News & Analysis as of

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CMS Guidance Paves Way for Medicaid Work Requirements

by Bass, Berry & Sims PLC on

The Centers for Medicare & Medicaid Services (CMS) started the year with a bang, issuing guidance on January 11, 2018, in support of Medicaid demonstration projects that condition coverage on beneficiary participation in work...more

Government Contracts Legislative and Regulatory Updates - January 2018

by Dentons on

Our January edition of "Government Contracts Legislative and Regulatory Update" offers a summary of the relevant changes that took place during the month of December. Highlights this month include: - President Trump...more

UK charities seeking opinions on their equivalency to US tax-exempt charities

by DLA Piper on

On 2 October 2017, the IRS provided guidance to US tax advisers for issuing opinions to the effect that a non-US charity is equivalent to an analogous tax-exempt US charity (Rev. Proc. 2017-53, 2017-40 IRB 263). Few non-US...more

EPA Deletes Several Superfund Sites from the NPL and Targets More in 2018 and Beyond

by Miles & Stockbridge P.C. on

U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt says that expediting cleanups at Superfund sites is one of his top priorities. Since 1980, EPA has had the authority to clean up contaminated sites and...more

CMS Issues Billing Guidance for Major Joint Replacement (Hip or Knee)

by Tucker Arensberg, P.C. on

In the January 11, 2018 issue of MLN Connects, CMS has now widely publicized that it issued billing guidance for major joint replacements (hip or knee) in May 2017 at ICN909065. CMS reports that major joint replacement is...more

Hey, You, Get Off Of My Cloud – New DOJ Approach To Remote Data Storage

by Bracewell LLP on

Last month, the Department of Justice’s Computer Crime and Intellectual Property Section, Criminal Division (“CCIPS”) issued new guidance advising prosecutors seeking enterprise customer data stored “in the cloud” to attempt...more

New CMS Guidance Regarding Health Care Texting and Involuntary Discharges

by Benesch on

The Centers for Medicare and Medicaid Services (CMS) periodically provides guidance to the State Survey Agency Directors which outlines areas of emphasis or important concerns for the health care industry. Two (2) recent...more

FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development

by Goodwin on

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance is intended to “describe best practices and...more

SEC Staff’s Latest Guidance Presents Dilemma for Companies Seeking to Exclude Shareholder Proposals on Environmental and Social...

by Dorsey & Whitney LLP on

On November 1, 2017, the SEC Division of Corporation Finance issued a Staff Legal Bulletin No. 14I (“SLB 14I”), which includes guidance on the scope and application of the “ordinary business” basis for excluding shareholder...more

China defers 10 percent withholding tax on dividend income reinvested into Encouraged Industries

by DLA Piper on

Prior to 2008, foreign investors were generally exempt from withholding income tax on dividend income derived from their investment in China under the prior PRC Enterprise Income Tax Law for Foreign Invested Enterprises and...more

End of the Year Updates from the Department of Transportation and Federal Aviation Administration

by FordHarrison on

The Department of Transportation (DOT) and Federal Aviation Administration (FAA) published a flurry of announcements to close out 2017. In addition to recapping several previous publications, the FAA released a new Advisory...more

In the Cloud: DOJ Issues New Guidance for Collecting Stored Data

The Justice Department is changing its approach to collecting data stored in the cloud. That’s the upshot of new DOJ guidance for criminal investigations issued late last month. The guidance, from the DOJ’s Computer Crime...more

Federal Reserve, OCC and FDIC Release Examiner Guidance for Institutions Affected by Major Disasters

by Shearman & Sterling LLP on

The US Board of Governors of the Federal Reserve System, the US Office of the Comptroller of the Currency, the US Federal Deposit Insurance Corporation, and the US National Credit Union Administration released interagency...more

2017, We Hardly Knew You: A Look Ahead to 2018

by Holland & Knight LLP on

Taking over as editors of Holland & Knight’s Government Contracts Blog has been a labor, but it has been a labor of love. Like the rest of the Government Contracts Team, we are passionate about staying on top of the latest...more

Labor Commissioner Issues New Guidance On Breaks

The California Labor Commissioner recently issued a Frequently Asked Questions (FAQ) memo regarding breaks and lactation accommodation. The FAQ memo contains no new concepts, but emphasizes the following longstanding...more

EU data protection advisory body issues guidance on setting “effective, proportionate and dissuasive” fines under the GDPR

by Ropes & Gray LLP on

The EU’s data protection advisory body, the Article 29 Data Protection Working Party (WP29), has adopted Guidelines on the application and setting of administrative fines for the purposes of the General Data Protection...more

Delaware Supreme Court Reins in Stockholder Ratification of Director Compensation

• Directors were not entitled to stockholder ratification defense where stockholders only approved the general parameters of director and employee bonuses • This marks the first time in nearly 60 years that Delaware’s...more

California Air Resources Board Clarifies 2018 LCFS Targets and POET II Case Approaches Major Milestone

by Latham & Watkins LLP on

Recent guidance published by the California Air Resources Board (ARB) clarifies the treatment of diesel fuels under the Low Carbon Fuel Standard (LCFS) in light of the Court of Appeals’ May 30, 2017 decision in POET I....more

USCIS Issues Guidance on TN Nonimmigrant Status for Economists

On November 20, 2017, United States Citizenship and Immigration Services (USCIS) issued a policy memorandum clarifying that the TN definition of “economists.” Background - On December 17, 1992, the presidents of the...more

Investment Services Regulatory Update - December 2017

by Vedder Price on

New Rules, Proposed Rules, Guidance and Alerts - NEW RULES - SEC Delays Form N-PORT EDGAR Filing Requirement by Nine Months - On December 8, 2017, the SEC adopted a temporary rule (the Temporary Rule) delaying by...more

FDA finalizes 3D printing guidance

by Hogan Lovells on

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. Please see full Publication below for...more

The Future of H-1B Visas May Be Scrooged

by Williams Mullen on

The H-1B visa program allows companies in the United States to temporarily employ foreign workers in “specialty occupations.” In recent months, several changes to the program have either been announced or proposed, with...more

Rx IP Update - December 2017

by Smart & Biggar on

PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more

Criminal antitrust prosecutions still loom for employers with ‘no-poaching,’ ‘wage-fixing’ agreements

by Thompson Coburn LLP on

Agreements to refrain from soliciting another company’s employees (“no poaching” agreements) recently came under increased scrutiny — including the ominous potential for felony charges. A year ago, under the Obama...more

Clarifying Digital Health and Software Regulation: FDA Releases Three New Guidance Documents

by Hogan Lovells on

On December 7, 2017, the Food and Drug Administration (FDA or the Agency) released three guidance documents that together aim to clarify the framework for the regulation of software and digital health products to bring FDA...more

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Cybersecurity

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