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
Eunice Lalanne
Eunice Lalanne supports Crowell Health Solutions, a strategic consulting firm affiliated with Crowell & Moring, to help clients pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health care. She is a health care policy consultant in the Washington, D.C. office.
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…
CMS opens Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model
In December 2023, the Centers for Medicare & Medicaid Services (CMS) announced a new model called the Transforming Maternal Health (TMaH) Model, the first of its kind to focus solely on improving maternal health care for Medicaid and Children’s Health Insurance Program (CHIP) beneficiaries. The model is intended to support state Medicaid agencies to address the physical health, mental health and social needs of mothers by developing whole-person approaches to pregnancy, childbirth, and postpartum care. The model’s overarching goal is to reduce disparities in access and treatment and to improve outcomes and experiences for mothers and their newborns. On June 26, 2024, CMS released the Notice of Funding Opportunity (NOFO) for states to apply. The NOFO will close for applications on September 20, 2024.Continue Reading CMS opens Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model
New federal guidelines for research security programs at covered institutions
On July 9, 2024, the Office of Science and Technology Policy (OSTP) released new guidance for federal research agencies that require certain research institutions (“covered institutions”) to certify that the institution has established and operates a research security program that includes certain specific standardized requirements. The certification requirements are in accordance with the National Security Presidential Memorandum-33 (NSPM-33) and the CHIPS and Science Act. The purpose of these guidelines is to address increased foreign risk to research security in the U.S. Research and Development (“R&D”) landscape and to preserve the open and collaborative nature of the R&D environment. The research security requirements are summarized below. Continue Reading New federal guidelines for research security programs at covered institutions
The Trusted Exchange Framework and Common Agreement (TEFCA) and State Data Exchange is Moving Forward in 2024
Health data exchange and interoperability have entered a new chapter in the U.S. In 2016, the 21st Century Cures Act (Cures Act) included a requirement that the Office of the National Coordinator for Health Information Technology (ONC) create a Trusted Exchange Framework and Common Agreement (TEFCA) for nationwide health information exchange. Seven years later, on December 12, 2023, ONC announced that the nationwide health data exchange governed by TEFCA is operational. At the signing event, many Department of Health and Human Services (HHS) officials celebrated the announcement including Secretary Xavier Becerra, Deputy Secretary Andrea Palm, and National Coordinator for Health Information Technology, Micky Tripathi.Continue Reading The Trusted Exchange Framework and Common Agreement (TEFCA) and State Data Exchange is Moving Forward in 2024
AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity
On April 18, 2024, the Department of Health and Human Services’ (HHS’) Agency for Healthcare Research and Quality (AHRQ) issued the Digital Healthcare Equity Framework (the Framework) to guide users and stakeholders to consider equity throughout the entire lifecycle when implementing digital healthcare solutions. AHRQ also released a separate implementation guide (the Guide) to outline best practices and examples to implement the Framework. The Framework’s guiding principles provide a clear purpose for the Framework and development of its domains while the separate Guide provides actionable steps on how to implement the Framework.
Digital healthcare developers and vendors, health systems, health plans, and clinical providers should review the Framework and Guide to assess equity during each phase of the digital healthcare lifecycle for digital health technologies. Specifically, the Framework recommends that these stakeholders should consider the Framework’s principles and recommendations to address the accessibility, purpose, security, privacy features, usability, and safety concerns applying to digital solutions.Continue Reading AHRQ Outlines Principles and Recommendations to Advance Digital Healthcare Equity
An Overview of the ACO Primary Care Flex (ACO PC Flex) Model
In March 2024, the Centers for Medicare & Medicaid Services (CMS) released a new voluntary model called the ACO Primary Care Flex Model (ACO PC Flex Model). This model focuses on primary care delivery within the Medicare Shared Savings Program (MSSP), which is Medicare’s longest-running program whereby health care practitioners and other providers and suppliers form an Accountable Care Organization (or ACO) to provide coordinated, high quality care to Medicare beneficiaries. Continue reading to learn more about the ACO PC Flex model.Continue Reading An Overview of the ACO Primary Care Flex (ACO PC Flex) Model
ONC Releases an Updated Draft of Their 2024–2030 Federal Health IT Strategic Plan
The Office of the National Coordinator for Health Information Technology (ONC) released a draft of their 2024–2030 Federal Health IT Strategic Plan (Draft Strategic Plan) on March 27, 2024, updating the 2020-2025 Federal Health IT Strategic Plan. In collaboration with 25 other federal organizations, the purpose of this strategic Plan is to create overall improvements in health care by aligning its health IT policies, programs, and investments and to signal priorities to the industry. This Draft Strategic Plan builds on the previous Plan, and includes objectives to address challenges in our healthcare landscape post-COVID as well as recognizing current disparities in health care access and outcomes.Continue Reading ONC Releases an Updated Draft of Their 2024–2030 Federal Health IT Strategic Plan
An Overview of the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model
In September 2023, the Centers for Medicare & Medicaid Services (CMS) released a new state total cost of care (TCOC) model called the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. This model follows in the footsteps of other successful state total cost of care (TCOC) models to improve health care spending, improve population health, and advance health equity by reducing disparities in health outcomes. Continue reading to learn more about the AHEAD model.Continue Reading An Overview of the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model
CMS Finalizes CY 2024 Medicare Physician Fee Schedule Rule
On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the calendar year (“CY”) 2024 Physician Fee Schedule (PFS) Final Rule (“CY 2024 PFS Final Rule”). The final rule reflects CMS’ broader strategy to promote a more equitable health care system.
Key Takeaways
- In the CY 2024 PFS Final Rule,