Last week, the Centers for Medicare and Medicaid Services (CMS) published a request for information (RFI) seeking public comment regarding areas of certification and testing of health IT as part of the Electronic Health Records (EHR) meaningful use program.

Beginning in 2018, participants in the Stage 3 Meaningful Use EHR incentive program must electronically report certain clinical quality measures using certified EHR technology.  CMS annually updates these clinical quality measures and requires that participants report using these most recent specifications.  However, CMS explains that it currently has no way to track implementation of these updates for already certified EHR technology.  As these clinical quality measures evolve, CMS believes that there is value in retesting certified models to ensure that the updated measures are accurately calculated and represented.  CMS explains that it previously declined to require recertification because of the associated burdens on health IT developers.  However, CMS notes that it recently received comments and requests from stakeholders to change this policy.

Accordingly, CMS is soliciting information regarding whether, and when, recertification should be required when a new version of certified EHR technology is available.  CMS is also soliciting comment on whether Health IT modules should undergo annual clinical quality measures testing through CMS approved testing tools and the ONC: Health IT Certification Program.  Specifically, CMS is seeking comment on the following:

  • What is the burden (both time and money) of additional testing and recertification?
  • What are the benefits of requiring additional testing and recertification?
  • How will it affect the timeline for clinical quality measures and standard updates?
  • What are the benefits and challenges of establishing a predictable cycle from measure development to provider data submission?

In the RFI, CMS is also soliciting comments on the number of clinical quality measures which a certified Health IT Module should be required to certify and potential changes to the process of testing Health IT Modules to increase the “robustness” of the testing.

CMS will accept comments on these proposals until February 29, 2016.

Covington Digital Health Team

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with…

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with lawyers who understand how the regulatory, IP, and commercial pieces of the digital health puzzle fit together is essential. Covington offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services. To learn more, click here.