The Centers for Medicare & Medicaid Services (CMS) Innovation Center (the Innovation Center) published its data-sharing strategy, which seeks to further enable data sharing while ensuring proper security, risk management, and privacy obligations. The strategy outlines the Innovation Center’s approach to identifying data sharing needs across Innovation Center models and highlights the importance of data in developing and testing innovative healthcare payment and service delivery models.
Continue Reading CMS Innovation Center Outlines Data Sharing PrinciplesHHS Reorganizes ONC and Bolsters AI Leadership
On July 25, the Department of Health and Human Services (HHS) announced a number of organizational changes, including renaming the Office of the National Coordinator for Health Information Technology (ONC) to the Assistant Secretary for Technology Policy and Office of the National Coordinator for Health Information Technology (ASTP/ONC), among other actions. These organizational changes reflect heightened focus to provide oversight and issue policies governing the use of individuals’ health data and the development of artificial intelligence (AI) technologies. It also demonstrates HHS’ aim to address recent cyberattacks against the healthcare sector entities.
Continue Reading HHS Reorganizes ONC and Bolsters AI LeadershipCMS Notice of Funding Opportunity for the Innovation in Behavioral Health Model Open Until September 9, 2024
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, 2024FDA 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 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 RuleFDA Issues Guidance on Using Electronic Health Records and Medical Claims Data in Clinical Studies
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 StudiesCMS 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) ModelCMS Releases CY 2025 Hospital OPPS Rule and ASC Proposed Rule
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule (CY 2025 OPPS/ASC Proposed Rule), which contains proposals to update OPPS and ASC payment rates by 2.6 percent in addition to proposals that address health disparities, expand access to behavioral health care, advance maternal health care, and promote safe, effective, and patient-centered care.
Continue Reading CMS Releases CY 2025 Hospital OPPS Rule and ASC Proposed RuleNew 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 institutionsWhat to Know about Gender-Affirming Care Following the Supreme Court’s Agreement to Review Sixth Circuit Decision
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 DecisionFDA Releases Revised Guidance on Promotional Labeling and Advertising Considerations of Biosimilar Products
On April 25, 2024, the U.S. Food and Drug Administration (FDA) issued and requested public comment on a revised draft guidance (Draft Guidance) providing recommendations related to promotional labeling and advertising that manufacturers, packers, and distributors (collectively “Firms”) should consider when promoting or advertising biosimilar products, including interchangeable biosimilar products, and their reference products. Stakeholders had until June 24, 2024 to submit comments on the Draft Guidance.
Continue Reading FDA Releases Revised Guidance on Promotional Labeling and Advertising Considerations of Biosimilar Products