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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.

Glenn Engelmann, Susan S. Lee, Michael W. Ryan

FDA releases long-awaited biological naming draft guidance and proposed rule

USA - September 9 2015 On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the…

Michael W. Ryan

Congress creates Independent Payment Advisory Board: are Medicare solvency decisions finally on the way?

United Kingdom - May 5 2010 As part of the health care reform legislation, and in an effort to help restrain growth in Medicare expenditures, Congress has created the Independent Payment Advisory Board, which has the authority to develop proposals that will become law if Congress fails to enact alternative proposals.

Eric Zimmerman

Reimbursement issues facing molecular pathology services in Calendar Year 2013 and beyond

USA - November 14 2012 The Centers for Medicare & Medicaid Services recently issued final regulations and a final payment guidance that address reimbursement for laboratories furnishing molecular pathology services

Elizabeth K. Isbey, Joan Polacheck, Eric Zimmerman

CMS proposes changes to modernize and update the clinical laboratory fee schedule

USA - July 16 2013 On July 8, 2013, the Centers for Medicare & Medicaid Services (CMS) released a pre-publication version of the 2014 Medicare Physician Fee Schedule…

Christine Park Song, John Warren