On December 17, 2024, the House Task Force on Artificial Intelligence (Task Force) released a highly-anticipated report titled, “Bipartisan House Task Force Report on Artificial Intelligence,” (the Report) which establishes guiding principles and issues recommendations to guide U.S. innovation in artificial intelligence (AI), including in the healthcare sector. The Report is intended to serve as
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FDA releases final guidance on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
On November 21st, the Food and Drug Administration (FDA) released final guidance for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review processes, which clarifies how the FDA will use third party review organizations (ROs) to review 510(k) submissions and EUA requests during a public health emergency. The guidance provides…
FDA Clarifies Enforcement Policy Around Communications of Scientific Information on Unapproved Uses of Drugs and Medical Devices
FDA approved drugs and medical devices are often studied further by sponsors and other firms to generate additional scientific information around other potential benefits and uses of those products. Providing the results of this additional scientific activity to health care providers (“HCPs”) has led to enforcement from the U.S. Food and Drug Administration (“FDA), as…
AMA’s CPT Editorial Panel Approves New Codes Covering Remote Patient Monitoring Services
On October 18, 2024, the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) Editorial Panel released a Summary of Panel Actions from its September 2024 Panel Meeting, which includes six new remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) codes in addition to revisions to the existing codes. Effective January 2026, these changes include…
End of Year Regulations on Interoperability
Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules…
RCE Issues Technical Guidance Governing TEFCA Exchange
Federal policy efforts to advance health data exchange and interoperability through the Trusted Exchange Framework and Common Agreement (TEFCA) have advanced rapidly in the past several months. Since TEFCA became operational in December 2023, the seven designated Qualified Health Information Networks (QHINs) have been facilitating data exchange under the TEFCA framework. The Sequoia Project, Inc.,…
HHS Releases Final Guidance for the Second Cycle of the Medicare Drug Price Negotiation Program
On October 2, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining the process for the second cycle of negotiations through the Medicare Drug Price Negotiation Program. This guidance provides additional information for manufacturer effectuation of negotiated prices for drugs, which the…
CMS Innovation Center Seeks Feedback on Medicare $2 Drug List Model
On October 9, the Centers for Medicare & Medicaid Services (CMS) Innovation Center, issued a Request for Information (RFI) about the Innovation Center’s proposed Medicare $2 Drug List Model (the M2DL Model), which aims to test whether offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes, and improve satisfaction…
FDA Calls Out a Migraine TV Ad for Misleading Viewers
The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements. The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie that their television ad for migraine medication, Ubrelvy, featuring Serena Williams “…makes false or misleading…
CMS Releases CY 2025 Medicare Physician Fee Schedule Proposed Rule
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule (2025 PFS Proposed Rule), which contains proposals to update PFS payment rates, improve payment for and access to behavioral health services, extended telehealth flexibilities, establish ways to enhance access to primary care…