HHS adopts final rules on health information interoperability and access

April 16, 20209 min

Legal Affairs author pic SheltonBy Allison Shelton and Beth Anne Jackson, Brown & Fortunato, P.C.

Amid the flurry of government actions, announcements, and other efforts to address the threat of COVID-19, the U.S. Department of Health and Human Services (HHS) released two final rules that will significantly impact the health care industry. On March 9, 2020, the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for

Legal Affairs author pic Jackson

Medicare and Medicaid Services (CMS) issued companion rules aimed at promoting interoperability and patient access to health information in accordance with the 21st Century Cures Act.

According to the preamble to the CMS final rule, the rules address a “critical issue in the U.S. health care system . . . that people cannot easily access their health information in interoperable forms.” Accordingly, the final rules adopt measures to promote seamless data exchange and to improve patient access to health information. This article provides an overview of some of the measures that will likely affect hospitals and practitioners.
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“Interoperability” refers to the ability of two or more health information systems to exchange and use information. To promote interoperability, the CMS final rule requires certain payers to make data available through two application programing interfaces (APIs), referred to as the “Patient Access API” and the “Provider Directory API.”  Each of these APIs must conform to the technical standards adopted under the ONC final rule.  Such standards are designed to enable data sharing with third-party software applications.

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Through the Patient Access API, CMS-regulated payers must make the following data available: adjudicated claims, encounters with capitated providers, enrollee cost-sharing, provider remittances, and clinical data maintained by the payer. Once available, patients will be able to access the information through any smartphone app or other third-party application of their choice. Further, patients may be able to share the information with their health care providers for integration into the patient’s electronic health record (EHR). In addition to the Patient Access API, certain payers must make data relating to their provider network available to the public through a Provider Directory API.
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The final rules address not only interoperability and patient access but also information blocking.  Information blocking includes anticompetitive activities designed to limit the availability and use of electronic health information. To address this issue, CMS will publicly report hospitals, clinicians, and groups that do not attest to preventing information blocking.  CMS will identify such clinicians and groups through reports submitted on the Promoting Interoperability performance category of MIPS. Likewise, CMS will identify hospitals through reports made under the Medicare FFS Promoting Interoperability Program.  Clinicians will be reported on Physician Compare, and hospitals will be reported on CMS’s website. CMS will also publicly report any provider that does not have digital contact information included in the National Plan and Provider Enumeration System (NPPES).

Finally, the CMS final rule includes a new Condition of Participation (CoP) which is applicable to hospitals that have EHR systems capable of generating admission, discharge, and transfer (ADT) messages. As a result, any hospital that has sought to qualify for the Medicare Promoting Interoperability Programs (formerly known as the EHR Incentive Programs) would be required to comply with the new CoP.
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Under the new CoP, a hospital must send electronic notifications to certain recipients upon a patient’s registration in the emergency department, admission to the hospital, and discharge or transfer from the hospital or emergency department. The notification must include the patient’s name, the treating practitioner, and the hospital’s name.  Further, hospitals must send such notifications to the patient’s established primary care practitioner, practice group or entity, and any other practitioner or entity identified by the patient as primarily responsible for the patient’s care. This includes post-acute care providers and suppliers to which the patient is being referred or transferred or that had a care relationship with the patient immediately preceding the hospital registration or admission. A hospital will not be required to provide the notification to the extent (i) no appropriate recipient can be identified despite reasonable efforts; (ii) the hospital has agreed to a patient requested restriction relating to the notice; or (iii) other federal or state law prohibits or limits the notice.

The ONC and CMS final rules should help hospitals and practitioners obtain a more complete picture of patients’ health care. In addition to generating benefits for the industry, the final rules create some new obligations for providers.  Toward the end of the year, CMS will begin to publicly report providers that do not have digital contact information in NPPES.  Therefore, all hospitals and practitioners should review and update their information. Surveyors and accrediting organizations will begin assessing compliance with the new CoP around September 2020.  To determine the applicability of the CoP, a hospital may need to contact its EHR vendor regarding the system’s ability to generate ADT messages. Thereafter, hospitals with such capability should take the necessary steps to ensure compliance with the CoP.

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