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BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs
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Letters, Testimony & Comments  •  July 16, 2018
First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making discoveries that were unimaginable a decade ago. The days of traditional chemical drugs that treat broad classes of patients in blunt ways are giving way to the development of entirely new ways to treat and ultimately cure disease for targeted patient populations using living organisms, including a patient’s own cells. We have already seen the first wave of these advances reach the marketplace, with many more already in the Food & Drug Administration (FDA) regulatory process.However, BIO and our members recognize that too many patients – even those with insurance – cannot afford the life-saving cures and treatments that biopharmaceutical companies are developing. We stand with the Trump Administration in our shared commitment to addressing this serious problem. To accomplish this, we must harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation. That’s why BIO has joined with stakeholders across the healthcare spectrum – including insurers, Pharmacy Benefit Mangers (PBMs), employers, and patient groups – in a coalition that developed and supports consensus, market-based reforms to lower drug costs without harming innovation.
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BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule
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Letters, Testimony & Comments  •  July 16, 2018
BIO’s comments on the Proposed Rule are focused on the following areas:  Proposed changes to the IPPS for coverage and payment of Chimeric Antigen Receptor T-cell (CAR T) Therapy and other Transformative Therapies;  Updates to the Medicare Severity – Diagnosis Related Groups (MS-DRG) to appropriately account for care delivered, including for patients with rare diseases;      Applications for FY 2019 New Technology Add-On Payments (NTAP) and the process for determination of receipt of NTAP status;  Improving patient outcomes and reducing burden through meaningful measures and expanding access to vaccines through appropriate quality measures; and  Requirements for hospitals to make public a list of their standard charges via the Internet.
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BIO Announces 2018 Start-up Stadium Winners
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Press Release  •  July 13, 2018
The Biotechnology Innovation Organization (BIO) today announced winners of the Start-up Stadium competition held last month at the BIO International Convention in Boston. During six sessions over four days, live presentations of 50 finalists were evaluated by expert judges with entrepreneurial, investment, start-up, economic development, capital formation, and academic backgrounds from both the public and private sectors. One winner was chosen for each session
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BIO's Comments on Proposed PTO Rules Change to Post-Grant Reviews
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Letters, Testimony & Comments  •  July 11, 2018
Comments of BIO on the United States Patent and Trademark Office’s proposed revisions to the standard for construing disputed claim terms in inter partes reviews, post-grant reviews, and covered business method reviews (“post-grant proceedings”). 
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BIO Recommendations for Tax Reform 2.0 Package
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Letters, Testimony & Comments  •  July 9, 2018
As the Ways and Means Committee begins to develop new tax legislation, it is imperative that they include policies to incentivize, or at a minimum remove obstacles that impede, the emerging biotechnology companies that are conducting life-changing and life-saving innovation.
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BIO Announces Programming Focused on Biobased Markets and Food for the 2018 World Congress in July
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Press Release  •  July 6, 2018
The Biotechnology Innovation Organization (BIO) today announced two programming tracks focused on biobased markets and specialty food ingredients, flavors and fragrances at the 2018 World Congress on Industrial Biotechnology. Programming around these topics will take place Tuesday, July 17, with four sessions for each of the two tracks.  
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BIO Comments on USDA-AMS National Bioengineered Food Disclosure Standard
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Press Release  •  July 3, 2018
The Biotechnology Innovation Organization (BIO) has submitted comments to USDA’s Agricultural Marketing Service (USDA-AMS) on its proposed rule for the National Bioengineered Food Disclosure Standard.
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BIO Comments on USDA-AMS National Bioengineered Food Disclosure Standard
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Letters, Testimony & Comments  •  July 3, 2018
RE: Proposed Rule- National Bioengineered Food Disclosure Standard- Doc. No. AMS-TM-17-0050 83; Fed. Reg. 19860 (May 4, 2018)
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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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