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Co-Pay Accumulator Programs
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Cost & Value of Biopharmaceuticals  •  June 29, 2018
Co-Pay Accumulator programs unfairly shift higher drug costs to patients In recent years, health insurance companies and pharmacy benefit managers (PBMs) have increasingly shifted an ever-greater share of the costs for specialty prescription medicines to their patients and beneficiaries. The cost-sharing requirements set by insurers for prescription medicines are often uniquely burdensome relative to other types of health care. For example, most patients are required to pay on average nearly five times more out of pocket for drugs than for hospital stays. To offset these costs, many pharmaceutical companies offer programs that assist patients with their out of pocket costs, including deductibles and co-pays, for their prescriptions. Recently, insurance plans and PBMs have been implementing so-called “copay accumulator” programs, which prevent funds provided by these assistance programs from applying to a patient’s out of pocket maximum or deductible. This can leave patients with steep costs to meet their deductible or out of pocket maximum when the value of patient assistance is exhausted. As David Lazarus, a columnist for the Los Angeles Times, recently noted, “Co-pay accumulators allow insurers to double dip: They get their full co-pay and they get to extend the duration of patients’ deductibles.” Others have also raised concerns about the impact on patients’ drug costs. In a May 2018 letter to state insurance commissioners on accumulator programs, a group of 60 HIV/AIDS advocacy groups noted that: “Plans are implementing these policies with no consumer notice, leaving consumers to find out that this policy is in place after they incur steep prescription drug cost-sharing mid-year. These policies are unfair to the consumer and will have significant individual and public health consequences.” Policy Position BIO and its members believe that insurance coverage policies should provide all patients access to appropriate treatments in a timely manner. Even…
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BIO Statement on the Senate Passage of the 2018 Farm Bill
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Press Release  •  June 28, 2018
Washington, D.C. (June 28, 2018) – The following statement may be attributed to Brent Erickson, Biotechnology Innovation Organization (BIO) Executive Vice President, Industrial and Environmental section, in response to the Senate passage of the 2018 Farm Bill:
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BIO Announces Plenary Sessions at the 2018 World Congress in July
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Press Release  •  June 28, 2018
The Biotechnology Innovation Organization (BIO) today released the list of speakers for plenary programs at the 2018 BIO World Congress on Industrial Biotechnology. The programs will feature executives and experts from the biofuels, biobased products, and agricultural industries who will discuss technologies revolutionizing industrial biotechnology, the evolution of biobased consumer products and the future of the biobased economy. The world’s largest conference on industrial biotechnology and partnering event will be held July 16-19, 2018 at the Pennsylvania Convention Center in Philadelphia.
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BIO Applauds SEC for Providing Regulatory Relief to Emerging Biotech Innovators
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Press Release  •  June 28, 2018
Today, the Securities and Exchange Commission (SEC) voted to broaden the pool of small companies that benefit from scaled disclosures.  The new definition of “smaller reporting company” (SRC) will reduce compliance burdens on small, innovative biotech companies and enable them to deploy capital and resources in more productive ways, such as investing in life-saving research in the lab or in the clinic.  
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BIO Announces GreenTech Investor Sessions at the 2018 World Congress in July
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Press Release  •  June 27, 2018
The Biotechnology Innovation Organization (BIO) today announced that nine emerging companies will make formal presentations to investors during GreenTech Investor Sessions at the 2018 BIO World Congress on Industrial Biotechnology. As part of GreenTech Investor Sessions, BIO will also host a panel discussion featuring representatives from investment firms to cover the most recent financial strategies and trends in industrial biotechnology. The world’s largest conference on industrial biotechnology and partnering event will be held July 16-19, 2018 at the Pennsylvania Convention Center in Philadelphia. 
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BIO Statement on Proposed 2019 RFS Volumes
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Press Release  •  June 26, 2018
Washington, D.C. (June 26, 2018) – Brent Erickson, Executive Vice President of the Biotechnology Innovation Organization’s (BIO) Industrial & Environmental Section, released the following statement today on the proposed Renewable Fuel Standard (RFS) 2019 volumes released by the Environmental Protection Agency (EPA):
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BIO Comments on FDA Draft Guidance on Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals
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Letters, Testimony & Comments  •  June 25, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals. The draft guidance is a positive step toward articulating a streamlined, science-based approach for nonclinical development of pharmaceuticals. BIO supports the FDA’s goal of getting safe, effective biopharmaceutical products to patients while avoiding the unnecessary use of animals. On the whole, BIO supports the draft guidance. While BIO understands the draft guidance is specific to severely debilitating or life-threatening hematologic disorders (SDLTHDs), BIO believes it could be used as a model for other disease areas. In the comments, BIO provides high-level comments to strengthen and clarify areas including examples of severely debilitating or life-threatening hematologic disorders, incorporation of ICH S9 guideline, and nonclinical studies vs. nonclinical assessments.
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Distinguished Professor and Dean from South Korea to Receive 2018 George Washington Carver Award
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Press Release  •  June 21, 2018
The Biotechnology Innovation Organization (BIO) today announced that Distinguished Professor Sang Yup Lee at the Department of Chemical and Biomolecular Engineering at the Korea Advanced Institute of Science and Technology (KAIST) will receive the 11th annual George Washington Carver Award for Innovation in Industrial Biotechnology. The award will be presented on Wednesday, July 18, 2018 during a plenary session at the 2018 BIO World Congress on Industrial Biotechnology. The world’s largest conference on industrial biotechnology and partnering event will be held July 16-19, 2018, at the Pennsylvania Convention Center in Philadelphia. 
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Corteva Agriscience’s Krysta Harden to Receive 2018 Rosalind Franklin Award
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Press Release  •  June 21, 2018
The Biotechnology Innovation Organization (BIO) today announced that Corteva AgriscienceTM Vice President of External Affairs and Chief Sustainability Officer Krysta Harden will receive the 5th annual Rosalind Franklin Award for Leadership in Industrial Biotechnology and Agriculture. Corteva Agriscience™ is the Agriculture Division of DowDuPont. The award will be presented on Wednesday, July 18, 2018 during a plenary session at the 2018 BIO World Congress on Industrial Biotechnology. The world’s largest conference on industrial biotechnology and partnering event will be held July 16-19, 2018, at the Pennsylvania Convention Center in Philadelphia. 
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BIO Statement on Growing American Food Exports Act of 2018
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Press Release  •  June 21, 2018
The Biotechnology Innovation Organization (BIO) today released the following statement in response to the introduction of the bipartisan “Growing American Food Exports Act of 2018” (S. 3103) by Senator Todd Young (R-IN), Senator Joe Donnelly (D-IN), Senator Roy Blunt (R-MO), and Senator Claire McCaskill (D-MO):
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