By Scott Roberts When conducting medical research, a researcher may want to obtain health information to use as data in a study. For observational studies, clinical data and treatment information can be especially useful, particularly when large amounts of clinical data are aggregated together. The Health Insurance Portability and Accountability Act, also known as “HIPAA,” …
DW Health Care Team – News & Success Stories
Effective January 1, 2013, Dickinson Wright PLLC expanded its practice in the Arizona and Southwestern U.S. legal and business communities, combining with Mariscal Weeks of Phoenix, Arizona, creating “Dickinson Wright/Mariscal Weeks”. This combination is part of a strategy that will solidify Dickinson Wright’s position as a leader in the North American marketplace and strengthen the …
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FTC Issues New Report on “Pay for Delay” Patent Settlements
By James M. Burns According to a new report by the Federal Trade Commission, brand-name pharmaceutical companies increased their use of “pay for delay” patent settlements last year (October 2011 – September 2012). Of the total 140 pharmaceutical patent infringement settlements in the year, the report identifies 40 as potential “pay for delay” settlements. This …
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Michigan Governor Vetoes Legislation Banning Health Insurers from Utilizing Most Favored Nation Clauses in Provider Contracts
By James M. Burns On December 6, the Michigan Legislature passed legislation (S.B. 1293) that would have prohibited health insurers and health maintenance organizations in the state from including “most favored nation” clauses in any provider contract. The legislation was expected to be signed into law by Michigan Governor Rick Snyder, but in an unexpected …
James M. Burns Comments on the Supreme Court’s Decision to Hear the Androgel “Pay for Delay” Pharmaceutical Patent Settlement Antitrust Case
James Burns, a Member in Dickinson Wright’s Washington D.C. office, commented to several health care publications on the United States Supreme Court’s decision to hear the Androgel antitrust case (FTC v. Watson Pharmaceuticals). The case involves so-called “pay for delay” settlements, in which a branded drug manufacturer typically sues a generic manufacturer for patent infringement, …
Clarifying an IRB’s Review of a Clinical Investigators’ Qualifications
By Scott Roberts On November 28, 2012, the Food and Drug Administration (“FDA”) issued draft guidance outlining an Institutional Review Board’s (“IRB”) responsibility for evaluating the qualifications of clinical investigators that are subject to Investigational New Drug (“IND”) regulations. The new guidance clarifies the role IRBs play in reviewing the qualifications of an investigator, which …
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OIG Finds Tennessee’s Amended False Claims Act Too Narrow, Requiring Tennessee to Go Back to the Drawing Board Again
By Rodney D. Butler Within the last few weeks, the Office of Inspector General (OIG) issued a letter to the State of Tennessee regarding its Medicaid Fraud False Claims Acts. Unfortunately for the State of Tennessee, the OIG provided notice that their statutory framework failed to meet the requirements of section 1909 of the Social …
Medicare Finalizes 2013 Physician Payment Schedule
By Ralph Levy, Jr. On November 1, 2012, the Centers for Medicare & Medicaid Services (CMS) finalized previously announced changes to the Medicare Physician Fee Schedule (MPFS) for services furnished by physicians during calendar year 2013. These payment changes will affect different specialties in different ways. For example, payments to family physicians will increase by …
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Criminal Action Taken Against Vermont Ultrasound Technologist for Accessing Records Without Authorization
By Tatiana Melnik The Rutland Herald of Vermont, reports that Kathy Tatro was sentenced in a Bennington, Vermont criminal court on Friday, November 23, 2012, to a suspended jail term of 6 to 12 months, 2 years of probation, 160 hours of community service, a $2,000 fine, and ordered to write a letter of apology …
Federal Trade Commission Takes Aim at Pharmaceutical Industry “Product Hopping”
By James M. Burns Declaring that “The potential for anticompetitive product design is particularly acute in the pharmaceutical industry,” on November 21 the FTC filed an amicus brief in Mylan Pharmaceuticals v. Warner Chilcott Public Limited Company (E.D. Pa.), urging the court not to accept the view that “product-hopping” (the practice of repeatedly reformulating a …
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