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Letters, Testimony & Comments

Centers for Medicare and Medicaid Services (CMS): Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2011 Payment Rates
August 31, 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent in 2011 and that the agency has recognized and addressed some of the problems with its rate-setting...
Centers for Medicare and Medicaid Services (CMS): Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2011 Payment Rates
August 31, 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent in 2011 and that the agency has recognized and addressed some of the problems with its rate-setting...
Biodefense: Public Health Security and Bioterrorism Preparedness and Response Act, Review and Republication of Toxin List
August 30, 2010
BIO agrees that prioritizing the select agents into stratified tiers based on an assessment of relative risk would be appropriate. We feel that such an exercise would help set federal government research, development and procurement priorities....
National Health Security Strategy: Biennial Implementation Plan
August 25, 2010
BIO supports the draft Biennial Implementation Plan’s goal to rapidly develop and adopt countermeasures that mitigate health consequences of a chemical, biological, radiological and nuclear attack.
Centers for Medicare and Medicaid Services (CMS): Statement to the Advisory Panel on Ambulatory Payment Classification Groups
August 24, 2010
BIO is concerned about problems in CMS methodology that continue to create instability in reimbursement for separately payable drugs and biologicals.
Centers for Medicare and Medicaid Services (CMS): Payment Policies Under the Physician Fee Schedule
August 24, 2010
Although BIO recognizes that preventing a significant cut in physician payment rates is largely within Congress' authority, we urge CMS to do anything in its power to mitigate cuts and ensure that Medicare beneficiaries continue to have access...
Advanced Biofuels: EPA’s Proposed Renewable Fuel Standard Volumes
August 19, 2010
BIO comments to the Environmental Protection Agency on the 2011 proposed renewable fuel standard volumes. The current proposed rule from EPA waives the cellulosic biofuel volume for 2011 to 5-17.1 million gallons (6.5-25.5 million gallons ethanol...
BIO supports the draft Biennial Implementation Plan’s goal to rapidly develop and adopt countermeasures that mitigate health consequences of a chemical, biological, radiological and nuclear attack.
August 16, 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines at first dollar.
Healthcare Reform: Group Health Plans and Health Insurance Coverage as Grandfathered Under Patient Protection and Affordable Care Act (PPACA)
August 16, 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines at first dollar.
FDA: Oversight of Laboratory Developed Tests (LDT)
August 15, 2010
BIO's comments to the FDA regarding LDT oversight.BIO represents companies that developed and manufacture LDTs consequently BIO companies should play a key role in working with the FDA as they develop plans regarding the oversight of LDTs....
Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period
August 13, 2010
BIO recently submitted written comments to the FDA on the impact of Risk Evaluation and Mitigation Strategies (REMS) on the healthcare delivery system and improvements to the process for selecting, modifying, and assessing REMS. BIO recommends...
GAO: Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
August 13, 2010
BIO responded to the GAO request for feedback regarding the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The comments recognize that these dual statutes governing pediatric research have been remarkably successful...
Comparative Effectiveness: Inventory for Comparative Effectiveness Research (CER)
August 9, 2010
BIO encourages ASPE to proceed with caution on the creation of an inventory and raises some methodological and structural considerations.
IRS Notice 2010-45: Notice that establishes the qualifying discovery project program under Section 48D of the Internal Revenue Code
August 3, 2010
SECTION 1. PURPOSE This notice establishes the qualifying therapeutic discovery project program under § 48D of the Internal Revenue Code (Code), as added to the Code by section 9023(a) of the Patient Protection and Affordable Care Act of...
Therapeutic Discovery Project Credit Statute: Text Included in the Patient Protection and Affordable Care Act
August 3, 2010
BIO advocated for the recently enacted new Therapeutic Discovery Project Credit program, which was created as a unique opportunity for companies in a loss position to earn tax credits for up to 50 percent of many of their R&D activities, and...
Inequitable conduct, patents: Therasense v. Becton Dickinson
August 2, 2010
BIO urges the Court of Appeals for the Federal Circuit to adopt a new rule that better accounts for the public interest in valid and clear patent rights than the inequitable conduct doctrine.
NIH: A Plan to Develop the Genetic Testing Registry
August 2, 2010
BIO supports the view that a system of genetic test registration is necessary to provide stakeholders with information about the spectrum of tests being offered. Making test performance characteristics and reference information (analytical...
Matrixx Initiatives v. James Siracusano and NECA-IBEW Pension Fund
August 1, 2010
BIO responded to the GAO request for feedback regarding the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The comments recognize that these dual statutes governing pediatric research have been remarkably successful in ensuri
July 30, 2010
BIO is concerned about CMS’ decision to open an NCA on a recently-approved therapy because it could establish a precedent that affects Medicare patient access to a wide range of innovative drug and biological therapies on a national basis.
National Coverage Analysis (NCA) Tracking Sheet for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer
July 30, 2010
BIO is concerned about CMS’ decision to open an NCA on a recently-approved therapy because it could establish a precedent that affects Medicare patient access to a wide range of innovative drug and biological therapies on a national basis.