Legal and practical healthcare information.
In a recent announcement, the Departments of Justice and Health & Human Services announced record recoveries of $4.2 billion in their 2012 fiscal year from healthcare fraud prevention and enforcement efforts. This is an increase from the $4.1 billion recovered during 2011. Highlighted areas of recovery included improper billing (overpayments and for services not performed) …
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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,” …
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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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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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 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, …
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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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 …
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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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 …