Health care reform implementation; the 340B program of the Health Resources and Services Administration (HRSA), specifically 340B drug pricing program issues, including program expansion and specific issues include: HRSA oversight, definition of patient, the ACA's expansion of covered 340B entities, issues concerning incenting antibiotic development; issues related to track and trace of pharmaceuticalsImplementation & Rule Making related to Generating Antibiotics Incentives Now (GAIN) Act (PL 112-144) and ongoing discussions surrounding next steps for protecting and promoting incentives for the developement of resistant pathogens including breakpoints
Reauthorization of the Prescription Drug User Fee Act; Reauthorization of the Medical Device User Fee Act; H.R. 1483, Drug Safety Enhancement Act of 2011
H.R. 2182, Generating Antibiotic Now (GAIN) Act (S.1734)
Implementation of Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148); Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152)
Implementation of the American Taxpayer Relief Act of 2012 Pub. L. 112-240, H.R. 8 H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014, setting forth appropriate budgetary levels for FY 15 through 2033, potential Medicare offsets that might be applied to prescription drugs, and budget resolution
S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014,potential Medicare offsets that might be applied to prescription drugs, budget resolution, issues concerning Medicare & Medicaid reimbursements H. Con. Res. 25 - Establishing the budget for the US Government for FY 2014, setting forth appropriate budgetary levels for FY 15 through 2033, potential Medicare offsets that might be applied to prescription drugs, and budget resolution
S. Con. Res. 8 - Concurrent Resolution on the Budget for FY 2014,potential Medicare offsets that might be applied to prescription drugs, budget resolution, issues concerning Medicare & Medicaid reimbursements, issues pertaining to the implementation of the federal budget sequester. Implementation of the "GAIN" provisions/Title VIII of the Food & Drug Administration Safety & Innovation Act (FDASIA) - PL 112-144; antibiotic product development incentive, limited population antibiotic product (LPAD) and breakpoint legislation; pharmaceutical track and trace legislation (HR 1919 - Safeguarding America's Pharmaceutical Act of 2013)
HCR - Health Issues MMM - Medicare/Medicaid BUD - Budget/Appropriations PHA - Pharmacy
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