Public Policy

Expert Analysis

Bringing Japan Into TPP Talks Is An Important Opportunity

The U.S. recently backed Japan’s entry into the Trans-Pacific Partnership talks. Japan’s participation makes the trade agreement potentially much more lucrative for U.S. exporters — but only if the historic formal and informal barriers that have marred bilateral U.S.-Japan trade relations for decades can somehow actually be addressed, says Terence Stewart of the Law Offices of Stewart and Stewart.
How New Carveout Policy Will Impact Cartel Plea Deals

The U.S. Department of Justice’s Antitrust Division has announced that it will no longer publicly list the names of individuals excluded from the protections afforded by corporate plea agreements. The consequences should be felt immediately in ongoing cartel investigations, and should also have important ramifications for future investigations, say attorneys with Hogan Lovells LLP.
What To Know About CMS' Recently Proposed Rule

Concerns about the Medicare appeals process and administrative burdens placed on both adjudicators and providers have been building over the last year, and recently, important changes, most notably, the proposed A/B rule, were announced that impact revenue strategies for hospitals in particular, say attorneys with Womble Carlyle Sandridge & Rice LLP.
Big Changes To Small Business '50 Percent Rule'

The National Defense Authorization Act of 2013 made important changes to the limitation on subcontracting, known as the “50 percent rule.” The changes may make compliance easier to calculate but harder to achieve, says Daniel Koch of Miles & Stockbridge PC.
DGCL Amendments Could Increase Negotiated Tender Offers

If adopted, recently proposed amendments to the Delaware General Corporation Law should have a meaningful impact on, and lead to the increased use of, two-step public company acquisition structures, says Clifford Neimeth of Greenberg Traurig LLP.
Spending Bill's China Cybersecurity Provision Is Unclear

The vague language of the China cyber-espionage provision in the continuing resolution to fund federal agencies through the rest of the fiscal year might be problematic because it could potentially apply to any part of a company’s supply chain. The provision also raises potentially significant international trade issues, say attorneys with Hogan Lovells LLP.
High Court Leaves Road Wide Open For CWA Citizen Suits

Recently in Decker v. Northwest Environmental Defense Center, the U.S. Supreme Court determined that the U.S. Environmental Protection Agency validly interpreted its stormwater runoff regulations, which will save many in the logging industry from the cost of the permitting process. The decision also leaves environmental groups ample freedom to bring future Clean Water Act suits, say attorneys with Vinson & Elkins LLP.
Sound The Alarm: Uninjured Plaintiffs Now Have Standing

The recent Second Circuit decision in National Resources Defense Council v. U.S. Food and Drug Administration sets a concrete example of the potential of Administrative Procedure Act actions involving products that are not yet proven harmful, sounding a warning alarm for regulatory agencies and manufacturers, says Jesse Morris of Weil Gotshal & Manges LLP.
Spotlight On Keepwells And Excluded Obligations

There has been considerable discussion in syndicated lending circles recently regarding how to account for a new swap “clearing requirement” that significantly impacts loan documentation and became enforceable on March 31, 2013. Two particularly important means for lenders to address the clearing requirement are “keepwells” and excluding guarantee obligations of entities that are not “eligible contract participants,” say Andrew Colao and Amara Gossin of Weil Gotshal & Manges LLP.
Va. Takes The Lead In Biosimilar Substitution Law

Recently, Virginia Gov. Bob McDonnell signed into law the nation’s first state law concerning substitution of biosimilars. The law’s requirements that pharmacists give notice of substitution to prescribers and of retail costs to patients differ significantly from the state’s existing law applicable to substitution of small-molecule drugs, say attorneys with Ropes & Gray LLP.