Build America Buy America What is it? How to qualify.
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Wiley's 10 Key Trade Developments: The CHIPS Act and Inflation Reduction Act (IRA)
Perfecting High-Performance Battery Chemistry With John Kem, American Battery Factory — Battery + Storage Podcast
Hot Topics in international trade
Video: Making Trade Inclusive for All Americans: A Conversation with AAEI's Eugene Laney Jr., Ph.D.
(Podcast) The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
The Briefing: Are LEGO Creations Based on Religious Texts Eligible for Copyright Protection?
Hot Topics in International Trade A Year in Review (Quickly)
Domesticating the Battery Supply Chain With ENTEK and KORE Power — Battery + Storage Podcast
What to Do if Your Suppliers Are in Distress - Is It Time to Find a New Supplier?
What to Do if Your Suppliers Are in Distress - Candid Conversations with Suppliers in Distress
What to Do if Your Suppliers Are in Distress - Identifying Suppliers in Distress
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
Podcast - Made in the USA Claims
The Labor Law Insider: Union Activity, Employment Engagement, and Changes in the Manufacturing Industry
WorldSmart: The Move to Mexico— Why Companies are Setting Sights on Mexico Post COVID
Proposition 65 – Changes That Will Impact the Cannabis Sector
Five Questions, Five Answers: Driving the I-75 with Rick Walker of GAMA Georgia
On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more
On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more
The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more
On September 5, 2023, the United States Government Accountability Office (GAO) published its report titled Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending.The report...more
The ability to directly negotiate drug prices has been a policy goal for Democrats for many years and was recently accomplished through the Inflation Reduction Act’s (“IRA”) Medicare Drug Price Negotiation Program (the...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced...more
The Inflation Reduction Act (the “IRA”) requires drug manufacturers to pay rebates to Medicare when the prices of their Part B and Part D prescription drug increase faster than the rate of inflation. We recently discussed the...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
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more
States remain at the forefront of legislative efforts on a range of issues relating to drug pricing, such as increasing price transparency, capping out-of-pocket costs for insulin, and limiting certain PBM practices. These...more
The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more
Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...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
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
Manufacturers and providers participating in the 340B Drug Pricing Program have entered into a new phase of tensions this summer, as manufacturers push back on the use of contract pharmacies by providers. At least one major...more
[co-authors: Sean Feely, Senior Public Policy Specialist and Julie E. Nolan, Senior Policy Advisor] • On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price...more
In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more
The pharmaceutical industry invests billions in research and development. And as a result, the pharmaceutical industry has brought—and continues to bring—beneficial, life-saving, life-prolonging, life-enhancing, and...more
On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more
On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more
The Office of Inspector General of the Department of Health and Human Services (“OIG”) released a proposed rule to eliminate safe harbor protection under the anti-kickback statute for drug price reductions that pharmaceutical...more