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Reported covered position: Director, Government Affairs
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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
GENENTECH INC via GENENTECH, INC
2017 · first_quarter · 1A
Intellectual Property and Process Patent Issues. Patent Litigation Reform.
Issues related to FDA and HHS program funding in the FY17 Labor, Health and Human Services, and Education and Related Agencies, and FY17 Agriculture, Rural Developments, Food and Drug Administrations, and Related Agencies Appropriations bills.
Source: Senate LDA
Implementation of Medicare pharmaceutical coverage and reimbursement issues; Medicare Part B reimbursement for physicians and implementation of related provisions of the Affordable Care Act; reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B drug payment model. Policies relating to 340B Program. Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act).
Implementation of Medicare pharmaceutical coverage and reimbursement issues; Medicare Part B reimbursement for physicians and implementation of related provisions of the Affordable Care Act; reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B drug payment model. Policies relating to 340B Program. Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act).
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Affordable and Safe Prescription Drug Importation Act
Client: GENENTECH INC · Firm: GENENTECH, INC
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Affordable and Safe Prescription Drug Importation Act
Client: GENENTECH INC · Firm: GENENTECH, INC
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Data Security and Breach Notification Act of 2015
Client: GENENTECH INC · Firm: GENENTECH, INC
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
Data Security and Breach Notification Act of 2015
Client: GENENTECH INC · Firm: GENENTECH, INC
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
H.R. 34 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. H.R. 34 21st Century Cures Act. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars. H.R.5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Client: GENENTECH INC · Firm: GENENTECH, INC
Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. H.R. 34 21st Century Cures Act. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars. H.R.5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Client: GENENTECH INC · Firm: GENENTECH, INC
H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Client: GENENTECH INC · Firm: GENENTECH, INC
Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. 21st Century Cures initiative. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars. H.R.5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Client: GENENTECH INC · Firm: GENENTECH, INC
H.R. 34 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
FY 2017 Labor, Health and Human Services, Education and Related Agencies Appropriations annual spending bill; Influenza antiviral allotment with the Centers for Disease Control Strategic National Stockpile issues concerning implementation of Patient Protection and Affordable Care Act Drug pricing H.R. 6, the 21st Century Cures Act Innovations for Healthier Americas Moonshot initiative Precision Medicine Implementation of issues related to Pharmaceutical Quality Security Accountability Act Issues related supply chain Drug safety and pedigree issues Issues related to the 340B program Issues related to follow on biologics
H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Sccoubtability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA".
Data Breach Notification and Punishing Cyber Criminals Act of 2015
Client: GENENTECH INC · Firm: GENENTECH, INC
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
Data Breach Notification and Punishing Cyber Criminals Act of 2015
Client: GENENTECH INC · Firm: GENENTECH, INC
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
H.R. 34 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017
Client: GENENTECH INC · Firm: GENENTECH, INC
S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
SGR Repeal and Medicare Provider Payment Modernization Act of 2015
Client: GENENTECH INC · Firm: GENENTECH, INC
issues related to H.R. 6, the 21st Century CURES Act; Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and Medicare Part B reimbursement for physicians and related provisions of The Affordable Care Act; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics; HR 1470 and S.810, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Medicare physician payment reform, payment for Part B drugs; Public Law 114-110, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for PART B drugs.
21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Reform of 340B program. Advocacy and education regarding HR 6 - 21st Century Cures Act; Implementation issues related to the Pharmaceutical Quality, Security and Accountibilty Act (P.L. 113-54) S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, Cancer Patient Protection; Ongoing issues related to the implementation of the Affordable Care Act - 21st H.R. 6- 21st Century Cures Act; Advocacy on issues related to the Pan-American Health Organization, the 340B during pricing program and Medicare Part B and pandemic planning. Drug pricing under 340B program; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Publaw 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related 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
issues related to H.R. 6, the 21st Century CURES Act; Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and Medicare Part B reimbursement for physicians and related provisions of The Affordable Care Act; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics; HR 1470 and S.810, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Medicare physician payment reform, payment for Part B drugs; Public Law 114-110, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for PART B drugs.
Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Pubic law 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related 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; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program; issues related to H.R. 6, the 21st Century CURES Act; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program;
SGR Repeal and Medicare Provider Payment Modernization Act of 2015
Client: GENENTECH INC · Firm: GENENTECH, INC
issues related to H.R. 6, the 21st Century CURES Act; Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and Medicare Part B reimbursement for physicians and related provisions of The Affordable Care Act; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics; HR 1470 and S.810, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Medicare physician payment reform, payment for Part B drugs; Public Law 114-110, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for PART B drugs.
Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", HR 1919 "Safeguarding America's Pharmaceuticals Act", Implementation issues related to the Pharmaceutical Quality, Security and Accountability Act (P.L. 113-54), Pharma supply chain issues, Issues related to 340b program; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program
Safeguarding America's Pharmaceuticals Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", HR 1919 "Safeguarding America's Pharmaceuticals Act", Implementation issues related to the Pharmaceutical Quality, Security and Accountability Act (P.L. 113-54), Pharma supply chain issues, Issues related to 340b program; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program
Preventing Regulatory Overreach To Enhance Care Technology Act of 2014
Client: GENENTECH INC · Firm: GENENTECH, INC
: 340B, Patent Terms, Appropriations, Pandemic Preparedness, Tamiflu Stockpile; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Publaw 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related 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; Issues related to the implementation of the follow-on biologiecs provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementationof Patient Protection and Afforedable Care Act; Drug pricing under 340B program; : Implementation issues related to the Pharmaceutical Quality, Security and Accountabilty Act (P.L. 113-54) S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, Cancer Patient Protection Act of 2013 pharma supply chain issues, issues related to the 340B Program;
Preventing Regulatory Overreach To Enhance Care Technology Act of 2014
Client: GENENTECH INC · Firm: GENENTECH, INC
21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Reform of 340B program. Advocacy and education regarding HR 6 - 21st Century Cures Act; Implementation issues related to the Pharmaceutical Quality, Security and Accountibilty Act (P.L. 113-54) S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, Cancer Patient Protection; Ongoing issues related to the implementation of the Affordable Care Act - 21st H.R. 6- 21st Century Cures Act; Advocacy on issues related to the Pan-American Health Organization, the 340B during pricing program and Medicare Part B and pandemic planning. Drug pricing under 340B program; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Publaw 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related 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
Pharmaceutical Quality, Security, and Accountability Act
Client: GENENTECH INC · Firm: GENENTECH, INC
Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", HR 1919 "Safeguarding America's Pharmaceuticals Act", Implementation issues related to the Pharmaceutical Quality, Security and Accountability Act (P.L. 113-54), Pharma supply chain issues, Issues related to 340b program; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program
Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023.
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023.
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
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; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals; Medical Countermeasure Stockpile 340B Drug Discounting Program; FOR - Issues related to the treatment of biologics in international health programs specifically under the Pan American Health Organization
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
Safeguarding America's Pharmaceuticals Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
Safeguarding America's Pharmaceuticals Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
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; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
Safeguarding America's Pharmaceuticals Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals; Medical Countermeasure Stockpile 340B Drug Discounting Program; FOR - Issues related to the treatment of biologics in international health programs specifically under the Pan American Health Organization
Safeguarding America's Pharmaceuticals Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
American Research and Competitiveness Act of 2014
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
American Research and Competitiveness Act of 2014
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
Medicare Prescription Drug Savings and Choice Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
Medicare Prescription Drug Savings and Choice Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
SGR Repeal and Medicare Beneficiary Access Act of 2013
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals; Medical Countermeasure Stockpile 340B Drug Discounting Program; FOR - Issues related to the treatment of biologics in international health programs specifically under the Pan American Health Organization
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; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
Pharmaceutical Quality, Security, and Accountability Act
Client: GENENTECH INC · Firm: GENENTECH, INC
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
Pharmaceutical Quality, Security, and Accountability Act
Client: GENENTECH INC · Firm: GENENTECH, INC
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; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
Pharmaceutical Quality, Security, and Accountability Act
Client: GENENTECH INC · Firm: GENENTECH, INC
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals; Medical Countermeasure Stockpile 340B Drug Discounting Program; FOR - Issues related to the treatment of biologics in international health programs specifically under the Pan American Health Organization
Pharmaceutical Quality, Security, and Accountability Act
Client: GENENTECH INC · Firm: GENENTECH, INC
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
American Research and Competitiveness Act of 2011
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
American Research and Competitiveness Act of 2011
Client: GENENTECH INC · Firm: GENENTECH, INC
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
Supporting the goals and ideals of "National Sudden Cardiac Arrest Awareness Month".
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
Supporting the goals and ideals of "National Sudden Cardiac Arrest Awareness Month".
Client: GENENTECH INC · Firm: GENENTECH, INC
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
Southern New Jersey Veterans Comprehensive Health Care Act
Client: GENENTECH INC · Firm: GENENTECH, INC
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Southern New Jersey Veterans Comprehensive Health Care Act
Client: GENENTECH INC · Firm: GENENTECH, INC
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
A bill to provide for the extension of a certain hydroelectric project located in the State of West Virginia.
Client: GENENTECH INC · Firm: GENENTECH, INC
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
A bill to provide for the extension of a certain hydroelectric project located in the State of West Virginia.
Client: GENENTECH INC · Firm: GENENTECH, INC
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Implementation of Medicare pharmaceutical coverage and reimbursement issues; Medicare Part B reimbursement for physicians and implementation of related provisions of the Affordable Care Act; reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B drug payment model. Policies relating to 340B Program. Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act).
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
GENENTECH INC via GENENTECH, INC
2017 · first_quarter · Q1
Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. Policies related to the 340B Drug Discount Program. Drug pricing issues. HR 1628, The American Health Care Act. S. 469 Affordable and Safe Prescription Drug Importation Act. Prescription Drug User Fee Act Agreements. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Stockpiling of medical countermeasures in advance of a potential pandemic. Implementation of issues related to the Security and Accountability Act (P.L. 113-54); Issues related to Pharma supply chain.
Implementation of Medicare pharmaceutical coverage and reimbursement issues; Medicare Part B reimbursement for physicians and implementation of related provisions of the Affordable Care Act; reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B drug payment model. Policies relating to 340B Program. Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act).
Intellectual Property and Process Patent Issues. Patent Litigation Reform.
Issues related to FDA and HHS program funding in the FY17 Labor, Health and Human Services, and Education and Related Agencies, and FY17 Agriculture, Rural Developments, Food and Drug Administrations, and Related Agencies Appropriations bills.
Filing targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
GENENTECH INC via GENENTECH, INC
2016 · fourth_quarter · Q4
H.R. 34 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. H.R. 34 21st Century Cures Act. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars. H.R.5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
Intellectual Property and Process Patent Issues. General IP Issues; Patent Litigation Reform; Transpacific Partnership Agreement.
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Filing targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
GENENTECH INC via GENENTECH, INC
2016 · third_quarter · Q3
S 3040/HR5926, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Intellectual Property and Process Patent Issues. General IP Issues; Patent Litigation Reform; Transpacific Partnership Agreement.
Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. 21st Century Cures initiative. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars. H.R.5122, To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Accountability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA". S.2912, Trickett Wendler Right to Try Act of 2016. Pandemic Preparedness and CDC strategic national stockpile H.R.5122 - To prohibit further action on the proposed rule regarding testing of Medicare part B prescription drug models.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
Filing targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
GENENTECH INC via GENENTECH, INC
2016 · second_quarter · Q2
H.R. 6 21st Century Cures Act. Innovation for Healthier Americans -- Senate HELP Committee. Implementation issues related to Pharmaceutical Quality Quality, Security & Sccoubtability Act (PL 113-54). Issues related to the 340B Drug Discount Program. Drug pricing issues. White House Cancer Moonshot & Precision Medicine initiatives. Part B Drug payment issues, CMMI Part B Payment model. Issues related to the implementation of the follow-on biologies provisions in P.L. 11-1148 "PPACA".
S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017. H.R.5054/S.2956, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017. Appropriations for Biosecurity Preparedness; HCR/CDC/HHS - Replenishment of Influenza Antiviral Stockpile.
Implementation of the Pharmaceutical, Quality, Safety & Accountability Act (P.L. 113-54). 340B drug discount program.
Intellectual Property and Process Patent Issues. General IP Issues; Patent Litigation Reform; Transpacific Partnership Agreement.
Issues relating to CMMI proposed CMMI Part B demo (81 FR 13229) 340B drug discount program. 21st Century Cures initiative. Implementation of Medicare Pharmaceutical coverage and reimbursement. Follow-on biologies and Medicare Physician Fee schedule rule to blend ASP for biosimilars.
S.456, Cyber Threat Sharing Act of 2015, S.177/H.R.1770, Data Security and Breach Notification Act of 2015, S.1027, Data Breach Notification and Punishing Cyber Criminals Act of 2015, S.961/H.R.2205, Data Security Act of 2015; data security and cybersecurity issues.
Filing targets: Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
GENENTECH INC via GENENTECH, INC
2016 · first_quarter · Q1
FY 2017 Labor, Health and Human Services, Education and Related Agencies Appropriations annual spending bill; Influenza antiviral allotment with the Centers for Disease Control Strategic National Stockpile issues concerning implementation of Patient Protection and Affordable Care Act Drug pricing H.R. 6, the 21st Century Cures Act Innovations for Healthier Americas Moonshot initiative Precision Medicine Implementation of issues related to Pharmaceutical Quality Security Accountability Act Issues related supply chain Drug safety and pedigree issues Issues related to the 340B program Issues related to follow on biologics
Payment policies for prescription drugs. Implementation of Medicare pharmaceutical coverage and reimbursement, 340B Program, dual eligible demonstrations, Medicare Part B reimbursement for physicians, and related provisions of the Affordable Care Act. Reimbursement adequacy and patient access issues associated with potential CMMI implementation of the proposed Medicare Part B Drug Payment Model.
GENENTECH INC via GENENTECH, INC
2015 · fourth_quarter · Q4
21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Reform of 340B program. Advocacy and education regarding HR 6 - 21st Century Cures Act; Implementation issues related to the Pharmaceutical Quality, Security and Accountibilty Act (P.L. 113-54) S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, Cancer Patient Protection; Ongoing issues related to the implementation of the Affordable Care Act - 21st H.R. 6- 21st Century Cures Act; Advocacy on issues related to the Pan-American Health Organization, the 340B during pricing program and Medicare Part B and pandemic planning. Drug pricing under 340B program; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Publaw 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related 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
GENENTECH INC via GENENTECH, INC
2015 · third_quarter · Q3
Public Law 111-148, the Patient Protection and Affordable Care Act 0 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; 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 onparticipating pharmaceutical manufacturers., Held preliminary discussion with Administration staff on anti-viral drugs in the strategic national stockpile.
intellectual property & process patent issues; MMM: Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B
GENENTECH INC via GENENTECH, INC
2015 · second_quarter · Q2
Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Pubic law 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related 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; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program; issues related to H.R. 6, the 21st Century CURES Act; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program;
GENENTECH INC via GENENTECH, INC
2015 · first_quarter · Q1
Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies; 340(b) Drug Discount Program.
Patent Terms, Pandemic Preparedness, Tamiflu Stockpile, Appropriations; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", HR 1919 "Safeguarding America's Pharmaceuticals Act", Implementation issues related to the Pharmaceutical Quality, Security and Accountability Act (P.L. 113-54), Pharma supply chain issues, Issues related to 340b program; Ongoing issues related to the implementation of the Affordable Care Act of 2010; Drug pricing under 340B program
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENENTECH INC via GENENTECH, INC
2014 · fourth_quarter · Q4
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; Regulatory and legislative activities regarding 340B program; Issues relating to biologics; S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; Issues related to the implementation of the Affordable Care Act of 2010; issues related to biosimilars; Issues concerning clinical trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act. Federal Drug. Drug pricing under 340B program; Medical reimbursement - advocacy on behalf of maintaining ASP+6%, 340B Drug Discounting Program - education of Congress on unintended growth of program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENENTECH INC via GENENTECH, INC
2014 · third_quarter · Q3
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals; Medical Countermeasure Stockpile 340B Drug Discounting Program; FOR - Issues related to the treatment of biologics in international health programs specifically under the Pan American Health Organization
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 presciption drug benefit. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010- Implementation; 340(b) Drug Discount Program;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENENTECH INC via GENENTECH, INC
2014 · second_quarter · 2A
Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies, 340(b) Drug Discount Program, 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 presciption 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 drug 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. S. 959 - Pharmaceutical Quality, Security, and Accountability Act- legislation regarding pharmacy compounding and track and trace proposals. 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 trace issues.
GENENTECH INC via GENENTECH, INC
2014 · second_quarter · Q2
BUD: FY15 Labor, HHS and Education Appropriations related to preparedness for pandemic influenza, HIV/AIDS, hepatitis screening, care and treatment, and access to breast cancer treatment, Issues related to FDA & HHS program funding, FY15 Labor Health and Human Services, and Education, and Related Agencies, H.R. 4800, and FY 15 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bills, Following issues related to the budget and appropriations process FY 13 appropriations for FDA as well as the potential outcomes for negotiations on altering sequestration targets via legislation.
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
GENENTECH INC via GENENTECH, INC
2014 · first_quarter · 1A
Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies., 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 presciption drug benefit. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010- Implementation issues related to Medicare and Medicaid reimbursement, fees assessd on the pharmaceutical industry, design and structure of the Medicare prescription drug 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 bilogics approval. All aspects. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis. S. 959 - Pharmaceutical Quality, Security, and Accountability Act- legislation regardng pharmacy compounding and track and trace proposals. Public Law 113-67, Continuing Appropriations Resolution for 2014 - General public health spending.
GENENTECH INC via GENENTECH, INC
2014 · first_quarter · Q1
FY13 Labor, HHS and Education Appropriation related to preparedness for pandemic influenca, HIV/AIDS programs, hepatitis screening, care and treatment, and access t breast cancer treatment; Following issues related to the budget and appropriations process FY 13 appropriations for FDA as well as the potential outcomes for negotiations on altering sequestration targets via legislation, Issues related to FDA & HHS program funding, FY15 Labor Health and Human Services, and Education, and Related Agencies, and FY 15 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bills.
Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies., 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 presciption drug benefit. Public Law 111-152, the Health Care and Education Reconciliation Act of 2010- Implementation issues related to Medicare and Medicaid reimbursement, fees assessd on the pharmaceutical industry, design and structure of the Medicare prescription drug 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 bilogics approval. All aspects. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis. S. 959 - Pharmaceutical Quality, Security, and Accountability Act- legislation regardng pharmacy compounding and track and trace proposals. Public Law 113-67, Continuing Appropriations Resolution for 2014 - General public health spending.
GENENTECH INC via GENENTECH, INC
2013 · fourth_quarter · Q4
Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare payment issues; Implementation issues related to Medicare and Medicaid reimbursement, fees assessd on the pharmaceutical industry, design and structure of the Medicare prescription drug 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 bilogics approval. General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis; Concerns regarding Medicare payment policies for Part B drugs; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B program, dual eligible demonstratins and relaed provisions Part B; Medicare reimbursement for physicians, and provisions of The Affordable Care Act.
GENENTECH INC via GENENTECH, INC
2013 · third_quarter · Q3
Issues relating to the treatment of biologics in international health programs; proposed cuts to Part B reimbursement. 340b reimbursement policy; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.; Issues concerning trials; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; S.959, Pharmaceutical Compounding Quality and Accountability Act; H.R. 1416, Cancer Patient Protection Act of 2013; S. 957, Drug Supply Chain Security Act; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; Pandemic preparedness, Tamiflu, Medicare coverage of Cancer Drugs, Appropriations; implementation of section 340B of the Public Health Service Act (42 U.S.C. 256b); Issues relating to the treatment of biologics in international health programs
GENENTECH INC via GENENTECH, INC
2013 · second_quarter · Q2
Part B reimbursement; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Medicare coverage and payment of Part B drugs and bilogicals; Implementation issues related to Medicare and Medicare reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare payment issues
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 drug benefit. Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - legislation related to re-authorization of user fees for prescription drug, medical device, and biologics approval. Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
GENENTECH INC via GENENTECH, INC
2013 · first_quarter · Q1
Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act;Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.; Implementation of H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA stimulus. Avastin-use in breast cancer treatment: general patient reform issue: implementation of the Affordable Care Act of 2010; proposed cuts to Part B reimbursement. 340b reimbursement policy; Issues related to the implementation of the Affordable Care Act of 2010; Issues relating to the treatment of biologics in international health programs.
Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare payment issues.; Medicare coverage and payment of Part B drugs and biologicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual elgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Proposed cuts to Part B reimbursement
GENENTECH INC via GENENTECH, INC
2012 · fourth_quarter · Q4
Implementation of HR 1; Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus, issues relating to PDUFA, stimulus, issues relating to comparative effectiveness and CMS coverage of FDA approved therapies; issues related to the PPS rule involving stroke guidelines; Implementation of the the follow-on biologics in P.L. 1111-148 "Patient Protection and Affordable Care Act; FY13 Labor HHS Appropriations legislation; issues related to FDA user fee reauthorization; H.R. 942 S. 1577, S 3187; Pedigree and biologics issues; H.R. 905; ASP issues: H.R.5651; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Medicare prescription Drug and Modernization Act of 2003; Avastin use in breast cancer treatment; general patient reform issues; implementation of the Affordable Care of 2010; proposed cuts to Part B reimbursement; 340 B reimbursement policy; Medicare/Medicaid Reimbursement
GENENTECH INC via GENENTECH, INC
2012 · third_quarter · Q3
PHA: proposed cuts to Part B reimbursement. 340b reimbursement policy;
TAX Monitoring proposals on US tax treatment of foreign-owned US Corporations; general tax issues and tax extenders (R&D tax credit) and tax treatment of foreign-owned US corporations.Research and Development Tax credit, alternative sales pricing; R&D Tax Credit (H.R. 942) FDA Appropriations, PDUFA Reauthorization; Issues related to comprehensive tax reform, tax treatment of foreign-owned U.S. corporations, and tax extenders, including R & D tax credit. S.3521, Family and Business Tax Cut Certainty Act of 2012 (tax extenders). Corporate tax reform issues (no specific legislation) Implementation of healthcare reform law. FDA drug approval and appeal oversight process. Issues related to patient and physician choice in medical treatments. PDUFA reauthorization. FY13 appropriations bills, including issues related to FDA funding and drug approval/review oversight process. Legislation related to altering sequestration targets. Issues related to comprehensive tax reform, tax treatment of foreign-owned U.S. corporations, and tax extenders, including R & D tax credit. S.3521, Family and Business Tax Cut Certainty Act of 2012 (tax extenders). Corporate tax reform issues (no specific legislation)
GENENTECH INC via GENENTECH, INC
2012 · second_quarter · Q2
Implementation of H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus, issues relating comparative effectiveness and CMS coverage of FDA approved therapies. Legislation on public health preparedness and response related to pandemic influenza. Avastin-use in breast cancer treatment; general patent reform issues; implementation of the Affordable Care Act of 2010; Implementation of healthcare reform law. FDA Drug Approval and appeal oversight process. Issues related to patient and physician choice in medical treatments. Monitor PDUFA reauthorization.; Monitor implementation of Medicare pharmaceutical coverage and reimbursement and 340B provisions if the Affordable Care Act; Advocacy related ensuring access to necessary medicines
FY13 Labor, HHS and Education Approporation related to preparedness for pandemic influenza, HIV/AIDS programs, heptatis screening, care and treatment, and access to breast cancer treatment; Following issues related to the budget and apropriations process FY13 appropriations for FDA as well as the potential outcomes fore negotiations on altering sequestration targets via legislation; Issues related to FDA and HHS program funding, FY13 Labor Health and Human Services, and Education, and Related agencies Appropriations bill; Budget/Appropriations (House and Senate Contact Only): Monitor FY13 appropriations process: FDA funding issues and drug approval/review oversight process. Monitor the potential outcomes for negotiations on altering sequestration targets via legislation. Monitor plans for issues related to comprehensive tax reform, tax treatment of foreign-owned U.S. corporations, and tax extenders (R & D tax credit).
GENENTECH INC via GENENTECH, INC
2012 · first_quarter · Q1
Implementation of H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA stimulus. Issues relating to comparative effectiveness and CMS coverage of FDA approved therapies. Issues related to PPS rule involving stroke guidelines. Implementation of the follow on biologic provision in P.L. 111-148 Patient Protection and Affordable Care Act. Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.; Prescription Drug User Free Act; Avastin - Use in breast cancer treatment; general patent reform issues; ASP +6 Melanoma research Foundation; Implementation of the Affordable Care of Act of 2010
General Patent reform issues S. 23: America Invents Act H.R. 1249 Leahy-Smith America Invents Act; Patent Reform Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENENTECH INC via GENENTECH, INC
2011 · first_quarter · 1A
Avastin, Lucentis, FDA, Appropriations; Issues concerning clinical trias. General health care reform (Patient Protection and Affordable Care Act). Congressional oversight issues; Legislation on public health preparedness and response to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels; FDA approval and enforcement issues; Prescription Drug User Fee Act (PDUFA), Avastin - use in breast cancer treatment, macular degeneration, S.726/HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act; HR 1548 - Pathway for Biosimilars Act, General support for Genentech products; HR1/1473 health care funding : FY 12 Labor HHS Appropriations legislation.
Monitor issues related to export rules and regulations, international patent issues; matters and other international issues impacting biotech and pharmaceuticals.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENENTECH INC via GENENTECH, INC
2011 · fourth_quarter · Q4
Advocacy related ensuring access to necessary medicines; implementation of H.R. and Modernization Act of 2003; Issues relating to PDUFA, stimulus, issues relating comparative effectiveness and CMS coverage of FDA approved therapies; Medicare coverage and payment of Part B drugs and biologics; Support for H.R. 452 Medicare Decision Accountability Act of 2011 and S.668: "Health Care Bureaucrats Elimination Act"; FDA approval and enforcement issues,340B payment and implementation issues; Medicare issues; Monitor implementation of Medicare Pharmaceutical coverage and reimbursement 340B provisions of the Affordable Care Act
Monitor and report on Food safety and supply chain issues;
GENENTECH INC via GENENTECH, INC
2011 · third_quarter · Q3
Monitor Drug Safety and pedigree legislation, advocacy related to ensuring access to necessary medicines, payment policies for prescription drugs, Prescription Drug User Free Act
Medicare Issues; Monitor implementation of Medicare Pharmaceutical converage and reimbursement provisions of the Affordable Care Act, Medicare coverage and payment of Part B drugs and biologicals. Support for H.R 452 "Medicare Decision Accountability Act of 2011 and S.668 "Health Care Bureaucrats Elmination Act".
Patent Reform, CPT - H.R. 243 Patent Lawsuit Reform Act of 2011; H.R. 1249 Leahy-Smith America Invents Act S.23-America Invents Act.
GENENTECH INC via GENENTECH, INC
2011 · second_quarter · Q2
Public Law 111-148, the Patient Protection and Affordable Care Act of 2009 - Implementation issues related to the authorization for comparatice effective research and the Patient-Centered Outcomes Research Institute.
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 Medicar 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. drug benefit. General issue and congressional oversight related to FDA approval and CMS coverage decisions regarding. Avastin and Lucentis.
GENENTECH INC via GENENTECH, INC
2011 · first_quarter · Q1
Avastin, Lucentis,FDA Appropriations; Issues concerning clincial trials. General health care reform (Patient Protection and Affordable Care Act). Congressional oversight issues; Legislation on public health preparedness and response to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels; FDA approval and enforcement issues; Presciption Drug User Fee Act (PDUFA), Avastin -use in breast cancer treatment, dry macular degeneration; S.726/HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act; HR 1548 - Pathway for Biosimilars Act, General support for Genentech products; HR1/1473 health care funding: FY 12 Labor HHS Appropriations legislation
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GENENTECH INC via GENENTECH, INC
2010 · fourth_quarter · 4A
S.515 & H.R. 1260 - Patent Reform Act of 2009
Labor HHS Appropriations - S.3230 & H.R. 3042, Homeland Security Appropriations S.3181 and HR 6947; Congress and Federal agencies: US House of Representatives: US Senate: HHS; Dept. of Homeland Security; Executive Office of the President; Office of Personnel Manangement; Dept., of Veteran Affairs
Monitor issues related to export rules and regulations, international patent issues, WTO matters and other international issues impacting biotech and pharmaceuticals.
GENENTECH INC via GENENTECH, INC
2010 · fourth_quarter · Q4
S. 515 & H.R. 1260 - Patent Reform Act of 2009
Monitor and report on food safety and supply chain issues
Following Issues related to the budget and appropriations process
GENENTECH INC via GENENTECH, INC
2010 · third_quarter · Q3
Patent Settlement Issues; Intellectual Property and Process Patent Issues;
Monitor food safety and supply chain issues
Implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act, stimulus provisions and economic recovery; payment policies for prescription drugs; Issues relating to compaarative effectiveness and follow-on biologics; HR 3200 and America's Healthy Future Act of 2009. Issues related to comparative effectiveness and follow-on biologics;
GENENTECH INC via GENENTECH, INC
2010 · second_quarter · Q2
Monitor implementation of Medicare pharmaceutical coverage and reimbusement provisions of P.L. 111-148 - Patient protection and Affordable CAre Act and P.L. 111-152 - Health Care and Education Reconciliation Act; Implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act, stimulus provisions and economic recovery; Issues related to comparative effectiveness and follow-on biologics; H.R. 3200 and America's health Future Act of 2009; H.R. 4213, the American jobs, Closing Tax Loopholes and Preventing Outsourcing Act of 2010 - eligibility changes for the 340B program, treatment of certain drugs for computation of Average Manufacturer's Price under the Medicaid program; Participatd in discussions with Senate Aging Comm staff on Medicare coverage payment issues related to cancer biotherapeutics;
Monitor issues related to export rules and regulations International patent issues WTO matters and other international trade issues impacting biotech and pharmaceuticals
GENENTECH INC via GENENTECH, INC
2010 · first_quarter · 1A
Implementation of HR1 Medicare Prescription Drug and Modernization Act of 2003 Issues relating to PDUFA, stimulus
Issues relating to government purchases and stockpiling of pandemic drugs - Tamiflu
Monitoring proposals on U.S. tax treatment of foreign corporations S. 506, Stop Tax Haven Abuse Act
GENENTECH INC via GENENTECH, INC
2010 · first_quarter · Q1
Monitor food safety and supply chain issues
H.R. 1908 Intellectual Property and Process Patent Issues S. 515 & H.R. 1260 - Patent Reform Act of 2009
Monitor issues related to export rules and regulations International patent issues WTO matters and other international trade issues impacting biotech and pharmaceuticals
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; general IP issues, transpacific partnership agreement;
trade Promotion Authority; Issues relating to U.S. trade policy
issues related to H.R. 6, the 21st Century CURES Act; Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementation of Patient Protection and Affordable Care Act; Drug pricing under 340B program; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and Medicare Part B reimbursement for physicians and related provisions of The Affordable Care Act; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics; HR 1470 and S.810, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Medicare physician payment reform, payment for Part B drugs; Public Law 114-110, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for PART B drugs.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
trade Promotion Authority; Issues relating to U.S. trade policy;
: 340B, Patent Terms, Appropriations, Pandemic Preparedness, Tamiflu Stockpile; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Publaw 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related 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; Issues related to the implementation of the follow-on biologiecs provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementationof Patient Protection and Afforedable Care Act; Drug pricing under 340B program; : Implementation issues related to the Pharmaceutical Quality, Security and Accountabilty Act (P.L. 113-54) S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, Cancer Patient Protection Act of 2013 pharma supply chain issues, issues related to the 340B Program;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Public Law 111-148, the Patient Protection and Affordable Care Act 0 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; 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., Held preliminary discussion with Administration staff on anti-viral drugs in the strategic national stockpile.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Concerns regarding Medicare payment policies for Part B drugs. Issues related to the 340B Drug discount program, Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement (Medicare Prescription Drug savings and Choice Act of 2013, Medicare Prescription Drug Price Negotiation Act of 2013 H.R. 928/h>r. 1102); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 4438 - American Research and Competitiveness Act of 2014; Issues related to 340, Medicare coverage and payment of Part B drugs and bilogicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. 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 settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimburesement issues
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
BUD: FY15 Labor, HHS and Education Appropriations related to preparedness for pandemic influenza, HIV/AIDS, hepatitis screening, care and treatment, and access to breast cancer treatment, Issues related to FDA & HHS program funding, FY15 Labor Health and Human Services, and Education, and Related Agencies, H.R. 4800, and FY 15 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bills, Following issues related to the budget and appropriations process FY 13 appropriations for FDA as well as the potential outcomes for negotiations on altering sequestration targets via legislation.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies, 340(b) Drug Discount Program, 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 presciption 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 drug 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. S. 959 - Pharmaceutical Quality, Security, and Accountability Act- legislation regarding pharmacy compounding and track and trace proposals. 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 trace issues.
Issues relating to biologics, S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act, proposed cuts to Part B reimbursement. 340b reimbursement policy, Issues related to the treatment of biologics in international health programs, 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.; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
FY13 Labor, HHS and Education Appropriation related to preparedness for pandemic influenca, HIV/AIDS programs, hepatitis screening, care and treatment, and access t breast cancer treatment; Following issues related to the budget and appropriations process FY 13 appropriations for FDA as well as the potential outcomes for negotiations on altering sequestration targets via legislation, Issues related to FDA & HHS program funding, FY15 Labor Health and Human Services, and Education, and Related Agencies, and FY 15 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bills.
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S. 959 "Pharmaceutical Compounding Quality and Accounting Act, HR 1416 "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", HR 1919 "Safeguarding America's Pharmaceuticals Act"; proposed cuts to Part B reimbursement. 340b reimbursement policy; MMM: Part B reimbursement; HCR: Issues related to the implementation of the Affordable Care Act of 2010, HCR: Issues relating to the treatment of biologics in international health programs, Reimbursement issues, 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 Medicar drug benefit.; Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act";Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; Issues relating to biologics
Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; Part B reimbursement, Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicard reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cance biotherapeutics. 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 ofr fiscal year 2014 and settin 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 204, revising the appropriate budgetary levles for fiscal year 2013, and setting forth the appropriate budgetary levels for fiscal years 2015 through 2023 - Medicare Part B drug reimbursement issues. S.399, American Family Economic Protection Acto f 2013 - sequestration issues affecting Medicare Part B drug reimbursement issues; S. 1871, the SGR Repeal and Medicar Beneficiary Access Act - Medicare physician payment and Part B drug reimburesement issues. H.R. 2810, the Medicare Patient Access and Quality Improvement Act - Medicare physician Payment and Part B drug reimbursement issues. Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues relate to the 340B Drug discount program; Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; PHA: Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.Implementation of P.L. 108-173, matters related to Medi care and Medicaid Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; HR 942 - American Research and Competitiveness Act of 2011; Issues related to 340B; Medicare coverage and payment of Part B drugs and bilogicals.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Reimbursement issues; Issues relating to the treatment of biologics in international health programs; Issues related to the implementation of the Affordable Care Act of 2010; proposed cuts to Part B reimbursement. 340b reimbursement policy; Implementation of H.R. S. 959, "Pharmaceutical Compounding Quality and Accounting Act", H.R 1416, "Cancer Patient Protection Act of 2013", S.957, "Drug Supply Chain Security", H.R. 1919, "Safeguarding America's Pharmaceuticals Act"
Monitor Drug Safety and pedigree legislation. Monitor legislation and oversight on compounding pharmacies.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Public Law 11-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics. Meetings with House and Senate staff on coverage/payment issues related to cancer biotherapeutics. P.L. 112-240, the American Taxpayer Relief Act of 2012 - Medicare payment issues.; 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 drug 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; Concerns regarding Medicare payment policies for Part B drugs. HCR: Issues related to the implementation of the follow-on biologics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; Medicare coverage and payment of Part B drugs and biologicals; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Pandemic preparedness, Tamiflu, Medicare coverage of Cancer Drugs, Appropriations.; S.959, Pharmaceutical Compounding Quality and Accountability Act; H.R. 1416, Cancer Patient Protection Act of 2013; S. 957, Drug Supply Chain Security Act; H.R. 1919, Safeguarding America's Pharmaceuticals Act of 2013; compounding issues; FY 13 Labor HHS Appropriations legislation; issues related to FDA user fee reauthorization; H.R. 942 S. 1577; S. 3187; Pedigree and biologics issues; H.R. 905: ASP issues; H.R. 5651; issues concerning drug compounding. Implementation of Patient Protection and Affordable Care Act; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; implementation of section 340B of the Public Health Service Act (42 U.S.C. 256b); Implementation of H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA stimulus. Avastin-use in breast cancer treatment: general patient reform isse: implementation of the Affordable Care Act of 2010; Issues relating to the treatment of biologics in international health programs.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
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 drug benefit. Public Law 112-144, the Food and Drug Administration Safety and Innovation Act - legislation related to re-authorization 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.; proposed cuts to Part B reimbursement. 340b reimbursement policy; matters related to Tamiflu
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Issues related to the PPPS rule involving stroke guidelines. Proposals to reduce Medicare payment for Part B biologics. Concerns regarding Medicare payment policies for Biologics; issues relating to Prescription Drug User Fee Act and SP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; H.R. 942- American Research & Competitiveness Act of 2011.; Medicare coverage and payment of Part B drugs and biologics; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eldgible demonstrations and related provisions Part B; Medicare reimbursement for physicians of The Affordable Care Act; proposed cuts to Part B reimbursement; implementation of Health reform; Legislation for CMS.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
MMM: implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Issues related to the PPS rule involving stroke guidelines. Proposals to reduce Medicare payment for Part B biologics. Concerns regarding Medicare payment policies for Biologics; Monitor implementation of Medicare pharmaceutical coverage and reimbursement and 340B provisions of the Affordable Care Act; Proposed cuts to Part B reimbursement
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Implementation of H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA,stimulus. Issues relating to comparative effectiveness and CMS coverage of FDA approved therapties. Issues related to the PPS ruel involving stroke guidelines. Implementation of the follow-on biologice provisions in P.L. 111-148- "Patient Protection and Affordable Care Act"; legislation on public health preparedness and response related to pandemic influenza. Influenz Pandemic Preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis; FDA Approval and enforcement issues. Issues relating to S.3187, FDA Safety and Innovation Act. Issues relating to antibiotic development incentives in HR 2182 and S 1734, "Generating Antibiotic Incentives Now Act of 2011"; Prescription Drug User Fee Act (PDUFA) Reauthorization;Issues related to the implementationof the Affordable Care Act of 2010;
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Advocacy related to ensuring access to necessary medicines; Proposed cuts to Part B reimbursement;Implementation of HR1 Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA stimulus; Issues relating to comparative effectiveness and CMS coverage of FDA approved therapies; Issues related to the PPS rule involving stroke guidelines; implementation of the follow-on biologic provisions in P.L. 111-148-"Patient Protection and Affordable Care Act"; issues related to pandemic preparedness and macular degeneration; legislation on public health preparedness and response related to pandemic influenza; influenza Pandemic Preparedness federal state and local levels; advocate for approval of Avastin for late stage breast cancer; Implementation of the Affordable Care of Act of 2010
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
FY11, FY12 Labor, HHS and Education Appropriation related to preparedness for pandemic influenza, HIV/AIDS programs, hepatitis screening, care and treatment, and access to breast cancer treatment. Implementation of H.R. 2346, S. 1054 FY09 Supplemental Appropriations related to preparedness for pandemic influenza.; issues related to pandemic preparedness and macular degeneration. FY11 appropriations process - including HR 1 and various Continuing Resolutions
Intellectual Property and Process Patent Issues; HR 1908, Patent Reform Act (all provisions); S.23 - Patent Reform Act; General Patent Reform Issues; Specfic issues lobbied (bill numbers): Patent reform legislation
Montior issues related to export rules and regulations, international patent issues, WTO matters, the Trans-Pacific, Partnership and other international issues impacting biotech and pharmaceuticals
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Labor HHS appropriations stock piling anti-virals for pandemic influenza; Cancer Research Issues - S.3686/HR_, Labor, HHS Appropriations Bill for FY2011; Monitoring the implementation for the Patient Protection and Affordable Care Act, including provisions related to comparative effectiveness research and a regulatory pathway for biosimilars; H.R.1 - Pandemic influenza funding: H.R.1105 Omnibus Appropriations Act of 2010, Food Safety Bill, H.R. 4872 Health Care& Education Reconciliation Act of 2011; issues concerning clincial trials; general health care reform (Patient Protection and Affordable Care Act); Congressional oversight issues; FDA approval and enforcement issues; Pandemic preparedness; Tamiflu; Avastin-breast cancer; following all issues related to health care reform; S.726/HR 1427 - promotiong innovation and access to life-saving Medicine Act; HR 1548 - Pathway for Biosimilars Act; General support for Genentech products; monitor and report on issues relate to implementation to health care reform; H.R. 1548 - Pathway for Biosimilars Act
Various issues related to the budget and appropriations process
Monitor and report on corporate tax issues; general tax issues and tax extenders
Monitor and report on food safety and supply chain issues
Medicare issues; payment policies for prescription drugs; implementation of H.R.1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patient Protection and Affordable Care Act; H.R.4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S726/H.R. 1427 Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Compartiveffectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act; American Health Future Act of 2009; Pharmaceutical Import Safety legislation.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Monitor issues related to export rules and regulations, international patent issues, WTO matters and other international issues impacting biotech and pharmaceuticals.
Monitor and report on corporate tax issues; general tax issues and tax extenders
Labor HHS appropriations stock piling anti-virals for pandemic influenza; Cancer Research Issues - S.3686/HR__, Labor, HHS Appropriations Bill for FY2011; Monitoring the implementation of the Patient Protection and Affordable Care Act, including provisions related to comparative effectiveness research and a regulatory pathway for biosimilars; H.R.1 - Pandemic influenza funding: H.R. 1105 Omnibus Appropriations Act of 2010, Food Safety Bill, H.R. 4872 Health Care & Education Reconciliation Act of 2010; issues concerning clincial trials; general health care refore (Patient Protection and Affordable Care Act); Congressional oversight issues; FDA approval and enforcement issues; Pandemic preparedness; Tamiflu; Avastin-breast cancer ; following all issues related to health care reform; S.726/HR 1427 - promoting innovation and access to life-saving Medicine Act; HR 1548 - Pathway for Biosimilars Act; General support for Genentech products; monitor and report on issues related to the implementation of health care reform; H.R. 1548 - Pathway for Biosimilars Act;
Medicare issues; payment policies for prescription drugs; implementation of H.R. 1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus; physician payment disclosure including S.301; Physician Payments Sunshine Act of 2009; HR 3962, Affordable Health Care for Americans Act; HR 3590, Patitient Protection and Affordable Care Act; H.R> 4872, the Reconciliation Act of 2010; Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R.1427, Promoting innovation and access to Life Savings Medicines Act; HR 3962, Affordable Health Care for America Act; Comparativ effectiveness legislation S. 1213; Patient-Centered Outcomes Research Act of 2009; HR 3200, America's Health Future Act; H.R. 1548-Pathway for Dissimilar Act; Legislative changes in health care reform bill regarding dissimilar; Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act", Affordable Health Choice Act;, American Health Future Act of 2009; Pharmaceutical Import safety legislation.
Labor HHS Appropriations - S. 3230 & H.R. 3042, Homeland Security Appropriations S.3181 and HR 6947; Congress and Federal Agencies: U.S. House of Representatives: US Senate: HHS; Dept. of Homeland Security; Executive Office of the President; Office of Personnel Management; Dept.of Veteran Affairs
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Labor HHS Appropriations - S. 3230 and H.R. 3042 Homeland Security Appropriations S.3181 and H.R. 6947
Monitor and report on corporate tax issues; Monitoring proposals on U.S. tax treatment of foreign corporations; S. 506, Stop Tax Haven Abuse Act;
Following issues related to the budget and appropriations process; Issues related to government purchases of pandemic drugs: Tamiflu; Seek Federal appropriations in the FY11 Labor, Health and Human Services and Education bill regarding pandemic influenza;HIV/AIDS programs and HCV screening, care and treatment; Implementation of H.R. 2346, S. 10554; FY09 Supplemental Appropriations related to preparedness for pandemic influenza; FY11 State Foreign Operations appropriations related to USAID and funding for Pandemic Influenza
Pandemic Preparedeness: Tamiflu; Advocate on legislative changes in the health care reform bill regarding biosimilars; Monitor changes to outpatient 340B presecription drug discount program, including related provisions included in HR 4213 - American Jobs and Closing Tax Loopholes Act; S. 3793, Job Creation and TAx Cuts Act; All healthcare and biotechnology legislation. Stockpiling of antiviral in preparation of a pandemic, HHS Appropriations bill H.R. 1548 - Pathway for Biosimilars Act FDA Approval and Enforcement Issues Cancer Research Issues S. 3686 FY 2011 Appropriations, HHS HCR issues concerning clinical trials Congressional oversight issues Implementation issues related to the Patient Protection and Affordable Care Act H.R. 1 - Pandemic influenza funding H.R. 1105 Omnibus Appropriations Act, Pandemic Funding Issues Food Safety Bill, H.R. 4872 Health Care and Education Reconciliation Act of 2010 H.R. 3974 Viral Hepatitis and LIver Cancer Control and Prevention Act of 2009 H.R. 3590 Patient Projection and Affordable Care Act-FTC issue Ryan White CARE Act reauthorization S. 726/HR 1427 - Promoting Innovation and Access to Life-Saving Medicine Act Educational meetings in Senate with candiate for Patient Centered Outcomes Research Institute Board (PCORI)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Personnel Management (OPM), SENATE, Veterans Affairs, Dept of (VA)
Monitor and report on corporate tax issues; Monitoring proposals on U.S. tax treatment of foreign corporations; S. 506, Stop Tax Haven Abuse Act;
Labor HHS Appropriations - S. 3230 and H.R. 3042 Homeland Security Appropriations S.3181 and H.R. 6947
Pandemic Preparedeness: Tamiflu; Advocate on legislative changes in the health care reform bill regarding biosimilars; Monitor changes to outpatient 340B presecription drug discount program, including related provisions included in HR 4213 - American Jobs and Closing Tax Loopholes Act, and ddraft Senate amendments to the legislation; Labor, Health and Human Services Appropriations bill; H.R. 1548 - Pathway for Biosimilars Act; Health care and biotechnology legislation, including H.R. 3490; Implementation of P.L. 111-148, "Patient Protection and Affordable Care Act" and P.L. 111-152, "Reconciliation Act of 2010", including comparative effectiveness provisions; S. 726/H.R. 1427 - Promoting Innovation and Access to Life-Saving Medicine Act; H.R. 1548 - Pathway for Biosimilars Act; Physician payment disclosure including S. 301; Physician Payments Sunshine Act of 2009; H.R. 3962, Affordable Health Care for Americans Act; H.R. 3590; Patient Protection and Affordable Care Act H.R. 4872, the Reconciliation Act of 2010; Follow on biologics includuing H.R. 154, the Pathway to Biosimilars Act; S. 726/H.R. 1427, Promoting Innovation and Access to Life Savings Medicines Act; H.R. 3962, Affordable health care for America Act; Comparative effectiveness legislation including S. 1213; Patient-Centered Outcomes Research Act of 2009; H.R. 3200, America's Health Future Act; H.R. 1548 - Pathway for Dissimilar Act; Legislative changes in the heatlh care reform bill regarding dissimilars; S. 1679 Affordeable Health Choice Act; S.1796, America's Health future Act of 2009; Pharmacuetical import safety legislation. H.R. 1105 Omnibus Appropriations Act of 2010; Supplemental Appropriations Act of 2010, Food Safety Issues concerning clinlical trials; H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 3590 Patient Protetion and Affordable Care Act - FTC issue Ryan White CARE Act reauthorization
Patent Settlement Issues; Intellectual Property and Process Patent Issues; H.R. 1908; S. 515 & HR. 1260 - Patent Reform Act of 2009; Monitor legislation regarding brand name and generic pharmaceutical agreement, patent fees, and post-grant review reforms.
Following issues related to the budget and appropriations process; Issues related to government purchases of pandemic drugs: Tamiflu; Seek Federal appropriations in the FY11 Labor, Health and Human Services and Education bill regarding pandemic influenza;HIV/AIDS programs and HCV screening, care and treatment; Implementation of H.R. 2346, S. 10554; FY09 Supplemental Appropriations related to preparedness for pandemic influenza; FY11 State Foreign Operations appropriations related to USAID and funding for Pandemic Influenza
Monitor food safety and supply chain issues
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Personnel Management (OPM), SENATE, Veterans Affairs, Dept of (VA)
Monitor issues related to export rules and regulations International patent issues WTO matters and other international trade issues impacting biotech and pharmaceuticals
Monitor food safety and supply chain issues
H.R. 1908 Intellectual Property and Process Patent Issues S. 515 & H.R. 1260 - Patent Reform Act of 2009
S. 565/H.R. 1458 - providing extended coverage for immunosuppressive drugs to beneficiaries under ther Medicare Program that have received a kidney transplant
Labor HHS Appropriations - S. 3230 and H.R. 3042 Homeland Security Appropriations S.3181 and H.R. 6947
Physician payment disclosure including S.301 Physician Payments Sunshine Act of 2009 H.R. 3962, Affordable health Care for Americans Act H.R. 3590, Patient Protection and Affordable Care Act H.R. 4872, the Reconciliation Act of 2010 Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act S. 726/H.R. 1427, Promoting Innovationo and Access to Life Saving Medicines Act H.R. 3962, Affordable Health Care for America Act Comparative effectiveness legislation including S. 1213 Patient-Centered Outcomes Research Act of 2009 H.R. 3200, America's Health Future Act H.R. 1548 - Pathway for Dissimilar Act Legislative changes in the health care reform bill regarding dissimilar Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act." Pandemic Preparedness - Tamiflu Exploring additional funding for antiviral stockpiling in response to H1N1 and H5N1 Pandemic Influenza H.R. 1105 - omnibus Appropriations Act FY10 labor HHS Appropriations Legislation H.R. 1105 - Omnibus Appropriations Act FY10 Labor HHS Appropriations legislation H.R. 2346 supplemental Appropriations Act of 2009 FY11 Labor, HHS and Education Appropriates related to preparedness for pandemic influenza, HIV/AIDS programs and HCV screening, care and treatment FY11 State Foreign Operations Appropriations related to USAID and funding for pandemic influenza H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 Ryan White CARE Act reauthorization S. 1679, Affordable Health Choices Act S. 1796, America's Healthy Future Act of 2009 Pharmaceutical import safety legislation
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Personnel Management (OPM), SENATE, Veterans Affairs, Dept of (VA)
Labor HHS Appropriations - S. 3230 and H.R. 3042 Homeland Security Appropriations S.3181 and H.R. 6947
Implementation of HR1 Medicare Prescription Drug and Modernization Act of 2003 Issues relating to PDUFA, stimulus
Issues relating to government purchases and stockpiling of pandemic drugs - Tamiflu
Monitoring proposals on U.S. tax treatment of foreign corporations S. 506, Stop Tax Haven Abuse Act
S. 565/H.R. 1458 - providing extended coverage for immunosuppressive drugs to beneficiaries under ther Medicare Program that have received a kidney transplant
Physician payment disclosure including S.301 Physician Payments Sunshine Act of 2009 H.R. 3962, Affordable health Care for Americans Act H.R. 3590, Patient Protection and Affordable Care Act H.R. 4872, the Reconciliation Act of 2010 Follow-on biologics including H.R. 154, the Pathway to Biosimilars Act S. 726/H.R. 1427, Promoting Innovationo and Access to Life Saving Medicines Act H.R. 3962, Affordable Health Care for America Act Comparative effectiveness legislation including S. 1213 Patient-Centered Outcomes Research Act of 2009 H.R. 3200, America's Health Future Act H.R. 1548 - Pathway for Dissimilar Act Legislative changes in the health care reform bill regarding dissimilar Follow-on biolotics provisions in P.L. 111-148 "Patient protection and Affordable Care Act." Pandemic Preparedness - Tamiflu Exploring additional funding for antiviral stockpiling in response to H1N1 and H5N1 Pandemic Influenza H.R. 1105 - omnibus Appropriations Act FY10 labor HHS Appropriations Legislation H.R. 1105 - Omnibus Appropriations Act FY10 Labor HHS Appropriations legislation H.R. 2346 supplemental Appropriations Act of 2009 FY11 Labor, HHS and Education Appropriates related to preparedness for pandemic influenza, HIV/AIDS programs and HCV screening, care and treatment FY11 State Foreign Operations Appropriations related to USAID and funding for pandemic influenza H.R. 3974, Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 Ryan White CARE Act reauthorization S. 1679, Affordable Health Choices Act S. 1796, America's Healthy Future Act of 2009 Pharmaceutical import safety legislation
Filing targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Personnel Management (OPM), SENATE, Veterans Affairs, Dept of (VA)