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BIO Submits Comments Re: Medicare CY 2019 Part D Proposed Rule

BIO supports CMS’s efforts to make changes to the Medicare Advantage, Medicare Fee-for-Service and the Part D Prescription Drug Benefit Programs in a manner that improves overall healthcare quality, while not compromising access to the most appropriate course of treatment. Our comments, detailed further in the balance of this letter, focus on the following areas: Request for Information to Require Pass through of Manufacturer Rebates at the Point of Sale to the Beneficiary Implementation of the Comprehensive Addiction and Recovery Act of 2016 (CARA) Treatment of Follow-On Biological Products as Generics for Non-LIS Catastrophic and LIS Cost-Sharing Revisions to Part D Tiering Exceptions Expedited Substitutions of Certain Generics and Other Midyear Formulary Changes Maximum Out-of-Pocket Limit and Cost-Sharing Limits for Medicare Parts A and B Services Flexibility in the Medicare Advantage Uniformity Requirements Any Willing Pharmacy Standards Terms and Conditions Medicare Advantage and Part D Prescription Drug Program Quality Rating System MA/Part D Artificial Limits

BIO Congratulates Alex Azar on Confirmation as Secretary of Health and Human Services

BIO Congratulates Alex Azar on Confirmation as Secretary of Health and Human Services   Washington, DC (January 24, 2018) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the confirmation of Alex Azar as United States Secretary of Health and Human Services (HHS):

BIO Releases First Report in a Series on the State of Innovation in Highly Prevalent Chronic Diseases

First-of-its-kind report highlights the need to stimulate development efforts for depression therapeutics.   Washington, DC (January 18, 2018) – Today, the Biotechnology Innovation Organization (BIO) released a new report, The State of Innovation in Highly Prevalent Chronic Diseases: Depression Therapeutics, the first in a series on the current funding and R&D land scape for drugs to treat highly prevalent, chronic diseases. 

BIO Statement on House Energy & Commerce Committee 340B Drug Pricing Program Review

Washington, DC (January 10, 2018) – BIO President and CEO Jim Greenwood issued the following statement regarding the review of the 340B drug pricing program released by the House Energy & Commerce Committee today:

BIO Applauds Support for Innovation in Trump Administration Task Force Report

“Biotechnology Sector is a Driver of the ‘Fourth Industrial Revolution’” Washington, D.C. (January 9, 2018) – The Biotechnology Innovation Organization (BIO) is applauding a new report from the Interagency Task Force on Agriculture and Rural Prosperity, which encourages growth and continued innovation in America’s biotechnology sector.

BIO Statement on Retirement of Senator Orrin Hatch

Washington, DC (January 2, 2018) – “BIO joins the nation – and the great state of Utah – in applauding Senator Hatch for his many years of service, and for proving time and time again to be a strong champion for biomedical innovation."

BIO Applauds House Passage of the Corporate Governance Reform and Transparency Act

Washington, DC (December 21, 2017) – Today, the Biotechnology Innovation Organization (BIO) applauds the House of Representatives for passing H.R. 4015, the Corporate Governance Reform and Transparency Act.  This bipartisan bill, sponsored by Reps. Sean Duffy (R-WI) and Gregory Meeks (D-NY), was approved by a 238-182 vote.

BIO Applauds USTR for Standing Up for Ag Innovation and Sound Science

U.S. Government and 16 like-minded WTO Members Call for Implementation of the Sanitary and Phytosanitary (SPS) Agreement Washington, D.C. (December 14, 2017) – The Biotechnology Innovation Organization (BIO) is applauding efforts by the United States Government and other World Trade Organization (WTO) members for committing to strengthen the implementation and application of Sanitary and Phytosanitary Measures (SPS Agreement).  

Dynamic Speaker Lineup Announced for BIO CEO & Investor Conference

The Biotechnology Innovation Organization (BIO) today announces preliminary programing for the upcoming BIO CEO & Investor Conference to be held February 12-13, 2018 in New York. The program will include a diverse group of industry luminaries at the forefront of exciting science in such areas as gene therapy and new oncology treatments.

REMS: BIO Comments on Draft Guidance on Format and Content of a Risk Evaluation and Mitigation Strategy Document

December 11th, 2017 ...