The Centers for Medicare & Medicaid Services (CMS) on Sept. 20, 2024, released the Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434) Final Rule....more
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more
On November 3, 2023, the US District Court for the District of South Carolina issued a landmark order in Genesis Health Care, Inc. v. Becerra, a case analyzing the definition of a “patient” under the 340B Program Statute. The...more
Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more
On May 26, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed an update to the Medicaid Drug Rebate Program (MDRP) rules, which includes provisions aimed at preventing 340B duplicate discounts on claims...more
The title of CMS’s May 26 proposed rule, “Misclassification of Drugs, Program Administration and Program Integrity Updates Under the MDRP,” buries the lede. Amid twenty Medicaid Drug Rebate Program-related proposals—some...more
The Inflation Reduction Act of 2022 (IRA) establishes the Medicare Prescription Drug Inflation Rebate Program, which requires drug companies to pay rebates, referred to as inflation rebates, to Medicare if they raise their...more
On March 23, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued long-awaited guidance regarding how drug manufacturers are to report multiple best prices (“BPs”) to the Medicaid Drug Rebate Program (“MDRP”)...more
Hello readers! Today’s post focuses on a topic we’ve touched on a few times in the past – Medicaid drug formularies. Back in December 2021, the state of Oregon released a draft Medicaid waiver proposal that caught the...more
The U.S. Department of Justice recently announced that Bristol-Myers Squibb (BMS) agreed to pay $75 million, plus interest, to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate...more
Here at the Medicaid and the Law Blog, we’ve spent the past couple of days going through the American Rescue Plan Act, legislation introduced in the U.S. House of Representatives last Friday that is the latest attempt by...more
As we begin the new year, we wanted to highlight two final developments from December 2020: First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more
Earlier this year, my colleague Ross Margulies and I told you about a new proposed rule issued by CMS that makes several changes to the Medicaid prescription drug rebate program, or the MDRP. Recently, CMS finalized the rule...more
On December 21, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that materially modifies current Medicaid Drug Rebate Program (MDRP) regulations, largely finalizing the proposed rule dated June...more
On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from...more
On June 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based...more
My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or...more
The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
On June 17, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a Proposed Rule (link) that would materially modify current Medicaid Drug Rebate Program (MDRP) regulations. Comments are due no later than 5:00 p.m....more
Last week the Department of Health and Human Services Office of Inspector General (OIG) published a report titled “Reasonable Assumptions in Manufacturer Reporting of AMP and Best Prices” (Report) that reviewed the use of...more
President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more
It is a time of change in the 340B Program. Manufacturers should closely monitor 340B Program developments and prepare to respond promptly and effectively to changes in legal requirements. This may make it necessary to devote...more
For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug...more
On March 23, 2018, the Centers for Medicare and Medicaid Services (CMS) published Final Notice that implements a substantially revised Medicaid National Drug Rebate Agreement (NDRA). All agreements currently in place will...more