eClinicalWorks Settlement Will Take the Sting Out of Switching to New EHR Systems

Electronic health record vendor eClinicalWorks’ has been fined $155 million for violating the False Claims Act. The company’s misfortune could be the urgent care industry’s (and patients’) gain, however, by making it easier for healthcare providers to switch from one EHR system to another. eClinicalWorks was sued over claims that it falsely certified that its EHR met all government criteria and that it failed to adequately test its software before release; to adequately debug systems in a reasonable amount of time; to ensure data portability and audit log requirements; and to reliably record lab and diagnostic imaging orders. The settlement requires the company to help customers switch to other vendors’ products at no charge—whereas doing so previously could cost its customers tens of thousands of dollars. Customers can also get updated versions of the company’s software at no cost.

Following are key points of the Corporate Integrity Agreement (CIA) between the Office of the Inspector General of the Department of Health and Human Services and eClinicalWorks (eCW). (The entire text of the CIA has been posted for public record at https://www.oig.hhs.gov/fraud/cia/agreements/eclinicalworks_05302017.pdf)

CIA Section Analysis:

1. Section I (Preamble) – the Preamble states that contemporaneously with the execution of the CIA, eCW is entering into a settlement agreement with the United States.
2. Section II. A.  – The period of compliance obligations assumed by eCW under the CIA shall be five years from the effective date of the CIA.  The “Effective Date” shall be the date on which the final signatory of the CIA executes the CIA (it is May 30, 2017).
3. Section II. C. 1. – “EHR Software” refers to software and related services or solutions (and any updates thereto) being developed, developed or marketed by eCW at any time before or during the term of this CIS that are or could be subject to ONC Health IT Certification Program Requirements or that affect the performance of any such software, services, and solutions.
4. Section III. D. (Obligations to Existing Customers and Future Customers).
   1. Provision of Upgrade Option to Existing Customers – “eCW shall as soon as practicable after the Effective Date make available to each of eCW’s current customers and users of the EHR Software (“Existing Customers”) the latest version of the EHR Software used by the Existing Customer and the latest updates to any drug database supported by the EHR Software used by the Existing Customer, including where relevant the Existing Customer’s preferred drug database from amount the supported options (the “Upgrade Option”).
      1. The Upgrade Option shall be provided at no additional charge to the Existing Customer (including, without limitation, any eCW mandated fees for implementation, installation, or training services).  eCW may charge for training and/or implementation services which are not mandated by eCW for implementation of the Upgrade Option but which nonetheless may be requested by an Existing Customer in connection with an update or upgrade
      2. The exercise of the Upgrade Option by an Existing Customer does not preclude the Existing Customer from also exercising the Data Transfer Option.

5. Section III. D. 2. (Data Transfer Option for Existing Customers) – eCW shall timely transfer the Existing Customer’s data without penalties or service charges (including, without limitation, any break fee or termination fee) other than contractual amounts still owed in connection with goods or services already provided (“the Data Transfer Option”).  eCW shall not be required to reimburse Existing Customers for any costs an Existing Customer may incur on its own as a result of a decision exercise the Data Transfer Option.
6. Section III.D.2. a. – an Existing Customer must exercise the Data Transfer Option within one year of the Initial Customer Notification (described in Section III.D.3.)
7. Section III.D.2.b. – Upon an Existing Customer’s exercising of the Data Transfer Option, eCW shall transfer all data held by eCW on behalf of the Existing Customer (including protected health information, and all other data and information provided by the Existing Customer or which eCW develops or receives on behalf of the Existing Customer, or has access to in connection with the Software Agreement) to the Existing customer or its designee in a commercially reasonable, structured format that allows for the customer’s data to be migrated to and useable by the customer’s subsequent EHR System and vendor, and provide timely good faith instructions on how this data is to be accessed by the customer’s subsequent EHR Vendor.
8. Section III.D.3 (Notifications to Existing Customers) – eCW must provide notifications to Existing Customers that meet the following requirements (“Customer Notifications”)
9. Section III.D.3.a. – Initial Customer Notification.  Within 60 days after the Effective Date, eCW shall cause to be sent to Existing Customers a Customer Notification with the following information format and content (“Initial Customer Notification”):
   1. The Initial Customer Notification shall be on eCW letterhead.
   2. The Initial Customer Notification shall include the following subject line: “IMPORTANT INFORMATION ABOUT YOUR EHR SOFTWARE AND SERVICES.  YOU HAVE NEW OPTIONS FREE OF CHARGE TO YOU.”
   3. The Initial Customer Notification must include the following introductory statement: “eCW recently entered into a settlement with the U.S. Department of Justice and the Office of the Inspector General, U.S. Department of Health and Human Services.  As part of the settlement, we offer the following to our customers.”
   4. The Initial Customer Notification must contain the following promises and undertakings from eCW to each Existing Customer, and eCW must present such promises and undertakings, and do all other things necessary, to make the promises and undertakings legally binding and enforceable against eCW:
      1. Each Existing Customer has the opportunity to receive from eCW, at no additional charge to Existing Customer:
         • An upgrade to the latest production version of the EHR Software in use by the Existing Customer; and
         • An upgrade to the latest update of any drug database supported by the EHR Software used by the Existing Customer.
      2. Throughout the term of the Existing Customer’s Software Agreement, Existing Customer also has the opportunity to receive from eCW, at no additional charge, such further updates, upgrades, software defect fixes, and patches to the EHR Software and the supported drug database as necessary to ensure that the EHR Software conforms with the ONC Health IT Certification Program.
   5. Notwithstanding the foregoing, the Initial Customer Notification may reference the limitation on eCW’s obligation to provide updates or upgrades set forth in this Section III.D.1.d. of this CIA.

10. Section III.D.3.b. – Notifications of Data Transfer Option.  If an Existing Customer requests the opportunity to transfer data to other EHR software within one year of the Initial Customer Notification, or inquires, in any manner and in any respect, about data transfer services, including the transfer, migration, and/or conversion of the Customer’s data (or any part thereof), eCW will notify the Existing Customer in writing of the Data Transfer Option.
11. Section III.D.4.c. – Where applicable, eCW will encourage Existing Customers to exercise the Upgrade Option, including by timely informing any Existing Customer that has not exercised the Upgrade Option of any known patient safety risks associated with the EHR Software.
12. Section III.D.5 – Following termination of eCW’S Software agreement and transfer of data, eCW can, within the limitations of this section, charge for continued access to eCW’s software.
13. Section III.D.6. – eCW must not restrict or prohibit, by contract or otherwise, the rights of Existing Customers to discuss problems with eCW’s EHR Software in any forum whatsoever.
14. Section III.F.1. (Compliance with Anti-Kickback Statute) – Focus Arrangements Procedures.  Within 120 days after the Effective Date, eCW shall create procedures reasonably designed to ensure that each existing or new or renewed Focus Arrangement does not violate Anti-Kickback Statute or the regulations, directives, and guidance related to these statutes.
15. Section IV – Successor Liability.  In the event eCW proposes to sell its business or purchase or establish a new business, the CIA shall be binding on the purchaser.