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BIO Applauds Senate Passage of the 21st Century Cures Act

Washington, DC (December 7, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. Senate:

BIO Applauds House Passage of the 21st Century Cures Act

Washington, DC (November 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. House of Representatives:

BIO Applauds Advancement of Precision Medicine Initiative

Washington, D.C. (February 26, 2016) – The Biotechnology Innovation Organization (BIO) Executive Vice President for Health Policy Dan Durham released the following statement regarding yesterday’s White House announcement of actions to accelerate the Precision Medicine Initiative:

BIO Comments on CMS PAMA Proposed Rule

The Biotechnology Industry Organization (BIO) submitted comments on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule entitled Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System.

BIO Praises the Release of 21st Century Cures Initiative Discussion Draft

Washington, D.C. (April 29, 2015) – The Biotechnology Industry Organization (BIO) today releases the following statement on the 21st Century Cures Initiative discussion draft shared by Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Rep. Frank Pallone, Jr. (D-NJ), Rep. Joe Pitts (R-PA), and Rep. Gene Green (D-TX). 

BIO Submits Comments to FDA on Next Generation Sequencing

BIO Comments Submitted to FDA on Regulation of LDTs

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on two draft guidance release on October 3, 2014, entitled Framework for Regulatory Oversight of Laboratory Developed Tests (the "Framework Guidance") and FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) (the "Notification Guidance) (Collectively the "LDT Guidance").

BIO Comments on 2013 Gapfill Payment Amounts CLFS

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for Medicare and Medicaid Services (CMS) on May 9, 2013.

Building a World-Class Innovative Therapeutic Biologics Industry in China

Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.

BIO Comments on New CMS Clinical Lab Fee Schedule Codes and Payment Determinations

The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations published by the Centers for Medicare and Medicaid Services (CMS) on August 31, 2012. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnologies, thereby expanding the boundaries of science to benefit society by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. Specifically related to advanced personalized diagnostic products, a number of BIO companies develop and market in vitro diagnostic technologies for a variety of research, investigational, and clinical uses. BIO is deeply concerned with CMS’ payment proposal regarding Multi-Analyte Assays with Algorithmic Analyses (MAAAs), and is concerned generally with the lack of transparency in the process through the annual CLFS meeting and publication of the proposed payment methodologies. BIO believes these proposed payments will threaten access to molecular pathology tests by Medicare beneficiaries and have a devastating impact on the advancement of personalized medicine.