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Healthcare Reform: Group Health Plans and Health Insurance Coverage as Grandfathered Under Patient Protection and Affordable Care Act (PPACA)

Aug 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)

Aug 15 2010

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GAO: Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

Aug 13 2010

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Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period

Aug 13 2010

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Comparative Effectiveness: Inventory for Comparative Effectiveness Research (CER)

Aug 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

Aug 3 2010
This Notice provides the procedures under which an eligible taxpayer may apply for certification from the IRS and HHS of a qualified investment with respect to a qualifying therapeutic discovery project as eligible for a credit or a grant under the program.

Therapeutic Discovery Project Credit Statute: Text Included in the Patient Protection and Affordable Care Act

Aug 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 at their option, exchange these credits for a grant, on 1:1 basis.

NIH: A Plan to Develop the Genetic Testing Registry

Aug 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.

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

Jul 30 2010

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National Coverage Analysis (NCA) Tracking Sheet for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

Jul 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.