BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B

Sep 14 2018
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 biologicals. As a threshold matter, we raise our concern with the implementation of a policy that can have such impacts in limiting access for beneficiaries in MA via the application of step therapy, as detailed in the Administration’s August 7th memo.2 As detailed in our letter to the Administration, we are particularly concerned with the lack of specificity or detail in this memo around critical patient protections and appropriate implementation, including ensuring: sufficient oversight by CMS; clear clinical criteria for step therapy policies; transparency into, and communication of, step therapy policies to beneficiaries and robust beneficiary protections; timely exceptions and appeals processes; sufficient protections for those on existing therapies; and protection for beneficiaries from higher cost-sharing.

PFDD: BIO Comments on FDA Draft Guidance Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

Sep 11 2018

September 11, 2018


BIO Comments on RFS Standards for 2019 and Biomass-Based Diesel Volumes for 2020

Aug 17 2018
The Biotechnology Innovation Organization (BIO) is pleased to provide comment on the U.S. Environmental Protection Agency’s (EPA’s) proposed rule on the Renewable Fuel Standard Program: Standards for 2019 and Biomass-Based Diesel Volume for 2020 (proposed rule).

BIO Submits Comments on FDA Draft Guidance: Limited Population Pathway for Antibacterial and Antifungal Drugs

Aug 14 2018
Re: Docket No. FDA-2018-D-2032: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD); Draft Guidance for Industry.”  

Biofuel and Agriculture Groups Petition to EPA regarding Lost RFS Volumes from Small Refinery Exemptions

Aug 7 2018
RE: Petition for Reconsideration of 40 C.F.R. §80.1405(c), EPA Docket No. EPA–HQ–OAR–2005–0161, promulgated in 75 Fed. Reg. 14,670 (Mar. 26, 2010); Petition for Reconsideration of Periodic Reviews for the Renewable Fuel Standard Program, 82 Fed. Reg. 58,364 (Dec. 12, 2017)

Pediatrics: BIO Comment on FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Aug 3 2018

August 3, 2018


BIO Led Coalition Letter in Support of Cellulosic Biofuel Technologies

Jul 31 2018
As the U.S. Environmental Protection Agency (EPA) begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), we encourage the agency to take a renewed look at commercial-ready cellulosic biofuels.

Letter to Rep. Barbara Comstock in Support of SUCCESS Act of 2018

Jul 26 2018

BIO sent the following letter to Representative Barbara Comstock following her introduction of H.R. 6390, the “Study of Underrepresented Classes Chasing Engineering and Science Success Act of...

BIO Submits Comments Re: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

Jul 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.

BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule

Jul 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.