Patient Access to Drugs in Shortage Act of 2012

Long Term Acute Care Hospitals, Issues pertaining to funding for the payment structure for Long Term Acute Care Hospitals Medicare and Medicaid Reimbursement, Issues pertaining to Disproportionate Share Hospital payments and possible reductions to provider payments. Medicare and Medicaid Reimbursement, Issues pertaining to Disproportionate Share Hospital payments and possible reductions to provider payments. H.R.6352, Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency ActIssues pertianing to funding for Graduate Medical Education and Indirect Medical Education. H.R. 6611, The Patient Access to Drugs in Shortage Act, Issues pertaining to the 340B program. H.R. 5707, Medicare Physician Payment Innovation Act of 2012, Issues pertaining to the SGR and changes to health delivery. H.R. 6575, The Medicare Audit Improvement Act of 2012, Issues pertaining to RAC audits.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 5 HEALTH Act/Protecting Access to Healthcare Act; HR 451, Healthcare Truth & Transparency Act; HR 1044, Medicare Access to Rural Anesthesiology Act; HR 452 Medicare Decisions Accountability Act of 2011; HR 2104 Consistency Accuracy Responsibility & Excellence in Medical Imaging & Radiation Therapy Act of 2011; S 296/HR 2245 Preserving Access to Life-Saving Medications Act of 2011; HR 6611 Patient Access to Drugs in Shortage Act; Health reform implementation.

Client expense: $230,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE

H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines

Client expense: $1,370,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office

FY 2014 Budget, FY 2013 Budget, Implementation of Health Care Reform, Implementation of Generic Biologics, Prescription Drug Safety, Counterfeit Drugs/Import Safety/Pedigree, Prescription Drug Shortages, Authorized Generics, Prescription Drug Importation/Re-Importation, drug shortages, prescription drug abuse and generic drugs H.R. 2182 Generating Antibiotic Incentives Now Act of 2011 H.R. 3026 - Safeguarding America's Pharmaceuticals Act of 2011 H.R. 3839 - Drug Shortage Prevention Act of 2012 H.R. 3988 - Generic Drug and Biosimilar User Fee Act of 2012 H.R. 3995 - Protecting Consumer Access to Generic Drugs Act of 2012 H.R. 4332 - Generic Drug Application Review Fairness Act of 2012 H.R. 5651 - Food and Drug Administration Reform Act of 2012 H.R.6160 - Stop Tampering of Prescription Pills Act of 2012 H.R. 6433 - FDA User Fee Corrections Act of 2012 H.R.6584 - Verifying Authority and Legality In Drug Compounding Act of 2012 H.R.6611 - Patient Access to Drugs in Shortage Act of 2012 H.R.6638 - S.A.F.E. Compounded Drugs Act of 2012 S. 44 Medicare Prescription Drug Negotiation Act S. 296 and H.R.2245 Preserving Access to Life-Saving Medication Act S. 373 Fair Prescription Drug Competition Act S. 1584 - Drug Safety and Accountability Act of 2011 S. 1734 - Generating Antibiotic Incentives Now Act of 2011 S. 2295 - Patient Safety and Generic Labeling Improvement Act S. 2516 - Food and Drug Administration Safety and Innovation Act S. 3187 Food and Drug Administration Safety and Innovation Act S.1855 - Pandemic and All-Hazards Preparedness Act Reauthorization of 2011

Client expense: $486,262 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Congressional Budget Office (CBO), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Patient Access to Drugs in Shortage Act (HR 6611) Cancer Drug Shortages Medicare SGR-based MD Reimbursement HR 905 Medicare Prompt Pay Legislation

Client expense: $158,250 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 296 A bill to amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages. All Provisions. H.R. 6611 Patient Access to Drugs In Shortage Act. All Provisions

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3765 - PL 112-078 Temporary Payroll Tax Cut Continuation Act of 2011. All provisions related to Medicare physician and hospital payments. H.R. 3630 Middle Class Tax Relief and Job Creation Act of 2012. All provisions related to Medicare physician and hospital payments. H.R. 2500 Equal Access and Parity for Multi-Campus Hospitals Act. All Provisions. P.L. 111-148 and P.L. 111-152 Affordable Care Act. All provisions related to health care reform including the Medicare and Medicaid programs, tax and insurance policies, graduate medical education, biomedical research, public and preventative health measures, and other policies concerning hospitals, physicians, health plans, employers, and individuals. S. 296 A bill to amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages. All Provisions. H.R. 6352 The Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act. All Provisions. S. 1627 Resident Physician Shortage Reduction Act of 2011. All Provisions. S. 3201 Graduate Medical Education Reform Act of 2012. All Provisions. H.R. 6611 Patient Access to Drugs In Shortage Act. All Provisions

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3765 - PL 112-078 Temporary Payroll Tax Cut Continuation Act of 2011. All provisions related to Medicare physician and hospital payments. H.R. 3630 Middle Class Tax Relief and Job Creation Act of 2012. All provisions related to Medicare physician and hospital payments. H.R. 2500 Equal Access and Parity for Multi-Campus Hospitals Act. All Provisions. P.L. 111-148 and P.L. 111-152 Affordable Care Act. All provisions related to health care reform including the Medicare and Medicaid programs, tax and insurance policies, graduate medical education, biomedical research, public and preventative health measures, and other policies concerning hospitals, physicians, health plans, employers, and individuals. Conference Report on H.R. 4348 Surface Transporation Extension Act of 2012/P.L. 112-141. Provisions related to Louisiana Medicaid Federal Medical Assistance Percentage. H.R. 6352 The Resident Physician Shortage Reduction and Graduate Medical Education Accountability and Transparency Act. All Provisions. S. 1627 Resident Physician Shortage Reduction Act of 2011. All Provisions. S. 3201 Graduate Medical Education Reform Act of 2012. All Provisions. H.R. 8 American Taxpayer Relief Act of 2012. All Provisions. H.R. 6611 Patient Access to Drugs In Shortage Act. All Provisions

Client expense: $160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE