3/2/2026 3:28:36 PM State 340B Contract Pharmacy Law Challenges Supported by the Administration By Ramana Rameswaran Law360 is reporting that the Administration is backing the pharmaceutical industry against state laws that prevent drug manufacturers...
2/25/2026 6:45:35 PM HRSA Issues Request for Information on 340B Rebate Model Pilot Program By Ramana Rameswaran Kate Hardey On February 17, 2026, the Health Resources and Services Administration (HRSA) published a Request for Information (RFI) in the Federal...
2/18/2026 5:47:59 PM From Indictment to Dismissal By Brandon McCarthy Most people are arrested and charged within a day of an offense being committed. Here, the DOJ charged my client with its most recent...
2/16/2026 5:22:53 PM HHS Provides Updated Model Notices of Privacy Practices By Lisa Prather To help HIPAA covered entities comply with updated rules for substance use disorder patient records, the U.S. Department of Health and...
2/13/2026 3:53:46 PM Reminder: Comments to the HHS Request for Information on Accelerating AI Adoption in Clinical Care due February 23, 2026. By Anthony Del Rio Vinal Patel Julia DeVincenzi As outlined in our previous post, the Department of Health and Human Services (HHS) has issued a significant Request for Information...
2/13/2026 2:36:17 PM Genetic Testing Enforcement Poised to Rise: What to Expect in the Coming Year By Ryan Meyer Taylor Stilwell On January 28, 2026, the U.S. Department of Health and Human Services Office of Inspector General (“HHS OIG”) released a report, “Total...
2/10/2026 10:51:34 PM FDA Cosmetics Compliance: Understanding FDA Records Access Under MoCRA By Kate Hardey Caitlin Kierum Vinal Patel The U.S. Food and Drug Administration ("FDA") released a draft guidance document in January 2026 titled "FDA Records Access Authority for...
2/5/2026 9:17:35 PM Pharmaceutical Direct to Consumer Programs: OIG's Low-Risk Roadmap for Drug Discounts & Congressional Concerns on TrumpRx Compliance By Kate Hardey Vinal Patel Caitlin Kierum On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory...
2/3/2026 10:55:45 PM Congress Probes Chinese Biotech GLP-1 Product Compliance By Kate Hardey Vinal Patel Caitlin Kierum Congress Probes Chinese Biotech GLP-1 Product Compliance Although the FDA recently implemented additional safeguards related to imported...
2/2/2026 9:29:50 PM FDA Clinical Decision Support Software Guidance Refresh : Clearer Rules, Broader Innovation By Anthony Del Rio Kate Hardey Vinal Patel Caitlin Kierum +1 more... Show less On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support...
1/23/2026 9:14:05 PM OCR Kicks Off 2026 with Reminders about "System Hardening" for HIPAA Covered Entities By Lisa Prather The January 2026 Cybersecurity Newsletter released by the U.S. Department of Health and Human Services Office for Civil Rights focuses on...
12/29/2025 8:36:08 PM CY 2026 Stark Law Designated Health Services Code List Update and Brief User Guide By Ramana Rameswaran Ashley Francois On December 1, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published its annual update to the Designated Health Services...
11/24/2025 9:58:01 PM Med Spas at the Intersection of Beauty, Wellness, and Law By Anthony Del Rio Julia DeVincenzi Medical spas (commonly called “med spas”) blend the clinical capabilities of an aesthetic medical practice with the hospitality and...
11/18/2025 2:59:46 PM Medicare Launches Prior Authorization Pilot for Select Services in Six States: What Hospitals Need to Know By Anthony Del Rio Vinal Patel Medicare is launching a significant new prior authorization initiative under the CMS Innovation Center’s Wasteful and Inappropriate...
11/17/2025 2:41:26 PM Unlocking Bespoke Product Approvals: FDA Puts Forth Plausible Mechanism Pathway By Kate Hardey On November 12, 2025, the New England Journal of Medicine published an article authored by FDA Commissioner Marty Makary and Center for...
10/22/2025 10:32:55 PM California Tightens Oversight of PE Involvement in Physician Platforms By Anthony Del Rio Caitlin Kierum California has enacted two new laws—AB 1415 and SB 351—effective January 1, 2026, that will materially affect private equity ownership...