GENENTECH, INC for GENENTECH INC

Medicare/Medicaid MMM

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B PAUSE Act) S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget Act of 2018). HR 4392 - reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) Issues related to Medicare and Medicaid coverage and reimbursement including Part B payment, step therapy policy proposal in Medicare Advantage, implementation of value-based reimbursement models Issues related to the 340B Drug Discount Program Issues related to drug pricing Medicare reimbursement for biosimilars MACRA treatment and reimbursement of Part B drugs Issues related to Part D Medicare Program including coverage gap and other offsets

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

Bills named: S. 2312 (115th), S. 2453 (115th), H.R. 4710 (115th), H.R. 5598 (115th), H.R. 2889 (115th), H.R. 4392 (115th), H.R. 6240 (115th), H.R. 1892 (115th), H.R. 6071 (115th)

Trade (domestic/foreign) TRD

Issues relating to trade policy and negotiations impacting the biopharmaceutical industry

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

Foreign Relations FOR

Issues related to Foreign Agents Registration Act (FARA), including Disclosing Foreign Influence Act -H.R. 4170/S. 2039

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

Bills named: H.R. 4170 (115th), S. 2039 (115th)

Financial Institutions/Investments/Securities FIN

Foreign Investment Risk Review Modernization Act (FIRRMA) H.R. 5841/S. 2098 , legislation that would reform the Committee on Foreign Investment in the United States (CFIUS)

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

Bills named: H.R. 5841 (115th), S. 2098 (115th)

Taxation/Internal Revenue Code TAX

H.R.1, Tax Reform Act of 2017 (Public Law No. 115-97) Issues related to the tax reform bill and implementation

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

Bills named: H.R. 1 (115th)

Copyright/Patent/Trademark CPT

Intellectual property and process patent issues Patent litigation reform

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

Health Issues HCR

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R. 6378 - To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 Issues related to the 340B Drug Discount Program Issues relating to drug pricing, reimbursement, step therapy, anti-kickback statute, biosimilars Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. General education about policies impacting pharmaceutical development, approval, reimbursement and pricing

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

Bills named: S. 2453 (115th), H.R. 6071 (115th), H.R. 6240 (115th), S. 2312 (115th), H.R. 5598 (115th), H.R. 6294 (115th), H.R. 6378 (115th), H.R. 2889 (115th), H.R. 4392 (115th), S. 974 (115th), S. 2852 (115th), H.R. 4710 (115th)

Budget/Appropriations BUD

S.3158/H.R.6470, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019; H.R.5961/S.2976, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2019; H.R. 1892, the Bipartisan Budget H.R. 1625, Consolidated Appropriation Act H.R.6157, Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 (P.L.115-245); Issues related to FDA and HHS program funding for the FY19 Labor, HHS, Education and Related Agencies, and FY19 Agriculture, Rural Developments, Food, and Drug Administrations, and Related Agencies Appropriation bills Issues related to Direct-To-Consumer Advertising, 340B, biosimilars, and public health

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

Bills named: H.R. 1625 (115th), H.R. 1892 (115th), S. 2976 (115th), S. 3158 (115th), H.R. 6157 (115th), H.R. 5961 (115th), H.R. 6470 (115th)

Pharmacy PHA

Drug Pricing Issues HR 4710, 340B Pause Act and other issues relating to the 340B Drug Discount Program

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

Bills named: H.R. 4710 (115th)

Medical/Disease Research/Clinical Labs MED

S. 2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R. 6378 - To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act Issues related to public health protection including influenza development and preparedness Issues related to antimicrobial and antiviral research and product development

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

Bills named: S. 2852 (115th), H.R. 6378 (115th)