Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Departments Finalize Transparency In Coverage Rules: What Health Plans And Issuers Need To Know
The Trump administration has finalized sweeping changes to healthcare price transparency rules, requiring health plans and insurers to standardize machine-readable pricing files, attest to data accuracy through executive certification, and provide consumers with personalized cost information by phone. These regulations, effective December 2026 through July 2028...
United States Healthcare
M
Mintz
Article
GLOBE Most Favored Nations Drug Pricing Model For Medicare Part B Drugs Finalized And Scaled Down By CMS
The Centers for Medicare & Medicaid Services has finalized the GLOBE Model, a mandatory rebate program for certain Medicare Part B drugs based on international price benchmarking. While the framework remains largely intact from the proposed rule, CMS dramatically narrowed the scope by adding three new drug exclusion categories and offering waivers for manufacturers participating in the GENEROUS Model, reducing projected savings by 97% and potentially affecting only four manufacturers.
United States Healthcare
GP
Goodwin Procter LLP
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Article
Benesch Healthcare Dialysis & Nephrology Digest No. 79
Benesch Healthcare Partner Jason Greis recently joined the BackTable Vascular & Interventional Podcast to discuss the growing scrutiny surrounding Medicare audits and what physicians and medical practices should know. During the conversation, he examined common audit triggers, the increasing use of artificial intelligence in audit activities, compliance and documentation best practices, and strategies for responding to audits and navigating the appeals process.
United States Healthcare
B
Benesch Friedlander Coplan & Aronoff LLP
Article
Fresenius Acquires Remaining 45% Stake In MAbxience For Up To €750 Million
Fresenius SE & Co. KGaA has completed its acquisition of the remaining 45% stake in mAbxience Holding S.L., a biosimilar manufacturer, for up to €750 million. The transaction makes mAbxience a wholly owned subsidiary within Fresenius Kabi's Biopharma business, providing the company with greater control over its biosimilar value chain from development through commercialization.
United States Healthcare
GP
Goodwin Procter LLP
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Article
FinCEN Targets $17.5 Billion In Suspected Health Care Fraud
The U.S. Treasury's Financial Crimes Enforcement Network has uncovered $17.5 billion in suspicious financial activity tied to health care fraud schemes, revealing how fraudulent providers exploit Medicare, Medicaid, and private insurance programs. Analysis of over 5,700 Bank Secrecy Act reports exposes sophisticated money laundering networks spanning all 50 states, with home health care businesses emerging as the most frequently identified perpetrators.
United States Government
BS
Ballard Spahr LLP
Article
Departments Finalize Transparency In Coverage Rules: What Health Plans And Issuers Need To Know
The Trump administration has finalized sweeping changes to healthcare price transparency rules, requiring health plans and insurers to standardize machine-readable pricing files, attest to data accuracy through executive certification, and provide consumers with personalized cost information by phone. These regulations, effective December 2026 through July 2028...
United States Healthcare
M
Mintz
See more
Article
GLOBE Most Favored Nations Drug Pricing Model For Medicare Part B Drugs Finalized And Scaled Down By CMS
The Centers for Medicare & Medicaid Services has finalized the GLOBE Model, a mandatory rebate program for certain Medicare Part B drugs based on international price benchmarking. While the framework remains largely intact from the proposed rule, CMS dramatically narrowed the scope by adding three new drug exclusion categories and offering waivers for manufacturers participating in the GENEROUS Model, reducing projected savings by 97% and potentially affecting only four manufacturers.
United States Healthcare
GP
Goodwin Procter LLP
Article
Benesch Healthcare Dialysis & Nephrology Digest No. 79
Benesch Healthcare Partner Jason Greis recently joined the BackTable Vascular & Interventional Podcast to discuss the growing scrutiny surrounding Medicare audits and what physicians and medical practices should know. During the conversation, he examined common audit triggers, the increasing use of artificial intelligence in audit activities, compliance and documentation best practices, and strategies for responding to audits and navigating the appeals process.
United States Healthcare
B
Benesch Friedlander Coplan & Aronoff LLP
Article
UK High Court Upholds Takeda’s Lisdexamfetamine SPC: Will The CJEU Agree?
The UK High Court has ruled on whether lisdexamfetamine (LDX), a pro-drug with no therapeutic activity before conversion to dextroamphetamine, can be considered an "active ingredient" for supplementary protection certificate purposes. This decision addresses a critical question in pharmaceutical patent law that has produced divergent outcomes across European jurisdictions and is currently before the CJEU in multiple pending referrals.
United States IP
JA
J A Kemp LLP
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