Medicare and Medicaid reforms coming in a second Obama administration *

USA - November 7 2012
While Mitt Romney and Paul Ryan campaigned on the promise to repeal the U.S. Patient Protection and Affordable Care Act, and to reform Medicare and Medicaid, their defeat does not mean the health industry should expect no change in 2013.

Co-authors: Eric Zimmerman, Patrick F. Healy.

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New flexibility for pharmaceutical and medical device companies in Massachusetts, but at a price *

USA - August 1 2012
In July 2012 Massachusetts amended its Gift Ban Law and its Anti-Kickback Statute, both of which are among the most restrictive state laws of their kind.

Co-authors: James S. Cohen, Jennifer S. Geetter, Joan Polacheck, Glenn Engelmann.

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IFPMA releases revised code for interactions with health care professionals and other stakeholders *

USA - March 16 2012
On March 1, 2012, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) issued a Code of Practice relating to interactions with the health care community, which replaces and expands upon its 2006 Code of Pharmaceutical Marketing Practices.

Co-authors: James S. Cohen, Joan Polacheck, Jana Grieb, Glenn Engelmann.

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FDA publishes draft biosimilars guidance *

USA - February 16 2012
The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, a U.S. Food and Drug Administration (FDA)-licensed biological reference product.

Co-authors: James S. Cohen, Kristin Connarn, Michael W. Ryan, Glenn Engelmann, Paul W. Radensky.

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CMS issues proposed rule implementing the "Federal Sunshine Law" reporting requirements *

USA - January 4 2012
The U.S. Centers for Medicare & Medicaid Services (CMS) released a proposed rule implementing the "Sunshine" provisions of the Affordable Care Act (ACA) that requires annual public reporting by certain drug and device manufacturers of payments made by them to physicians and teaching hospitals and of physician ownership interests in such manufacturers.

Co-authors: Lesley DeRenzo, Emily J. Cook, Joan Polacheck, Bernadette M. Broccolo.

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