EHR Reporting Program Invites Public Feedback

The Electronic Health Record (EHR) Reporting Program was established by the Office of the National Coordinator for Health Information Technology (ONC) as required by the 21st Century Cures Act (the Cures Act). The purpose of the EHR Reporting Program is to collect end user and developer reports on comparative information for certified health information technology (HIT). The Cures Act identified several domains for reporting, such as interoperability, usability and user-centered design, privacy and security, and conformance to certification standards. The Urban Institute (the contractor engaged by ONC for this program) released draft developer measures for public comment; the comment period ends September 14, 2021.

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ONC publishes Health IT Standards Bulletin addressing race and ethnicity

The Office of the National Coordinator for Health Information Technology (ONC) has published a Health IT Standards Bulletin describing the capabilities that certified health information technology (HIT) must demonstrate for capturing and exchanging patient race and ethnicity data. Certified HIT must be able to record race and ethnicity at a detailed level of granularity consistent with the race and ethnicity code system used by the Centers for Disease Control and Prevention (CDC). The CDC code system includes over 900 concepts for race and ethnicity, which are organized to roll up to the Office of Management and Budget minimum categories for race and ethnicity.

 

Certified HIT must be capable of recording each of a patient's race and ethnicity codes in a manner that most closely aligns to how the patient self-identifies. A certified HIT module must also be able to record whether a patient chose not to provide information for race, ethnicity or both. The certification criteria do not specify how many of the CDC code sets must be displayed in the certified HIT demographics module; this is to be determined by the developers in concert with the end users.

EHR vendor pays $3.8 million to settle kickback allegations

CareCloud Health, Inc., a developer of electronic health record (EHR) software, agreed on April 28, 2021 to pay $3.8 million to settle a whistleblower suit charging it with violations of the False Claims Act and anti-kickback statute. The case arose out of the vendor's "Champions Program", in which CareCloud offered credits and bonuses to existing customers to recommend the vendor's EHR products. Participating customers were required to enter into an agreement that prohibited them from sharing negative information to potential new clients.

FDA amends medical device classification regulations to exclude certain software functions

On April 19, 2021, the Food and Drug Administration (FDA) published a final rule amending its regulations relating to medical device classification to conform to the 21st Century Cures Act (Cures Act). The Cures Act had amended the Food, Drug and Cosmetic Act to exclude certain software functions from the definition of device. Software that transfers, stores or displays data or medical information is excluded, unless the function interprets or analyzes data. The regulatory changes affect eight classifications of devices.

 

In most cases, the changes do not completely remove the type of device from FDA regulation, but rather distinguish those functions that remain within the definition of medical device from those which were excluded by the Cures Act. For example, with regard to a Picture Archiving and Communications System (PACS) device, the functions of storing and displaying medical images no longer fall within the definition of medical device. However, complex image processing such as image manipulation, enhancement or quantification remain device functions subject to FDA regulation.

 

The affected classifications are:

  • Calculator/data processing module for clinical use
  • Continuous glucose monitor secondary display
  • Automated indirect immunofluorescence microscope and software-assisted system
  • Medical device data system
  • Home uterine activity monitor
  • Medical image storage device
  • Medical image communications device
  • Picture archiving and communications system

New fact sheets on FHIR API

The Office of the National Coordinator for Health Information Technology (ONC) has published four fact sheets on Fast Healthcare Interoperability Resources (FHIR). FHIR is an application programming interface (API) focused standard developed by the standards developing organization Health Level 7 (HL7) for use in exchanging health information. An FHIR Resource defines the component data elements, constraints on data and data relationships that make up an exchangeable patient record. There are 145 Resources in the 4th release of FHIR.

 

The FHIR API is based on established web standards, specifically Representational State Transfer (REST). An example of a RESTful data request would be a user's search for a location in Google Maps. The request in the web browser identifies the receiving system (Google), the application (Maps), the Resource requested (place), and the address requested by the user. An analogous request using FHIR would identify the Resource requested (such as a single patient, or the patient's care plan). To process the request, the server behind the electronic health record system would have to be programmed with the type of Resources and interactions it can support.

ONC proposes expanding core data for interoperability

The Office of the National Coordinator for Health Information Technology (ONC) has published a draft version 2 of the United States Core Data for Interoperability (USCDI). The USCDI establishes a baseline set of data to be exchanged across care settings. Version 1 of the USCDI was adopted as part of the ONC’s 21st Century Cures Act final rule published on May 1, 2020. The USCDI is incorporated into the certification standards for electronic health technology, and also is significant for application of the information blocking prohibition. Information blocking is a practice of a developer of certified health information technology, a health care provider, or health information exchange that interferes with access, exchange or use of electronic health information (EHI). Before October 6, 2022, EHI covered by the information blocking prohibition is limited to the data elements included in the USCDI.

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EHR vendor settles anti-kickback claims for $18.25 million

On January 28, 2021, the Department of Justice (DOJ) announced that athenahealth Inc. (Athena) agreed to pay $18.25 million to resolve lawsuits brought under the Anti-Kickback Statute and False Claims Act. Athena is a vendor of electronic health record (EHR) software. The suits were initially filed by whistleblowers under the qui tam provisions of the False Claims Act and the DOJ elected to intervene.

The Anti-Kickback Statute makes it illegal to offer, pay, solicit or receive any remuneration in exchange for referral of patients, or referral for sales of goods or services that could be paid for under a federal health care program. Athena allegedly engaged in three marketing programs that violated the Anti-Kickback Statute: paying for customers and prospective customers to attend “Concierge Events”, including payment of travel, luxury accommodations, tickets to sporting events and meals; paying kickbacks to existing customers under a “Lead Generation” program for referring prospective new clients; and agreeing to pay competing vendors for referrals when their clients discontinued use of the other vendor’s EHR.

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