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BIO Submits Comments Re: 2017 Star Ratings Update

BIO Draft Comments in Response to the 2017 Star Ratings Update Request for Comments Note to Members: CMS requires that responses to individual proposed updates be submitted through an online form individually. Given these formatting requirements, BIO’s draft comments will not follow our traditional comment letter format.  

BIO Submits Comments Re: Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule

Re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for Specific Providers, Including Changes Related to the Electronic Health Record Incentive Program; Proposed Rule Dear Acting Administrator Slavitt: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on 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 and Proposed Fiscal Year 2016 Rates Proposed Rule (the “Proposed Rule”), including with respect to the Hospital Inpatient Quality Reporting (IQR) Program and the Hospital Value-Based Purchasing (VBP) Program. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products. 

BIO Submits Comments Re: Nondiscrimination in Health Programs and Activities

The Biotechnology Industry Organization (BIO) is pleased to submit the following comments in response to the Department of Health and Human Services’ (HHS’s) Proposed Rule entitled “Nondiscrimination in Health Programs and Activities” published on September 8, 2015 (the “Proposed Rule”).1 BIO represents biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

Amici Curiae of BIO and PhRMA in ePlus Inc. v. Lawson Software

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BIO Expresses Support for Tax Extender Legislation

BIO today welcomed legislation to extend critical tax incentives that are important to biotechnology companies. The legislation would make permanent the important Research & Development Tax Credit.

BIO Comments on Draft Patents (Amendment) Rule 2015

The Biotechnology Industry Organization (BIO) greatly appreciates the opportunity to provide comments/suggestions of the stakeholders on the Draft Patents (Amendment) Rules 2015 published by the Ministry of Commerce & Industry.

BIO Comments on CMS PAMA Proposed Rule

The Biotechnology Industry Organization (BIO) submitted comments on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule entitled Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System.

BIO and PPMD Launch Initiative to Share Best Practices on Patient Preference Studies

BIO and Parent Project Muscular Dystrophy (PPMD) announce the launch of a new initiative designed to share best practices for the development of disease-specific patient preference studies. Through this effort, BIO and PPMD will produce a document outlining key considerations to help guide stakeholders on the development of patient preference studies, which can be used for multiple purposes, including informing the drug development and regulatory processes...

Biotech Leader Provides Testimony Before House Capital Markets Subcommittee

BIO supports legislation to follow up on the success of the JOBS Act

Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Bio

Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology.