This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more
The Master List for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) comes from a November 2019 final rule that created the list to serve as a library of items that have been identified as potential...more
OIG and CMS, through a coordinated effort, have issued sweeping and much-anticipated final changes to the Anti-kickback and Stark rules. These changes are generally industry-friendly. Introduction - On November 20,...more
As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services...more
On Friday of last week, HHS published two long-awaited final rules implementing significant changes to the regulations under the Stark Law and Anti-Kickback Statute (AKS). The two final rules are: (i) Revisions to the Safe...more
On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (commonly known as the Stark...more
President Donald Trump’s action to repeal 2010’s Patient Protection and Affordable Care Act (ACA) should not be a surprise. After all, President Trump, along with many other candidates for office, made repeal of the ACA a...more
This Week: The Senate and House pass legislation to repeal the Affordable Care Act but without enough votes to override a potential veto... However, this is the first time repeal legislation makes it to the President’s...more
This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more
On May 28, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) published a proposed rule to establish a prior authorization process for certain durable medical equipment,...more