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Arnold & Porter
The European Commission has published a proposal for a Regulation reinforcing the European Medicines Agency's ("EMA") role in crisis preparedness and management for medicinal products...
United States
Akin Gump Strauss Hauer & Feld LLP
Happy Thanksgiving everyone. In a pre-holiday flurry, the Trump Administration has released four long-awaited health care policies impacting a wide range of health industry participants.
Hall, Render, Killian, Health & Lyman
Late this afternoon, the Centers for Medicare & Medicaid Services ("CMS") and Office of Inspector General ("OIG") released long-awaited and highly anticipated Stark and Anti-Kickback Statute...
Hall, Render, Killian, Health & Lyman
In health care, actions under the False Claims Act ("FCA") typically allege conduct that is knowingly in violation of one or more of Medicare's conditions of payment—part of an amorphous contract...
Mintz
On November 20, 2020, the Department of Health & Human Services (HHS) finalized significant changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law...
Wilson Elser Moskowitz Edelman & Dicker LLP
This issue of the Long-Term Care Newsletter offers an analysis of the unprecedented regulatory actions and new guidelines and requirements
Proskauer Rose LLP
The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation: (1) if it affects less than 200,000 persons in the United States, or ...
Hall, Render, Killian, Health & Lyman
On November 16, 2020, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") released a Special Fraud Alert
Morrison & Foerster LLP
I was counsel of record on an amicus brief in California v. Texas for four law professors arguing that even if the Affordable Care Act's individual mandate is unconstitutional...
Morrison & Foerster LLP
MoFo & GSAS Harvard Biotech Club's new course, "Legal Topics for Scientists, Entrepreneurs, and Start Ups," started on November 11
Riker Danzig Scherer Hyland & Perretti
The Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule on federal payment amounts to states that elect to establish a Basic Health Program ("BHP")...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On November 9, 2020, FDA issued final guidance on "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trail Designs,"
Schwabe Williamson & Wyatt
With the onset of colder weather, the return of students to colleges, and pandemic fatigue, the news is that the next six to twelve weeks could be the worst yet for the pandemic
Chamberlain, Hrdlicka, White, Williams & Aughtry
494 pages of guidance on 62 pages of new final regulations that impact employer sponsored group health plans.
Holland & Knight
On Nov. 4, 2020, the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking and proposed regulatory changes that would...
Mintz
Smart Building Technologies was acquired by Fidelity Building Services Group for an undisclosed amount. Smart Building Technologies offers solutions for building automation ...
Mintz
This month, we are thrilled to feature Yield10 Bioscience, Inc., an agricultural bioscience company developing crop innovations to improve global food security.
Morrison & Foerster LLP
The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of...
Benesch Friedlander Coplan & Aronoff
Fresenius contends that as only one of the three allegations brought forward by a former area manager actually resulted in a settlement...
Foley & Lardner
The Centers for Medicare & Medicaid Services (CMS) issued updated guidance on the thresholds that Applicable Manufacturers and Group Purchasing Organizations are required to report annually under the Sunshine Act.
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