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Reimbursement and Health Policy

The 340B Drug Discount Program

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. This white paper examines the history and original intent of the program as well as highlights key findings to help policymakers ensure that the 340B program meets its stated purpose and to provide a roadmap for next steps to be considered.

The Reimbursement Landscape for Novel Diagnostics: Current Limitations.

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time.

BioBytes: The Biotech Drug Delivery Timeline

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life.

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

BioBytes: What are biosimilars?

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. 

Data Exclusivity and Biotech Competition: Separating Fact from Fiction

Myths abound regarding data exclusivity and the ability of an innovator to extend the period of data exclusivity as provided in the health care reform bill passed by the U.S. House of Representatives and legislation currently under consideration in the Senate.

BioBytes 108 - What are Stem Cells?

What's a stem cell? Where does it come from? Learn more about how biotechnology is utilizing stem cells to create tomorrow's cures for today's diseases.

BIO's Principles for Payment System Reform (PSR) Policies
Health Reform Debate Heats Up and Slows Down

The health reform debate is heating up and, in at least one respect, slowing down a bit.

Preparing Before the Storm: The Reimbursement Policy Disaster

During Tuesday's panel, we had the opportunity to lay the foundation of Medicare reimbursement policy, and discuss current trends and how health reform my impact reimbursement for biotechnology therapies in the future.

BIO’s Principles on Universal Access to Health Care
Guide to Biotechnology 2008

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

2007-2008 BIO Milestones

Today, the biotechnology industry is enjoying more success and influence than ever before. Our industry’s innovations continue to improve the lives of people worldwide, and the advancement of these innovations is supported by the work of BIO.

Growing The Nation's Biotech Sector

States and regions throughout the United States are investing to create a business climate that supports the specific needs of the biosciences sector.

The Complexities of Comparative Effectiveness

Letters, Testimony & Comments

BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter
March 1 2013
Medicaid, Children’s Health Insurance Programs, and Exchanges
February 21 2013
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) proposed rule on the Medicaid, Children’s Health Insurance Programs (CHIP) and Exchanges Eligibility and Essential Health Benefits (EHB) provisions of the Patient Protection and Affordable Care Act (PPACA).
CED: BIO's Comments in response to the Centers for Medicare and Medicaid Services’ (CMS) Draft Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development in the context of coverage decision
January 28 2013
340B: BIO’s Comments to HRSA Regarding the Burden to Conduct 340B Audits
December 21 2012
EHB: BIO’s Comments on the Essential Health Benefits Proposed Rule
December 21 2012
More Letters, Testimony & Comments →

Press Releases

BIO Applauds House Committee Vote to Repeal IPAB
March 6 2012
BIO applauded the House Energy and Commerce Committee’s passage of the Medicare Decisions Accountability Act, H.R. 452, which would repeal the Independent Payment Advisory Board (IPAB) established in the health care reform law.
BIO Announces Policy Panel Keynote Session for 2011 BIO International Convention
April 19 2011
Democratic and Republican party leaders and strategists will share their differing perspectives in a keynote panel, titled "The Future of Healthcare Reform," during a Keynote Luncheon at the 2011 BIO International Convention.
The Future of Healthcare Policy to be Plenary Discussion at 13th Annual BIO CEO & Investor Conference
February 9 2011
BIO announces that former Senator John B. Breaux (D-LA), former Member, Senate Finance Committee, along with former Congressman Jim McCrery III (R-LA), former Ranking Member, House Ways & Means Committee, will be panelists at the 13th Annual BIO CEO & Investor Conference.
Challenges in Reimbursement Hamper Development of Novel Diagnostics
January 6 2011
BIO releases a report by Health Advances on the limitations of the nation’s reimbursement system for novel diagnostics and the impact of these limitations. 
Media Registration for the 2011 BIO International Convention Now Available Online
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.
More Press Releases →