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HTMLFDA Commits to Moving Forward with LDT Regulation
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
December 1, 2015, previously published on November 24, 2015
Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that FDA would move forward with finalizing its plan to regulate...

 

HTMLDNA Sequencing Workshop and Drug Pricing Developments
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
December 1, 2015, previously published on November 20, 2015
On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics.

 

HTMLGenetic Testing, Genome Sequencing, and the FDA
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
December 1, 2015, previously published on November 13, 2015
In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) - any test that detects a disease, condition, or infection - to the rapidly developing world of genetic and genomic testing services. As the health...

 

HTMLAlbany County Supreme Court Upholds $199,000 “Hard Cap” on State Funded Executive Compensation, While Striking “Soft Cap” on Funding From All Sources
Christina T. Holder, Pamela Landman, Brian T. McGovern; Cadwalader, Wickersham & Taft LLP;
Legal Alert/Article
November 30, 2015, previously published on November 25, 2015
On November 13, 2015, the New York State Supreme Court, Albany County issued a decision in LeadingAge et al. v. Shah,1 upholding in part and invalidating in part regulations issued by the Department of Health to implement Executive Order 38, limiting executive compensation and administrative...

 

HTMLWaivers of Certain Fraud and Abuse Laws Permitted in CJR Model
Robert P. Charrow; Greenberg Traurig, LLP;
Legal Alert/Article
November 27, 2015, previously published on November 18, 2015
On Nov. 16, 2015, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a Final Rule implementing a new Medicare program in which acute care hospitals in certain geographic areas will be responsible for a retrospective bundled payment for episodes of care to beneficiaries admitted for...

 

HTMLData Protection Regulations Apply When Comparison Added After NDS Filed
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
November 27, 2015, previously published on November 11, 2015
In this case, Hospira applied for judicial review of a decision of the Minister of Health, refusing to issue it a Notice of Compliance (NOC) for its drug oxaliplatin. The Minister had found that Hospira compared to Sanofi's innovative drug ELOXATIN oxaliplatin, and thus the data protection...

 

HTMLCMS Final Rule Includes Revisions to Stark Law
Jessica Bechtel; Taft Stettinius & Hollister LLP;
Legal Alert/Article
November 27, 2015, previously published on November 12, 2015
On Oct. 30, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a final Medicare physician fee schedule rule that adds two new exceptions and clarifies certain terminology and requirements of the federal physician self-referral law (the “Stark Law”). This final rule with...

 

HTMLFDA Explores Use of Term "Natural" on Human Food Labeling
Edgar J. Asebey, Jonathan Berman, Colleen Heisey, Katherine M. Llewellyn, Cristiana Spontoni; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 13, 2015
FDA is requesting public comments on (i) whether it is appropriate to define the term "natural" and, if so (ii) how the agency should define "natural," and (iii) whether it should determine appropriate use of the term on food labels. FDA considers a human food to be...

 

HTMLCMS and OIG Issue Final Fraud and Abuse Waivers in Connection with the Medicare Shared Savings Program
Thomas E. Dutton, David W. Grauer, Andrew G. Jack, John M. Kirsner, David T. Morris; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 2015
On October 29, 2015, the Centers for Medicare & Medicaid Services ("CMS") and the U.S. Department of Health and Human Services' Office of Inspector General ("OIG") published a final rule ("Final Rule") finalizing the waivers of the application of various fraud and...

 

HTMLFDA Holds Back-to-Back Workshops on Next-Generation Sequencing Diagnostic Tests
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Cristiana Spontoni; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 2015
Last week, FDA held two workshops to gather information on developing a flexible approach for the regulation of next generation sequencing ("NGS") in vitro diagnostic tests. NGS tests facilitate the rapid sequencing and analysis of segments of DNA, yielding information that can be used to...

 


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