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HTMLECR Episode XI: Rewriting the Guide to the Galaxy - Satellites Passed to Commerce Control
Reid Whitten; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 6, 2015, previously published on Novembe 6, 2014
Glancing through the fictional but fascinating Hitchhiker’s Guide to the Galaxy (Rsch. Ford Prefect; Pub. Megadodo Publications), one might recognize that the assertions therein are a bit confusing. Similarly, one might become confused when reviewing another, less whimsical, guide to the...

 

HTMLUpdate: Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions Before Bringing Suit
Michelle C. Kim, Peter S. Reichertz; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 5, 2015, previously published on December 16, 2014
In our previous blog post of November 11, 2014, we noted that Celltrion had filed a declaratory judgment action against Kennedy Trust for Rheumatology Research for invalidity of certain patents covering methods of treating rheumatoid arthritis. Celltrion Healthcare Co. v. Kennedy Trust for...

 

HTMLNew FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?
Peter S. Reichertz, Carrie A. Ross; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 5, 2015, previously published on January 5, 2015
Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the Orange Book, called the “Reference Listed Drug” or “RLD”. Issues have...

 

HTMLIf They Could Be All You Wanted: The FCC Gets Serious About Small Cells
J. Aaron George, Douglas A. "Drew" Svor, Dave Thomas; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
February 5, 2015, previously published on October 28, 2014
Say what you will about inside-the-Beltway leadership vacuums, political gridlock and the indecipherable output from the grey, grinding gears of our government agencies, but once in a while Washington actually gets it right. Or mostly right.

 

HTMLCMS’ Proposed Regulations Include Significant Antitrust Implications For Entities Interested In Forming ACOs
Helen Cho Eckert, David R. Garcia; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on January 5, 2015
The Centers for Medicare & Medicaid Services (CMS) released proposed regulations to clarify and build on current regulatory requirements for Accountable Care Organizations (ACOs) that participate in the Medicare Shared Savings Program (MSSP). Among the changes is one addressing when an ACO must...

 

HTMLAFL-CIO’s Industry Wide Agreement May Have Wide Reach in Hospitality Industry
Rachel J. Tischler; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on January 5, 2015
Mid-way through 2012, the Hotel Association of New York City and the New York Hotel & Motel Trades Council, AFL-CIO (the “Union”), renewed a seven-year collective bargaining agreement known as the Industry Wide Agreement, or IWA. While the IWA controls nearly all aspects of the...

 

HTMLNation’s Highest Court Schedules Oral Arguments in King v. Burwell
Florence Wang; Sheppard Mullin Richter Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on December 23, 2014
A Supreme Court of the United States (SCOTUS) spokesperson announced on December 22, 2014, that the Court will hear oral arguments in King v. Burwell on March 4, 2015. This means that not only could the highest court soon resolve the circuit split on the case’s key issue, but that the future...

 

HTMLCalifornia Insurance Commissioner Issues Emergency Regulations Affecting Narrow Provider Networks
Eugene Y.C. Ngai; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on January 12, 2015
On January 5, 2015, Commissioner Dave Jones issued emergency regulations affecting health insurers with respect to access to provider networks in response to consumer complaints that appointments with physicians are hard to obtain, that in-network care is far away, and that in-network provider...

 

HTMLWhat Can You Expect in 2015 Regarding HIPAA Enforcement?
Lynsey Mitchel; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on December 22, 2014
As of earlier this month, 1,170 breaches involving 31 million records have been reported to the Department of Health and Human Services (HHS) since mandated reporting of breaches began in September 2009. An increase in the number of breaches isn’t the only statistic on the rise. Although...

 

HTMLCMS Defines “Uninsured” for Medicaid DSH Payments But Leaves Impact on Hospital-Specific Payments Undefined
Florence Wang; Sheppard Mullin Richter Hampton LLP;
Legal Alert/Article
January 30, 2015, previously published on December 11, 2014
CMS’ Final Rule, “Medicaid; Disproportionate Share Hospital Payments - Uninsured Definition”, published on December 3, 2014, may offer relief to some hospitals receiving Medicaid disproportionate share hospital (DSH) payments under the Social Security Act. Starting December 31,...

 


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