Medicaid Newborn Coverage Act of 2011

S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act

Client expense: $3,150,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill

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

S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D REMS FCLCA

Client expense: $1,430,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D

Client expense: $1,500,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D

Client expense: $1,500,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Elibibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D

Client expense: $2,550,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D

Client expense: $1,020,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws Biosimilars 21st Century Cures PDUFA 340B Drug Discount Program Low-income Subsidy in Part D

Client expense: $1,410,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws

Client expense: $1,190,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR)

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActFSA/HSA - Support reinstating coverage of OTC products HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices GMP related to manufacturing sites Federal BTC and GMO labeling laws

Client expense: $2,580,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices

Client expense: $920,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices

Client expense: $1,560,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351/S 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices

Client expense: $1,100,000 · Firm income: Not reported

Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act Dextromethorphan - Age Restrictions - Controlling bulk shipments - PACT ActPseudoephedrine - Promote e-tracking; oppose Rx legislation FSA/HSA - Support reinstating coverage of OTC products Enhance supply and shipping parameters for beta-Propiolactone HR 351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program Drug Distribution Security (Track & Trace) Certified Importer Program MDUFA (MIdical Device User Fee Act) Implementation Medical Device Tax Repeal Drug Importation Limitations on lawful use of caffeine Reimbursement for medical devices

Client expense: $3,290,000 · Firm income: Not reported

Education on the importance of maintaining the competitive elements of the Part D prescription drug program and to oppose legislative efforts to impose mandatory government rebates in that program. H.R. 8: American Taxpayer Relief Act of 2012 as it relates to sequestration and Medicare, including updates to the Medicare Sustainable Growth rate formula for physicians and related issues.H.R. 351: Legislation to repeal the Independent Payment Advisory Board (IPAB).

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Insurance Market Reform General Issues; State Based Regulations: Exchanges/Sales Across State Lines HR. 762; Medical Loss Ratios: MLR Broker FeesIPAB - Medicare Decisions Accountability Act of 2011 HR. 351 Healthcare Quality: Delivery System Incentives to Promote Better Care; Patient Safety and Quality Improvement; Payment Reforms; Patient-Centered Primary/Medical Home; Bundled Payments; Wellness/Health Disparities; Employer & School Wellness; Chronic Care & Medical Management; Childhood Obesity; Infant Mortality Federal Employee Health Benefit Program (FEHBP) regarding proposals to allow additional types of carriers including regional PPOs to be included in the coverage options offered by OPM.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Public Law 111-5, the American Recovery and Reinvestment Act of 2009 - Implementation issues related to Medicare incentives and penalties for adoption of health information technology, comparative effectiveness issues. Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid physician payments, comparative effectiveness research, quality reporting and improvement initiatives.Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid physician payments. Public Law 111-192 (H.R. 3962), the Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010 - Medicare physician payment issues. P.L. 112-096, the Middle Class Tax Relief and Job Creation Act of 2012 - issues related to Medicare and Medicaid physician payments. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare physician payment issues. H. Con. Res. 25, Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023; and S.Con.Res. 8, An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2014, revising the appropriate budgetary levels for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare physician payment and drug reimbursement issues. S. 388, American Family Economic Protection Act of 2013 - sequestration issues affecting Medicare physician payments and drug reimbursement issues. H.R. 1310, Medicare Patient Empowerment Act of 2013, all provisions S. 236, Medicare Patient Empowerment Act, all provisions H.R. 351, Protecting Seniors' Access to Medicare Act of 2013, all provisions S. 351, Protecting Seniors' Access to Medicare Act of 2013, all provisions S. 1180, Medicare Data Access for Transparency and Accountability Act, all provisions H.R. 1701, Cutting Costly Codes Act of 2013, all provisions S. 972, Cutting Costly Codes Act of 2013, all provisions H.R. 1179, Improving Access to Medicare Coverage Act of 2013, all provisions S. 569, Improving Access to Medicare Coverage Act of 2013, all provisions The Medicare Payment Stability and Premium Security Act ( Draft bill) Medicare Program - Long term reform proposals for the Medicare physician payment system. Medicare Program - Regulatory and administrative issues with the Medicare physician formula. Medicare Program - Shared Savings/Accountable Care Organizations Medicare program - Value-based modifier Medicare program - Quality Reporting Programs Medicare program - New payment models/measuring quality performance Medicare and Medicaid programs - Tavenner CMS nomination Medicaid program - Primary care bonus Discussions concerning potential debt limit extension and deficit reduction legislation - physician payment issues.