On January 14, 2025, the State Administration for Market Regulation (SAMR, 国家市场监督管理总局) published the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Guidelines, 医药企业防范商业贿赂风险合规指引). The Guidelines are the final version of the Draft Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (the Draft or the Draft Guidelines) which were published
Health Care
Ohio Decides to Raise Medicaid Reimbursement Rates. Now, If Only Other States Followed Suit…
Ohio, in its infinite wisdom, has decided to take a bold step forward in healthcare by raising its Medicaid reimbursement rates. And when I say “bold,” I mean “a historic, mind-blowing $3.4 billion per year” kind of bold. That’s right—Ohio, the state known for its questionable attempts at chili and a certain football team that…
Update: Appellate Showdown Over FCA Qui Tam Provision’s Constitutionality Reaches Eleventh Circuit
As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to hold that the qui tam provision of the federal False Claims Act violates the Appointments Clause…
This Week in 340B: January 7 – 13, 2025
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of…
Medical: Application for approval of IVF settlement.
By Bill Madden
Bopping & Anor v Monash IVF Pty Ltd & Ors [2024] VSC 785 (Link to AUSTLII).
A little belatedly, this note (with thanks to Janine McIlwraith) draws attention to a settlement approval in a group proceeding.
The plaintiffs had brought claims in a group proceeding. The first, second and fourth to eighth defendants all…
AMA’s CPT Editorial Panel Approves New Codes Covering Remote Patient Monitoring Services
On October 18, 2024, the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) Editorial Panel released a Summary of Panel Actions from its September 2024 Panel Meeting, which includes six new remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) codes in addition to revisions to the existing codes. Effective January 2026, these changes include…
Generative AI update (NSW).
By Bill Madden
The NSW District Court has published Practice Note 2 (Link to court website), which adopts the NSW Supreme Court practice note Gen 23.
3 February 2025 is the District Court commencement date.
With thanks to David Jones, drawing this to my attention.
[BillMaddensWordpress #2343]
HHS Proposes Significant Updates to HIPAA Security Rule
The U.S. Department of Health and Human Services (HHS) has proposed changes to its Health Insurance Portability and Accountability Act (HIPAA) Security Rule designed to enhance the cybersecurity of health care providers, health plans, and related entities.
The Upshot
- If finalized, the changes would represent the first update to the HIPAA Security Rule in more
…
DOJ Brings Nationwide False Claims Act Lawsuit Against CVS for Alleged Violations of Controlled Substances Act
On December 13, the U.S. Department of Justice (DOJ) intervened in a False Claims Act (FCA) lawsuit alleging that CVS Pharmacy Inc. and its subsidiaries improperly sought federal reimbursement for prescriptions filled in violation of the Controlled Substances Act (CSA).
2025 Healthcare Mergers & Acquisitions: What To Expect; How To Prepare; Choosing The Right Deal
2025 promises to see a significant increase in the volume of healthcare mergers, acquisitions and consolidations. On Thursday, January 23, Rivkin Radler’s first Health Law Executive Briefing, 2025 Healthcare Mergers & Acquisitions, will take the form of a Q&A session led by Benjamin Malerba and featuring Norton Travis, veteran healthcare executive and the newest member…