Health Policy

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On April 11, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the proposed rule for the Fiscal Year (FY) 2026 update to the Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS). This annual update adjusts Medicare payment policies and rates for inpatient and long-term care hospitals.​Continue Reading CMS Issues FY 2026 Hospital IPPS Proposed Rule and LTCH PPS Proposed Rule

On April 11, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the proposed rule for the Fiscal Year (FY) 2026 update to the Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS). This annual update adjusts Medicare payment policies and rates for inpatient and long-term care hospitals.​Continue Reading CMS Issues FY 2026 Hospital IPPS Proposed Rule and LTCH PPS Proposed Rule

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

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

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

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 representations and suggestions about the efficacy of Ubrelvy.” The letter focused on efficacy claims made in the advertisement.  The 30-second ad shows Serena Williams experiencing symptoms of a migraine while getting ready to go on stage. The ad then goes on to show how one dose of Ubrelvy helped Serena feel better, and she is later shown smiling and laughing as she walks onto a talk show stage. The FDA’s letter explains that in the original storyboard for the ad, Serena experiences migraine pain in the afternoon and feels better before her talk show appearance in the evening. The FDA contends that the televised ad does not accurately portray the time lapse that was in the storyboard version. The FDA stated that, “This compelling before-and-after presentation in conjunction with claims such as, “One dose works fast to eliminate migraine pain” and “UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN” (emphasis added) misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” The letter also claims that the ad “…misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.” Continue Reading FDA Calls Out a Migraine TV Ad for Misleading Viewers