TARPLIN STRATEGIES LLC for GENENTECH, INC.

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 prescription. 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 bilogics approval. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis. Held discussions with Administration staff about 340B program requirements on participating pharmaceutical manufacturers. H.R.6, 21st Century Cures Act, all provisions

Contacted: Executive Office of the President (EOP); Health & Human Services, Dept of (HHS); Health Resources & Services Administration (HRSA); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Centers For Disease Control & Prevention (CDC); Centers For Medicare and Medicaid Services (CMS); SENATE

Bills named: H.R. 6 (114th)

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. Meetings with Administration and congressional staff on coverage/payment issues related to cancer biotherapeutics, 340B program. Meetings with Administration staff concerning the President's precision medicine initiative. Public Law 114-113, Consolidated Appropriations Act, 2016, provisions relating to HHS and FDA appropriations and program authority. Public Law 114-74, Bipartisan Budget Act of 2015, provisions relating to HHS and FDA funding, including changes to sequestration levels, possible changes to Medicare Part B payments.

Contacted: Centers For Medicare and Medicaid Services (CMS); Health Resources & Services Administration (HRSA); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); Health & Human Services, Dept of (HHS); Office of Management & Budget (OMB); SENATE; Centers For Disease Control & Prevention (CDC)

Medicare/Medicaid MMM

Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics Public Law 114-10, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for Part B drugs. Public Law 114-113, Consolidated Appropriations Act, 2016, provisions relating to HHS and FDA appropriations and program authority, possible changes to Medicare program. Public Law 114-74, Bipartisan Budget Act of 2015, provisions relating to HHS and FDA funding, including changes to sequestration levels, possible changes to Medicare Part B payments. Meetings with executive branch officials regarding innovative Part B reimbursement plans for bio pharmaceuticals.

Contacted: Centers For Medicare and Medicaid Services (CMS); Centers For Disease Control & Prevention (CDC); SENATE; Health & Human Services, Dept of (HHS); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Health Resources & Services Administration (HRSA)