OOn May 24, 2025, Robert F. Kennedy, Jr. and the Make America Healthy Again (MAHA) Commission are expected to submit the Make our Children Healthy Again Assessment to President Trump as required by the President’s February 13 Executive Order (EO) establishing the Commission.[1] The EO directed Secretary Kennedy and the MAHA Commission to assess potential contributors to childhood chronic disease in America, focusing on the American diet, absorption of toxic material, medical treatments, lifestyle, environmental factors, Government policies, and food production technique.

Continue Reading MAHA’s Vision for Healthier Diets: Awaiting Concrete Steps and Assessing Challenges 

This year, thousands of individuals in Southern California were impacted by the Palisades Fire and Eaton Fire. The fires were the second and fourth most destructive in the state’s history.[1] In 2024, millions of individuals in the southeastern United States were impacted by Hurricanes Helene and Milton. These hurricanes made landfall less than two weeks apart, establishing a new record for the shortest interval between two significant hurricanes in Florida.[2] The Southern California wildfires and Hurricanes Helene and Milton exemplify the pattern of increasingly severe and frequent natural disasters attributed to a changing climate. Such climate-related disasters have profound implications for healthcare systems, underscoring the necessity for coordinated efforts between federal and state governments to ensure the continuity of healthcare services and access to medical care. As a result of the Southern California wildfires, over 700 people were evacuated from nursing homes and other care facilities.[3] In Florida alone, over 350 healthcare facilities were evacuated as a preventative measure against Hurricane Milton.[4] Hundreds of other healthcare facilities throughout the region faced evacuations, closures, and damage as result of the hurricanes. Preparedness and swift response measures at all levels of government are essential to safeguard lives in the face of natural disasters.

Continue Reading The Role of Federal and State Governments in Maintaining Healthcare During Natural Disasters

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 a blueprint for Members of Congress as they conduct oversight and introduce legislation to address advances in AI technologies, including the regulation of health-specific AI applications.

Continue Reading House Task Force on AI Issues Report and Proposes Healthcare Recommendations

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 guidance on the FDA’s conduct of both the 510(k) Third Party Review Program and EUA third party review, including guidance on device eligibility and procedures for 510(k) Third Party Review Organizations, and expectations for Third Party review to ensure quality, consistency, and conflict prevention.

Continue Reading FDA releases final guidance on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

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 those additional uses and benefits have not been evaluated by the FDA. If a firm communicates information about unapproved uses of an approved product, it could lead to a determination by FDA that the firm is promoting an unapproved intended use, which could lead to enforcement action for distributing a misbranded or adulterated product.  In an effort to provide recommendations on how to avoid FDA enforcement activity when providing the results of this additional scientific activity, FDA recently issued final guidance on how to communicate scientific information on unapproved uses (“SIUU”) of approved or cleared medical products to HCPs while avoiding FDA enforcement action.

Continue Reading FDA Clarifies Enforcement Policy Around Communications of Scientific Information on Unapproved Uses of Drugs and Medical Devices

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 removing the current requirement for healthcare providers to receive 16 days’ worth of data to bill RPM codes. The AMA CPT Editorial Panel likely made these updates in response to stakeholder feedback that the 16-day billing threshold was not necessary in certain clinical use cases. Additionally, two new codes will reimburse providers for 10-19 minutes of managing RPM or RTM data in a month.  

Continue Reading AMA’s CPT Editorial Panel Approves New Codes Covering Remote Patient Monitoring Services

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 adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Final Rule), and create a new Information Blocking exception under Protecting Care Access (HTI-3 Final Rule), published on December 16th and 17th, respectively.

Continue Reading End of Year Regulations on Interoperability

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., the TEFCA Recognized Coordinating Entity (RCE) or the organization responsible for providing oversight and the governing approach for QHINs, released over the past several months (on July 1, August 6, and November 13, 2024) its latest batch of Standard Operating Procedures (SOPs), which are written procedures or other provisions that are adopted pursuant to the Common Agreement. In the below summary, we outline a number of TEFCA-related policy developments and highlight considerations from the SOPs that are important to health information networks (HINs)/health information exchanges (HIEs) and other entities keeping apprised of interoperability policy developments.

Continue Reading RCE Issues Technical Guidance Governing TEFCA Exchange

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 statute refers to as Maximum Fair Prices (MFPs). Within this guidance, CMS intends to ensure that individuals with Medicare can access drugs at negotiated prices from both cycles in 2026 and 2027.

Continue Reading HHS Releases Final Guidance for the Second Cycle of the Medicare Drug Price Negotiation Program

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 with the Medicare Part D prescription drug benefit. The RFI includes a sample list of prescription drugs that it intends to include and seeks input from healthcare stakeholders on the sample list of drugs and other features (i.e., outreach efforts and maximizing stakeholder participation) of the model. Comments in response to the RFI may be submitted through the Innovation Center’s online survey portal by December 9, 2024.

Continue Reading CMS Innovation Center Seeks Feedback on Medicare $2 Drug List Model