blocking will be liable for civil monetary penalties or "appropriate disincentives," although the proposed ONC rule did not specify what they will be. Hospitals or physicians that acknowledge obstructing the exchange of information with patients or with each other will be publicly identified. The ONC rule also lists seven exceptions to information blocking in areas such as privacy, security, and patient harm.

Starting in 2020, hospitals will be required to electronically inform physicians and other providers when their patients are admitted, discharged, or transferred. "As a condition of participation in Medicare, we are requiring that all hospitals send electronic notifications to designated healthcare providers when patients are admitted, discharged, or transferred from the hospital to improve transitions of care between medical settings to improve patient safety, coordination, and overall care," stated CMS Administrator Seema Verma at a news conference.

The government has officially endorsed the Fast Health Interoperability Resources (FHIR) standard for exchanging clinical data, which will be required in certified electronic health records (EHRs). FHIR-based application programming interfaces (APIs), which can be used to link EHR data to apps of the patient's choosing, will also be required.

To get their products certified, EHR developers will also have to program the capability to electronically export all the health information that they "produce and electronically manage." This means that patients will have access to their complete electronic records and that physicians can automatically export their current EHR data when they switch EHR systems.

To create clinical summaries, certified EHRs will use the new US Core Data for Interoperability (USCDI) in place of the Common Clinical Data Set. The USCDI expands the data types available for interoperability. Among the new data categories are various kinds of clinical notes, pediatric vital signs, patient contact information, and information on the provenance of clinical data.

ONC has developed 10 recommendations for the voluntary certification of health IT for pediatric care. Among them are the inclusion of growth charts, weight-based computation of drug doses, age- and weight-specific single-dose range checking, and the ability to document all guardians and caregivers.

Increased Options for Patients

The CMS proposed rule will increase patients' access to claims data and give them a mechanism to interpret and use that data.

In 2018, CMS launched its Blue Button 2.0 API for traditional Medicare beneficiaries. The goal of that program is to allow patients to access their claims data electronically through a variety of apps. Over 1500 app developers are building tools designed to work with this API, Verma said. Seven apps are already available.

Under the proposed rule, private insurers who operate Medicare Advantage plans, Medicaid plans, Children's Health Insurance Program plans, and federal insurance marketplace plans will all have to develop FHIR-based APIs for their members.

Nearly 40 million Medicare beneficiaries will potentially be able to access their claims data through the Blue Button 2.0 API, Verma said. By 2020, she added, all health plans doing business with the government will be required to have similar APIs. At that point, about 125 million patients will have access to claims data, she said. When so many private insurers' members have this option, she predicted, the plans will probably extend it all of their members.

Verma anticipates that many patients will take this information with them as they move from one healthcare provider to another. In addition, she pointed out, FHIR-based APIs will allow patients to aggregate their clinical summaries from multiple patient portals instead of having to download a summary from the portal of each provider they see. The apps they use will help them understand the data and will enable them to share it with the next provider they visit.

Under ONC's proposed rule, said Donald Rucker, MD, national coordinator for Health IT, healthcare providers and EHR vendors will not be allowed to charge consumers for using their data in third-party apps. "That's part of the payment for care," he said.

However, an app developer can charge consumers for their services. In addition, healthcare providers can charge fees to third-party developers whose apps consume their EHR data. The fees must be based on the provider's costs to provide access to or to exchange or use the data.

The deadline for comments on CMS's and ONC's proposed rules is early April.

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