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CMS Proposes Definition Of Meaningful Use Of EHR; ONC Publishes Interim Final Rule Regarding EHR Certification And Standards

Client Alert | 1 min read | 01.05.10

On December 31, 2009, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) announced proposed rules to implement provisions of the American Recovery and Reinvestment Act of 2009 (Recovery Act) relating to the adoption of Electronic Health Records (EHR) and other Health Information Technology (HIT). The new regulations would provide standards and guidance for programs designed to encourage "eligible professionals" (EP), eligible hospitals, and critical access hospitals (CAH) to make "meaningful use" of EHRs and HIT. Providers making "meaningful use" of EHRs and HIT qualify for higher Medicare payments.

"Meaningful use" is a term defined by CMS, applicable to both Medicare and Medicaid, and describes the use of HIT that furthers the secure exchange of information and coordination of care among health care professionals; reduces health disparities; engages patients and their families in healthcare; and improves quality, safety, efficiency, and overall public health. CMS's proposed rule uses a three-stage process, requiring increasingly more robust criteria for demonstrating meaningful use. The first stage, which begins in 2011, focuses on "electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information for care coordination purposes, and initiating the reporting of clinical quality measures and public health information."

To qualify as a meaningful EHR user for 2011, CMS would require an EP or eligible hospital to demonstrate that they meet several dozen objectives and their associated measures as set forth in 42 C.F.R. § 495. CMS will ensure compliance with these standards initially through attestation, but eventually through direct submission of clinical quality measures via EHR technology. Based on the results of the first phase, CMS intends to propose through future rulemaking two additional stages of the criteria for meaningful use, beginning in 2013 and 2015 respectively.

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Client Alert | 5 min read | 12.12.25

Eleventh Circuit Hears Argument on False Claims Act Qui Tam Constitutionality

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument....

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