TARPLIN STRATEGIES LLC for GENENTECH, INC.

Health Issues HCR

Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow-on biologics. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit.

Contacted: SENATE; Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP)

Pharmacy PHA

Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to FDA approval of follow-on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicare prescription drug benefit. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid reimbursement, fees assessed on the pharmaceutical industry, design and structure of the Medicare prescriptiondrug benefit. Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - legislation related to reauthorization of user fees for prescription drug, medical device, and biologics approval. All aspects. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis Public Law 113-67, Continuing Appropriations Resolution for 2014 - General public health spending. Public Law 113-54 - the Drug Quality and Security Act - drug compounding and track and trace issues.

Contacted: Office of Management & Budget (OMB); Executive Office of the President (EOP); SENATE; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Medicare/Medicaid MMM

Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics. Meetings with Administration and congressional staff on coverage/payment issues related to cancer biotherapeutics, 340B program. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare 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 Part B drug reimbursement issues. S. 388, American Family Economic Protection Act of 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues. S. 1871, the SGR Repeal and Medicare Beneficiary Access Act - Medicare physician payment and Part B drug reimbursement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician payment and Part B drug reimbursement issues. S.2000 - The SGR Repeal and Medicare Provider Payment Modernization Act of 2014 - possible reimbursement changes for Part B drugs. H.R.4015 -The SGR Repeal and Medicare Provider Payment Modernization Act of 2014 - possible reimbursement changes for Part B drugs. Public Law 113-93 - The Protecting Access to Medicare Act of 2014 - possible reimbursement changes for Part B drugs.

Contacted: Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; SENATE; Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB)

Bills named: H.R. 2810 (113th), S. 2000 (113th), S.Con.Res. 8 (113th), H.R. 4015 (113th), S. 1871 (113th), S. 388 (113th), H.Con.Res. 25 (113th)