Close

BIO Comments to USDA’s Office of Budget and Program Analysis on Identifying Regulatory Reform Initiatives, September 15, 2017

Sep 21 2017
United States Department of Agriculture Jamie L. Whitten Building, Room 101-A 1400 Independence Ave SW Washington DC 20250 Re: Identifying Regulatory Reform Initiatives Dear Ms. Adcock: The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the USDA’s request for information on “Identifying Regulatory Reform Initiatives,” published in the Federal Register on July 17, 2017.1 Thank you for the opportunity to provide input as the U.S. Department of Agriculture (USDA or the Agency) considers opportunities to improve customer service and remove unintended barriers to participation in its programs in ways that least interfere with its customers and allow USDA to accomplish its mission.

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

Sep 20 2017
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

Sep 20 2017
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.

SB 539 complaint

Sep 1 2017

DSCSA: BIO Files Comments on FDA Product Identifier Compliance Policy

Sep 1 2017

Dear Sir/Madam:

...

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

Aug 31 2017
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 comments to USD-AMS on the National Bioengineered Food Disclosure Law (RE: Questions Under Consideration)

Aug 25 2017

August 25, 2017

...

BIO Submits Comments Re: Medicare CY 2018 Updates to the Quality Payment Program

Aug 23 2017
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) CY 2018 Updates to the Quality Payment Program Proposed Rule. BIO supports the development and implementation of the Quality Payment Program (QPP) tracks: Advanced Alternative Payment Models (APMs) and the Merit Based Incentive Payment System (MIPS), in a manner that improves overall healthcare quality, while not compromising access to the most appropriate care and treatment.

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

Aug 8 2017
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Proposed Policy Changes and Fiscal  Year 2018 Rates Proposed Rule on June 13, 2017. BIO supports the development and use of appropriate, evidence-based quality measures throughout the healthcare system as a component of improving efficiency and clinical outcomes; additionally, we support policy proposals driven at increasing access to innovative care. BIO's comments in the letter are divided into two sections - the first focusing on the proposals contained in the FY 2018 Proposed Rule, and the second for providing feedback on the Request for Information.

BIO's 2017 Special 301 Submission

Jul 31 2017
BIO submitted a report to the United States Trade Representative regarding the agency’s 2017 Special 301 Review.