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BIO Submits Comments Re: MIPS, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models RFI

Dec 22 2015
Andy Slavitt Acting Administrator Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, M.D. 22224 BY ELECTRONIC DELIVERY RE: CMS Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models Dear Acting Administrator Slavitt: The Biotechnology Industry Organization is pleased to submit feedback in response to the Centers for Medicare and Medicaid Services’ (CMS’s) Request for Information entitled “CMS Regarding Implementation of the Merit-Based Incentive Payment System (MIPS), Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models,” (the “RFI”) released October 1, 2015.

BIO Submits Comments Re: 2017 Star Ratings Update

Dec 22 2015
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

Dec 22 2015
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

Dec 17 2015
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.

BIO Comments on Draft Patents (Amendment) Rule 2015

Dec 15 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

Dec 8 2015
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.

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

Dec 1 2015
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.

Quality Metrics: BIO Comments on FDA Draft Guidance Request for Quality Metrics

Nov 23 2015
In general, BIO is supportive of FDA’s effort to modernize regulatory oversight of drug quality and promotion of post-approval improvements, and of FDA’s quality metrics initiative overall. Assessing across organizations, programs, products, and processes can be a considerable challenge, and many factors, including where a particular product is in its lifecycle, may influence some measures. As a result, BIO is supportive of FDA’s intent to use the quality metrics gathered as a tool and in context with other sources of quality data and not as the sole way for FDA to determine the state of quality within sites or products. It would be helpful for FDA to more clearly state the intended use of the collected metrics and the benefits to industry. We understand that regulatory relief (e.g., less frequent inspections, post-approval manufacturing change categories) may be granted based on positive high-quality metrics; however, it is unclear whether FDA would use low-quality metrics as an indicator to increase inspections at a particular entity. We believe metrics can provide a valuable tool to quantify product quality and can assist the Agency in developing a risk-based inspection program. It will be important to view these metrics in their proper context and in the broader set of information and knowledge FDA possesses. BIO recommends that FDA clarify that the quality metrics data will be used as an input to the risk-based inspection model and for surveillance purposes only; FDA will not take compliance actions solely based on quality metrics data evaluation. In addition, BIO requests that clarity be provided regarding the extent to which CBER will implement this new approach for facilities it inspects.

BIO Submits Comments on the Establishment of CDRH PEAC

Nov 19 2015
The Biotechnology Industry Organization (BIO) thanks the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) for the opportunity to submit comments to the public docket entitled Establishment of the Patient Engagement Advisory Committee; Establishment of a Public Docket; Request for Comments1 (the “Public Docket”).

BIO Submits Comments Re: 340B "Mega" Guidance

Oct 30 2015
The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to submit the following comments in response to the proposed Notice, issues by the Health Resources and Services Administration (“HRSA”) and published in the Federal Register on August 28, 2015, entitled 340B Drug Pricing Program Omnibus Guidance [RIN-9096-AB08] (“Proposed Notice”).