In January 2024, the Centers for Medicare and Medicaid Services (CMS) announced a new innovation care delivery model that seeks to bridge the gap between behavioral and physical health. The Innovation in Behavioral Health (IBH) Model aims to improve the quality of care and behavioral and physical health outcomes for adults with moderate to severe mental health conditions and substance use disorders (SUDs). The IBH Model will service beneficiaries who are enrolled in Medicare and Medicaid, including those who are dual eligible.[1] These populations experience higher than average rates of mental health conditions or SUDs, or both, highlighting the importance of a model that integrates behavioral and physical healthcare as well as addressing health-related social needs (HRSN).[2]

Continue Reading CMS Notice of Funding Opportunity for the Innovation in Behavioral Health Model Open Until September 9, 2024

Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical research and clinical trials. Stephen Holland is Senior Counsel in Crowell’s Government Affairs Group and previously served as Senior Health Counsel to the U.S. House Committee on Energy and Commerce, where he advised on FDA policy, including legislation related to medical devices and laboratory developed tests.

The FDA has provided answers to the most common questions it has received regarding its final rule on laboratory developed tests (LDTs) (the “Final Rule”).  The answers are styled as FAQs that are organized by topic areas.  The FAQs can be found here.  If there is a question that is not answered, the FDA encourages individuals to submit questions to the FDA through the mailbox at ldtfinalrule@fda.hhs.gov.  The FDA notes that it intends to update the FAQs periodically so entities should check the webpage often for additional answers. 

Continue Reading FDA Publishes FAQs Around Its Recent Laboratory Developed Tests Final Rule

Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical research and clinical trials. Stephen Holland is Senior Counsel in Crowell’s Government Affairs Group and previously served as Senior Health Counsel to the U.S. House Committee on Energy and Commerce, where he advised Members of Congress and their staffs on FDA policy.

On July 25, the Food and Drug Administration (FDA) issued final guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products. The guidance aims to provide drug sponsors with considerations should they wish to use real-world data (RWD) drawn from electronic health records (EHRs) or medical claims data in their clinical studies to support regulatory decisions related to the safety and efficacy of a drug.

Continue Reading FDA Issues Guidance on Using Electronic Health Records and Medical Claims Data in Clinical Studies

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

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

On Monday, June 24, 2024, the U.S. Supreme Court agreed to review last year’s Sixth Circuit decision that allowed Tennessee to keep its ban on gender-affirming care for minors in place. The Supreme Court will determine whether the Tennessee restrictions on gender-affirming care infringe on the Fourteenth Amendment rights of transgender youth for equal protection under the law.[1] The Court did not act on the Biden administration’s petition to review a similar case focused on Kentucky’s gender-affirming care ban for minors; however, the Court’s decision on the Tennessee ban will ultimately determine how the Kentucky case moves forward. The Court will begin their arguments on the Tennessee gender-affirming care ban in the fall. The decision to review the Biden administration’s appeal comes at a time when 39% of transgender youth aged 13-17 are living in states that have bans on gender-affirming care.[2]

Continue Reading What to Know about Gender-Affirming Care Following the Supreme Court’s Agreement to Review Sixth Circuit Decision

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

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

In recent years, organizations have been developing and using predictive models, which are powered by artificial intelligence (AI) and machine learning (ML) technologies, for numerous use cases in clinical and health care settings, including to aid in clinical decision-making. Currently, healthcare AI systems and tools have both clinical and administrative applications, namely monitoring patients, recommending treatments, predicting health trajectories, recording clinical notes, optimizing operational processes, and supporting population health management.

The Department of Health and Human Services (HHS) and federal agencies have been developing policies to advance transparency and manage risks for the development and use of AI/ML-powered health care technologies. Most recently, the Office of the National Coordinator for Health Information Technology (ONC) issued regulations that addresses predictive models and health AI systems.

Continue Reading Taking a Closer Look at ONC’s AI Transparency Regulations

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