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
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CMS 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
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
FDA 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
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
CMS 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
CMS 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
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
What 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
FDA 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