Navigating the Inflation Reduction Act: Insights on Brownfield Energy Community Credits - Energy Law Insights
Consumer Finance Monitor Podcast Episode: A Close Look at the Consumer Financial Protection Bureau’s Final Credit Card Late Fee Rule: Have Cardholders Been Dealt a Winning or Losing Hand?
Time to Amend the Defend Trade Secrets Act
Consumer Finance Monitor Podcast Episode: A Close Look at the Consumer Financial Protection Bureau’s Credit Card Late Fees Proposal with Special Guest Todd J. Zywicki
Podcast: The Briefing by the IP Law Blog - SCOTUS Issues First IP Ruling of 2022 in Unicolors, Inc. v. H&M Hennes & Maurits, LP
The Briefing by the IP Law Blog: SCOTUS Issues First IP Ruling of 2022 in Unicolors, Inc. v. H&M Hennes & Maurits, LP
PODCAST: Williams Mullen's Trending Now: An IP Podcast - DMCA Takedowns – Benefits to Content Owner
Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care
Challenges for Infrastructure Projects in the Current Environment
No Harbor is Limitless: Restrictions of the Federal Anti-Kickback Statute's Safe Harbor Provisions
The SECURE Act: Significant Changes for Retirement Plans and IRAs
PODCAST: Williams Mullen's Benefits Companion - New Hardship Distribution Regulations for 401(k) Plans
Overview For Employers: More State Pay Equity Laws Coming Online
PODCAST: Recruiting and Retention: Can Your 401K Make a Difference?
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
Jones Day Talks: Navigating Foreign Direct Investment in Germany
Podcast: Tax Reform and Its Impact on Exempt Organizations, One Year In
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Bill on Bankruptcy: Easterbrook Turns the Tide on Student Loans
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
Well, it was good while it lasted. On September 27th, the Departments issued new FAQs regarding implementation of provisions of The Transparency in Coverage Final Rules (TiC Final Rules). ...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more
Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here...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
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...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
On November 20, 2020, the U.S. Department of Health & Human Services (HHS) finalized a rule to take effect in 2022, which eliminates the safe harbor under the federal anti-kickback statute for manufacturer rebates to Medicare...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
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
On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more
On August 6, 2020, the United States Court of Appeals for the Sixth Circuit upheld the conviction of a patient recruiter in a Medicare kickback case, finding insufficient evidence to demonstrate that the recruiter was a “bona...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
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
President Trump signed four executive orders on July 24, 2020, that appear to push forward the administration’s efforts to lower prescription drug costs and pass the savings on to consumers. ...more
Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
This Week in Washington: The House and Senate are back from Thanksgiving recess. Congress is expected to be in session until or about Dec. 20....more
This week in Washington: House returns from recess and has scheduled hearing on caring for aging Americans; Senate to hold hearing on rising electronic cigarette use among youth and will hold a confirmation hearing for Dr....more
Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules...more
As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more