Ropes & Gray LLP

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Boston, MA 02199-3600, United States

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Regulators Re-Propose Minimum Margin Requirements for Uncleared Swaps

U.S. Federal banking regulators (the “Prudential Regulators”) recently re-proposed rules providing for minimum margin requirements for uncleared swaps and security-based swaps executed by swap dealers, security-based swap…more
| Securities Law

Department of the Treasury and the Internal Revenue Service to Issue Regulations Limiting Taxpayers’ Ability to Benefit from Undertaking “Inversion Transactions”

On September 22, 2014 the Department of the Treasury and the Internal Revenue Service provided official notice to taxpayers of their intention to issue regulations limiting taxpayers’ ability to benefit from undertaking…more
| Business Organizations, International Law & Trade, Taxation

OIG Issues Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons

On September 19, 2014, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Coupons (the “Advisory Bulletin”) warning pharmaceutical…more
| Health, Insurance, Science, Computers, & Technology

SEC Brings First Action Against a Private Equity Fund Adviser for Misallocation of Portfolio Company Expenses

On September 22, 2014, the Securities and Exchange Commission (“SEC”) charged private equity fund adviser Lincolnshire Management, Inc. (“Lincolnshire”) with breaching its fiduciary duty to two of its private equity funds by…more
| Civil Procedure, Commercial Law & Contracts, Finance & Banking, Business Torts, Securities Law

Game On! Recent Legal Developments and Tax Issues for Collegiate Athletics

This is a period of unprecedented change for collegiate athletics, with potentially surprising tax consequences to the parties involved. Within the past six months, a federal district court held that the antitrust laws prevent…more
| Antitrust & Trade Regulation, Art, Entertainment, & Sports Law, Education, Labor & Employment Law, Personal Injury

CFTC Provides Exemptive Relief for Commodity Pool Operators Relying on the JOBS Act’s General Solicitation Amendments and Clarifies Certain Recordkeeping and Reporting Requirements Applicable to Certain Registered CPOs

Earlier this week, the Commodity Futures Trading Commission’s (“CFTC”) Division of Swap Dealer and Intermediary Oversight (the “Division”) issued a series of exemptive and no-action letters applicable to commodity pool operators…more
| Commercial Law & Contracts, Communications & Media Law, Finance & Banking, Securities Law

CMS Offers Global Settlement of Inpatient Status Claims with Pending Appeals

On August 29, 2014, the Centers for Medicare & Medicaid Services (“CMS”) announced a global settlement offer to acute care and critical access hospitals with currently pending appeals of inpatient status claims denials. Citing…more
| Health

U.S. Department of Justice Files False Claims Action Against 3 PODs and Physician Investors for Physician and Hospital Claims

On September 8, 2014, the U.S. Department of Justice (DOJ) filed a False Claims Act (FCA) case in the Central District of California against Reliance Medical Systems, two related distributors (Apex Medical Technologies and…more
| Health, Government Contracting

Final Guidance on 2014 Certified EHR Technology Requirements and Implementation of Stage 3 Meaningful Use Requirements

On September 4, 2014, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) issued a final rule (the “Final Rule”) that adopts, without…more
| Health, Science, Computers, & Technology

Bankruptcy Court Holds That Secured Creditors Can Be “Crammed Down” With Below-Market Rate Replacement Notes

On August 26, 2014, in the case In re MPM Silicones, LLC, Case No. 14-22503 (Bankr. S.D.N.Y.) (“Momentive”), the United States Bankruptcy Court for the Southern District of New York held that secured creditors could be “crammed…more
| Bankruptcy, Commercial Law & Contracts, Finance & Banking

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a…more
| Administrative Law, Health, Science, Computers, & Technology

FDA Releases Long-Awaited LDT Regulatory Framework and Finalizes Companion Diagnostics Guidance

On July 31, 2014, the Food and Drug Administration (FDA) took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices (IVDs). First, FDA released its long-awaited plan for…more
| Administrative Law, Health, Science, Computers, & Technology

SEC Adopts Reforms for Money Market Funds

On July 23, 2014, the Securities and Exchange Commission (the “SEC”) voted three-to-two to adopt significant new reforms for money market funds (“MMFs”) (the “Final Rule”). The reforms are intended to reduce the susceptibility…more
| Commercial Law & Contracts, Finance & Banking, Securities Law

China Unveils Detailed Rules to Implement the Core Device Regulation

The amended Regulation for the Supervision and Administration of Medical Devices (the “Regulation,” also known as the State Council Order No. 650), which came into force on June 1, 2014, set the new framework for China’s device…more
| Health, Science, Computers, & Technology

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating…more
| Administrative Law, Health, Science, Computers, & Technology
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