EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
Drug Pricing Initiatives During the Trump Presidency
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more
Federal and state enforcement activity involving pharmacy fraud tops the list of categories in this edition of Rivkin Rounds’ Fraud Week. We’ll list just a sampling of cases....more
Key Points - Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs. The Second Circuit has upheld HHS’ prohibition of co-pay...more
On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more
Key Points - Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs. Co-pay programs remain unavailable to participants in federal...more
Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more
A federal district court recently decided that private litigants may proceed in a Racketeer Influenced and Corrupt Organization Act (RICO) lawsuit predicated on violations of the Anti-Kickback Statute (AKS). The plaintiffs...more
For companies looking to monetize their hard-earned innovations in digital health, there is a minefield of potential healthcare enforcement to avoid. As discussed in Part I of this alert, such healthcare enforcement can lead...more
Pharmaceutical Care Management Association (“PCMA”) lawsuit results in delayed implementation of Final Rule while Biden Administration review is ongoing - Pursuant to a Court Order, implementation of the U.S. Dept. Health...more
In November 2020, the Department of Health and Human Services (HHS) finalized a regulation aimed at lowering prescription drug prices and out-of-pocket spending for prescription drugs by excluding rebates on prescription...more
In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final rules to modernize regulations implementing the federal...more
The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more
On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more
On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more
On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more
Providers have a new tool in their toolbox to promote population health. The Health and Human Services Office of Inspector General (OIG) has adopted a new, extremely broad safe harbor that allows certain providers to give...more
Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more
Before the COVID-19 pandemic derailed even the best-laid plans, the Trump Administration and Congress were focused on a different public health issue: drug pricing. For years, President Trump has targeted “Big Pharma” as...more
Final Rule largely tracks prior proposal to make significant changes to the Discount Safe Harbor and other regulatory safe harbors to the Federal Anti-Kickback Statute. The Department of Health and Human Services Office of...more
On November 20, 2020, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a final rule as part of ongoing administration drug pricing reform efforts and in conjunction with the...more
On September 13, 2020, President Trump issued an Executive Order seeking to establish most favored nation ("MFN") pricing for Medicare drug payments. The Trump Administration's Order, 'Lowering Drug Prices by Putting America...more
The U.S. Department of Justice and U.S. Health and Human Services Office of Inspector General recently announced the indictment of a pharmacy marketer who allegedly received and paid kickbacks in violation of the federal...more
Prescription drug prices are one of the biggest drivers of rising health care costs. To address this issue, the Trump administration issued its Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to...more
On July 24, 2020, President Trump signed four Executive Orders related to drug pricing that direct the Secretary of Health and Human Services (HHS) to take a number of actions aimed at lowering prescription drug prices. These...more
The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” A fourth Executive Order tying...more