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BIO Submits Comments Re: Medicare CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule regarding the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biological. In this letter, BIO responds to CMS’s proposals in the order in which the Agency addresses each issue in the Proposed Rule, for ease of reference. However, there are several issues of particular importance to our members given the goal of ensuring patient access to necessary vaccines, treatments, and therapies.

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

BIO submitted comments on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Proposed Rule for calendar year (CY) 2018 (the "Proposed Rule").  BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. With these goals in mind, we have evaluated each of CMS’s proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals in more detail in the balance of the letter.

BIO Statement on California’s Drug Price Reporting & Transparency Bill

California Senate Bill 17 is bad for patient and does not deliver on its purported promises

FDA Commissioner, Dr. Scott Gottlieb, to Address BIO Patient and Health Advocacy Summit

The head of the United States Food and Drug Administration, Dr. Scott Gottlieb, will be the keynote speaker at the BIO Patient and Health Advocacy Summit, October 2-3 at the Mayflower Hotel in Washington, DC. The annual event brings together attendees representing patient advocacy groups, health care providers, academia, government, think tanks, professional societies and the biotechnology industry and provides a forum for lively discussions on timely health policy issues and best practices. 

PhRMA and BIO Initiate Litigation to Challenge Unconstitutional Provisions of Nevada’s SB 539

Washington, DC (September 1, 2017) – The Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) today initiated litigation in the United States District Court for the District of Nevada challenging provisions of SB 539, a Nevada law that would violate patent rights and negate trade secret protection for designated diabetes medicines in a way that would harm patients and chill future biomedical innovation.

SB 539 complaint

DSCSA: BIO Files Comments on FDA Product Identifier Compliance Policy

Dear Sir/Madam:

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BIO Asks EPA To Use a Forward-Looking Methodology in Setting Renewable Fuel Standards

BIO today submitted comments on EPA's proposed rule on the Renewable Fuel Standard Program: Standards for 2018 and Biomass-Based Diesel Volume for 2019.

BIO comments on EPA’s proposed rule on the Renewable Fuel Standard Program: Standards for 2018 and Biomass-Based Diesel Volume for 2019

BIO requests that EPA revise its proposed 2018 RFS rule to build upon the successes of the 2017 RFS and send a signal that there will be market growth for advanced and cellulosic biofuels. The proposed rule in its current form puts at risk industry progress and development with a new methodology that will in effect limit the volumes for cellulosic biofuels.

BIO files Amicus Brief supporting rehearing en banc in Helsinn v. Teva Phamaceuticals (US Court of Appeals for the Federal Circuit)

BIO files Amicus Brief supporting rehearing en banc in Helsinn v. Teva Phamaceuticals (US Court of Appeals for the Federal Circuit)