Ropes & Gray LLP

Upcoming Deadline for Form SHC - Holdings of Foreign Securities

Recently, the Department of the Treasury released the final instructions for the reporting requirements of the Treasury International Capital Benchmark Form SHC (herein referred to as “Form SHC”) for the 2016 calendar year. Form…more
| Finance & Banking, Securities Law

DOL Issues Additional Interpretative Guidance on New Fiduciary Rule

On January 13, 2017, the U.S. Department of Labor (the “DOL”) issued the second in a planned three-part set of FAQs on its new fiduciary rule. (For details on the fiduciary rule, see our prior Alert, and for details on the first…more
| Consumer Protection, Finance & Banking, Labor & Employment Law, Securities Law

HHS Finalizes Major Changes to the Common Rule

On January 18, 2017, the U.S. Department of Health and Human Services (HHS), together with fifteen other federal Departments and Agencies, issued a final rule intended to revise and modernize the federal Policy for the…more
| Health

FDA Finalizes Guidance on Postmarket Management of Medical Device Cybersecurity

On December 28, 2016, the Food and Drug Administration (FDA) issued final guidance on the postmarket management of cybersecurity in medical devices. The guidance outlines nonbinding recommendations on how device manufacturers…more
| Administrative Law, Privacy, Science, Computers, & Technology

Prime Minister confirms that the UK will exit the EU single market

In a speech made this afternoon, Prime Minister Theresa May confirmed that the UK will leave the European Union (EU) and will not seek membership of the single market. Instead, the UK will seek the “greatest possible access” to…more
| Elections & Politics, International Law & Trade

CFTC Adopts Amended Position Limit Aggregation Rules – Action by Asset Managers May Be Required

The U.S. Commodity Futures Trading Commission (the “CFTC”) has issued amended aggregation rules for determining compliance with speculative position limits established by the CFTC in futures contracts and options thereon. The…more
| Securities Law

CMS Finalizes Testing of New Episode Payment Models and MSSP Track 1+ ACO

On January 3, 2017, CMS published a final rule addressing three care coordination models: - Cardiac care: CMS added two new cardiac care episode payment models (“EPMs”) for items and services furnished to patients…more
| Government Contracting, Health

Mondelez Agrees to Pay $13 Million to Settle FCPA Charges Related to Alleged Bribery in India

On January 6, 2017, the U.S. Securities and Exchange Commission (“SEC”) announced that Illinois-based multinational confectionery company Mondelez International Inc. and its subsidiary Cadbury agreed to settle Foreign Corrupt…more
| Business Organizations, Mergers & Acquisitions, International Law & Trade, Securities Law

Seventh Circuit Applies Escobar Standard to Once Again Reject False Claims Act Liability Based on Implied False Certification Theory

On October 24, 2016, the Seventh Circuit applied the standard announced by the Supreme Court in United Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016), for False Claims Act (“FCA”) liability under…more
| Civil Procedure, Education, Government Contracting

The New FDA: Product Development, Pricing and Beyond - Part 2

What impact will the incoming Trump administration have on the 2017 health care and life sciences regulatory outlook? In this two-part podcast, The New HHS: Tom Price and Value-Based Health Care and The New FDA: Product…more
| Elections & Politics, Health, Science, Computers, & Technology

Enforcement Trends: Sanctions and International Risk (Transcript)

How will the regulatory and enforcement landscape change under a new Presidential administration? In this podcast, Michael Casey and Alex Rene of Ropes & Gray’s government enforcement practice group discuss the potential impact…more
| Elections & Politics, International Law & Trade

The New HHS: Tom Price and Value-Based Health Care - Part 1

What impact will the incoming Trump administration have on the 2017 health care and life sciences regulatory outlook? In this two-part podcast, The New HHS: Tom Price and Value-Based Health Care and The New FDA: Product…more
| Elections & Politics, Health, Science, Computers, & Technology

Enforcement Trends: Anti-Corruption and the Foreign Corrupt Practices Act

How will the enforcement landscape change under a new administration? In this podcast, Colleen Conry, Alex Rene and Michael Casey of Ropes & Gray’s government enforcement practice in Washington, D.C., discuss the potential…more
| Business Organizations, Elections & Politics, International Law & Trade

First Circuit Rejects Whistleblower’s Fraud on the FDA FCA Theory

On December 23, 2016, the First Circuit held that a relator under the federal False Claims Act (“FCA”) failed to plausibly plead that defendant medical device manufacturers caused the submission of false claims for reimbursement…more
| Civil Procedure, Government Contracting, Health, Science, Computers, & Technology

HHS OIG Expands Anti-Kickback Safe Harbors and Civil Monetary Penalties Law Exceptions; Issues Guidance on Gifts of Nominal Value

On December 7, 2016, the Office of Inspector General (the “OIG”) of the U.S. Department of Health and Human Services (“HHS”) issued a final rule modifying the safe harbors to the anti-kickback statute1 and the civi monetary…more
| Government Contracting, Health
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Contact

Prudential Tower
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Boston, MA 02199-3600, United States

  • 617 951 7000
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