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The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S....more
On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more
As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
The U.S. District Court for the District of Columbia handed down a major victory to Medicare Advantage issuers on September 7, 2018, vacating a 2014 CMS regulation relating to Medicare Advantage overpayments. ...more